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SHR-A2009 (HER3 ADC)SHR-A2009 (HER3 ADC)
5 · 2024-01-01 → 2025-09-02
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FDA Fast Track and clinical trials for HER3-targeting ADC in NSCLC and other solid tumors.HER3靶向ADC在非小细胞肺癌等实体瘤中获得FDA快速通道资格并开展临床试验。
2024-01-01Hengrui's self-developed HER3-targeting ADC SHR-A2009 received FDA Fast Track Designation for EGFR-mutant metastatic NSCLC after prior therapy.恒瑞自主研发的HER3靶向ADC注射用SHR-A2009获得美国FDA快速通道资格，用于经治的EGFR突变转移性非小细胞肺癌。
2024-05-26Hengrui received clinical trial approvals for injections SHR-9839, SHR-A1921, and SHR-A2009 for advanced malignant tumors.恒瑞收到注射用SHR-9839、SHR-A1921和SHR-A2009的临床试验批准，用于晚期恶性肿瘤。
2025-02-27Hengrui's subsidiaries Suzhou Suncadia and Shanghai Shengdi received NMPA clinical trial approvals for injection SHR-A2009 (HER3-targeting ADC, global first-in-class) and adebrelimab injection (anti-PD-L1 mAb); cumulative R&D investment ~115 million yuan and ~785 million yuan respectively.恒瑞子公司苏州盛迪亚和上海盛迪获国家药监局批准，开展注射用SHR-A2009（靶向HER3的ADC，全球首创）和阿得贝利单抗注射液（抗PD-L1单抗）的临床试验；累计研发投入分别约1.15亿元和7.85亿元。
2025-05-09Hengrui Medicine's subsidiaries received 7 clinical trial approval notices from the NMPA for drugs including Adebrelimab, SHR-8068, Bevacizumab, SHR-1826, SHR-A1904, SHR-A2009, and SHR-A2102.恒瑞医药子公司收到国家药监局7项药物临床试验批准通知书，涉及阿得贝利单抗、SHR-8068、贝伐珠单抗、SHR-1826、SHR-A1904、SHR-A2009和SHR-A2102。
2025-09-02Hengrui's subsidiary Suzhou Shengdiya received clinical trial approval for SHR-A2009, a HER3-targeting ADC, for advanced solid tumors.恒瑞子公司苏州盛迪亚获注射用SHR-A2009（HER3靶向ADC）临床试验批准，用于晚期实体瘤。
SHR8554 / Fumarate Tageridine (Aisute)SHR8554 / 富马酸泰吉利定 (艾苏特)
7 · 2024-01-03 → 2025-11-17
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China's first Class 1 opioid analgesic approved for postoperative pain, later included in NRDL and explored for ICU sedation.中国首个1类阿片类镇痛药获批用于术后疼痛，后纳入医保并探索ICU镇静用途。
2024-01-03Hengrui's NDA for SHR8554 (fumageline tigilidine injection), a MOR-biased agonist for postoperative pain, was accepted by NMPA.恒瑞SHR8554注射液（富马酸泰吉利定注射液）用于术后镇痛的上市许可申请获国家药监局受理。
2024-01-31Hengrui received NMPA approval for its self-developed fumarate tigilidine injection (SHR8554), China's first Class 1 opioid analgesic, for moderate-to-severe pain after abdominal surgery.恒瑞获国家药监局批准自主研发的富马酸泰吉利定注射液上市，为中国首个1类阿片类镇痛创新药，用于腹部手术后中重度疼痛。
2024-02-01Hengrui's self-developed Class 1 opioid analgesic Fumarate Tageridine Injection (brand: Aisute) approved by NMPA for moderate-to-severe pain after abdominal surgery; cumulative R&D investment about 166 million yuan.恒瑞医药自主研发的1类阿片类镇痛药富马酸泰吉利定注射液（商品名：艾苏特）获国家药监局批准用于腹部手术后中重度疼痛；累计研发投入约1.66亿元。
2024-04-17First-in-class innovative opioid analgesic fumarate tagexifu injection (Aisute) approved for moderate-to-severe postoperative abdominal pain; NDA for vunakizumab injection (SHR-1314, anti-IL-17A) for ankylosing spondylitis accepted by NMPA.1类创新药富马酸泰吉利定注射液（艾苏特）获批用于腹部手术后中重度疼痛；夫那奇珠单抗注射液（SHR-1314）用于强直性脊柱炎的上市申请获受理。
2024-11-28Hengrui Medicine's self-developed innovative drug fumarate tagexifu injection (Aisute), the first domestically developed biased μ-opioid receptor agonist, was included in the NRDL for the first time.恒瑞医药自主研发的创新药富马酸泰吉利定注射液（艾苏特），中国首个自主研发的偏向性μ阿片受体激动剂，首次纳入国家医保目录。
2025-03-16Received drug registration certificate for tagegrelin fumarate injection (1st-in-class opioid analgesic) for new indication: moderate-to-severe postoperative pain.获富马酸泰吉利定注射液（1类阿片类镇痛创新药）新增适应症“术后中重度疼痛”的药品注册证书。
2025-11-17Hengrui received NMPA Clinical Trial Approval for Fumarate Tageridine injection (μ-opioid receptor biased agonist, China's first self-developed Class 1 opioid analgesic, approved Jan 2024) for mechanical ventilation sedation in ICU patients.恒瑞医药收到国家药监局关于富马酸泰吉利定注射液（μ阿片受体偏向性激动剂，2024年1月国内获批，中国首个自主研发1类阿片类镇痛创新药）用于ICU机械通气镇痛的《药物临床试验批准通知书》。
Chengdu Shengdi (subsidiary) approvals成都盛迪（子公司）获批
12 · 2024-01-03 → 2026-06-25
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Abiraterone nanocrystal, tacrolimus ER, perfluorohexyloctane eye drops, and other approvals from Chengdu Shengdi.成都盛迪的醋酸阿比特龙纳米晶、他克莫司缓释胶囊、全氟己基辛烷滴眼液等获批。
2024-01-03Hengrui's subsidiary Chengdu Shengdi received NMPA approval for abiraterone acetate tablet (II) (Airuiji), a nanocrystal formulation for prostate cancer.恒瑞子公司成都盛迪获国家药监局批准醋酸阿比特龙片(II)（艾瑞吉®）上市，为纳米晶制剂，用于前列腺癌。
2024-01-29Hengrui's subsidiary Chengdu Shengdi received FDA approval for tacrolimus extended-release capsules ANDA, the first generic in the US and China.恒瑞子公司成都盛迪获美国FDA批准他克莫司缓释胶囊简略新药申请，为美国和中国首仿药。
2025-07-03Hengrui subsidiary Chengdu Shengdi received drug registration certificate for perfluorohexyloctane eye drops (Hengqin) for meibomian gland dysfunction-related dry eye; cumulative R&D investment ~108 million yuan.恒瑞子公司成都盛迪获得全氟己基辛烷滴眼液（恒沁®）药品注册证书，用于睑板腺功能障碍相关干眼；累计研发投入约1.08亿元。
2025-07-25Hengrui acquired 1.4587% equity of subsidiary Chengdu Shengdi from 9 individuals for 40.0144 million yuan in cash, raising its stake to 97.3866%.恒瑞医药以现金4001.44万元收购9名自然人持有的成都盛迪医药1.4587%股权，持股比例升至97.3866%。
2025-09-09Hengrui's subsidiary Chengdu Shengdi received NMPA approval for icosapent ethyl soft capsules to reduce triglycerides and cardiovascular event risk.恒瑞子公司成都盛迪获国家药监局批准，二十碳五烯酸乙酯软胶囊上市，用于降低甘油三酯和心血管事件风险。
2025-11-24Hengrui's subsidiary Chengdu Shengdi Pharma received NMPA approval for Paricalcitol Soft Capsules (chemical Class 3, first domestic generic) for prevention and treatment of secondary hyperparathyroidism in CKD stage 3-4. R&D investment ~57.94 million yuan.恒瑞子公司成都盛迪医药的帕立骨化醇软胶囊（化学药品3类，国内首家仿制药）获国家药监局批准上市，用于预防和治疗慢性肾脏病3-4期继发性甲状旁腺功能亢进症，累计研发投入约5794万元。
2025-12-28Hengrui's subsidiary Chengdu Shengdi signs a non-exclusive commercialization services framework agreement with Hansoh Pharma's subsidiary Jiangsu Haosen for Hengrui's newly approved Paricalcitol soft capsules (for secondary hyperparathyroidism in CKD).恒瑞子公司成都盛迪与翰森制药子公司江苏豪森签署非独家商业化服务框架协议，委托豪森为恒瑞新获批的帕立骨化醇软胶囊（用于慢性肾病继发性甲状旁腺功能亢进）提供商业化服务。
2026-01-09Subsidiary Chengdu Shengdi received NMPA acceptance of marketing authorization application for Fumarate Likang Kepan (HRS-5965) capsule, a class 1 new drug for paroxysmal nocturnal hemoglobinuria (PNH).子公司成都盛迪收到国家药监局受理富马酸立康可泮（HRS-5965）胶囊的上市许可申请，为1类新药用于阵发性睡眠性血红蛋白尿症。
2026-03-16Hengrui Medicine's subsidiary Chengdu Shengdi received NMPA acceptance of marketing authorization application for HRS-5965 (fumarate licopanib) capsules, a complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH); cumulative R&D investment ~252 million yuan.恒瑞医药子公司成都盛迪获国家药监局受理富马酸立康可泮（HRS-5965）胶囊上市许可申请，为补体因子B抑制剂，用于阵发性睡眠性血红蛋白尿症（PNH）；累计研发投入约2.52亿元。
2026-04-10Hengrui's subsidiary Chengdu Shengdi received NMPA clinical trial approval for HRS-5765 tablets, a first-in-class drug for heart failure, with cumulative R&D investment of about 13.8 million yuan.恒瑞医药子公司成都盛迪收到国家药监局关于HRS-5765片的临床试验批准，该药为1类新药用于心力衰竭，累计研发投入约1380万元。
2026-05-26Hengrui's subsidiary Chengdu Shengdi received NMPA clinical trial approval for HRS-1635 tablets, a novel anti-tumor drug for B-cell malignancies, with cumulative R&D investment of approximately RMB 23.6 million.恒瑞医药子公司成都盛迪医药收到国家药监局关于HRS-1635片的《药物临床试验批准通知书》，该药为自主研发的创新型抗肿瘤药物，拟用于B细胞恶性肿瘤，累计研发投入约2360万元。
2026-06-25NMPA approved Hengrui's subsidiary Chengdu Shengdi's Cyclosporine Eye Drops (IV), China's first and only 0.1% anhydrous cyclosporine eye drop for dry eye disease. R&D investment ~103M yuan.国家药监局批准恒瑞医药子公司成都盛迪的环孢素滴眼液（IV）上市，该产品为中国首个且唯一0.1%无水环孢素滴眼液，适用于干眼所致的泪液生成减少。研发投入约1.03亿元。
Adebrelimab (anti-PD-L1) combination trials阿得贝利单抗 (抗PD-L1) 联合试验
39 · 2024-01-04 → 2026-06-25
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Extensive clinical trials combining adebrelimab with chemotherapy, ADCs, and other agents across multiple cancer types.阿得贝利单抗联合化疗、ADC和其他药物在多种癌症中开展广泛临床试验。
2024-01-04Hengrui's subsidiaries received NMPA clinical trial approvals for adebrelimab, SHR-2002 (PVRIG-TIGIT bispecific), and SHR-8068 (anti-CTLA-4) in combination for advanced solid tumors.恒瑞子公司获国家药监局临床试验批准，开展阿得贝利单抗、SHR-2002（PVRIG-TIGIT双抗）和SHR-8068（抗CTLA-4）联合治疗晚期实体瘤研究。
2024-01-08Hengrui's subsidiaries received NMPA clinical trial approvals for adebrelimab, SHR-A1921 (TROP-2 ADC), and SHR-8068 in combination for advanced solid tumors.恒瑞子公司获国家药监局临床试验批准，开展阿得贝利单抗、注射用SHR-A1921（TROP-2 ADC）和SHR-8068联合治疗晚期实体瘤研究。
2024-01-16Hengrui's subsidiary received NMPA clinical trial approval for adebrelimab combined with chemoradiotherapy for locally advanced cervical cancer (Phase II).恒瑞子公司获国家药监局临床试验批准，开展阿得贝利单抗联合同步放化疗用于局部晚期宫颈癌的II期研究。
2024-01-30Hengrui's subsidiaries received NMPA clinical trial approvals for adebrelimab and SHR-8068 (anti-CTLA-4) for lung cancer.恒瑞子公司获国家药监局临床试验批准，开展阿得贝利单抗和SHR-8068（抗CTLA-4）用于肺癌研究。
2024-02-22Hengrui's subsidiary Shanghai Shengdi received NMPA clinical trial approval for Adebrelimab injection (anti-PD-L1 mAb) combined with chemotherapy for neoadjuvant treatment of resectable stage II/III EGFR-mutant NSCLC; cumulative R&D investment about 564.37 million yuan.恒瑞医药子公司上海盛迪获国家药监局批准阿得贝利单抗注射液（抗PD-L1单抗）联合化疗新辅助治疗可切除Ⅱ/Ⅲ期EGFR突变非小细胞肺癌临床试验；累计研发投入约5.6437亿元。
2024-02-27Hengrui's subsidiaries received NMPA clinical trial approval for Adebrelimab injection combined with SHR-A1811 (HER2-targeting ADC) for breast cancer.恒瑞医药子公司获国家药监局批准阿得贝利单抗注射液联合注射用SHR-A1811（靶向HER2的ADC）用于乳腺癌的临床试验。
2024-03-18Hengrui and its subsidiaries received NMPA clinical trial approvals for HRS-1167 tablets, adebrelimab injection, HRS2398 tablets, and SHR-A1921 injection.恒瑞医药及子公司获得国家药监局关于HRS-1167片、阿得贝利单抗注射液、HRS2398片和注射用SHR-A1921的临床试验批准通知书。
2024-03-28Hengrui's subsidiaries received NMPA clinical trial approvals for adebrelimab injection and SHR-A1904 injection (Claudin18.2-targeting ADC).恒瑞子公司获得国家药监局关于阿得贝利单抗注射液和注射用SHR-A1904（靶向Claudin18.2的ADC）的临床试验批准通知书。
2024-04-08Subsidiaries received clinical trial approval for adebrelimab injection combined with SHR-A1811 and chemotherapy for HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma (Phase Ib/II).子公司获得阿得贝利单抗注射液联合SHR-A1811和化疗用于HER2表达晚期胃或胃食管结合部腺癌的Ib/II期临床试验批准。
2024-04-09Received clinical trial approvals for 5 drugs: HRS-4642 (KRAS G12D), adebrelimab, SHR-A1904 (Claudin18.2 ADC), SHR-9839, and SHR-A1921 (TROP2 ADC) for advanced solid tumors.获得5款药物临床试验批准：HRS-4642注射液（KRAS G12D）、阿得贝利单抗、注射用SHR-A1904（Claudin18.2 ADC）、注射用SHR-9839、注射用SHR-A1921（TROP2 ADC），用于晚期实体瘤。
2024-04-10Subsidiaries received clinical trial approvals for SHR-A2102 (Nectin-4 ADC), adebrelimab, SHR-8068 (anti-CTLA-4 mAb), and abiraterone acetate tablet (II) (nanocrystal formulation, first in China).子公司获得注射用SHR-A2102（Nectin-4 ADC）、阿得贝利单抗、SHR-8068注射液（抗CTLA-4单抗）、醋酸阿比特龙片（Ⅱ）（中国首个纳米晶制剂）的临床试验批准。
2024-10-28Hengrui and its subsidiaries received NMPA clinical trial approvals for multiple drugs: HRS-4642 (KRAS G12D inhibitor), Adebrelimab, SHR-1826, SHR-9839, SHR-8068, and Bevacizumab.恒瑞医药及子公司收到国家药监局多项药物临床试验批准，包括HRS-4642注射液（KRAS G12D抑制剂）、阿得贝利单抗注射液、注射用SHR-1826、注射用SHR-9839、SHR-8068注射液和贝伐珠单抗注射液。
2024-11-01Hengrui Medicine received clinical trial approval for SHR-1826, HRS-4642, adebrelimab, SHR-9839, SHR-8068, and bevacizumab injections in a multi-center, open-label Phase Ib/II study for advanced solid tumors.恒瑞医药获得注射用SHR-1826、HRS-4642注射液、阿得贝利单抗注射液、注射用SHR-9839、SHR-8068注射液和贝伐珠单抗注射液在晚期实体瘤中的多中心、开放IB/II期临床研究批准。
2024-12-18Hengrui's subsidiaries received NMPA clinical trial approval for injection SHR-1501 (IL-15 fusion protein) combined with Adebrelimab injection (anti-PD-L1) for non-muscle invasive bladder cancer.恒瑞医药子公司收到国家药监局关于注射用SHR-1501（IL-15融合蛋白）联合阿得贝利单抗注射液（抗PD-L1）用于非肌层浸润性膀胱癌的药物临床试验批准通知书。
2024-12-25Hengrui's subsidiaries received NMPA clinical trial approval for multiple drugs: injection SHR-4602, SHR-A1811, Adebrelimab injection, and SHR-8068 injection, for combination therapy in advanced solid tumors.恒瑞医药子公司收到国家药监局关于注射用SHR-4602、注射用SHR-A1811、阿得贝利单抗注射液、SHR-8068注射液的药物临床试验批准通知书，用于晚期实体瘤的联合治疗。
2025-03-06Subsidiaries received clinical trial approvals for SHR-A1811, bevacizumab, adebrelimab, and SHR-8068 combination in advanced solid tumors.子公司获注射用SHR-A1811、贝伐珠单抗、阿得贝利单抗、SHR-8068联合治疗晚期实体瘤的临床试验批准。
2025-03-07Subsidiaries received clinical trial approvals for SHR-4602, SHR-A2102 (Nectin-4 ADC), and adebrelimab in advanced solid tumors.子公司获注射用SHR-4602、SHR-A2102（Nectin-4 ADC）及阿得贝利单抗在晚期实体瘤中的临床试验批准。
2025-03-26Subsidiaries received clinical trial approvals for SHR-A2102, adebrelimab, and bevacizumab combination regimen.子公司获注射用SHR-A2102、阿得贝利单抗、贝伐珠单抗联合方案的临床试验批准。
2025-04-14Hengrui's subsidiaries receive NMPA clinical trial approvals for HRS-7058 capsules/tablets (KRAS G12C inhibitor), adebrelimab injection (PD-L1 mAb), bevacizumab injection (VEGF mAb), and SHR-1826 injection (c-MET ADC); cumulative R&D investments ~RMB 63.91M, 805.09M, 333.49M, and 58.40M respectively.恒瑞子公司收到国家药监局关于HRS-7058胶囊/片（KRAS G12C抑制剂）、阿得贝利单抗注射液（PD-L1单抗）、贝伐珠单抗注射液（VEGF单抗）和注射用SHR-1826（c-MET ADC）的临床试验批准；累计研发投入分别约6391万元、8.05亿元、3.33亿元和5840万元。
2025-04-22Hengrui's subsidiaries Suzhou Shengdiya and Shanghai Shengdi receive NMPA clinical trial approval for SHR-8068 injection (anti-CTLA-4 mAb) and adebrelimab injection (PD-L1 mAb) combination therapy.恒瑞子公司苏州盛迪亚和上海盛迪收到国家药监局关于SHR-8068注射液（抗CTLA-4单抗）联合阿得贝利单抗注射液（PD-L1单抗）的临床试验批准。
2025-06-05Hengrui received NMPA clinical trial approvals for SHR-A1811, Adebrelimab injection, and Famitinib malate capsules; cumulative R&D investment over 22 billion yuan.恒瑞医药获得注射用SHR-A1811、阿得贝利单抗注射液和苹果酸法米替尼胶囊的临床试验批准，累计研发投入超22亿元。
2025-06-20Hengrui received NMPA clinical trial approvals for 6 drugs: SHR2554, SHR-A1811, SHR-A2102, Adebrelimab, SHR-A1904, and SHR-1701; cumulative R&D investment over 32 billion yuan.恒瑞医药获得SHR2554片、注射用SHR-A1811等6个药物的临床试验批准，累计研发投入超32亿元。
2025-07-17Hengrui and its subsidiaries received clinical trial approvals for four drugs: SHR-8068 injection (anti-CTLA-4 mAb), adebrelimab injection (anti-PD-L1), bevacizumab injection (anti-VEGF), and apatinib mesylate tablets; cumulative R&D investments: ~214 million, ~887 million, ~345 million, ~587 million yuan respectively.恒瑞医药及子公司获得SHR-8068注射液（抗CTLA-4单抗）、阿得贝利单抗注射液（抗PD-L1）、贝伐珠单抗注射液（抗VEGF）、甲磺酸阿帕替尼片四项药物的临床试验批准；累计研发投入分别约2.14亿、8.87亿、3.45亿、5.87亿元。
2025-08-01Hengrui Medicine's subsidiaries received NMPA clinical trial approval for SHR-8068, Adebrelimab, and Bevacizumab combination for advanced solid tumors.恒瑞医药子公司获国家药监局批准，开展SHR-8068、阿得贝利单抗及贝伐珠单抗联合治疗晚期实体瘤的临床试验。
2025-08-13Hengrui received NMPA clinical trial approval for SHR-A2102 (Nectin-4 ADC) combined with Adebrelimab for recurrent/metastatic head and neck squamous cell carcinoma.恒瑞医药获国家药监局批准，开展注射用SHR-A2102（Nectin-4 ADC）联合阿得贝利单抗治疗复发/转移性头颈鳞癌的临床试验。
2025-08-18Hengrui received NMPA clinical trial approval for HRS-4508 (TKI), SHR-A1811, Adebrelimab, and Bevacizumab combination for HER2-aberrant solid tumors.恒瑞医药获国家药监局批准，开展HRS-4508、注射用SHR-A1811、阿得贝利单抗及贝伐珠单抗联合治疗HER2通路异常实体瘤的临床试验。
2025-10-13Hengrui's subsidiaries Suzhou Sdiya Bio, Shanghai Hengrui Pharma, and Shanghai Sdiya Pharma received NMPA clinical trial approvals for injection SHR-A2102 (Nectin-4 ADC, cumulative R&D ~225M yuan), Adebrelimab injection (anti-PD-L1 mAb, cumulative R&D ~939M yuan), and injection SHR-1802 (humanized mAb, cumulative R&D ~62M yuan) for Phase Ib/II study in advanced solid tumors.恒瑞子公司苏州盛迪亚、上海恒瑞、上海盛迪收到NMPA临床试验批准，涉及注射用SHR-A2102（Nectin-4 ADC，累计研发投入约2.25亿元）、阿得贝利单抗注射液（抗PD-L1单抗，累计研发投入约9.39亿元）、注射用SHR-1802（人源化单抗，累计研发投入约6209万元），用于晚期实体瘤Ib/II期研究。
2025-11-17Hengrui and its subsidiaries received NMPA Clinical Trial Approvals for 9 drugs including HRS-4642 (KRAS G12D inhibitor), SHR-1701 (PD-L1/TGF-βRII bifunctional fusion protein), SHR-7367 (FAP/CD40 bispecific antibody), SHR-8068 (anti-CTLA-4 mAb), Adebrelimab, Bevacizumab, SHR-A2102, Famitinib, and Dalpiciclib for various solid tumors.恒瑞医药及子公司收到国家药监局关于9款药物的《药物临床试验批准通知书》，包括HRS-4642（KRAS G12D抑制剂）、SHR-1701（PD-L1/TGF-βRII双功能融合蛋白）、SHR-7367（FAP/CD40双抗）、SHR-8068（抗CTLA-4单抗）、阿得贝利单抗、贝伐珠单抗、SHR-A2102、法米替尼和达尔西利。
2025-11-21Hengrui and subsidiaries received NMPA Clinical Trial Approvals for 9 drugs including SHR-9839(sc), SHR-A2009 (HER3-ADC), SHR-1826, HRS-4642, Adebrelimab, Trastuzumab Rekang (SHR-A1811), SHR-A2102 (Nectin-4-ADC), HRS-7058 capsule and tablet for various solid tumors.恒瑞医药及子公司收到国家药监局关于9款药物的《药物临床试验批准通知书》，包括SHR-9839(sc)、SHR-A2009（HER3-ADC）、SHR-1826、HRS-4642、阿得贝利单抗、瑞康曲妥珠单抗（SHR-A1811）、SHR-A2102（Nectin-4-ADC）、HRS-7058胶囊和片剂。
2025-11-27Hengrui and subsidiaries received NMPA Clinical Trial Approvals for HRS-7058 capsule/tablet (KRAS G12C inhibitor, R&D ~63.91 million yuan), SHR-9839(sc), Adebrelimab, Bevacizumab, and SHR-A2102 for solid tumor combination therapy.恒瑞医药及子公司收到国家药监局关于HRS-7058胶囊/片（KRAS G12C抑制剂，研发投入约6391万元）、SHR-9839(sc)、阿得贝利单抗、贝伐珠单抗和SHR-A2102用于实体瘤联合治疗的《药物临床试验批准通知书》。
2025-12-29Hengrui and its subsidiaries receive NMPA clinical trial approval for a multi-drug combination study (SHR-4375, Adebrelimab, SHR-8068, Bevacizumab, HRS-4642, SHR-9839(sc)) in advanced solid tumors.恒瑞医药及子公司收到国家药监局关于SHR-4375注射液、阿得贝利单抗注射液、SHR-8068注射液、贝伐珠单抗注射液、HRS-4642注射液、注射用SHR-9839(sc)联合用于晚期实体瘤的临床试验批准通知书。
2026-01-21Subsidiaries Shanghai Hengrui and Shanghai Shengdi received NMPA clinical trial approvals for SHR-7787 injection combined with Adebelimumab injection for tumor treatment.子公司上海恒瑞、上海盛迪收到国家药监局对SHR-7787注射液联合阿得贝利单抗注射液的临床试验批准，用于肿瘤治疗。
2026-03-04Hengrui Medicine's subsidiaries Suzhou Shengdiya and Shanghai Hengrui received NMPA clinical trial approval for SHR-A2102 (Nectin-4 ADC) combined with adebrelimab ± SHR-8068 (anti-CTLA-4) or almonertinib in non-small cell lung cancer.恒瑞医药子公司苏州盛迪亚和上海恒瑞获国家药监局批准注射用SHR-A2102（Nectin-4 ADC）联合阿得贝利单抗±SHR-8068（抗CTLA-4）或阿美替尼在非小细胞肺癌中开展临床试验。
2026-03-06Hengrui Medicine's subsidiary Shanghai Shengdi received NMPA clinical trial approval for adebrelimab (anti-PD-L1) combined with SHR-8068 and chemoradiotherapy for locally advanced resectable rectal cancer (Phase II/III).恒瑞医药子公司上海盛迪获国家药监局批准阿得贝利单抗（抗PD-L1）联合SHR-8068和放化疗用于局部进展期可切除直肠癌围术期治疗（II/III期临床）。
2026-03-06Hengrui Medicine's subsidiary Shanghai Shengdi received NMPA clinical trial approval for adebrelimab combined with S-1 and oxaliplatin (SOX) vs placebo for resectable gastric or gastroesophageal junction cancer (Phase III).恒瑞医药子公司上海盛迪获国家药监局批准阿得贝利单抗联合替吉奥和奥沙利铂（SOX）对比安慰剂用于可切除胃癌或胃食管结合部癌围手术期治疗（III期临床）。
2026-03-11Hengrui Medicine received NMPA clinical trial approval for SHR-9803 injection (1 class biologic) combined with adebrelimab ± bevacizumab ± chemotherapy for advanced malignant solid tumors.恒瑞医药获国家药监局批准注射用SHR-9803（1类治疗用生物制品）联合阿得贝利单抗±贝伐珠单抗±化疗用于晚期恶性实体瘤临床试验。
2026-05-08Hengrui and its subsidiaries received NMPA clinical trial approvals for HRS-6093 tablets (KRAS G12D inhibitor), SHR-9839 (sc), SHR-1826 (c-Met ADC), Adebrelimab injection, and SHR-8068 injection for various advanced solid tumors.恒瑞医药及子公司收到国家药监局关于HRS-6093片（KRAS G12D抑制剂）、注射用SHR-9839（sc）、注射用SHR-1826（c-Met ADC）、阿得贝利单抗注射液、SHR-8068注射液的《药物临床试验批准通知书》，用于多种晚期恶性实体瘤。
2026-05-13Hengrui's subsidiaries received NMPA clinical trial approvals for SHR-3821 injection (humanized antibody for advanced solid tumors), Adebrelimab injection, and Relafuzumab alpha injection (PD-L1/TGF-βRII bispecific).恒瑞医药子公司收到国家药监局关于SHR-3821注射液（人源化抗体，晚期实体瘤）、阿得贝利单抗注射液、瑞拉芙普α注射液的《药物临床试验批准通知书》。
2026-06-25NMPA approved a new perioperative indication for Hengrui's subsidiary Shanghai Shengdi's Adebrelimab injection (阿得贝利单抗注射液) for NSCLC, making it the first domestic PD-L1 inhibitor approved for NSCLC perioperative treatment. Phase III data showed 53.8% major pathological response rate, 74.8% 2-year event-free survival, 48% reduction in recurrence/progression/death risk. Cumulative R&D ~1.225 billion yuan.国家药监局批准恒瑞医药子公司上海盛迪的阿得贝利单抗注射液新增非小细胞肺癌（NSCLC）围术期适应症，成为国内首个获批该适应症的国产PD-L1抑制剂。III期数据显示主要病理缓解率53.8%，2年无事件生存率74.8%，降低48%的复发/进展/死亡风险。累计研发投入约12.25亿元。
Oteseconazole (Ruibikang)奥特康唑 (瑞必康)
2 · 2024-01-05 → 2024-11-28
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Imported antifungal for vulvovaginal candidiasis, shipped from Lianyungang base and included in NRDL.进口抗真菌药用于外阴阴道念珠菌病，从连云港基地发货并纳入医保。
2024-01-05Hengrui's imported antifungal oteseconazole was shipped from its Lianyungang international manufacturing base for clinical use in vulvovaginal candidiasis.恒瑞引进的抗真菌药奥特康唑从连云港国际化制剂生产基地发货，用于外阴阴道假丝酵母菌病临床使用。
2024-11-28Hengrui Medicine's self-developed innovative drug oteseconazole capsules (Ruibikang), the company's first Class 1 innovative drug in anti-infective therapy, was included in the NRDL for the first time.恒瑞医药自主研发的创新药奥特康唑胶囊（瑞必康），公司在抗感染治疗领域上市的首个1类创新药，首次纳入国家医保目录。
Irinotecan liposome (II)盐酸伊立替康脂质体(II)
3 · 2024-01-07 → 2026-03-13
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Approved for pancreatic cancer, Phase III results published in Nature journal showing 37% death risk reduction.获批用于胰腺癌，III期结果发表在Nature子刊，显示降低37%死亡风险。
2024-01-07Hengrui received NMPA approval for irinotecan hydrochloride liposome injection (II) for pancreatic cancer, combined with fluorouracil and leucovorin.恒瑞获国家药监局批准盐酸伊立替康脂质体注射液(II)，联合氟尿嘧啶和亚叶酸钙用于胰腺癌治疗。
2024-11-07Hengrui Medicine announced that a Phase III study of irinotecan liposome (II) combined with 5-FU/LU for second-line treatment of locally advanced or metastatic pancreatic cancer was published in Nature Signal Transduction and Targeted Therapy; the combination reduced death risk by 37%.恒瑞医药宣布伊立替康脂质体（Ⅱ）联合5-FU/LV二线治疗局部晚期或转移性胰腺癌的III期研究发表于《自然》子刊《信号转导与靶向治疗》；联合方案降低死亡风险37%。
2026-03-13Hengrui Medicine's subsidiary Shanghai Hengrui received NMPA clinical trial approval for irinotecan hydrochloride liposome injection (II) combined with oxaliplatin/5-FU/leucovorin vs gemcitabine/capecitabine for adjuvant pancreatic cancer (Phase III).恒瑞医药子公司上海恒瑞获国家药监局批准盐酸伊立替康脂质体注射液（II）联合奥沙利铂/5-氟尿嘧啶/亚叶酸钙对比吉西他滨/卡培他滨用于胰腺癌术后辅助治疗（III期临床）。
SGLT2i / DPP-4i / metformin combos (Ruiqinda, Ruiqin, HR20031)SGLT2i/DPP-4i/二甲双胍复方制剂 (瑞沁达、瑞沁、HR20031)
6 · 2024-01-07 → 2025-10-24
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Fixed-dose combinations for type 2 diabetes, including SGLT2i+metformin, SGLT2i+DPP-4i+metformin triple, and new indications.2型糖尿病固定剂量复方制剂，包括SGLT2i+二甲双胍、SGLT2i+DPP-4i+二甲双胍三联及新适应症。
2024-01-07Hengrui's subsidiary Shandong Shengdi received NMPA approval for Henggliflozin Metformin ER tablets (I)/(II) (Ruiqinda), a fixed-dose SGLT2i+metformin combo for type 2 diabetes.恒瑞子公司山东盛迪获国家药监局批准恒格列净二甲双胍缓释片(I)/(II)（瑞沁达），为SGLT2抑制剂与二甲双胍固定复方，用于2型糖尿病。
2024-06-30Hengrui received NMPA drug registration certificate for a second indication of proline henggliflozin tablets (脯氨酸恒格列净片), making it the only SGLT2 inhibitor in China approved for combination with DPP-IV inhibitors and metformin in type 2 diabetes.恒瑞医药收到国家药监局关于脯氨酸恒格列净片第二个适应症的药品注册证书，使其成为中国唯一获批与DPP-IV抑制剂和二甲双胍联合治疗的SGLT2抑制剂。
2024-07-01Hengrui Medicine's self-developed Class 1 new drug Proline Henggliflozin (Ruiqin) received NMPA approval for a second indication: combination with Repaglinide and Metformin for type 2 diabetes.恒瑞医药自主研发的1类新药脯氨酸恒格列净（瑞沁）获国家药监局批准新增第2项适应症：联合磷酸瑞格列汀和二甲双胍用于2型糖尿病。
2024-11-28Hengrui Medicine's self-developed SGLT2 inhibitor henagliflozin tablets (Ruiqin) successfully renewed NRDL inclusion with a new indication added for combination therapy in type 2 diabetes.恒瑞医药自主研发的SGLT2抑制剂脯氨酸恒格列净片（瑞沁）成功续约国家医保目录，并新增联合治疗2型糖尿病的适应症。
2025-05-22Hengrui Medicine's subsidiary received a drug registration certificate from the NMPA for Retagliptin Metformin Tablets (I)/(II), China's first self-developed DPP-4 inhibitor combined with metformin fixed-dose combination for type 2 diabetes.恒瑞医药子公司获国家药监局颁发瑞格列汀二甲双胍片（Ⅰ）/（Ⅱ）药品注册证书，该药是中国首个自主研发的DPP-4抑制剂联合二甲双胍固定复方制剂，用于2型糖尿病。
2025-10-24Hengrui's subsidiary Shandong Sdiya Pharma received NMPA approval for Henggliflozin Retagliptin Metformin extended-release tablets (I)/(II) (HR20031), China's first self-developed oral triple fixed-dose combination for type 2 diabetes.恒瑞子公司山东盛迪医药收到NMPA批准，恒格列净瑞格列汀二甲双胍缓释片（I）/（II）（HR20031片）上市，是中国首个自主研发的口服降糖三药联合固定复方制剂，用于2型糖尿病。
SHR-1707 (anti-Aβ mAb)SHR-1707 (抗Aβ单抗)
1 · 2024-01-11
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Phase Ib study for Alzheimer's disease with expected results.阿尔茨海默病Ib期研究，结果待公布。
2024-01-11Hengrui disclosed that its anti-Aβ monoclonal antibody SHR-1707 for Alzheimer's disease is in Phase Ib clinical study with expected results.恒瑞披露其抗Aβ单克隆抗体SHR-1707用于阿尔茨海默病正在开展Ib期临床研究，结果符合预期。
Dalian Wanchun Buling arbitration大连万春布林仲裁案
1 · 2024-01-26
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Arbitration request dismissed; Hengrui had sought to freeze CNY 200 million in assets.仲裁请求被驳回，恒瑞曾申请冻结2亿元资产。
2024-01-26Hengrui's arbitration request against Dalian Wanchun Buling was dismissed by the tribunal; Hengrui had sought to freeze CNY 200 million in assets.恒瑞对大连万春布林的仲裁请求被仲裁庭驳回；恒瑞此前申请冻结2亿元财产。
Share buyback programs股份回购计划
24 · 2024-02-01 → 2026-05-07
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Multiple share buyback programs for employee stock ownership plans, totaling billions of yuan.多项股份回购计划用于员工持股计划，总额达数十亿元。
2024-02-01Hengrui repurchased 14.1123 million shares (0.22% of total equity) via centralized bidding as of Jan 31, 2024, with total payment of 625 million yuan; highest price 47.01 yuan/share, lowest 41.09 yuan/share.截至2024年1月31日，恒瑞医药通过集中竞价累计回购股份1411.23万股（占总股本0.22%），已支付总金额6.25亿元；最高价47.01元/股，最低价41.09元/股。
2024-03-01Hengrui repurchased 14.1123 million shares (0.22% of total equity) for 625 million yuan via centralized bidding as of Feb 29, 2024.截至2024年2月29日，恒瑞医药通过集中竞价交易累计回购股份1411.23万股（占总股本0.22%），支付总金额6.25亿元。
2024-05-15Hengrui completed its previous share buyback, repurchasing 14,351,878 shares (0.22% of total) for 634.67 million yuan, for employee stock ownership plan.恒瑞完成前次股份回购，累计回购14,351,878股（占总股本0.22%），耗资6.35亿元，用于员工持股计划。
2024-05-15Hengrui announced a new share buyback plan of 600 million to 1.2 billion yuan at up to 67.38 yuan per share, for employee stock ownership plan.恒瑞公布新一轮股份回购计划，拟以不超过67.38元/股回购6亿至12亿元，用于员工持股计划。
2024-06-20Hengrui repurchased 370,000 shares (0.01% of total) via centralized bidding at prices between 40.58-40.77 yuan, totaling 15.05 million yuan, as part of a 600M-1.2B yuan buyback plan for employee stock ownership.恒瑞医药通过集中竞价交易首次回购37万股（占总股本0.01%），成交价40.58-40.77元，总金额1505万元，作为6-12亿元回购计划的一部分用于员工持股计划。
2024-09-02Hengrui Medicine repurchased 2.5832 million shares (0.04% of total equity) for 103 million yuan as of August 31, 2024, under its 600-1200 million yuan buyback plan for employee stock ownership.恒瑞医药截至2024年8月31日累计回购258.32万股（占总股本0.04%），支付金额1.03亿元，用于员工持股计划。
2024-10-08Hengrui repurchased 4.5561 million shares (0.07% of total equity) for 187 million yuan via centralized bidding as of Sep 30, 2024, under a 600-1200 million yuan buyback plan for employee stock ownership.截至2024年9月30日，恒瑞医药通过集中竞价交易累计回购股份455.61万股（占总股本0.07%），支付总金额1.87亿元，回购计划总额为6-12亿元用于员工持股计划。
2025-01-02Hengrui Medicine repurchased 5.1811 million shares (0.08% of total share capital) via centralized bidding from May 2024 to Dec 31, 2024, at a total cost of RMB 218 million, with price range of RMB 39.00-57.54 per share.恒瑞医药于2024年5月至2024年12月31日通过集中竞价交易累计回购股份518.11万股（占总股本0.08%），成交价区间39.00-57.54元/股，总金额2.18亿元。
2025-02-05Hengrui Medicine repurchased 5.53 million shares (0.09% of total equity) via centralized竞价 trading from Jan 1 to Jan 31, 2025, at a total cost of 233.90 million yuan, with prices ranging from 39.00 to 57.54 yuan per share.恒瑞医药于2025年1月1日至31日通过集中竞价交易累计回购553万股（占总股本0.09%），成交价区间39.00-57.54元/股，总金额2.339亿元。
2025-05-07Hengrui Medicine disclosed that as of April 30, 2025, it had repurchased 8.5841 million shares (0.13% of total equity) for a total of 376 million yuan under its share buyback plan.恒瑞医药披露截至2025年4月30日，已累计回购858.41万股（占总股本0.13%），总金额3.76亿元。
2025-05-15Hengrui Medicine completed its share buyback plan, repurchasing a total of 12.9051 million shares (0.20% of total equity) for approximately 601 million yuan.恒瑞医药完成股份回购计划，累计回购1290.51万股（占总股本0.20%），总金额约6.01亿元。
2025-08-20Hengrui announced a share buyback of ¥1B-2B (price ≤¥90.85/share) for an A-share employee stock ownership plan covering up to 14M shares.恒瑞医药公告拟回购10-20亿元A股股份（价格上限90.85元/股），用于A股员工持股计划，规模不超过1400万股。
2025-09-02Hengrui announced a share buyback plan of RMB 1-2 billion at up to RMB 90.85 per share for employee stock ownership, but had not yet started repurchases as of Aug 31.恒瑞公告10-20亿元股份回购方案（上限90.85元/股）用于员工持股计划，截至8月31日尚未实施回购。
2025-09-04Hengrui repurchased 270,000 A-shares for the first time at a total cost of approximately RMB 18.31 million.恒瑞首次回购A股27万股，总金额约1831万元。
2025-10-09Hengrui repurchased 4.5724 million A-shares (0.07% of total) as of Sep 30, 2025, at prices between 67.20-70.00 yuan/share, totaling 315.4042 million yuan, for employee stock ownership plan.截至2025年9月30日，恒瑞医药以集中竞价交易方式回购A股股份457.24万股（占总股本0.07%），价格区间67.20-70.00元/股，总金额3.154042亿元，用于员工持股计划。
2025-10-10Hengrui repurchased 907,300 A-shares (0.0143% of total) on Oct 10, 2025, at 68.05-69.66 yuan/share, totaling ~62.4383 million yuan, for employee stock ownership plan.恒瑞医药于2025年10月10日回购A股907,300股（占总股本0.0143%），价格区间68.05-69.66元/股，总金额约6243.83万元，用于员工持股计划。
2025-10-17Hengrui repurchased 392,600 A-shares on Oct 17, 2025, at 65.00-65.41 yuan/share, totaling ~25.5768 million yuan, for employee stock ownership plan.恒瑞医药于2025年10月17日回购A股392,600股，价格区间65.00-65.41元/股，总金额约2557.68万元，用于员工持股计划。
2025-11-03Hengrui repurchased 7.9188 million A-shares (0.12% of total equity) as of Oct 31, 2025, spending ~535.43 million yuan at prices between 62.90 and 70.00 yuan per share, under a 1-2 billion yuan buyback plan for employee stock ownership.截至2025年10月31日，恒瑞医药以集中竞价交易方式回购A股791.88万股（占总股本0.12%），支付总金额约5.35亿元，回购价格区间62.90-70.00元/股，用于员工持股计划。
2025-11-21Hengrui updated share buyback progress: cumulative repurchase of 8.8987 million shares (0.13% of total equity) as of Nov 21, 2025, spending ~595.22 million yuan at prices between 59.32 and 70.00 yuan per share.恒瑞医药更新回购进展：截至2025年11月21日，累计回购A股889.87万股（占总股本0.13%），支付总金额约5.95亿元，回购价格区间59.32-70.00元/股。
2026-01-27Company repurchased 907.37 million A-shares (0.14% of total) for 605 million yuan under the 1-2 billion yuan buyback plan for employee stock ownership.公司累计回购907.37万股A股（占总股本0.14%），耗资6.05亿元，用于员工持股计划，回购计划总额10-20亿元。
2026-02-26Hengrui Medicine repurchased 276,000 shares (0.0043% of total equity) via centralized bidding on the Shanghai Stock Exchange at an average price of CNY 56.63 per share, totaling approximately CNY 15.63 million, for its A-share employee stock ownership plan.恒瑞医药于2026年2月26日通过上交所集中竞价交易回购276,000股（占总股本0.0043%），均价每股56.63元，总额约1563万元，用于A股员工持股计划。
2026-03-02Hengrui Medicine repurchased 10.6944 million A-shares (0.16% of total shares) for about 697.77 million yuan as of Feb 28, 2026, under a 1-2 billion yuan buyback plan for employee stock ownership.恒瑞医药截至2026年2月28日累计回购A股1069.44万股（占总股本0.16%），耗资约6.98亿元，用于员工持股计划，回购计划总额10-20亿元。
2026-04-02Hengrui Medicine repurchased 11.9474 million A-shares (0.18% of total shares) as of March 31, 2026, spending 766 million yuan at prices between 53.52 and 70 yuan per share, for an employee stock ownership plan.恒瑞医药截至2026年3月31日累计回购1194.74万股A股（占总股本0.18%），使用资金7.66亿元，回购价格区间53.52-70元/股，用于员工持股计划。
2026-05-07As of April 30, 2026, Hengrui Medicine had repurchased 12.0562 million shares (0.18% of total equity) via centralized竞价, spending approximately RMB 771.98 million, with prices ranging from RMB 53.52 to RMB 70.00 per share.截至2026年4月30日，恒瑞医药通过集中竞价交易方式累计回购股份1205.62万股（占总股本0.18%），支付总金额约7.72亿元，购买价格区间为53.52元/股至70.00元/股。
SHR-A1811 / Trastuzumab Rezetecan (Aivita, Ruikang)SHR-A1811 / 瑞康曲妥珠单抗 (艾维塔、瑞康)
15 · 2024-02-04 → 2026-04-29
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HER2-targeting ADC with multiple breakthrough therapy designations, approved for NSCLC and breast cancer, and multiple combo trials.HER2靶向ADC，获得多项突破性疗法认定，获批用于非小细胞肺癌和乳腺癌，并开展多项联合试验。
2024-02-04Hengrui's subsidiary Suzhou Shengdiya's injection SHR-A1811 (HER2-targeting ADC) was proposed for breakthrough therapy designation by CDE; it already has four breakthrough therapy designations.恒瑞医药子公司苏州盛迪亚的注射用SHR-A1811（靶向HER2的ADC）被药审中心拟纳入突破性治疗品种公示名单；该药已有四个适应症获突破性疗法认定。
2024-06-05SHR-A1811 (HER2-targeting ADC) from subsidiary Suzhou Sdi Biopharma was proposed for breakthrough therapy designation by CDE for HER2-positive unresectable or metastatic biliary tract cancer.子公司苏州盛迪亚生物医药的注射用SHR-A1811（HER2靶向ADC）被国家药监局药审中心拟纳入突破性治疗品种，用于HER2阳性不可切除或转移性胆道癌。
2024-07-16Hengrui Medicine's innovative drug SHR-A1811 monotherapy for previously treated HER2-mutant advanced non-small cell lung cancer study published in Nature sub-journal STTT (IF:40.8).恒瑞医药创新药SHR-A1811单药用于既往经治HER2突变晚期非小细胞肺癌的研究在《自然》子刊STTT（IF:40.8）发表。
2024-09-13Hengrui's marketing authorization application for Recombinant Herceptin biosimilar injection (SHR-A1811, HER2 ADC) for HER2-mutant non-small cell lung cancer was accepted by the NMPA and granted priority review; R&D investment ~624 million yuan.恒瑞医药注射用瑞康曲妥珠单抗（SHR-A1811，HER2 ADC）上市许可申请获国家药监局受理并纳入优先审评，用于HER2突变非小细胞肺癌，研发投入约6.24亿元。
2024-12-16Hengrui's subsidiary Suzhou Suncadia Biopharmaceutical's injection Ruikang trastuzumab (SHR-A1811, HER2 ADC) was included in the CDE's breakthrough therapy designation list for treating HER2-expressing platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; cumulative R&D investment approximately 715 million yuan.恒瑞医药子公司苏州盛迪亚生物医药的注射用瑞康曲妥珠单抗（SHR-A1811，HER2 ADC）被国家药监局药审中心纳入拟突破性治疗品种公示名单，用于治疗HER2表达的铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌，累计研发投入约7.15亿元。
2025-01-16Subsidiaries Suzhou Sdiya and Shanghai Hengrui received NMPA clinical trial approval for SHR-A1811 (HER2 ADC) and SHR-9839 injections; SHR-A1811 cumulative R&D investment ~RMB 849 million, SHR-9839 ~RMB 57.45 million.子公司苏州盛迪亚和上海恒瑞收到国家药监局关于注射用SHR-A1811（HER2 ADC）和注射用SHR-9839的临床试验批准；SHR-A1811累计研发投入约8.49亿元，SHR-9839约5745万元。
2025-03-19Injection of ruikang trastuzumab (SHR-A1811, HER2 ADC) included in breakthrough therapy designation list for HER2+ recurrent/metastatic cervical cancer (8th breakthrough designation).注射用瑞康曲妥珠单抗（SHR-A1811，HER2 ADC）拟纳入突破性治疗品种，用于HER2表达复发/转移性宫颈癌（第8次突破性疗法认定）。
2025-08-06Hengrui's Ruikang Trastuzumab (SHR-A1811) combo with Adebrelimab and chemo for gastric/GEJ adenocarcinoma received US FDA Orphan Drug Designation.恒瑞医药注射用瑞康曲妥珠单抗联合阿得贝利单抗及化疗用于胃癌/胃食管结合部腺癌获美国FDA孤儿药资格认定。
2025-08-11Hengrui's Ruikang Trastuzumab (SHR-A1811) and Adebrelimab were included in NMPA's breakthrough therapy designation list for PD-L1+ triple-negative breast cancer.恒瑞医药注射用瑞康曲妥珠单抗和阿得贝利单抗被国家药监局纳入拟突破性治疗品种名单，用于PD-L1阳性三阴性乳腺癌。
2025-10-23Hengrui's subsidiary Suzhou Sdiya Bio received NMPA clinical trial approval for injection Ruikang Trastuzumab (HER2-targeting ADC, cumulative R&D ~1.415B yuan) for a Phase III study in neoadjuvant early or locally advanced HER2-positive breast cancer; the drug was already approved in China in May 2025 for NSCLC.恒瑞子公司苏州盛迪亚收到NMPA临床试验批准，注射用瑞康曲妥珠单抗（靶向HER2的ADC，累计研发投入约14.15亿元）用于初治早期或局部晚期HER2阳性乳腺癌新辅助III期研究；该药已于2025年5月在国内获批用于非小细胞肺癌。
2025-11-25Hengrui's subsidiary Suzhou Shengdiya Bio received NMPA Clinical Trial Approval for Trastuzumab Rekang (SHR-A1811) injection for HER2-amplified solid tumors. The drug was approved in China in May 2025 for HER2-mutant NSCLC; R&D investment ~1.415 billion yuan.恒瑞子公司苏州盛迪亚生物医药收到国家药监局关于注射用瑞康曲妥珠单抗（SHR-A1811）用于HER2扩增实体瘤的《药物临床试验批准通知书》。该药2025年5月国内获批用于HER2突变NSCLC，累计研发投入约14.15亿元。
2025-12-12Hengrui's subsidiary Suzhou Shengdiya receives NMPA clinical trial approval for SHR-A1811(sc) injection, a subcutaneous formulation of the HER2 ADC (Ruikang Trastuzumab), for advanced solid tumors; no similar subcutaneous product is on the global market.恒瑞子公司苏州盛迪亚收到国家药监局关于SHR-A1811(sc)注射液（HER2 ADC瑞康曲妥珠单抗的皮下制剂）用于晚期实体瘤的临床试验批准通知书，全球尚无同类皮下制剂上市。
2026-03-20Hengrui Medicine's NMPA approved new indication for self-developed Class 1 innovative drug trastuzumab rezetecan (SHR-A1811, HER2 ADC): for HER2-positive advanced/metastatic breast cancer after prior anti-HER2 therapy; cumulative R&D investment ~1.888 billion yuan.恒瑞医药自主研发的1类创新药注射用瑞康曲妥珠单抗（SHR-A1811，HER2 ADC）获国家药监局批准新增适应症：用于既往接受过抗HER2治疗的HER2阳性局部晚期或转移性乳腺癌；累计研发投入约18.88亿元。
2026-04-20Hengrui's subsidiary Suzhou Shengdi's injection trastuzumab rezetecan (SHR-A1811) received its 11th breakthrough therapy designation from CDE, for HER2-positive recurrent/metastatic breast cancer in combination with pertuzumab; cumulative R&D investment about 1.971 billion yuan.恒瑞医药子公司苏州盛迪亚的注射用瑞康曲妥珠单抗（SHR-A1811）获得CDE第11项突破性治疗品种认定，联合帕妥珠单抗用于HER2阳性复发/转移性乳腺癌，累计研发投入约19.71亿元。
2026-04-29Hengrui's subsidiary Suzhou Shengdi's HER2 ADC trastuzumab rezetecan (Aivita) received NMPA approval for a new indication: HER2-positive advanced/metastatic breast cancer after prior anti-HER2 therapy, its second approved indication.恒瑞医药子公司苏州盛迪亚的HER2 ADC瑞康曲妥珠单抗（艾维达）获国家药监局批准新增适应症，用于既往接受过抗HER2治疗的HER2阳性晚期/转移性乳腺癌，为第二项适应症。
HRS-7535 (oral GLP-1R agonist)HRS-7535 (口服GLP-1R激动剂)
8 · 2024-02-06 → 2026-06-18
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Oral small-molecule GLP-1R agonist for weight loss and type 2 diabetes, licensed to Kailera, positive Phase III results.口服小分子GLP-1R激动剂，用于减重和2型糖尿病，授权给Kailera，III期结果阳性。
2024-02-06Hengrui's subsidiary Shandong Shengdi received NMPA clinical trial approval for HRS-7535, an oral small-molecule GLP-1R agonist, for Phase II weight-loss trial; cumulative R&D investment about 79.55 million yuan.恒瑞医药子公司山东盛迪获国家药监局批准HRS-7535片（口服小分子GLP-1R激动剂）开展减重适应症Ⅱ期临床试验；累计研发投入约7955万元。
2024-05-16Hengrui licensed exclusive rights (ex-Greater China) for GLP-1 portfolio (HRS-7535, HRS9531, HRS-4729) to US Hercules, receiving 19.9% equity, $110 million upfront/near-term milestones, up to $200 million development/regulatory milestones, up to $5.725 billion sales milestones, and tiered royalties.恒瑞将GLP-1产品组合（HRS-7535、HRS9531、HRS-4729）除大中华区外的全球独家权利许可给美国Hercules公司，获得19.9%股权、1.1亿美元首付款及近期里程碑、最高2亿美元开发及监管里程碑、最高57.25亿美元销售里程碑及分层销售提成。
2024-06-03Hengrui Medicine licensed out three GLP-1 product candidates (HRS7535, HRS9531 injection and oral tablet) to Hercules for a $100M upfront, $10M tech transfer fee, up to $200M clinical milestones, up to $5.725B sales milestones, tiered royalties, and 19.9% equity in Hercules.恒瑞医药将三款GLP-1产品候选物（HRS7535、HRS9531注射剂和口服片剂）授权给Hercules，获得1亿美元首付款、1000万美元技术转移费、不超过2亿美元临床里程碑、不超过57.25亿美元销售里程碑、分级销售分成以及Hercules 19.9%的股权。
2026-01-12Subsidiary Shandong Shengdi received NMPA clinical trial approval for HRS-7535 tablet, an oral small-molecule GLP-1R agonist, for hypertension with overweight or obesity.子公司山东盛迪收到国家药监局临床试验批准，HRS-7535片（口服小分子GLP-1R激动剂）用于高血压合并超重或肥胖。
2026-01-28Subsidiary Shandong Shengdi received NMPA clinical trial approval for HRS-7535 tablet to conduct phase III study for hypertension with overweight or obesity.子公司山东盛迪收到国家药监局临床试验批准，HRS-7535片开展高血压合并超重或肥胖适应症的III期临床研究。
2026-01-29Subsidiary Shandong Shengdi received NMPA clinical trial approval for HRS-7535 tablet to conduct phase III study for chronic kidney disease (CKD).子公司山东盛迪收到国家药监局临床试验批准，HRS-7535片开展慢性肾脏病适应症的III期临床研究。
2026-05-27Hengrui and Kailera announced positive top-line Phase III results for oral small-molecule GLP-1 receptor agonist HRS-7535 (KAI-7535) in 284 Chinese type 2 diabetes patients, showing HbA1c reductions of 1.40%-1.68% across three dose groups.恒瑞医药与美国Kailera公司共同宣布，口服小分子GLP-1受体激动剂HRS-7535（KAI-7535）在中国284名2型糖尿病患者中的III期临床试验取得积极顶线结果，三个剂量组糖化血红蛋白降幅达1.40%-1.68%。
2026-06-18Hengrui and Kailera Therapeutics announced positive topline results from the Phase III OUTSTAND-2 trial of oral small-molecule GLP-1 receptor agonist HRS-7535 (KAI-7535) in 810 Chinese T2DM patients; HbA1c reduction of 1.50%-1.68% at 32 weeks. Hengrui plans to file an NDA in China for T2DM this year.恒瑞医药与美国Kailera Therapeutics公司宣布口服小分子GLP-1受体激动剂HRS-7535（大中华区外称KAI-7535）在中国810名2型糖尿病受试者中开展的III期临床试验（OUTSTAND-2）取得积极顶线结果，32周HbA1c降幅达1.50%-1.68%。恒瑞计划今年在中国递交HRS-7535用于2型糖尿病治疗的上市申请。
SHR-1314 / Vunakizumab (Andajing)SHR-1314 / 夫那奇珠单抗 (安达静)
7 · 2024-02-18 → 2025-04-08
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Anti-IL-17A mAb approved for plaque psoriasis and ankylosing spondylitis, first autoimmune drug from Hengrui.抗IL-17A单抗获批用于斑块状银屑病和强直性脊柱炎，恒瑞首个自免药物。
2024-02-18Hengrui's subsidiary Suzhou Shengdiya's Funaqizumab injection (SHR-1314, anti-IL-17A mAb) NDA accepted by NMPA for active ankylosing spondylitis; cumulative R&D investment about 368.15 million yuan.恒瑞医药子公司苏州盛迪亚的夫那奇珠单抗注射液（SHR-1314，抗IL-17A单抗）上市许可申请获国家药监局受理，用于活动性强直性脊柱炎；累计研发投入约3.6815亿元。
2024-08-08Hengrui subsidiary Suzhou Shengdiya received NMPA clinical trial approval for vunakizumab (SHR-1314) injection, targeting IL-17A for autoimmune diseases.恒瑞子公司苏州盛迪亚获国家药监局批准夫那奇珠单抗（SHR-1314）注射液临床试验，靶向IL-17A用于自身免疫疾病。
2024-08-27Hengrui subsidiary Suzhou Shengdiya received NMPA drug registration certificate for vunakizumab (Andajing) injection, a class 1 innovative drug for moderate-to-severe plaque psoriasis in adults; first self-immune disease drug from Hengrui, breaking import monopoly.恒瑞子公司苏州盛迪亚获国家药监局药品注册证书，批准1类新药夫那奇珠单抗注射液（安达静）上市，用于成人中重度斑块状银屑病；系恒瑞首个自免领域创新药，打破进口垄断。
2024-08-30Hengrui held first shipment ceremony for vunakizumab (Andajing) injection from Suzhou Shengdiya production base to hospitals and pharmacies nationwide.恒瑞医药举行夫那奇珠单抗注射液（安达静）首批发货仪式，从苏州盛迪亚生产基地发往全国医院和药房。
2024-09-03Hengrui's first autoimmune disease innovative drug, Vunakizumab injection (Andajing), an anti-IL-17A monoclonal antibody for moderate-to-severe plaque psoriasis, received its first prescription in China.恒瑞医药首个自免创新药夫那奇珠单抗注射液（安达静）开出全国首张处方，用于中重度斑块状银屑病。
2025-02-13Hengrui's subsidiary Suzhou Suncadia Biopharma received NMPA clinical trial approval for vunakizumab injection (anti-IL-17A mAb) to treat non-radiographic axial spondyloarthritis; cumulative R&D investment ~489 million yuan.恒瑞子公司苏州盛迪亚获国家药监局批准，开展夫那奇珠单抗注射液（抗IL-17A单抗）治疗放射学阴性中轴型脊柱关节炎的临床试验；累计研发投入约4.89亿元。
2025-04-08Hengrui's subsidiary Suzhou Shengdiya receives NMPA drug registration certificate for vunakizumab injection (IL-17A mAb) for a new indication: active ankylosing spondylitis in adults; cumulative R&D investment ~RMB 651 million.恒瑞子公司苏州盛迪亚收到国家药监局药品注册证书，夫那奇珠单抗注射液（IL-17A单抗）新增适应症：活动性强直性脊柱炎成人患者；累计研发投入约6.51亿元。
Tianjin Hengrui radiopharmaceuticals天津恒瑞放射性药物
5 · 2024-02-20 → 2026-01-05
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Copper-64 production, PSMA-targeted PET and therapy agents for prostate cancer and FAP-positive tumors.铜-64生产，PSMA靶向PET和治疗药物用于前列腺癌及FAP阳性肿瘤。
2024-02-20Hengrui's subsidiary Tianjin Hengrui achieved independent batch production of Copper-64 chloride solution, enabling PET imaging and theranostic applications.恒瑞医药子公司天津恒瑞实现氯化铜[64Cu]溶液的自主批量生产，可用于PET显像及诊疗一体化应用。
2024-12-25Hengrui's subsidiary Tianjin Hengrui Pharmaceutical received NMPA clinical trial approval for HRS-4357 injection, a self-developed class 1 radiopharmaceutical for PSMA-positive prostate cancer, with cumulative R&D investment of approximately 48.06 million yuan.恒瑞医药子公司天津恒瑞医药收到国家药监局关于HRS-4357注射液的药物临床试验批准通知书，该药为自主研发的化学药品1类放射性治疗类创新药，用于PSMA阳性前列腺癌，累计研发投入约4806万元。
2025-01-03Subsidiary Tianjin Hengrui received NMPA clinical trial approval for HRS-6768 injection, a self-developed Class 1 radiopharmaceutical innovative drug for FAP-positive advanced solid tumors; cumulative R&D investment ~RMB 18.89 million.子公司天津恒瑞收到国家药监局关于HRS-6768注射液的临床试验批准，该药为自主研发的化学药品1类放射性治疗创新药，用于成纤维细胞活化蛋白阳性的晚期实体瘤；累计研发投入约1889万元。
2025-03-27Subsidiary received clinical trial approval for HRS-1738 injection, a PSMA-targeted PET diagnostic for prostate cancer.子公司获HRS-1738注射液（PSMA靶向PET诊断药物）用于前列腺癌成像的临床试验批准。
2026-01-05Company and subsidiaries Chengdu Shengdi and Tianjin Hengrui received NMPA clinical trial approval for HRS-4357 injection (radiopharmaceutical) combined with HRS-5041 tablet (AR PROTAC) for PSMA-positive prostate cancer.公司及子公司成都盛迪、天津恒瑞收到国家药监局临床试验批准，HRS-4357注射液（放射性治疗药物）联合HRS-5041片（AR PROTAC）用于PSMA阳性前列腺癌。
SHR-A1912 (CD79b ADC)SHR-A1912 (CD79b ADC)
2 · 2024-02-22 → 2024-04-17
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FDA Fast Track for relapsed/refractory diffuse large B-cell lymphoma.获FDA快速通道资格用于复发/难治性弥漫大B细胞淋巴瘤。
2024-02-22Hengrui's injection SHR-A1912 (CD79b-targeting ADC) received FDA Fast Track designation for relapsed/refractory diffuse large B-cell lymphoma; cumulative R&D investment about 30.47 million yuan.恒瑞医药注射用SHR-A1912（靶向CD79b的ADC）获美国FDA快速通道资格，用于复发/难治性弥漫大B细胞淋巴瘤；累计研发投入约3047万元。
2024-04-17SHR-A1912 (CD79b ADC) and SHR-A1921 (TROP-2 ADC) received FDA Fast Track Designation for R/R DLBCL and platinum-resistant ovarian cancer respectively.注射用SHR-A1912（CD79b ADC）和注射用SHR-A1921（TROP-2 ADC）分别获得美国FDA快速通道资格，用于复发/难治性弥漫大B细胞淋巴瘤和铂耐药卵巢癌。
HRS-1167 (PARP1 inhibitor)HRS-1167 (PARP1抑制剂)
4 · 2024-02-29 → 2025-04-20
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Oral PARP1 inhibitor in multiple clinical trials for solid tumors, licensed out in 2023.口服PARP1抑制剂，在实体瘤中开展多项临床试验，2023年对外授权。
2024-02-29Hengrui and its subsidiaries received NMPA clinical trial approvals for HRS-1167 (oral PARP1 inhibitor), SHR-A1921 (TROP-2-targeting ADC), and Abiraterone acetate tablet (I); cumulative R&D investment about 177 million yuan.恒瑞医药及子公司获国家药监局批准HRS-1167片（口服PARP1抑制剂）、注射用SHR-A1921（靶向TROP-2的ADC）和醋酸阿比特龙片（I）的临床试验；累计研发投入约1.77亿元。
2024-03-01Hengrui Medicine and its subsidiaries received NMPA clinical trial approvals for HRS-1167 tablets, SHR-A1921 injection, and abiraterone acetate tablets (II).恒瑞医药及子公司获得国家药监局关于HRS-1167片、注射用SHR-A1921和醋酸阿比特龙片（II）的临床试验批准通知书。
2024-08-29Hengrui and subsidiary Chengdu Shengdi received NMPA clinical trial approvals for HRS-1167 tablets (PARP1 inhibitor), HRS-5041 tablets (AR-PROTAC for prostate cancer), and SHR2554 tablets (EZH2 inhibitor for malignancies).恒瑞医药及子公司成都盛迪获国家药监局批准HRS-1167片（PARP1抑制剂）、HRS-5041片（AR-PROTAC用于前列腺癌）和SHR2554片（EZH2抑制剂用于恶性肿瘤）临床试验。
2025-04-20Hengrui receives NMPA clinical trial approval for HRS-1167 tablets (PARP1 inhibitor, second-generation) for metastatic prostate cancer; cumulative R&D investment not disclosed.恒瑞医药收到国家药监局关于HRS-1167片（第二代PARP1抑制剂）的临床试验批准，用于转移性前列腺癌；累计研发投入未披露。
HRS-7058 (KRAS G12C inhibitor)HRS-7058 (KRAS G12C抑制剂)
1 · 2024-03-04
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Clinical trials for KRAS G12C mutated advanced solid tumors.针对KRAS G12C突变晚期实体瘤的临床试验。
2024-03-04Hengrui's subsidiary Shandong Shengdi received NMPA clinical trial approval for HRS-7058 tablets and capsules targeting KRAS G12C mutated advanced solid tumors.恒瑞子公司山东盛迪获得国家药监局关于HRS-7058片和胶囊的临床试验批准，用于治疗KRAS G12C突变晚期实体瘤。
Policy proposals & government cooperation政策建议与政府合作
4 · 2024-03-06 → 2026-04-21
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Chairman's NRDL proposal, cooperation with Jinan High-tech Zone, Tianjin government, and Hong Kong OASES.董事长关于医保目录的建议，与济南高新区、天津市政府、香港引进办合作。
2024-03-06Hengrui chairman Sun Piaoyang proposed including more domestic innovative drugs into the National Essential Drug List and strengthening primary care application.恒瑞董事长孙飘扬建议将更多国产创新药纳入《国家基本药物目录》，加强基层医疗机构应用。
2024-08-16Hengrui signed a project cooperation framework agreement with Jinan High-tech Zone Management Committee for collaboration in innovative drug R&D, production, and biomedical industry development.恒瑞医药与济南高新区管委会签署项目合作框架协议，在创新药械研发、创新药物生产、生物医药产业高质量发展等方面开展合作。
2025-04-21Hengrui signs strategic cooperation framework agreement with Tianjin municipal government; its innovation drug industrial base in Tianjin breaks ground with an investment of RMB 1 billion.恒瑞医药与天津市政府签署战略合作框架协议；天津创新药物产业基地开工，投资10亿元。
2026-04-21Hengrui Medicine officially signed as a key enterprise with the Hong Kong SAR Government's Office for Attracting Strategic Enterprises (OASES) on April 20, 2026.恒瑞医药于2026年4月20日正式签约成为香港特区政府引进重点企业办公室（OASES）的重点引进企业。
Beijing Northern Operations Headquarters北京北方运营总部
1 · 2024-03-13
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Construction of Northern Operations Headquarters and industrialization base in Yizhuang, Beijing.在北京亦庄建设北方运营总部和产业化基地。
2024-03-13Hengrui started construction of its Northern Operations Headquarters and Industrialization Base in Yizhuang, Beijing, including a global clinical trial management center and biotech R&D center.恒瑞医药在北京亦庄启动北方运营总部和产业化基地项目建设，包括全球临床试验管理中心和生物创新药研发中心。
Peking University Cancer Hospital Yunnan partnership北京大学肿瘤医院云南医院合作
1 · 2024-03-14
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Strategic cooperation to accelerate anti-tumor drug R&D and clinical research.战略合作加速抗肿瘤药物研发和临床研究。
2024-03-14Hengrui signed a strategic cooperation agreement with Peking University Cancer Hospital Yunnan Hospital to accelerate anti-tumor drug R&D and clinical research.恒瑞医药与北京大学肿瘤医院云南医院签署战略合作协议，加速抗肿瘤新药研发和临床研究。
INS068 (insulin/GLP-1 analog)INS068 (胰岛素/GLP-1类似物)
1 · 2024-03-20
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Clinical trial approval for type 1 and type 2 diabetes.获批临床试验用于1型和2型糖尿病。
2024-03-20Hengrui's INS068 injection for type 1 and type 2 diabetes received clinical trial implied approval from CDE.恒瑞医药INS068注射液用于1型和2型糖尿病治疗获得CDE临床试验默示许可。
Thiotepa injection塞替派注射液
1 · 2024-03-25
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First domestic product approved for transplant preconditioning in severe beta-thalassemia children.国内首个获批用于重症β-地中海贫血儿童移植预处理的药物。
2024-03-25Hengrui received NMPA drug registration certificate for thiotepa injection, the first domestic product approved for transplant preconditioning in severe beta-thalassemia children.恒瑞医药获得注射用塞替派药品注册证书，为国内首个获批移植预处理适应症的产品，用于重型β-地中海贫血儿童。
SHR-7631 / SHR-4849 / SHR-3821 / SHR-7787 / SHR-4375 / SHR-3792 / SHR-4712 / SHR-4506 / SHR-7782 / SHR-2524 / SHR-3836 / SHR-5421 / SHR-6914 / SHR-3079 / SHR-1049 / SHR-9803 / SHR-4658 / SHR-4610 / SHR-2906 / SHR-1681 / SHR-4394 / SHR-1501 / SHR-1316(sc) / SHR-9839(sc) / SHR-1826 / SHR-2102 / SHR-1904 / SHR-1905 / SHR-1819 / SHR-2173 / SHR-1139 / SHR-2106 / SHR-3276 / SHR-6934 / SHR-9803 / SHR-9539 / SHR-7367 / SHR-1802 / SHR-3836 / SHR-5421 / SHR-6914 / SHR-3079 / SHR-1049 / SHR-9803 / SHR-4658 / SHR-4610 / SHR-2906 / SHR-1681 / SHR-4394 / SHR-1501 / SHR-1316(sc) / SHR-9839(sc) / SHR-1826 / SHR-2102 / SHR-1904 / SHR-1905 / SHR-1819 / SHR-2173 / SHR-1139 / SHR-2106 / SHR-3276 / SHR-6934 / SHR-9803 / SHR-9539 / SHR-7367 / SHR-1802SHR-7631 / SHR-4849 / SHR-3821 / SHR-7787 / SHR-4375 / SHR-3792 / SHR-4712 / SHR-4506 / SHR-7782 / SHR-2524 / SHR-3836 / SHR-5421 / SHR-6914 / SHR-3079 / SHR-1049 / SHR-9803 / SHR-4658 / SHR-4610 / SHR-2906 / SHR-1681 / SHR-4394 / SHR-1501 / SHR-1316(sc) / SHR-9839(sc) / SHR-1826 / SHR-2102 / SHR-1904 / SHR-1905 / SHR-1819 / SHR-2173 / SHR-1139 / SHR-2106 / SHR-3276 / SHR-6934 / SHR-9803 / SHR-9539 / SHR-7367 / SHR-1802
107 · 2024-03-26 → 2026-06-25
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Multiple novel biologic candidates entering clinical trials for various solid tumors and autoimmune indications.多个新型生物候选药物进入临床试验，针对多种实体瘤和自身免疫适应症。
2024-03-26Hengrui's subsidiary Suzhou Shengdiya received NMPA clinical trial approval for SHR-7631 injection targeting advanced solid tumors.恒瑞子公司苏州盛迪亚获得国家药监局关于注射用SHR-7631的临床试验批准，用于晚期实体瘤。
2024-04-08Subsidiary Guangdong Hengrui received clinical trial approval for SHR-1139 injection, a first-in-class biologic for psoriasis, with cumulative R&D investment of approximately 29.38 million yuan.子公司广东恒瑞收到SHR-1139注射液（银屑病治疗用生物制品，全球同靶点首个进入临床）的临床试验批准，累计研发投入约2938万元。
2024-04-09Received clinical trial approvals for HRS-9231 (novel MRI contrast agent, first-in-class in China), SHR-4597 (inhalation for asthma), and SHR-2173 (for systemic lupus erythematosus). Cumulative R&D investments: 31.59M, 35.22M, 18.93M yuan respectively.获得HRS-9231注射液（新一代造影剂，国内尚无同类产品）、SHR-4597吸入剂（支气管哮喘）、SHR-2173注射液（系统性红斑狼疮）的临床试验批准，累计研发投入分别为3159万、3522万、1893万元。
2024-04-18Subsidiary received clinical trial approval for HRS2398 sustained-release tablet (ATR inhibitor, first-in-class globally) for tumors, with cumulative R&D investment of approximately 40.29 million yuan.子公司获得HRS2398缓释片（ATR抑制剂，全球尚无同靶点药物获批）的临床试验批准，累计研发投入约4029万元。
2024-04-18Subsidiary received clinical trial approval for SHR-3276 injection, a novel biologic enhancing immune cell function for tumors, with cumulative R&D investment of approximately 13.22 million yuan.子公司获得SHR-3276注射液（全新治疗用生物制品，增强免疫细胞功能）的临床试验批准，累计研发投入约1322万元。
2024-05-08Hengrui's subsidiary Chengdu Shengdi received clinical trial approval for HRS-5965 capsule to treat IgA nephropathy and other complement-mediated kidney diseases.恒瑞子公司成都盛迪收到HRS-5965胶囊临床试验批准，用于治疗IgA肾病等补体介导的肾小球疾病。
2024-05-14Hengrui's subsidiary Guangdong Hengrui received clinical trial approval for SHR-2173 injection to treat IgA nephropathy.恒瑞子公司广东恒瑞收到SHR-2173注射液临床试验批准，用于治疗IgA肾病。
2024-05-16Hengrui's SHR0302 alkali gel received clinical trial approval for vitiligo.恒瑞SHR0302碱凝胶获得临床试验批准，用于白癜风。
2024-05-20Hengrui's subsidiary Guangdong Hengrui received clinical trial approval for SHR-1905 injection (TSLP monoclonal antibody) for chronic obstructive pulmonary disease.恒瑞子公司广东恒瑞收到SHR-1905注射液（TSLP单克隆抗体）临床试验批准，用于慢性阻塞性肺疾病。
2024-05-29Hengrui received clinical trial approval for SHR0302 alkali gel (topical JAK1 inhibitor) for vitiligo.恒瑞收到SHR0302碱凝胶（外用JAK1抑制剂）临床试验批准，用于白癜风。
2024-05-30Hengrui's subsidiaries received clinical trial approvals for SHR-9539 injection (T-cell engager for multiple myeloma) and HRS-5346 tablet (small molecule for lipoprotein disorders).恒瑞子公司收到SHR-9539注射液（用于多发性骨髓瘤的T细胞衔接器）和HRS-5346片（用于脂蛋白紊乱的小分子药物）的临床试验批准。
2024-06-04Subsidiaries Shanghai Hengrui Pharma and Suzhou Sdi Biopharma received NMPA clinical trial approval for SHR-4849 injection, a therapeutic biologic targeting solid tumors.子公司上海恒瑞医药和苏州盛迪亚生物医药收到国家药监局关于SHR-4849注射液的临床试验批准，该药为治疗用生物制品，靶向晚期恶性实体瘤。
2024-06-30Subsidiary Fujian Shengdi Pharma received NMPA clinical trial approval for HRS-7249 injection, a first-in-class drug for hyperlipidemia that lowers triglycerides.子公司福建盛迪医药收到国家药监局关于HRS-7249注射液的临床试验批准，该药为1类创新药，用于治疗高脂血症，可降低甘油三酯。
2024-07-01Hengrui Medicine subsidiary Fujian Shengdi received NMPA clinical trial approval for its self-developed Class 1 innovative drug HRS-7249 injection for hyperlipidemia.恒瑞医药子公司福建盛迪收到国家药监局对其自主研发的1类创新药HRS-7249注射液用于高脂血症的临床试验批准。
2024-07-04Hengrui Medicine subsidiary Guangdong Hengrui received NMPA clinical trial approval for its self-developed Class 1 innovative drug HRS-9813 tablets for idiopathic pulmonary fibrosis (IPF).恒瑞医药子公司广东恒瑞收到国家药监局对其自主研发的1类创新药HRS-9813片用于特发性肺纤维化（IPF）的临床试验批准。
2024-07-21Hengrui Medicine received NMPA clinical trial approval for hetrombopag olamine tablets for chronic liver disease patients with thrombocytopenia undergoing invasive procedures or surgery.恒瑞医药收到国家药监局对海曲泊帕乙醇胺片用于计划接受有创性操作或手术的慢性肝病伴血小板减少症患者的临床试验批准。
2024-08-08Hengrui received NMPA clinical trial approval for HRS-4508 tablets, a novel tyrosine kinase inhibitor for advanced solid tumors; cumulative R&D investment about 19.24 million yuan.恒瑞医药获国家药监局批准HRS-4508片临床试验，该药为新型酪氨酸激酶抑制剂，用于晚期实体瘤；累计研发投入约1924万元。
2024-08-08Hengrui subsidiary Guangdong Hengrui received NMPA clinical trial approval for SHR-1819 injection, targeting IL-4Rα for type 2 inflammatory diseases (e.g., prurigo nodularis); global reference drug Dupixent had 2023 sales of ~$11.59 billion; cumulative R&D investment about 100.06 million yuan.恒瑞子公司广东恒瑞获国家药监局批准SHR-1819注射液临床试验，靶向IL-4Rα用于2型炎症相关疾病（如结节性痒疹）；全球参照药Dupixent 2023年销售额约115.9亿美元；累计研发投入约10006万元。
2024-08-08Hengrui subsidiaries Shanghai Shengdi, Shanghai Hengrui, and Suzhou Shengdiya received NMPA clinical trial approvals for SHR-3821 injection (humanized antibody for advanced malignant solid tumors) and SHR-7787 injection (class 1 biologic for T-cell targeted killing of solid tumors).恒瑞子公司上海盛迪、上海恒瑞和苏州盛迪亚获国家药监局批准SHR-3821注射液（人源化抗体用于晚期恶性实体瘤）和SHR-7787注射液（1类治疗用生物制品，靶向杀伤实体瘤）临床试验。
2024-08-13Hengrui received NMPA clinical trial approval for SHR7280 tablets (oral GnRH receptor antagonist) for phase II trial in uterine fibroids with menorrhagia; cumulative R&D investment about 174 million yuan.恒瑞医药获国家药监局批准SHR7280片（口服GnRH受体拮抗剂）开展II期临床试验，用于伴有月经过多的子宫肌瘤；累计研发投入约1.74亿元。
2024-08-15Hengrui subsidiary Guangdong Hengrui received NMPA clinical trial approval for SHR-2106 injection, a monoclonal antibody for active primary Sjögren's syndrome; no similar product approved globally.恒瑞子公司广东恒瑞获国家药监局批准SHR-2106注射液临床试验，该药为单克隆抗体，用于活动性原发性干燥综合征；全球尚无同类产品获批。
2024-09-23Hengrui received NMPA clinical trial approval for HRS-2129 tablets, a first-in-class drug for acute and chronic pain; R&D investment ~29.83 million yuan.恒瑞医药HRS-2129片获国家药监局临床试验批准，用于急慢性疼痛，国内外尚无同类产品上市，研发投入约2983万元。
2024-09-29Hengrui received NMPA clinical trial approval for SHR-1905 injection (TSLP monoclonal antibody) for adolescent asthma (ages 12-17); R&D investment ~122.07 million yuan.恒瑞医药SHR-1905注射液（TSLP单抗）获国家药监局临床试验批准，用于12-17周岁青少年哮喘，研发投入约1.2207亿元。
2024-10-09Hengrui received NMPA clinical trial approval for HRS-2183 injection, a first-in-class drug for severe Gram-negative bacterial infections including carbapenem-resistant strains; R&D cost ~19.35 million yuan.恒瑞医药收到国家药监局临床试验批准，注射用HRS-2183（国内外尚无同类产品）用于治疗革兰阴性菌引起的严重感染（包括碳青霉烯耐药菌感染）；累计研发费用约1935万元。
2024-10-15Hengrui's subsidiary Beijing Shengdi received NMPA clinical trial approval for SHR-6934 injection, a first-in-class biologic for heart failure; R&D cost ~8.24 million yuan.恒瑞医药子公司北京盛迪医药收到国家药监局临床试验批准，SHR-6934注射液（国内外尚无同类产品）用于治疗心力衰竭；累计研发费用约824万元。
2024-10-25Hengrui's subsidiary Fujian Shengdi received NMPA clinical trial approval for HRS-9563 injection, a first-in-class drug for hypertension; R&D cost ~42.8 million yuan.恒瑞医药子公司福建盛迪医药收到国家药监局临床试验批准，HRS-9563注射液（国内外尚无同类产品）用于治疗高血压；累计研发费用约4280万元。
2024-11-14Hengrui Medicine's subsidiary Guangdong Hengrui Pharma received clinical trial approval for SHR-2173 injection, a self-developed biologic for primary immune thrombocytopenia (ITP), with no similar drug on the market globally.恒瑞医药子公司广东恒瑞医药收到SHR-2173注射液治疗原发免疫性血小板减少症的临床试验批准，该药为自主研发的生物制品，全球尚无同类药物上市。
2024-11-14Hengrui Medicine's subsidiary Fujian Shengdi Pharma received clinical trial approval for HRS-5632 injection, a first-in-class chemical drug for lipoprotein disorders, with no similar drug approved globally.恒瑞医药子公司福建盛迪医药收到HRS-5632注射液治疗脂蛋白紊乱的临床试验批准，该药为1类化学药物，全球暂无同类药物获批。
2024-11-21Hengrui Medicine's subsidiaries Shanghai Hengrui Pharma and Shandong Shengdi Pharma received clinical trial approval for HRS-6208 capsules, a novel small-molecule inhibitor for anti-tumor therapy.恒瑞医药子公司上海恒瑞医药和山东盛迪医药收到HRS-6208胶囊的临床试验批准，该药为新型小分子抑制剂，用于抗肿瘤治疗。
2024-11-26Hengrui Medicine's subsidiary Guangdong Hengrui Pharma received clinical trial approval for SHR-1819 injection, a self-developed anti-IL-4Rα monoclonal antibody, for Phase Ib/II trial in pediatric and adolescent atopic dermatitis (ages 6-17).恒瑞医药子公司广东恒瑞医药收到SHR-1819注射液治疗6-17岁儿童和青少年特应性皮炎的Ib/II期临床试验批准，该药为自主研发的抗IL-4Rα单抗。
2024-12-10Hengrui's subsidiaries received NMPA clinical trial approval for HRS-3802 sustained-release tablet, a novel CDK inhibitor for advanced malignant solid tumors, with cumulative R&D investment of approximately 10.25 million yuan.恒瑞医药子公司收到国家药监局关于HRS-3802缓释片的药物临床试验批准通知书，该药为新型细胞周期蛋白依赖性激酶抑制剂，用于晚期恶性实体瘤，累计研发投入约1025万元。
2024-12-10Hengrui and its subsidiary received NMPA clinical trial approval for injection SHR-4394, a self-developed biologic for prostate cancer, with cumulative R&D investment of approximately 18.42 million yuan.恒瑞医药及子公司收到国家药监局关于注射用SHR-4394的药物临床试验批准通知书，该药为自主研发的治疗用生物制品，拟用于治疗前列腺癌，累计研发投入约1842万元。
2024-12-13Hengrui's subsidiary Guangdong Hengrui Pharmaceutical received NMPA clinical trial approval for SHR-2173 injection, a self-developed biologic for lupus nephritis, with cumulative R&D investment of approximately 45.03 million yuan.恒瑞医药子公司广东恒瑞医药收到国家药监局关于SHR-2173注射液的药物临床试验批准通知书，该药为自主研发的治疗用生物制品，用于狼疮肾炎，累计研发投入约4503万元。
2024-12-20Hengrui's subsidiaries received NMPA clinical trial approval for injection SHR-1681, a self-developed class 1 biologic targeting tumor cell surface antigens for malignant solid tumors, with cumulative R&D investment of approximately 7.21 million yuan.恒瑞医药子公司收到国家药监局关于注射用SHR-1681的药物临床试验批准通知书，该药为自主研发的1类治疗用生物制品，可特异性结合肿瘤细胞表面抗原，用于恶性实体瘤，累计研发投入约721万元。
2025-01-10Subsidiary Guangdong Hengrui received NMPA clinical trial approval for SHR-1819 injection, a self-developed anti-IL-4Rα monoclonal antibody for chronic spontaneous urticaria; cumulative R&D investment ~RMB 125 million.子公司广东恒瑞收到国家药监局关于SHR-1819注射液的临床试验批准，该药为自主研发的靶向人IL-4Rα重组人源化单抗，用于慢性自发性荨麻疹；累计研发投入约1.25亿元。
2025-01-10Subsidiary Suzhou Sdiya received NMPA clinical trial approval for SHR-4375 injection, a self-developed biologic for advanced malignant solid tumors; cumulative R&D investment ~RMB 31.08 million.子公司苏州盛迪亚收到国家药监局关于SHR-4375注射液的临床试验批准，该药为自主研发的治疗用生物制品，用于晚期恶性实体瘤；累计研发投入约3108万元。
2025-01-14Subsidiaries Shanghai Hengrui and Suzhou Sdiya received NMPA clinical trial approval for SHR-9839(sc) injection, a self-developed humanized antibody for advanced malignant tumors; cumulative R&D investment ~RMB 57.45 million.子公司上海恒瑞和苏州盛迪亚收到国家药监局关于注射用SHR-9839(sc)的临床试验批准，该药为自主研发的人源化抗体药物，用于晚期恶性肿瘤；累计研发投入约5745万元。
2025-03-09Subsidiaries received clinical trial approval for HRS-4029, a novel neuroprotectant for acute ischemic stroke.子公司获注射用HRS-4029（新型神经保护剂）用于急性缺血性卒中的临床试验批准。
2025-03-17Subsidiary received clinical trial approval for HRS-6213 injection, a PET diagnostic imaging agent for solid tumors.子公司获HRS-6213注射液（PET诊断显像剂）用于实体肿瘤诊断和评估的临床试验批准。
2025-03-26Received clinical trial approval for SHR-9803, a biologic that activates anti-tumor immunity, in advanced solid tumors.获注射用SHR-9803（激活抗肿瘤免疫活性的生物制品）在晚期实体瘤中的临床试验批准。
2025-03-27Subsidiary received clinical trial approval for HRS-5817 injection, a chemical drug for overweight/obesity.子公司获HRS-5817注射液（化学药物）用于超重或肥胖适应症的临床试验批准。
2025-04-01Hengrui's subsidiary Guangdong Hengrui receives NMPA clinical trial approval for HRS-9813 capsules, a first-in-class innovative drug for idiopathic pulmonary fibrosis (IPF); cumulative R&D investment ~RMB 98.27 million.恒瑞子公司广东恒瑞收到国家药监局关于HRS-9813胶囊的临床试验批准，该药为1类创新药，用于特发性肺纤维化（IPF）；累计研发投入约9827万元。
2025-04-03Hengrui's subsidiaries Shandong Shengdi and Shanghai Hengrui receive NMPA clinical trial approval for HRS-6719 tablets, a novel small-molecule inhibitor for advanced solid tumors; cumulative R&D investment ~RMB 20.33 million.恒瑞子公司山东盛迪和上海恒瑞收到国家药监局关于HRS-6719片的临床试验批准，该药为新型小分子抑制剂，用于晚期实体瘤；累计研发投入约2033万元。
2025-04-13Hengrui receives NMPA clinical trial approval for HRS-9190 injection, a first-in-class drug for muscle relaxation during anesthesia; cumulative R&D investment ~RMB 6.26 million.恒瑞医药收到国家药监局关于注射用HRS-9190的临床试验批准，该药为1类新药，用于麻醉诱导期气管插管及术中骨骼肌松弛；累计研发投入约626万元。
2025-04-13Hengrui's subsidiaries Shanghai Hengrui and Suzhou Shengdiya receive NMPA clinical trial approval for SHR-3792 injection, a novel anti-tumor candidate for advanced solid tumors; cumulative R&D investment ~RMB 32.71 million.恒瑞子公司上海恒瑞和苏州盛迪亚收到国家药监局关于SHR-3792注射液的临床试验批准，该药为创新型抗肿瘤候选药物，用于晚期实体瘤；累计研发投入约3271万元。
2025-04-14Hengrui's subsidiary Guangdong Hengrui receives NMPA clinical trial approval for SHR-1819 injection (anti-IL-4Rα mAb) for allergic rhinitis; cumulative R&D investment ~RMB 150 million.恒瑞子公司广东恒瑞收到国家药监局关于SHR-1819注射液（抗IL-4Rα单抗）的临床试验批准，用于过敏性鼻炎；累计研发投入约1.5亿元。
2025-04-18Hengrui's subsidiaries Shanghai Hengrui and Beijing Shengdi receive NMPA clinical trial approval for SHR-4658 injection, a first-in-class drug for heart failure; cumulative R&D investment ~RMB 31.61 million.恒瑞子公司上海恒瑞和北京盛迪收到国家药监局关于SHR-4658注射液的临床试验批准，该药为1类创新药，用于心力衰竭；累计研发投入约3161万元。
2025-04-20Hengrui's subsidiary Guangdong Hengrui receives NMPA clinical trial approval for HRS-9813 capsules for progressive pulmonary fibrosis (PPF); cumulative R&D investment ~RMB 98.27 million.恒瑞子公司广东恒瑞收到国家药监局关于HRS-9813胶囊的临床试验批准，用于进展性肺纤维化（PPF）；累计研发投入约9827万元。
2025-04-27Hengrui's subsidiary Suzhou Shengdiya receives NMPA clinical trial approval for carrelizumab injection (anti-PD-1 mAb) for a new indication.恒瑞子公司苏州盛迪亚收到国家药监局关于注射用卡瑞利珠单抗（抗PD-1单抗）的临床试验批准，用于新适应症。
2025-04-29Hengrui's subsidiary Fujian Shengdi receives NMPA clinical trial approval for HRS-5635 injection (siRNA drug for hepatitis B) in combination with pegylated interferon α; cumulative R&D investment ~RMB 130 million.恒瑞子公司福建盛迪收到国家药监局关于HRS-5635注射液（乙肝siRNA药物）联合聚乙二醇干扰素α的临床试验批准；累计研发投入约1.3亿元。
2025-05-09Hengrui Medicine's subsidiary received a clinical trial approval notice from the NMPA for SHR-1316(sc) injection, a self-developed humanized anti-PD-L1 monoclonal antibody subcutaneous formulation for first-line treatment of extensive-stage small cell lung cancer.恒瑞医药子公司获国家药监局批准SHR-1316(sc)注射液临床试验，该药为自主研发的人源化抗PD-L1单克隆抗体皮下制剂，用于广泛期小细胞肺癌一线治疗。
2025-05-26Hengrui Medicine's subsidiaries received a clinical trial approval notice from the NMPA for SHR-4712 injection, a self-developed class 1 biologic for advanced solid tumors, with cumulative R&D investment of approximately 24.92 million yuan.恒瑞医药子公司获国家药监局批准SHR-4712注射液临床试验，该药为自主研发的1类治疗用生物制品，用于晚期实体瘤，累计研发投入约2492万元。
2025-05-30Hengrui Medicine's subsidiary received a clinical trial approval notice from the NMPA for HRS9531 injection, a novel GIPR/GLP-1R dual agonist for type 2 diabetes in adults with inadequate glycemic control on basal insulin.恒瑞医药子公司获国家药监局批准HRS9531注射液临床试验，该药为新型GIPR/GLP-1R双激动剂，用于接受基础胰岛素治疗血糖仍控制不佳的成人2型糖尿病。
2025-06-13Hengrui received NMPA clinical trial approval for Remimazolam tosylate injection for sedation in pediatric (3-17 years) general anesthesia; cumulative R&D investment about 173 million yuan.恒瑞医药获得注射用甲苯磺酸瑞马唑仑临床试验批准，用于3-17岁儿童和青少年全身麻醉手术镇静，累计研发投入约1.73亿元。
2025-06-27Hengrui's subsidiary Beijing Shengdi received NMPA clinical trial approval for HRS-8829 injection concentrate, a small molecule drug for acute ischemic stroke; R&D investment about 9.74 million yuan.恒瑞医药子公司北京盛迪获得HRS-8829注射用浓溶液临床试验批准，用于急性缺血性卒中，研发投入约974万元。
2025-07-03Hengrui subsidiary Suzhou Shengdiya received clinical trial approval for SHR-4506 injection, a self-developed Class 1 biologic for advanced malignant tumors; cumulative R&D investment ~19.92 million yuan.恒瑞子公司苏州盛迪亚获得SHR-4506注射液临床试验批准，为自主研发的1类治疗用生物制品，用于晚期恶性肿瘤；累计研发投入约1992万元。
2025-07-08Hengrui subsidiary Guangdong Hengrui received clinical trial approval for HRS-9821 inhalation powder, a PDE3/PDE4 inhibitor for COPD maintenance treatment; cumulative R&D investment ~38.43 million yuan.恒瑞子公司广东恒瑞获得HRS-9821吸入粉雾剂临床试验批准，为PDE3/PDE4抑制剂，用于COPD维持治疗；累计研发投入约3843万元。
2025-07-08Hengrui subsidiary Guangdong Hengrui received clinical trial approval for SHR-2173 injection, a self-developed biologic for primary membranous nephropathy; cumulative R&D investment ~64.07 million yuan.恒瑞子公司广东恒瑞获得SHR-2173注射液临床试验批准，为自主研发的治疗用生物制品，用于原发性膜性肾病；累计研发投入约6407万元。
2025-07-24Hengrui subsidiary Beijing Shengdi received clinical trial approval for HRS8179 injection to prevent severe cerebral edema after large hemispheric infarction; cumulative R&D investment ~47.4 million yuan.恒瑞子公司北京盛迪获得注射用HRS8179临床试验批准，用于预防大脑半球大面积梗死后严重脑水肿；累计研发投入约4740万元。
2025-07-24Hengrui subsidiary Shandong Shengdi received clinical trial approval for HRS-1893 tablets, a highly selective cardiac myosin small molecule inhibitor for heart failure with preserved ejection fraction (HFpEF); cumulative R&D investment ~60.67 million yuan.恒瑞子公司山东盛迪获得HRS-1893片临床试验批准，为高选择性心肌肌球蛋白小分子抑制剂，用于射血分数保留的心力衰竭；累计研发投入约6067万元。
2025-07-31Hengrui and subsidiary Chengdu Shengdi received clinical trial approval for HRS-5041 tablets, a novel AR-PROTAC small molecule for prostate cancer.恒瑞医药及子公司成都盛迪获得HRS-5041片临床试验批准，为新型AR-PROTAC小分子，用于前列腺癌。
2025-08-14Hengrui received NMPA clinical trial approval for SHR-7782 injection, a novel biologic targeting tumor cell surface antigens for advanced solid tumors.恒瑞医药获国家药监局批准，开展SHR-7782注射液（靶向肿瘤细胞表面抗原的新型生物制品）治疗晚期实体瘤的临床试验。
2025-08-25Hengrui received NMPA clinical trial approval for HRS-6093, an oral KRAS G12D inhibitor for solid tumors with G12D mutations.恒瑞医药获国家药监局批准，开展HRS-6093片（口服KRAS G12D抑制剂）治疗携带G12D突变实体瘤的临床试验。
2025-08-25Hengrui's subsidiary Fujian Shengdi received NMPA clinical trial approval for HRS-2162, a novel muscle relaxant antagonist.恒瑞医药子公司福建盛迪获国家药监局批准，开展HRS-2162注射液（新一代肌松药拮抗剂）的临床试验。
2025-09-02Hengrui received clinical trial approval for HRS-7172, a novel anti-tumor small molecule inhibitor targeting RAS mutations/amplifications, for advanced solid tumors.恒瑞获HRS-7172片（新型抗肿瘤小分子抑制剂，靶向RAS突变/扩增）临床试验批准，用于晚期实体瘤。
2025-09-04Hengrui's subsidiary Ruishi Bio received clinical trial approval for RSS0393 ointment, a PDE4 small molecule inhibitor for inflammatory conditions.恒瑞子公司瑞石生物获RSS0393软膏（PDE4小分子抑制剂）临床试验批准，用于炎症性疾病。
2025-09-04Hengrui and its subsidiary Fujian Shengdi received clinical trial approval for HRS-4729 injection, a GLP-1R/GIPR/GCGR triple agonist for weight loss and liver fat reduction.恒瑞及子公司福建盛迪获HRS-4729注射液（GLP-1R/GIPR/GCGR三激动剂）临床试验批准，用于减重和减少肝脏脂肪。
2025-10-13Hengrui's subsidiary Guangdong Hengrui Pharma received NMPA clinical trial approval for SHR-1905 injection (TSLP monoclonal antibody) for atopic dermatitis, with global competitor Tezspire (AstraZeneca/Amgen) having 2024 sales of ~$1.22B.恒瑞子公司广东恒瑞医药收到NMPA临床试验批准，SHR-1905注射液（TSLP单克隆抗体）用于特应性皮炎，全球同类产品Tezspire（阿斯利康/安进）2024年销售额约12.2亿美元。
2025-11-03Hengrui Medicine received NMPA Clinical Trial Approval Notice for Reviramide Tablets (second-generation AR inhibitor) combined with HS-20093 for prostate cancer. The product has been on market since 2022; global sales of similar products reached ~$11.037 billion in 2024.恒瑞医药收到国家药监局关于瑞维鲁胺片（第二代AR抑制剂）联合注射用HS-20093用于前列腺癌的《药物临床试验批准通知书》。该产品已于2022年上市，同类产品2024年全球销售额约110.37亿美元。
2025-11-07Hengrui received NMPA Clinical Trial Approval for HRS-2430 injection, an intravenous general anesthetic. Similar products (etomidate, midazolam, remimazolam) had global sales of ~$773 million in 2024; R&D investment ~24.6 million yuan.恒瑞医药收到国家药监局关于HRS-2430注射液（静脉全身麻醉药）的《药物临床试验批准通知书》。同类产品2024年全球销售额约7.73亿美元，累计研发投入约2460万元。
2025-11-07Hengrui's subsidiary Shanghai Shengdi Pharma received NMPA Clinical Trial Approval for SHR-4610 injection, a self-developed innovative anti-tumor drug for advanced solid tumors. R&D investment ~7.36 million yuan.恒瑞子公司上海盛迪医药收到国家药监局关于SHR-4610注射液（自主研发创新型抗肿瘤药物，用于晚期实体瘤）的《药物临床试验批准通知书》，累计研发投入约736万元。
2025-11-13Hengrui received NMPA Clinical Trial Approval for Reviramide Tablets to conduct Phase III trial for prostate cancer. The drug was approved in 2022 for high-volume metastatic hormone-sensitive prostate cancer.恒瑞医药收到国家药监局关于瑞维鲁胺片开展前列腺癌Ⅲ期临床试验的《药物临床试验批准通知书》。该药已于2022年获批用于高瘤负荷转移性激素敏感性前列腺癌。
2025-11-17Hengrui and subsidiary Shandong Shengdi Pharma received NMPA Clinical Trial Approvals for HRS-6209 capsule (novel selective CDK4 inhibitor for advanced solid tumors, R&D ~80.37 million yuan) and HRS-2189 tablet (novel KAT6 inhibitor for advanced malignancies, R&D ~49 million yuan).恒瑞医药及子公司山东盛迪医药收到国家药监局关于HRS-6209胶囊（新型选择性CDK4抑制剂，用于晚期恶性实体瘤，研发投入约8037万元）和HRS-2189片（新型KAT6抑制剂，用于晚期恶性肿瘤，研发投入约4900万元）的《药物临床试验批准通知书》。
2025-11-21Hengrui's subsidiary Guangdong Hengrui Pharma received NMPA Clinical Trial Approval for SHR-1139 injection, a self-developed biologic for pyoderma gangrenosum, with no similar drug approved globally. R&D investment ~100.13 million yuan.恒瑞子公司广东恒瑞医药收到国家药监局关于SHR-1139注射液（自主研发治疗用生物制品，用于坏疽性脓皮病，国内外尚无同类药物获批）的《药物临床试验批准通知书》，累计研发投入约1.0013亿元。
2025-11-25Hengrui received NMPA Clinical Trial Approval for HRS-8364 tablet, a self-developed innovative anti-tumor drug for advanced solid tumors, with no similar drug approved globally. R&D investment ~21.65 million yuan.恒瑞医药收到国家药监局关于HRS-8364片（自主研发创新型抗肿瘤药物，用于晚期实体瘤，国内外尚无同类药物获批）的《药物临床试验批准通知书》，累计研发投入约2165万元。
2025-11-27Hengrui and subsidiary Ruishi Bio received NMPA Clinical Trial Approval for Sulfate Ivarmacitinib Tablets and SHR0302 Alkali Gel for vitiligo treatment. Ivarmacitinib is a selective JAK1 inhibitor with no oral同类 drug approved globally; R&D investment ~1.091 billion yuan.恒瑞医药及子公司瑞石生物医药收到国家药监局关于硫酸艾玛昔替尼片和SHR0302碱凝胶用于治疗白癜风的《药物临床试验批准通知书》。艾玛昔替尼为高选择性JAK1抑制剂，全球无口服同类药物获批，累计研发投入约10.91亿元。
2025-12-12Hengrui's subsidiary Fujian Shengdi receives NMPA clinical trial approval for HRS9531 injection, a novel GIPR/GLP-1R dual agonist, for metabolic dysfunction-associated steatohepatitis (MASH); cumulative R&D investment ~519 million yuan.恒瑞子公司福建盛迪收到国家药监局关于HRS9531注射液（新型GIPR/GLP-1R双激动剂）用于代谢相关脂肪性肝炎的临床试验批准通知书，累计研发投入约5.19亿元。
2025-12-12Hengrui's subsidiary Ruishi Bio receives NMPA clinical trial approval for RSS0343 tablets, an oral small-molecule Class 1 new drug, for chronic rhinosinusitis without nasal polyps and chronic obstructive pulmonary disease.恒瑞子公司瑞石生物收到国家药监局关于RSS0343片（口服小分子1类新药）用于慢性鼻窦炎不伴鼻息肉和慢性阻塞性肺疾病的临床试验批准通知书。
2025-12-12Hengrui's subsidiary Shandong Shengdi receives NMPA clinical trial approval for HRS-1780 tablets, a mineralocorticoid receptor antagonist, for heart failure with LVEF ≥40%.恒瑞子公司山东盛迪收到国家药监局关于HRS-1780片（盐皮质激素受体拮抗剂）用于左室射血分数≥40%的心力衰竭的临床试验批准通知书。
2025-12-19Hengrui's subsidiary Beijing Shengdi receives NMPA clinical trial approval for SHR-2906 injection, a self-developed biologic for overweight and obesity; no similar drug approved globally; cumulative R&D investment ~17.06 million yuan.恒瑞子公司北京盛迪收到国家药监局关于SHR-2906注射液（自主研发的治疗用生物制品）用于超重或肥胖的临床试验批准通知书，国内外尚无同类药物获批，累计研发投入约1706万元。
2025-12-19Hengrui and its subsidiaries receive NMPA clinical trial approvals for SHR-9539 injection (a T-cell-engaging biologic for multiple myeloma, R&D ~39.93 million yuan) and HRS-3738 tablets (a novel CRBN E3 ligase modulator for hematologic tumors, R&D ~63.63 million yuan).恒瑞医药及子公司收到国家药监局关于SHR-9539注射液（募集活化T细胞的生物制品，用于多发性骨髓瘤，研发投入约3993万元）和HRS-3738片（新一代CRBN E3泛素连接酶调节剂，用于血液肿瘤，研发投入约6363万元）的临床试验批准通知书。
2025-12-19Hengrui's subsidiary Shanghai Hengrui receives NMPA clinical trial approval for injectable Leuprorelin Acetate microspheres, a generic of a foreign-origin drug not yet marketed in China, for prostate cancer; cumulative R&D investment ~24.68 million yuan.恒瑞子公司上海恒瑞收到国家药监局关于注射用醋酸亮丙瑞林微球（仿制境外已上市但境内未上市的原研药）用于前列腺癌的临床试验批准通知书，累计研发投入约2468万元。
2025-12-24Hengrui's subsidiary Suzhou Shengdiya receives NMPA clinical trial approval for injectable SHR-A2102, a self-developed Nectin-4-targeting ADC (payload: TOP1i), for advanced solid tumors and esophageal cancer; cumulative R&D investment ~248 million yuan.恒瑞子公司苏州盛迪亚收到国家药监局关于注射用SHR-A2102（自主研发的靶向Nectin-4的ADC，有效载荷为TOP1i）用于晚期实体瘤和食管癌的临床试验批准通知书，累计研发投入约2.48亿元。
2025-12-29Hengrui's subsidiary Shanghai Hengrui receives NMPA clinical trial approval for HRS-6257 tablets, a novel drug for acute and chronic pain; no drug targeting the same mechanism is approved in China; cumulative R&D investment ~15.58 million yuan.恒瑞子公司上海恒瑞收到国家药监局关于HRS-6257片（用于急慢性疼痛的创新药）的临床试验批准通知书，国内尚无同靶点药物获批，累计研发投入约1558万元。
2026-01-05Subsidiary Fujian Shengdi Pharmaceutical received NMPA clinical trial approval for HRS9531 injection (GLP-1R/GIPR dual agonist) combined with HRS-5817 injection for adult obesity or overweight.子公司福建盛迪医药收到国家药监局临床试验批准，HRS9531注射液（GLP-1R/GIPR双激动剂）联合HRS-5817注射液用于成人肥胖或超重。
2026-01-09Company and subsidiaries received NMPA clinical trial approvals for four drugs: SHR-4394 injection, HRS-5041 tablet, Zemitostat tablet (SHR-2554), and Rezvilutamide tablet, for various cancer indications.公司及子公司收到国家药监局对注射用SHR-4394、HRS-5041片、泽美妥司他片（SHR-2554）、瑞维鲁胺片四款药物的临床试验批准，用于多种癌症适应症。
2026-01-20Subsidiary Shandong Shengdi received NMPA clinical trial approval for HRS-2141 tablet (I) and (II), a fixed-dose combination for type 2 diabetes.子公司山东盛迪收到国家药监局临床试验批准，HRS-2141片（Ⅰ）、（Ⅱ）为固定剂量复方制剂用于2型糖尿病。
2026-01-20Company and subsidiaries received NMPA clinical trial approvals for SHR-9839 (sc) injection and HRS-4642 injection for advanced colorectal cancer and KRAS G12D mutant tumors.公司及子公司收到国家药监局对注射用SHR-9839（sc）和HRS-4642注射液的临床试验批准，用于晚期结直肠癌和KRAS G12D突变肿瘤。
2026-01-26Company received NMPA clinical trial approval for SHR-1049 injection as monotherapy for advanced solid tumors.公司收到国家药监局临床试验批准，SHR-1049注射液单药用于晚期实体瘤。
2026-03-04Hengrui Medicine's subsidiary Shandong Shengdi received NMPA clinical trial approval for HRS-1780 tablets, a mineralocorticoid receptor antagonist for primary aldosteronism; cumulative R&D investment ~70.4 million yuan.恒瑞医药子公司山东盛迪获国家药监局批准HRS-1780片临床试验，为盐皮质激素受体拮抗剂，拟用于原发性醛固酮增多症；累计研发投入约7040万元。
2026-03-09Hengrui Medicine's subsidiary Fujian Shengdi received NMPA clinical trial approval for HRS9531 injection (GIPR/GLP-1R dual agonist) for chronic kidney disease (CKD); no similar drug approved globally for CKD.恒瑞医药子公司福建盛迪获国家药监局批准HRS9531注射液（GIPR/GLP-1R双激动剂）用于慢性肾脏病（CKD）临床试验；全球暂无同类药物获批该适应症。
2026-03-11Hengrui Medicine's subsidiary Suzhou Shengdiya received NMPA clinical trial approval for SHR-2524 injection (2.1/2.3 class biologic) for hepatocellular carcinoma; cumulative R&D investment ~10.1 million yuan.恒瑞医药子公司苏州盛迪亚获国家药监局批准SHR-2524注射液（2.1/2.3类治疗用生物制品）用于肝细胞癌临床试验；累计研发投入约1010万元。
2026-03-16Hengrui Medicine's subsidiary Guangdong Hengrui received NMPA clinical trial approval for SHR-1819 injection (anti-IL-4Rα mAb) combined with SHR-1905 injection (anti-TSLP mAb) for atopic dermatitis; cumulative R&D investment ~346 million yuan and ~257 million yuan respectively.恒瑞医药子公司广东恒瑞获国家药监局批准SHR-1819注射液（抗IL-4Rα单抗）联合SHR-1905注射液（抗TSLP单抗）用于特应性皮炎临床试验；累计研发投入分别约3.46亿元和2.57亿元。
2026-03-20Hengrui Medicine's subsidiary Shanghai Hengrui received NMPA clinical trial approval for SHR-3836 injection, a self-developed innovative anti-tumor drug for multiple myeloma; cumulative R&D investment ~31.7 million yuan.恒瑞医药子公司上海恒瑞获国家药监局批准SHR-3836注射液（自主研发创新型抗肿瘤药物）用于多发性骨髓瘤临床试验；累计研发投入约3170万元。
2026-03-26Hengrui Medicine's subsidiary Fujian Shengdi received NMPA clinical trial approval for HRS9531 injection for reducing major adverse cardiovascular events in patients with atherosclerotic cardiovascular disease.恒瑞医药子公司福建盛迪获国家药监局批准HRS9531注射液用于降低动脉粥样硬化性心血管疾病患者的主要心血管不良事件风险临床试验。
2026-04-15Hengrui's subsidiary Shandong Shengdi received NMPA clinical trial approval for HRS-7156 tablets, a first-in-class drug for heart failure, with cumulative R&D investment of about 37.6 million yuan.恒瑞医药子公司山东盛迪收到国家药监局关于HRS-7156片的临床试验批准，该药为1类新药用于心力衰竭，累计研发投入约3760万元。
2026-04-20Hengrui's subsidiary Fujian Shengdi received NMPA clinical trial approval for HRS9531 injection for weight management in adolescents (≥12 and <18 years) with overweight/obesity; NDA for adults was accepted in September 2025.恒瑞医药子公司福建盛迪收到国家药监局关于HRS9531注射液的临床试验批准，用于青少年超重和肥胖患者；成人长期体重管理上市申请已于2025年9月获受理。
2026-04-28Hengrui's subsidiary Guangdong Hengrui received NMPA clinical trial approval for SHR-2173 injection, a biologic for generalized myasthenia gravis, with cumulative R&D investment of about 134 million yuan.恒瑞医药子公司广东恒瑞收到国家药监局关于SHR-2173注射液的临床试验批准，该药为治疗用生物制品用于全身型重症肌无力，累计研发投入约1.34亿元。
2026-05-08Hengrui received NMPA clinical trial approval for HRS-3005 tablets, a novel anti-tumor drug for B-cell malignancies, with cumulative R&D investment of approximately RMB 26.2 million.恒瑞医药收到国家药监局关于HRS-3005片的《药物临床试验批准通知书》，该药为自主研发的创新型抗肿瘤药物，拟用于B细胞恶性肿瘤，累计研发投入约2620万元。
2026-05-14Hengrui's subsidiary received NMPA clinical trial approval for SHR-3079 injection, a novel anti-tumor drug for B-cell non-Hodgkin lymphoma, with cumulative R&D investment of approximately RMB 23.4 million.恒瑞医药子公司收到国家药监局关于SHR-3079注射液的《药物临床试验批准通知书》，该药为自主研发的创新型抗肿瘤药物，拟用于B细胞非霍奇金淋巴瘤，累计研发投入约2340万元。
2026-05-14Hengrui's subsidiary Ruishi Biopharma received NMPA clinical trial approval for RSS0393 latex, a PDE4 inhibitor for atopic dermatitis, with cumulative R&D investment of approximately RMB 53 million.恒瑞医药子公司瑞石生物医药收到国家药监局关于RSS0393乳胶的《药物临床试验批准通知书》，该产品为含PDE4小分子抑制剂的乳胶，拟用于特应性皮炎，累计研发投入约5300万元。
2026-05-26Hengrui's subsidiary Suzhou Shengdiya received NMPA clinical trial approval for SHR-5421 injection, a novel anti-tumor drug for multiple myeloma, with cumulative R&D investment of approximately RMB 20.3 million.恒瑞医药子公司苏州盛迪亚生物医药收到国家药监局关于注射用SHR-5421的《药物临床试验批准通知书》，该药为自主研发的创新型抗肿瘤药物，拟用于多发性骨髓瘤，累计研发投入约2030万元。
2026-05-28Hengrui's subsidiary Guangdong Hengrui received NMPA clinical trial approval for SHR-1819 injection, a humanized anti-IL-4Rα monoclonal antibody for atopic dermatitis in children aged 6 months to 5 years, with cumulative R&D investment of approximately RMB 361 million.恒瑞医药子公司广东恒瑞医药收到国家药监局关于SHR-1819注射液的《药物临床试验批准通知书》，该药为靶向人IL-4Rα的重组人源化单克隆抗体，适应症为6月-5岁儿童特应性皮炎，累计研发投入约3.61亿元。
2026-06-09Hengrui and its subsidiaries received NMPA clinical trial approvals for HRS-6209 (novel selective CDK4 inhibitor, cumulative R&D ~159M yuan), HRS-8080 (oral SERD, cumulative R&D ~313M yuan), and HRS-9813 (self-developed Class 1 innovative drug, cumulative R&D ~177M yuan).恒瑞医药及子公司收到国家药监局关于HRS-6209胶囊（新型选择性CDK4抑制剂，累计研发投入约1.59亿元）、HRS-8080片（口服雌激素受体降解剂，累计研发投入约3.13亿元）、HRS-9813胶囊（自主研发1类创新药，累计研发投入约1.77亿元）的《药物临床试验批准通知书》。
2026-06-16Hengrui received NMPA clinical trial approval for HRS-7525, a self-developed innovative anti-tumor drug for solid tumors; no similar product approved domestically. Cumulative R&D ~24.6 million yuan.恒瑞医药收到国家药监局关于HRS-7525片的《药物临床试验批准通知书》，该药为自主研发的创新型抗肿瘤药物，拟用于治疗实体瘤，国内暂无同类产品获批上市。累计研发投入约2460万元。
2026-06-16Hengrui's subsidiary Suzhou Shengdiya received NMPA clinical trial approval for SHR-6914 injection, a self-developed innovative anti-tumor drug for prostate cancer; no similar drug approved globally.恒瑞医药子公司苏州盛迪亚收到国家药监局关于SHR-6914注射液的《药物临床试验批准通知书》，该药为自主研发的创新型抗肿瘤药物，拟用于治疗前列腺癌，国内外暂无同类药物获批上市。
2026-06-25Hengrui received NMPA clinical trial approval for HRS-4508, a novel selective tyrosine kinase inhibitor for advanced solid tumors (breast cancer, lung cancer). Cumulative R&D ~81.8M yuan.恒瑞医药收到国家药监局关于HRS-4508片的《药物临床试验批准通知书》，该药为新型、高效、选择性酪氨酸激酶抑制剂，拟用于晚期实体瘤（乳腺癌、肺癌等）。累计研发投入约8180万元。
SHR-A1921 (TROP-2 ADC)SHR-A1921 (TROP-2 ADC)
3 · 2024-03-28 → 2024-07-29
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FDA Fast Track and breakthrough therapy for platinum-resistant ovarian cancer, multiple combo trials.获FDA快速通道资格和突破性疗法认定用于铂耐药卵巢癌，开展多项联合试验。
2024-03-28Hengrui's SHR-A1921 injection received FDA Fast Track designation for platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.恒瑞医药注射用SHR-A1921获得美国FDA快速通道资格，用于铂耐药复发上皮性卵巢癌、输卵管癌及原发性腹膜癌。
2024-05-26Hengrui's injection SHR-A1921 (TROP-2 ADC) was granted breakthrough therapy designation by CDE for platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.恒瑞注射用SHR-A1921（TROP-2 ADC）被国家药监局药审中心拟纳入突破性治疗品种，用于铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌。
2024-07-29Hengrui Medicine subsidiary Suzhou Shengdi received NMPA clinical trial approval for injection SHR-A1921 (TROP-2 ADC) combined with almonertinib or bevacizumab and carboplatin/cisplatin for advanced solid tumors.恒瑞医药子公司苏州盛迪亚收到国家药监局对注射用SHR-A1921（TROP-2 ADC）联合阿美替尼或贝伐珠单抗及卡铂/顺铂用于晚期实体瘤的临床试验批准。
Fluzoparib / Apatinib (PARP + VEGFR combo)氟唑帕利 / 阿帕替尼 (PARP+VEGFR联合)
6 · 2024-04-02 → 2026-01-29
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Breakthrough therapy, NDA priority review, and approval for gBRCA-mutated breast cancer and other indications.突破性疗法、NDA优先审评和获批用于gBRCA突变乳腺癌及其他适应症。
2024-04-02Fluzoparib capsules and apatinib mesylate tablets were included in the breakthrough therapy designation list by the CDE for gBRCA-mutated HER2-negative breast cancer.氟唑帕利胶囊和甲磺酸阿帕替尼片被CDE纳入突破性治疗品种名单，用于gBRCA突变的HER2阴性乳腺癌。
2024-04-25NDA for fluzoparib capsules and apatinib mesylate tablets accepted by NMPA and proposed for priority review.氟唑帕利胶囊和甲磺酸阿帕替尼片的药品上市许可申请获国家药监局受理，拟纳入优先审评。
2024-05-21Hengrui received NMPA drug registration certificate for fluzoparib capsule (PARP inhibitor) for a third indication: maintenance therapy after first-line platinum chemotherapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.恒瑞收到氟唑帕利胶囊（PARP抑制剂）药品注册证书，获批第三个适应症：用于晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌一线含铂化疗后的维持治疗。
2024-12-02Hengrui received NMPA drug registration certificates for Fluzoparib capsules and Apatinib mesylate tablets for a new indication: fluzoparib alone or combined with apatinib for HER2-negative metastatic breast cancer with germline BRCA mutation in adult patients who have received prior chemotherapy.恒瑞医药收到国家药监局核准签发的氟唑帕利胶囊和甲磺酸阿帕替尼片药品注册证书，新增适应症为氟唑帕利单药或联合阿帕替尼用于既往接受过化疗的伴有胚系BRCA突变的HER2阴性转移性乳腺癌成年患者。
2025-10-27Hengrui's NDA for Fuzuloparib capsules (PARP inhibitor) combined with abiraterone and prednisone/prednisolone for first-line treatment of DRD+ metastatic castration-resistant prostate cancer was accepted by NMPA.恒瑞医药氟唑帕利胶囊（PARP抑制剂）联合阿比特龙和泼尼松/泼尼松龙用于DNA修复基因缺陷阳性转移性去势抵抗性前列腺癌一线治疗的上市许可申请获NMPA受理。
2026-01-29Company and subsidiary Suzhou Shengdiya received NMPA acceptance of marketing application for Camrelizumab injection combined with Apatinib mesylate tablet for unresectable hepatocellular carcinoma (new indication).公司及子公司苏州盛迪亚收到国家药监局受理卡瑞利珠单抗注射液联合甲磺酸阿帕替尼片用于不可切除肝细胞癌的新适应症上市申请。
Dalpiciclib (CDK4/6 inhibitor)达尔西利 (CDK4/6抑制剂)
5 · 2024-04-12 → 2026-06-15
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Phase III success in early breast cancer adjuvant therapy, NDA acceptance, and new indication approval.早期乳腺癌辅助治疗III期成功，NDA获受理，新适应症获批。
2024-04-12Received clinical trial approval for dalpiciclib mesylate tablets combined with HRS8807 tablets for breast cancer.获得羟乙磺酸达尔西利片联合HRS8807片用于乳腺癌的临床试验批准。
2025-02-23Hengrui announced that its phase III trial (SHR6390-III-303) of dalpiciclib (CDK4/6 inhibitor) combined with endocrine therapy for HR+/HER2- early breast cancer adjuvant treatment met the primary endpoint at first interim analysis, significantly reducing recurrence risk; pre-NDA communication filed with CDE; cumulative R&D investment ~1.178 billion yuan.恒瑞医药宣布羟乙磺酸达尔西利片（CDK4/6抑制剂）联合内分泌治疗HR+/HER2-早期乳腺癌辅助治疗的III期研究首次期中分析达主要终点，显著降低复发风险；已向CDE递交上市前沟通申请；累计研发投入约11.78亿元。
2025-03-03Phase III trial of dalpiciclib (SHR6390) for HR+/HER2- breast cancer adjuvant therapy met primary endpoint at first interim analysis.达尔西利（SHR6390）用于HR+/HER2-乳腺癌辅助治疗的III期试验首次期中分析达到主要终点。
2025-05-08Hengrui Medicine's NDA for its self-developed CDK4/6 inhibitor Dalpiciclib mesylate tablets (SHR6390) was accepted by the NMPA for adjuvant treatment of HR+/HER2- early or locally advanced breast cancer.恒瑞医药自主研发的CDK4/6抑制剂羟乙磺酸达尔西利片的药品上市许可申请获国家药监局受理，用于HR+/HER2-早期或局部晚期乳腺癌辅助治疗。
2026-06-15NMPA approved a new indication for Hengrui's self-developed CDK4/6 inhibitor Dalpiciclib (羟乙磺酸达尔西利片): adjuvant therapy for HR+/HER2- high-risk early breast cancer, based on a Phase III trial showing 3-year iDFS rates of 89.1% vs 86.2% (HR=0.56). Cumulative R&D investment ~1.287 billion yuan.国家药监局批准恒瑞医药自主研发的CDK4/6抑制剂羟乙磺酸达尔西利片新增适应症：联合内分泌治疗用于HR+/HER2-高复发风险早期乳腺癌辅助治疗，基于III期试验显示3年无侵袭性疾病生存期率89.1% vs 86.2%（HR=0.56）。累计研发投入约12.87亿元。
Annual & quarterly financial results年度及季度财务业绩
13 · 2024-04-17 → 2026-04-22
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Revenue and profit growth driven by innovative drug sales and licensing income.创新药销售和授权收入推动营收和利润增长。
2024-04-172023 annual results: revenue 22.82 billion yuan (+7.26% YoY), net profit 4.302 billion yuan (+10.14% YoY), innovative drug revenue 10.637 billion yuan (+22.1% YoY), R&D investment 6.15 billion yuan. Proposed dividend 2 yuan per 10 shares.2023年年报：营收228.2亿元（+7.26%），净利润43.02亿元（+10.14%），创新药收入106.37亿元（+22.1%），研发投入61.50亿元。拟每10股派发现金红利2.00元。
2024-04-172024 Q1 results: revenue 5.998 billion yuan (+9.20% YoY), net profit 1.369 billion yuan (+10.48% YoY), operating cash flow 1.255 billion yuan (+486.35% YoY).2024年一季报：营收59.98亿元（+9.20%），净利润13.69亿元（+10.48%），经营性现金流净额12.55亿元（+486.35%）。
2024-05-06Hengrui Medicine reported Q1 2024 revenue of 5.998 billion yuan, up 9.20% YoY; net profit of 1.369 billion yuan, up 10.48% YoY.恒瑞医药公布2024年第一季度营业收入59.98亿元，同比增长9.20%；归属净利润13.69亿元，同比增长10.48%。
2024-08-21Hengrui reported 2024 H1 results: revenue 13.601 billion yuan (+21.78% YoY), net profit 3.432 billion yuan (+48.67% YoY); innovative drug revenue (excluding licensing) 6.612 billion yuan (+33% YoY); included 160 million euros from Merck Healthcare as licensing upfront payment.恒瑞医药发布2024年半年报：营业收入136.01亿元（同比+21.78%），净利润34.32亿元（同比+48.67%）；创新药收入（不含对外许可）66.12亿元（同比+33%）；确认默克医疗1.6亿欧元对外许可首付款。
2024-10-24Hengrui reported Q3 2024 results: revenue 20.189 billion yuan (+18.67% YoY), net profit 4.62 billion yuan (+32.98% YoY); included 160 million euro upfront from Merck Healthcare license deal.恒瑞医药发布2024年三季报：前三季度营业收入201.89亿元（同比+18.67%），净利润46.2亿元（同比+32.98%）；包含Merck Healthcare的1.6亿欧元对外许可首付款。
2025-03-30FY2024 results: revenue RMB 27.985B (+22.63% YoY), net profit RMB 6.337B (+47.28% YoY); proposed dividend RMB 0.20 per share.2024年年报：营业收入279.85亿元（同比+22.63%），净利润63.37亿元（同比+47.28%）；拟每10股派发现金股利2.00元。
2025-04-01Hengrui Medicine releases 2024 annual report: revenue of RMB 27.985 billion, +22.63% YoY; net profit of RMB 6.337 billion, +47.28% YoY; innovative drug sales of RMB 13.892 billion (incl. tax), +30.60% YoY, accounting for over half of revenue.恒瑞医药发布2024年年报：营业收入279.85亿元，同比增长22.63%；归母净利润63.37亿元，同比增长47.28%；创新药销售收入138.92亿元（含税），同比增长30.60%，贡献逾一半营收。
2025-04-24Hengrui releases Q1 2025 results: revenue of RMB 7.206 billion, +20.14% YoY; net profit of RMB 1.874 billion, +36.90% YoY; includes USD 75 million upfront from IDEAYA Biosciences license as revenue.恒瑞医药发布2025年一季报：营业收入72.06亿元，同比增长20.14%；归母净利润18.74亿元，同比增长36.90%；包含IDEAYA Biosciences授权首付款7500万美元确认为收入。
2025-08-20Hengrui reported 2025 H1 results: revenue ¥15.761B (+15.88% YoY), net profit ¥4.45B (+29.67% YoY); innovative drug sales reached ¥7.57B.恒瑞医药发布2025年半年报：营收157.61亿元（同比+15.88%），净利润44.50亿元（同比+29.67%）；创新药销售收入75.70亿元。
2025-09-01Hengrui reported 2025 H1 revenue of RMB 15.76 billion, net profit of RMB 4.45 billion (+29.7% YoY), including RMB 1.99 billion in out-licensing income.恒瑞公布2025年上半年营收157.6亿元，归母净利润44.5亿元（同比增长29.7%），其中对外许可收入19.9亿元。
2025-10-27Hengrui reported Q3 2025 results: Q3 revenue 7.427B yuan (+12.72% YoY), net profit 1.301B yuan (+9.53% YoY); first 9 months revenue 23.188B yuan (+14.85% YoY), net profit 5.751B yuan (+24.50% YoY); R&D expenses 4.945B yuan in first 9 months.恒瑞医药发布2025年第三季度业绩：第三季度营收74.27亿元（同比+12.72%），净利润13.01亿元（同比+9.53%）；前三季度营收231.88亿元（同比+14.85%），净利润57.51亿元（同比+24.50%）；前三季度研发费用49.45亿元。
2026-03-25Hengrui Medicine reported 2025 annual results: revenue 31.629 billion yuan (+13.02% YoY), net profit 7.711 billion yuan (+21.69% YoY); innovative drug sales 16.342 billion yuan (+26.09%), accounting for 58.34% of drug revenue; proposed dividend 2 yuan per 10 shares.恒瑞医药发布2025年年报：营业收入316.29亿元（同比+13.02%），净利润77.11亿元（同比+21.69%）；创新药销售收入163.42亿元（同比+26.09%），占药品收入58.34%；拟每10股派发现金股利2元。
2026-04-22Hengrui reported Q1 2026 revenue of 8.141 billion yuan (+12.98% YoY), net profit of 2.282 billion yuan (+21.78% YoY); innovative drug sales reached 4.526 billion yuan (+25.75%), accounting for 61.69% of drug sales; licensing revenue of 787 million yuan.恒瑞医药2026年第一季度营收81.41亿元（同比+12.98%），净利润22.82亿元（同比+21.78%）；创新药销售收入45.26亿元（同比+25.75%），占药品销售收入61.69%；对外许可收入7.87亿元。
Out-licensing & partnership deals对外授权与合作交易
11 · 2024-04-17 → 2026-05-12
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Major licensing deals with Merck KGaA, IDEAYA, GSK, BMS, and others for ADCs, GLP-1, and early-stage assets.与默克、IDEAYA、GSK、百时美施贵宝等就ADC、GLP-1和早期资产达成重大授权交易。
2024-04-17In 2023, completed 5 out-licensing deals with total transaction value over USD 4 billion, involving PARP1 inhibitor HRS-1167, Claudin18.2 ADC SHR-A1904, EZH2 inhibitor SHR2554, TSLP mAb SHR-1905, TKI pyrotinib, and PD-1 inhibitor camrelizumab.2023年达成5项对外授权合作，总交易金额超40亿美元，涉及PARP1抑制剂HRS-1167、Claudin18.2 ADC SHR-A1904、EZH2抑制剂SHR2554、TSLP单抗SHR-1905、TKI吡咯替尼、PD-1抑制剂卡瑞利珠单抗。
2024-11-01Hengrui Medicine disclosed 11 overseas license-out deals for innovative drugs including PD-1 inhibitor camrelizumab, HER1/HER2/HER4 targeted drug pyrotinib, EZH2 inhibitor SHR2554, TSLP mAb SHR-1905, PARP1 inhibitor HRS-1167, Claudin-18.2 ADC SHR-A1904, and GLP-1 product portfolio.恒瑞医药披露了11项创新药海外授权合作，包括PD-1抑制剂卡瑞利珠单抗、HER1/HER2/HER4靶向药吡咯替尼、EZH2抑制剂SHR2554、TSLP单抗SHR-1905、PARP1抑制剂HRS-1167、Claudin-18.2 ADC药物SHR-A1904和GLP-1类产品组合。
2024-12-29Hengrui signed a license agreement with IDEAYA Biosciences for SHR-4849 (DLL3-targeting ADC), granting exclusive rights outside Greater China for development, manufacturing, and commercialization; Hengrui receives $75 million upfront, up to $200 million in development milestones, and up to $770 million in sales milestones, plus tiered royalties.恒瑞医药与IDEAYA Biosciences签署SHR-4849（靶向DLL3的ADC）项目授权许可协议，授予大中华区以外的全球独家开发、生产和商业化权利；恒瑞获得7500万美元首付款、累计不超过2亿美元研发里程碑款和不超过7.7亿美元销售里程碑款，以及分级销售提成。
2025-03-25Signed exclusive license agreement with Merck Sharp & Dohme for oral Lp(a) inhibitor HRS-5346 (Phase II in China); $200M upfront, up to $1.77B milestones, plus royalties ex-Greater China.与默沙东就口服Lp(a)抑制剂HRS-5346（中国II期）签署独家许可协议；2亿美元首付款，最高17.7亿美元里程碑付款，及大中华区外销售提成。
2025-04-07Hengrui licenses SHR7280 (oral GnRH receptor antagonist) to Merck KGaA for exclusive commercialization in mainland China; receives EUR 15 million upfront, milestone payments, and double-digit royalties on net sales.恒瑞医药将SHR7280（口服GnRH受体拮抗剂）授权给德国默克集团，获得中国大陆独家商业化权益；首付款1500万欧元，里程碑付款及两位数净销售额提成。
2025-07-28Hengrui signed a deal with GSK granting global rights (ex-China) for PDE3/4 inhibitor HRS-9821 and exclusive options for up to 11 preclinical projects; GSK pays $500 million upfront, with potential milestones up to ~$12 billion plus tiered royalties.恒瑞医药与GSK达成协议，将PDE3/4抑制剂HRS-9821的全球独家权利（不含中国）及至多11个临床前项目的独家选择权许可给GSK；GSK支付5亿美元首付款，潜在里程碑付款约120亿美元及分级销售提成。
2025-08-01Hengrui licensed global rights (ex-China) of HRS-9821 (PDE3/4 inhibitor for COPD) and options for up to 11 other assets to GSK for $5B upfront and up to $12B milestones.恒瑞医药将HRS-9821（COPD的PDE3/4抑制剂）海外权益及至多11个项目的独家选择权许可给GSK，首付5亿美元，里程碑付款最高120亿美元。
2025-09-05Hengrui licensed global rights (ex-China) of HRS-1893, a Myosin inhibitor for obstructive hypertrophic cardiomyopathy, to US Braveheart Bio for $75M upfront and up to $1.013B in milestones.恒瑞将HRS-1893（心肌肌球蛋白抑制剂，用于梗阻性肥厚型心肌病）海外权益授权给美国Braveheart Bio，首付款7500万美元，里程碑付款最高10.13亿美元。
2025-12-28Hengrui Medicine licenses SHR6508 (a novel calcimimetic for secondary hyperparathyroidism in dialysis patients, Phase III) to Hansoh Pharma for exclusive development and commercialization in mainland China, receiving an upfront payment of 30 million yuan, potential milestone payments up to 190 million yuan, and tiered royalties up to 9%.恒瑞医药将SHR6508（新型钙敏感受体变构调节剂，用于透析患者继发性甲状旁腺功能亢进，III期临床）独家许可给翰森制药在中国大陆开发、生产和商业化，获得首付款3000万元，最高1.9亿元里程碑付款及最高9%销售提成。
2026-03-25Hengrui Medicine's 2025 annual report disclosed that the company completed 5 overseas licensing deals in 2025, with total potential transaction value exceeding $27 billion since 2023; 2025 licensing revenue recognized 3.392 billion yuan.恒瑞医药2025年年报披露，2025年完成5笔海外授权交易，自2023年起累计完成12笔，潜在总交易价值超过270亿美元；2025年确认对外许可收入33.92亿元。
2026-05-12Hengrui and Bristol-Myers Squibb (BMS) signed a global strategic collaboration and license agreement for 13 early-stage assets in oncology, hematology, and immunology. BMS will pay up to $9.5 billion (including $600 million upfront) with a potential total value of ~$15.2 billion.恒瑞医药与百时美施贵宝（BMS）达成全球战略合作及许可协议，共同推进13款肿瘤学、血液学及免疫学早期项目。BMS将支付可达9.5亿美元（含6亿美元首付款），潜在总交易额约152亿美元。
New drug approvals & regulatory milestones新药获批与监管里程碑
39 · 2024-04-17 → 2026-06-22
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Approvals and breakthrough therapy designations for innovative drugs and new indications in China and the US.在中国和美国获批的创新药及新适应症，以及突破性疗法认定。
2024-04-17In 2023, 3 Class 1 innovative drugs (adebelimab, retagliptin phosphate, oteseconazole) and 4 Class 2 new drugs were approved for marketing. 5 new indications approved, including 9th indication for camrelizumab.2023年3款1类创新药（阿得贝利单抗、磷酸瑞格列汀、奥特康唑）和4款2类新药获批上市；5项新适应症获批，包括卡瑞利珠单抗第9个适应症。
2024-04-18SHR-A2102 (Nectin-4 ADC) received FDA Fast Track Designation for advanced urothelial carcinoma, the 4th product to receive this designation.注射用SHR-A2102（Nectin-4 ADC）获得美国FDA快速通道资格，用于晚期尿路上皮癌，为公司第4款获此认定的产品。
2024-06-11Hengrui's self-developed Nectin-4 ADC SHR-A2102 received FDA Fast Track designation for advanced urothelial carcinoma, the fourth ADC to receive such designation in 2024.恒瑞医药自主研发的Nectin-4 ADC SHR-A2102获得美国FDA快速通道资格，用于晚期尿路上皮癌，这是2024年第四个获得该资格的ADC。
2024-08-11Hengrui received NMPA supplemental approval for paclitaxel (albumin-bound) injection to add indication: first-line treatment of metastatic pancreatic cancer in combination with gemcitabine; cumulative R&D investment about 52.91 million yuan.恒瑞医药获国家药监局补充批准注射用紫杉醇（白蛋白结合型）新增适应症：联合吉西他滨用于转移性胰腺癌一线治疗；累计研发投入约5291万元。
2024-09-09Hengrui's SHR-1918 injection (ANGPTL3 monoclonal antibody for homozygous familial hypercholesterolemia) was included in the NMPA's breakthrough therapy designation list.恒瑞医药SHR-1918注射液（ANGPTL3单抗，用于纯合子家族性高胆固醇血症）被国家药监局纳入拟突破性治疗品种公示名单。
2024-09-19Hengrui's marketing authorization application for Relafup-α injection (SHR-1701, anti-PD-L1/TGF-βRII bifunctional fusion protein) for first-line gastric or gastroesophageal junction adenocarcinoma was accepted by the NMPA; R&D investment ~587.86 million yuan.恒瑞医药瑞拉芙普-α注射液（SHR-1701）上市许可申请获国家药监局受理，用于胃及胃食管结合部腺癌一线治疗，研发投入约5.8786亿元。
2024-09-25Hengrui received NMPA clinical trial approval for Flutemetamol F-18 injection, a PET diagnostic agent for beta-amyloid plaques in Alzheimer's disease; R&D investment ~22.88 million yuan.恒瑞医药氟[18F]美他酚注射液获国家药监局临床试验批准，用于阿尔茨海默病PET成像诊断，研发投入约2288万元。
2024-10-09Hengrui received NMPA clinical trial approval for Fluorine-18 Metafol injection to evaluate brain beta-amyloid plaques in Alzheimer's disease via PET imaging; R&D cost ~22.88 million yuan.恒瑞医药子公司天津恒瑞收到国家药监局临床试验批准，氟[18F]美他酚注射液用于评估阿尔茨海默病脑内β-淀粉样蛋白聚集的PET成像；累计研发费用约2288万元。
2024-10-12Hengrui's HR19042 capsule was granted breakthrough therapy designation by CDE for active autoimmune hepatitis; R&D cost ~95.47 million yuan.恒瑞医药HR19042胶囊被国家药监局药品审评中心纳入突破性治疗品种，用于活动性自身免疫性肝炎；累计研发费用约9547万元。
2024-10-15Hengrui's NDA for Hetrombopag olamine tablets was accepted by NMPA for combination immunosuppressive therapy in treatment-naïve severe aplastic anemia patients aged ≥15.恒瑞医药海曲泊帕乙醇胺片药品上市许可申请获国家药监局受理，适应症为联合免疫抑制治疗用于15岁及以上初治重型再生障碍性贫血患者。
2024-12-05Hengrui's subsidiary Shanghai Hengrui Pharmaceutical's injection SHR-A2102 (Nectin-4 targeting ADC) was included in the CDE's breakthrough therapy designation list for treating locally advanced or metastatic urothelial carcinoma after prior platinum chemotherapy and PD-(L)1 inhibitor failure.恒瑞医药子公司上海恒瑞医药的注射用SHR-A2102（靶向Nectin-4的ADC）被国家药监局药审中心纳入拟突破性治疗品种公示名单，用于治疗既往含铂化疗和PD-(L)1抑制剂治疗失败的局部晚期或转移性尿路上皮癌。
2025-01-09NMPA accepted the marketing authorization application for SHR4640 tablets, a self-developed Class 1 anti-gout drug for primary gout with hyperuricemia; Phase III trial completed Aug 2024 showed superiority over allopurinol; cumulative R&D investment ~RMB 280 million.国家药监局受理SHR4640片的药品上市许可申请，该药为自主研发的1类抗痛风药物，用于原发性痛风伴高尿酸血症；2024年8月完成III期临床试验，疗效优于别嘌醇；累计研发投入约2.8亿元。
2025-01-10NMPA approved the marketing of Recaticimab (SHR-1209) injection, a self-developed anti-PCSK9 monoclonal antibody for lowering LDL-C, marking Hengrui's first Class 1 innovative drug in the cardiovascular field.国家药监局批准注射用瑞卡西单抗（SHR-1209）上市，该药为自主研发的抗PCSK9单抗，用于降低低密度脂蛋白胆固醇，是恒瑞医药在心血管疾病领域上市的首个1类创新药。
2025-01-12Subsidiary Guangdong Hengrui received the Drug Registration Certificate for Recaticimab injection, the world's first ultra-long-acting PCSK9 monoclonal antibody, bringing Hengrui's total approved Class 1 innovative drugs to 18.子公司广东恒瑞收到注射用瑞卡西单抗的《药品注册证书》，该药为全球首个超长效PCSK9单抗，恒瑞医药获批上市的1类创新药增至18款。
2025-01-23NMPA accepted the marketing authorization application for Shudi Insulin Injection, a self-developed Class 1 biologic and China's first self-developed long-acting insulin analog for type 2 diabetes; two Phase III trials completed Dec 2024 showed non-inferiority to insulin glargine; cumulative R&D investment ~RMB 349 million.国家药监局受理舒地胰岛素注射液的药品上市许可申请，该药为自主研发的1类治疗用生物制品，是国内首个自主研发的长效胰岛素类似物，用于治疗成人2型糖尿病；两项III期试验于2024年12月完成，非劣效于甘精胰岛素；累计研发投入约3.49亿元。
2025-02-17Hengrui's subsidiary Chengdu Shengdi Pharma received NMPA acceptance of the marketing authorization application for HR19034 eye drops (atropine sulfate) to slow myopia progression in children aged 6-12; cumulative R&D investment ~50.32 million yuan.恒瑞子公司成都盛迪医药HR19034滴眼液（硫酸阿托品）用于延缓6-12岁儿童近视进展的上市许可申请获国家药监局受理；累计研发投入约5032万元。
2025-03-03NDA for atropine sulfate eye drops to slow myopia progression in children accepted by NMPA.硫酸阿托品滴眼液延缓儿童近视进展的上市许可申请获国家药监局受理。
2025-03-28HRS-5965 capsule (complement factor B inhibitor) included in breakthrough therapy designation list for primary IgA nephropathy.HRS-5965胶囊（补体因子B抑制剂）拟纳入突破性治疗品种，用于原发性IgA肾病。
2025-05-29Hengrui Medicine's subsidiary received conditional NMPA approval for its self-developed class 1 innovative drug, injection of Ruikang Trastuzumab (SHR-A1811), a HER2 ADC for HER2-mutant NSCLC, the first domestically developed ADC for this indication.恒瑞医药子公司获国家药监局附条件批准自主研发的1类创新药注射用瑞康曲妥珠单抗（SHR-A1811）上市，该药为HER2 ADC，用于HER2突变非小细胞肺癌，是国内首个获批该适应症的自主研发ADC。
2025-05-29Hengrui Medicine received NMPA conditional approval for its class 1 innovative drug Faminitinib capsules (Aibit), combined with Camrelizumab, for recurrent or metastatic cervical cancer after platinum-based chemotherapy.恒瑞医药获国家药监局附条件批准1类创新药苹果酸法米替尼胶囊（艾比特）上市，联合卡瑞利珠单抗用于复发或转移性宫颈癌。
2025-05-29Hengrui Medicine's subsidiary received NMPA approval for its class 1 innovative drug Fosrolapitant Palonosetron injection, China's first ultra-long-acting original antiemetic injection for preventing chemotherapy-induced nausea and vomiting.恒瑞医药子公司获国家药监局批准1类创新药注射用磷罗拉匹坦帕洛诺司琼上市，该药是中国首个超长效原研复方止吐针剂，用于预防化疗引起的恶心呕吐。
2025-06-30Hengrui received NMPA approval for new indications of Bupivacaine liposome injection: postoperative regional analgesia via popliteal sciatic nerve block and adductor canal block in adults.恒瑞医药布比卡因脂质体注射液新增适应症获批：成人腘窝坐骨神经阻滞和收肌管阻滞术后区域镇痛。
2025-07-01Hengrui's bupivacaine liposome injection (Bupivacaine Liposome) approved for new indications: adult popliteal sciatic nerve block and adductor canal block for postoperative regional analgesia.恒瑞医药布比卡因脂质体注射液新增适应症获批：成人腘窝坐骨神经阻滞和收肌管阻滞术后区域镇痛。
2025-08-12Hengrui's marketing application for Hetrombopag Olamine tablets (new indication: ITP in adults and children ≥6) was accepted by NMPA.恒瑞医药海曲泊帕乙醇胺片新适应症（原发免疫性血小板减少症成人及≥6岁儿童）上市许可申请获国家药监局受理。
2025-08-18Hengrui's marketing application for Hetrombopag Olamine tablets (new indication: chemotherapy-induced thrombocytopenia) was accepted by NMPA.恒瑞医药海曲泊帕乙醇胺片新适应症（化疗所致血小板减少症）上市许可申请获国家药监局受理。
2025-11-03Hengrui's subsidiary Chengdu Shengdi Pharma's HRS-5965 capsule (complement factor B inhibitor) was proposed for priority review by CDE for paroxysmal nocturnal hemoglobinuria in adults. Novartis's Fabhalta is the only competitor globally with ~$129 million sales in 2024.恒瑞子公司成都盛迪医药的HRS-5965胶囊（补体因子B抑制剂）被CDE拟纳入优先审评，用于治疗阵发性睡眠性血红蛋白尿症成人患者。全球仅诺华的Fabhalta获批，2024年销售额约1.29亿美元。
2025-12-02Hengrui Medicine's injection of Remimazolam Tosylate (a short-acting benzodiazepine sedative) for sedation during mechanical ventilation in ICU has its marketing authorization application accepted by the NMPA, based on two pivotal studies (HR7056-302 and HR7056-206).恒瑞医药注射用甲苯磺酸瑞马唑仑（短效苯二氮䓬类镇静药）用于重症监护期间机械通气时镇静的药品上市许可申请获国家药监局受理，基于两项关键研究（HR7056-302和HR7056-206）。
2025-12-17Hengrui's injectable SHR-A1904 (a CLDN18.2-targeting ADC) is granted Breakthrough Therapy designation by the CDE for previously treated CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.恒瑞医药注射用SHR-A1904（靶向CLDN18.2的ADC）被国家药监局药审中心纳入突破性治疗品种，用于既往接受治疗的CLDN18.2阳性晚期胃或胃食管交界处腺癌。
2026-01-07Subsidiary Suzhou Shengdiya Biopharmaceutical received NMPA approval for its self-developed class 1 innovative drug Relafuputa alfa injection (anti-PD-L1/TGF-βRII bifunctional fusion protein) for first-line treatment of PD-L1 positive gastric or gastroesophageal junction adenocarcinoma.子公司苏州盛迪亚生物医药收到国家药监局批准，其自主研发的1类创新药瑞拉芙普α注射液（抗PD-L1/TGF-βRII双功能融合蛋白）用于PD-L1阳性胃及胃食管结合部腺癌一线治疗。
2026-01-12Subsidiary Suzhou Shengdiya Biopharmaceutical's injection SHR-1826 (c-Met targeted ADC) was granted breakthrough therapy designation by CDE for c-Met overexpressing non-small cell lung cancer.子公司苏州盛迪亚生物医药的注射用SHR-1826（c-Met靶向ADC）被药审中心纳入突破性治疗品种，用于c-Met过表达非小细胞肺癌。
2026-01-27Subsidiary Shandong Shengdi's HRS-5346 tablet (oral Lp(a) inhibitor) was granted breakthrough therapy designation by CDE for elevated lipoprotein(a).子公司山东盛迪的HRS-5346片（口服Lp(a)抑制剂）被药审中心纳入突破性治疗品种，用于脂蛋白(a)水平升高。
2026-01-29Subsidiary Beijing Shengdi's SHR-1918 injection was included in priority review list by CDE for homozygous familial hypercholesterolemia (HoFH).子公司北京盛迪的SHR-1918注射液被药审中心纳入优先审评品种，用于纯合子型家族性高胆固醇血症。
2026-01-30Subsidiary Fujian Shengdi received NMPA acceptance of marketing application for Phosphorus Rolapitant Palonosetron injection (HR20013) for prevention of chemotherapy-induced nausea and vomiting (moderate emetogenic).子公司福建盛迪收到国家药监局受理注射用磷罗拉匹坦帕洛诺司琼（HR20013）的上市申请，用于预防中度致吐性化疗引起的恶心呕吐。
2026-03-13Hengrui Medicine's NMPA approved new indication for self-developed Class 1 innovative drug hetrombopag olamine tablets: combined with immunosuppression for treatment-naive severe aplastic anemia (SAA) in patients aged ≥15; cumulative R&D investment ~633 million yuan.恒瑞医药自主研发的1类创新药海曲泊帕乙醇胺片获国家药监局批准新增适应症：联合免疫抑制治疗用于15岁及以上初治重型再生障碍性贫血（SAA）；累计研发投入约6.33亿元。
2026-03-13Hengrui Medicine's NMPA accepted marketing authorization application for self-developed insulin glargine/liraglutide fixed-ratio combination injection (Shudi insulin noliglipide) for type 2 diabetes; cumulative R&D investment ~330 million yuan.恒瑞医药自主研发的舒地胰岛素诺利糖肽注射液（长效基础胰岛素类似物/GLP-1受体激动剂固定比例复方制剂）上市许可申请获国家药监局受理，用于2型糖尿病；累计研发投入约3.3亿元。
2026-04-16Hengrui's subsidiary Shanghai Hengrui's injection SHR-A2102, a Nectin-4-targeting ADC, was granted breakthrough therapy designation by CDE for cervical cancer after platinum and PD-(L)1 failure; cumulative R&D investment about 388 million yuan.恒瑞医药子公司上海恒瑞的注射用SHR-A2102（靶向Nectin-4的ADC）被CDE纳入突破性治疗品种，用于含铂化疗及PD-(L)1抑制剂治疗失败的宫颈癌，累计研发投入约3.88亿元。
2026-05-28Hengrui received NMPA approval for its self-developed Class 1 innovative drug Luzunolei sodium tablets (SHR4640 tablets), China's first self-developed new-generation high-selective URAT1 inhibitor for gout with hyperuricemia.恒瑞医药收到国家药监局批准，其自主研发的1类创新药鲁兹诺雷钠片（SHR4640片）上市，该产品是中国首个自主研发的新一代高选择性URAT1抑制剂，适用于痛风伴高尿酸血症。
2026-06-11Hengrui's subsidiary Shanghai Hengrui's ADC drug SHR-A2102 was included in the NMPA breakthrough therapy list for the second time, for treating recurrent or metastatic cervical cancer after platinum chemo and PD-(L)1 inhibitor failure.恒瑞医药子公司上海恒瑞的抗体偶联药物（ADC）注射用SHR-A2102第二次被国家药监局药品审评中心纳入突破性治疗品种名单，适应症为治疗含铂化疗及PD-(L)1抑制剂治疗失败的复发或转移性宫颈癌。
2026-06-22EMA accepted Hengrui's marketing authorization application for Rezvilutamide (瑞维鲁胺片, brand name: 艾瑞恩®), a second-generation AR inhibitor for high-burden mHSPC, based on Phase III CHART study showing 41% reduction in death risk (median OS 78.8 vs 44.8 months). Cumulative R&D ~733M yuan.欧洲药品管理局（EMA）正式受理恒瑞医药递交的瑞维鲁胺片（商品名：艾瑞恩®）上市许可申请，该药为第二代AR抑制剂，用于高瘤负荷转移性激素敏感性前列腺癌，基于III期CHART研究显示死亡风险降低41%（中位OS 78.8个月 vs 44.8个月）。累计研发投入约7.33亿元。
Clinical trial progress临床试验进展
7 · 2024-04-22 → 2026-04-03
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Initiation and updates of Phase I-III clinical trials for various drug candidates.多个候选药物的I-III期临床试验启动与更新。
2024-04-22Subsidiary received clinical trial approval for camrelizumab injection (anti-PD-1 mAb) for a new indication.子公司获得注射用卡瑞利珠单抗（人源化抗PD-1单克隆抗体）的临床试验批准。
2024-04-25Received clinical trial approval for insulin aspart injection.获得门冬胰岛素注射液的临床试验批准。
2024-04-29Initiated Phase III clinical trial for HR17031 injection (insulin/GLP-1) in type 2 diabetes patients inadequately controlled on metformin ± another oral drug, comparing with insulin glargine.启动HR17031注射液（胰岛素/GLP-1）在2型糖尿病中的III期临床试验，与甘精胰岛素比较。
2024-05-29Hengrui's subsidiary Fujian Shengdi received clinical trial approval for HRS9531 tablet (oral GLP-1/GIP dual agonist) for type 2 diabetes and weight management.恒瑞子公司福建盛迪收到HRS9531片（口服GLP-1/GIP双激动剂）临床试验批准，用于2型糖尿病和体重管理。
2024-10-02Hengrui initiated a Phase III clinical study of CS1002/SHR-8068 (anti-CTLA-4 mAb) combined with Adebrelimab and Bevacizumab for first-line treatment of advanced hepatocellular carcinoma (HCC).恒瑞医药启动了CS1002/SHR-8068（抗CTLA-4单抗）联合阿得贝利单抗及贝伐珠单抗一线治疗晚期肝细胞癌（HCC）的III期临床研究。
2024-11-01Hengrui Medicine's subsidiary Fujian Shengdi Pharma received clinical trial approval for HRS-9563 injection, a first-in-class drug targeting a novel antihypertensive target, for treating hypertension.恒瑞医药子公司福建盛迪医药收到HRS-9563注射液治疗高血压的临床试验批准，该药为作用于新型降压靶点的1类新药。
2026-04-03Hengrui's HR19042 capsule for primary IgA nephropathy showed significant reduction in proteinuria and delayed renal function decline in a Phase II/III study presented at the World Congress of Nephrology in Yokohama, Japan.恒瑞医药HR19042胶囊治疗原发性IgA肾病的II/III期研究在日本横滨世界肾脏病学大会上公布，显示显著降低尿蛋白并延缓肾功能下降。
Executive & governance高管与公司治理
7 · 2024-04-28 → 2026-05-28
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Shareholding changes, board resolutions, auditor appointments, and dividend plans.持股变动、董事会决议、审计师任命及分红方案。
2024-04-28Company registered capital changed from 6,397,477,594 yuan to 6,379,002,274 yuan.公司注册资本由639747.759400万元变更为637900.227400万元。
2025-06-15Director and Senior Vice President Sun Jieping plans to reduce holdings by up to 476,700 shares (0.007% of total) via centralized竞价 trading due to personal capital needs.董事、高级副总裁孙杰平因个人资金需求，计划通过集中竞价减持不超过47.67万股（占总股本0.007%）。
2025-12-10Hengrui Medicine's board approves a proposal to amend the company's articles of association, including adding 'R&D, manufacturing and sales of pharmaceutical packaging materials and products' to the business scope and abolishing the board of supervisors, subject to shareholder approval.恒瑞医药董事会审议通过公司章程修正案，拟在经营范围中增加“药品包装材料和药品包装制品的研发、制造与销售”，并取消监事会设置，尚需股东大会审议。
2026-03-25Hengrui Medicine's board approved a related-party transaction to increase investment in associate Shanghai RuiHongdi Pharmaceutical, maintaining 38% stake; pricing at 7.60 yuan per registered capital yuan.恒瑞医药董事会审议通过向参股公司上海瑞宏迪医药有限公司增资的关联交易议案，增资后持股比例保持38%；增资价格为每1元注册资本7.60元。
2026-03-25Hengrui Medicine's board approved a 2025 profit distribution plan of 2 yuan per 10 shares (total ~1.326 billion yuan) and authorized 2026 interim dividend; total 2025 cash distribution including buybacks ~2.304 billion yuan (29.88% of net profit).恒瑞医药董事会审议通过2025年度利润分配预案：每10股派发现金红利2元（合计约13.26亿元），并授权2026年中期分红；2025年度现金分红总额（含回购）约23.04亿元，占净利润29.88%。
2026-03-25Hengrui Medicine's board approved renewal of Ernst & Young Hua Ming as 2026 domestic auditor and Ernst & Young (HK) as overseas auditor; 2025 audit fees totaled 2.6 million yuan.恒瑞医药董事会审议通过续聘安永华明为2026年度国内审计机构、安永香港为境外审计机构；2025年度审计费用合计260万元。
2026-05-28Hengrui announced it will hold its 2026 Q1 earnings call on June 3, 2026, via Shanghai Stock Exchange Roadshow Center, with the president, independent directors, CFO, and board secretary attending.恒瑞医药公告将于2026年6月3日下午在上证路演中心以网络互动形式召开2026年第一季度业绩说明会，公司总裁、独立董事、首席财务官和董事会秘书将出席。
ESMO / ASCO conference presentationsESMO/ASCO会议报告
2 · 2024-05-06 → 2024-07-30
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Multiple oncology research results accepted at major international conferences.多项肿瘤研究成果被国际顶级学术会议接收。
2024-05-06Hengrui Medicine announced 78 studies accepted at ASCO 2024, including 4 oral presentations, covering 8 approved innovative drugs and several unapproved ones.恒瑞医药宣布78项研究入选2024年ASCO年会，包括4项口头报告，涉及8款已上市创新药及多款未上市产品。
2024-07-30Hengrui Medicine announced 34 oncology research results from 13 innovative drugs accepted at the 2024 ESMO conference, including 3 oral presentations and 31 posters covering multiple cancer types.恒瑞医药宣布13款创新药的34项抗肿瘤研究成果入选2024年ESMO大会，包括3项口头报告和31项壁报，覆盖多种癌症类型。
HRS5580 (postoperative nausea/vomiting)HRS5580 (术后恶心呕吐)
1 · 2024-05-08
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Clinical trial approval for prevention of postoperative nausea and vomiting.获批临床试验用于预防术后恶心呕吐。
2024-05-08Hengrui's subsidiary Fujian Shengdi received clinical trial approval for injection HRS5580 to prevent postoperative nausea and vomiting.恒瑞子公司福建盛迪收到注射用HRS5580临床试验批准，用于预防术后恶心和呕吐。
Hutchison China MediTech surufatinib combo trial和黄医药索凡替尼联合试验
1 · 2024-05-14
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Phase II/III trial of surufatinib plus camrelizumab for pancreatic cancer.索凡替尼联合卡瑞利珠单抗治疗胰腺癌的II/III期试验。
2024-05-14Hutchison China MediTech initiated a Phase II/III trial of surufatinib plus Hengrui's camrelizumab, nab-paclitaxel, and gemcitabine for first-line metastatic pancreatic ductal adenocarcinoma; first patient dosed on May 8, 2024.和黄医药启动索凡替尼联合恒瑞卡瑞利珠单抗、白蛋白结合型紫杉醇和吉西他滨用于一线转移性胰腺导管腺癌的II/III期试验，首名受试者于2024年5月8日给药。
FDA regulatory actions (camrelizumab + apatinib)FDA监管行动 (卡瑞利珠单抗+阿帕替尼)
4 · 2024-05-17 → 2025-03-21
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CRL for HCC BLA due to manufacturing issues, resubmission accepted, second CRL received.因生产问题收到肝细胞癌BLA的CRL，重新提交获受理，收到第二封CRL。
2024-05-17Hengrui received a Complete Response Letter from FDA for camrelizumab plus apatinib BLA for unresectable/metastatic hepatocellular carcinoma; FDA cited manufacturing site inspection deficiencies and travel restrictions; Hengrui plans to resubmit.恒瑞收到FDA关于卡瑞利珠单抗联合阿帕替尼用于不可切除或转移性肝细胞癌生物制品许可申请的完整回复信，FDA指出生产场地检查缺陷和旅行限制；恒瑞计划重新提交。
2024-10-15Hengrui's resubmitted BLA for Camrelizumab plus Rivoceranib (Apatinib) for first-line unresectable/metastatic hepatocellular carcinoma was accepted by FDA; PDUFA target date Mar 23, 2025.恒瑞医药重新提交的注射用卡瑞利珠单抗联合甲磺酸阿帕替尼片用于不可切除或转移性肝细胞癌一线治疗的生物制品许可申请获FDA受理；PDUFA目标审评日期为2025年3月23日。
2024-11-01Hengrui Medicine's 'dual-Ai' combination (camrelizumab + apatinib) marketing application was re-accepted by the US FDA.恒瑞医药的“双艾”组合（卡瑞利珠单抗+阿帕替尼）上市申请重新获得美国FDA受理。
2025-03-21Received FDA Complete Response Letter for BLA of camrelizumab + apatinib ('dual Ai') for unresectable/metastatic HCC; FDA cited need for further manufacturing site inspection response.收到FDA关于卡瑞利珠单抗联合阿帕替尼（“双艾”组合）用于不可切除/转移性肝细胞癌BLA的完整回复函，FDA要求进一步答复生产场地检查问题。
FDA inspection & warning letter (Lianyungang site)FDA检查与警告信 (连云港基地)
2 · 2024-06-06 → 2024-07-16
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Form 483 and warning letter for Lianyungang formulation site; company responded and stated no impact on exports.连云港制剂基地收到483表格和警告信；公司已回复并表示不影响出口。
2024-06-06Hengrui received an FDA Form 483 for its Lianyungang formulation site, citing deficiencies in aseptic assurance and cleaning validation; company submitted corrective responses and stated no impact on US exports or PD-1 combo BLA.恒瑞医药收到美国FDA 483表格，涉及连云港制剂生产场地，指出无菌保障和清洁验证缺陷；公司已提交整改答复，称未影响对美出口或PD-1组合疗法BLA。
2024-07-16Hengrui Medicine received an FDA warning letter for its Lianyungang formulation production site (No. 38 Huanghe Road) citing two deficiencies in quality control documentation and CGMP compliance. Company says no impact on product quality or exports.恒瑞医药收到FDA对其连云港制剂生产场地（黄河路38号）的警告信，指出质量控制文档和CGMP合规方面的两项缺陷。公司表示不影响产品质量和出口。
Linperlisib NDA withdrawal (Yingli)林普利塞NDA撤回 (璎黎)
1 · 2024-06-07
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Partner Yingli voluntarily withdrew NDA for new PTCL indication.合作伙伴璎黎主动撤回PTCL新适应症NDA。
2024-06-07Partner Yingli Pharma voluntarily withdrew the NDA for linperlisib (林普利塞) for a new PTCL indication; Yingli is conducting a randomized controlled study for resubmission.合作伙伴璎黎药业主动撤回林普利塞片新适应症（PTCL）的上市申请；璎黎药业正在开展随机对照研究以重新提交。
HRS-9231 / HRS-4597 / HRS-2173 / HRS-2129 / HRS-2183 / HRS-9563 / HRS-5632 / HRS-6208 / HRS-3802 / HRS-4029 / HRS-6213 / HRS-1738 / HRS-5817 / HRS-9190 / HRS-9821 / HRS-8829 / HRS-8179 / HRS-1893 / HRS-6093 / HRS-2162 / HRS-7172 / HRS-2430 / HRS-8364 / HRS-6257 / HRS-3005 / HRS-7525 / HRS-5765 / HRS-7156 / HRS-1635 / HRS-6719 / HRS-1301 / HRS-5346 / HRS-5965 / HRS-7535 / HRS-9531 / HRS-4729 / HRS-4508 / HRS-7058 / HRS-4642 / HRS-1167 / HRS-5041 / HRS-1358 / HRS-8080 / HRS-6209 / HRS-2189 / HRS-1780 / HRS-2141 / HRS-3738 / HRS-5635 / HRS-9821 / HRS-1893 / HRS-5346 / HRS-5965 / HRS-7535 / HRS-9531 / HRS-4729 / HRS-4508 / HRS-7058 / HRS-4642 / HRS-1167 / HRS-5041 / HRS-1358 / HRS-8080 / HRS-6209 / HRS-2189 / HRS-1780 / HRS-2141 / HRS-3738 / HRS-5635HRS-9231 / HRS-4597 / HRS-2173 / HRS-2129 / HRS-2183 / HRS-9563 / HRS-5632 / HRS-6208 / HRS-3802 / HRS-4029 / HRS-6213 / HRS-1738 / HRS-5817 / HRS-9190 / HRS-9821 / HRS-8829 / HRS-8179 / HRS-1893 / HRS-6093 / HRS-2162 / HRS-7172 / HRS-2430 / HRS-8364 / HRS-6257 / HRS-3005 / HRS-7525 / HRS-5765 / HRS-7156 / HRS-1635 / HRS-6719 / HRS-1301 / HRS-5346 / HRS-5965 / HRS-7535 / HRS-9531 / HRS-4729 / HRS-4508 / HRS-7058 / HRS-4642 / HRS-1167 / HRS-5041 / HRS-1358 / HRS-8080 / HRS-6209 / HRS-2189 / HRS-1780 / HRS-2141 / HRS-3738 / HRS-5635
6 · 2024-06-17 → 2025-02-26
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Numerous novel small-molecule candidates entering clinical trials across oncology, metabolic, cardiovascular, and other therapeutic areas.众多新型小分子候选药物进入临床试验，涵盖肿瘤、代谢、心血管等多个治疗领域。
2024-06-17Hengrui and subsidiary Shandong Shengdi Pharma received NMPA clinical trial approval for HRS7415 tablets and HRS-8080 tablets for combination therapy in breast cancer.恒瑞医药及子公司山东盛迪医药收到国家药监局关于HRS7415片和HRS-8080片的临床试验批准，用于乳腺癌联合治疗。
2024-07-21Hengrui Medicine and subsidiary Shandong Shengdi received NMPA clinical trial approval for dalpiciclib tablets (Airuikang) combined with HRS-1358 tablets for breast cancer.恒瑞医药及子公司山东盛迪收到国家药监局对羟乙磺酸达尔西利片（艾瑞康）联合HRS-1358片用于乳腺癌的临床试验批准。
2024-07-26Hengrui Medicine and subsidiary Shandong Shengdi received NMPA clinical trial approval for HRS-1358 tablets, HRS-8080 tablets, and HRS-6209 capsules for breast cancer and malignant tumors.恒瑞医药及子公司山东盛迪收到国家药监局对HRS-1358片、HRS-8080片、HRS-6209胶囊用于乳腺癌及恶性肿瘤的临床试验批准。
2024-11-08Hengrui Medicine received clinical trial approvals for HRS-2189 tablets, HRS-5041 tablets, HRS-1358 tablets, HRS-8080 tablets, SHR-8068 injection, adebrelimab injection, and HRS-6209 capsules.恒瑞医药获得HRS-2189片、HRS-5041片、HRS-1358片、HRS-8080片、SHR-8068注射液、阿得贝利单抗注射液和HRS-6209胶囊的临床试验批准。
2024-12-11Hengrui and its subsidiary received NMPA clinical trial approval for HRS-4729 injection, a self-developed GLP-1R/GIPR/GCGR triple agonist peptide for obesity or overweight, with cumulative R&D investment of approximately 19.56 million yuan.恒瑞医药及子公司收到国家药监局关于HRS-4729注射液的药物临床试验批准通知书，该药为自主研发的GLP-1R/GIPR/GCGR三激动剂多肽类药物，用于肥胖或超重，累计研发投入约1956万元。
2025-02-26Hengrui's subsidiary Shandong Shengdi Pharma received NMPA clinical trial approval for HRS-1301 tablets (first-in-class chemical drug) to treat hyperlipidemia; cumulative R&D investment ~18.36 million yuan.恒瑞子公司山东盛迪医药获国家药监局批准，开展HRS-1301片（1类化学新药）治疗高脂血症的临床试验；累计研发投入约1836万元。
National Science & Technology Progress Award国家科技进步奖
1 · 2024-06-24
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Second prize for lung cancer radiotherapy combined with targeted and immunotherapy project involving camrelizumab.涉及卡瑞利珠单抗的肺癌放疗联合靶向和免疫治疗项目获二等奖。
2024-06-24Hengrui's project 'Key mechanisms and clinical application of radiotherapy combined with molecular targeted and immunotherapy for lung cancer' won the second prize of the National Science and Technology Progress Award, involving its PD-1 drug camrelizumab.恒瑞医药参与的“肺癌放疗联合分子靶向和免疫治疗的关键机制与临床应用”项目荣获国家科学技术进步奖二等奖，涉及其PD-1药物卡瑞利珠单抗。
Guangzhou Ruiling Medical / Suzhou Ruiling Medical (subsidiaries)广州瑞领医疗 / 苏州瑞领医疗 (子公司)
2 · 2024-06-28 → 2025-06-05
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New subsidiaries established for cell technology R&D and drug production.新设子公司从事细胞技术研发和药品生产。
2024-06-28Guangzhou Ruiling Medical Co., Ltd. was established with registered capital of 10 million yuan, wholly owned by Shanghai Ruihongdi Pharma, which is jointly held by Hengrui Medicine and Jiangsu Hengrui Pharma Group.广州瑞领医药有限公司成立，注册资本1000万元，由上海瑞宏迪医药有限公司全资持股，后者由恒瑞医药和江苏恒瑞医药集团有限公司共同持股。
2025-06-05Hengrui established Suzhou Ruiling Medical Co., Ltd. with registered capital of 50 million yuan, engaging in cell technology R&D and drug production.恒瑞医药成立苏州瑞领医药有限公司，注册资本5000万元，从事细胞技术研发和药品生产。
US generic drug approvals美国仿制药获批
3 · 2024-07-02 → 2024-11-01
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FDA ANDA approvals for bupivacaine liposome, paclitaxel albumin-bound, and tacrolimus ER capsules.布比卡因脂质体、紫杉醇白蛋白结合型和他克莫司缓释胶囊获得FDA ANDA批准。
2024-07-02Hengrui Medicine's bupivacaine liposome injection (Aihengping) received FDA ANDA approval, becoming the first generic approved in the US for this product.恒瑞医药的布比卡因脂质体注射液（艾恒平）获得美国FDA的ANDA批准，成为该品种在美国获批的首个仿制药。
2024-10-10Hengrui received FDA ANDA approval for paclitaxel (albumin-bound) injection, becoming the first generic manufacturer in the US; global sales of the drug ~$2.597 billion in 2023; R&D cost ~52.91 million yuan.恒瑞医药注射用紫杉醇（白蛋白结合型）获得美国FDA仿制药批准，为首家在美国获批该品种仿制药的厂家；2023年全球销售额约25.97亿美元；累计研发费用约5291万元。
2024-11-01Hengrui Medicine's bupivacaine liposome injection, paclitaxel for injection (albumin-bound), and tacrolimus extended-release capsules were approved for marketing in the US; the first is the first generic globally, the latter two are first generics approved by the US FDA.恒瑞医药的布比卡因脂质体注射液、注射用紫杉醇（白蛋白结合型）和他克莫司缓释胶囊获准在美国上市；前者是全球首仿药，后两者为美国FDA批准的首仿药。
CStone promotion agreement (avapritinib)基石药业推广协议 (阿伐替尼)
1 · 2024-07-03
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Exclusive promotion rights in mainland China for avapritinib tablets.获得阿伐替尼片在中国大陆的独家推广权。
2024-07-03Hengrui Medicine and CStone Pharmaceuticals signed an agreement granting Hengrui exclusive promotion rights in mainland China for the precision therapy drug Taizhihua (avapritinib tablets). CStone receives RMB 35 million upfront payment.恒瑞医药与基石药业达成协议，获得精准治疗药物泰吉华（阿伐替尼片）在中国大陆的独家推广权。基石药业获得3500万元人民币首付款。
Suzhou Shengdi GMP compliance苏州盛迪GMP合规
1 · 2024-07-07
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Passed GMP inspection for 10,000L bioreactor production line for carrelizumab.通过卡瑞利珠单抗10000L生物反应器生产线的GMP检查。
2024-07-07Hengrui Medicine subsidiary Suzhou Shengdi passed Jiangsu Provincial Drug Administration GMP compliance inspection for its 10,000L stainless steel bioreactor production line for injectable carrelizumab (Airuika).恒瑞医药子公司苏州盛迪亚通过江苏省药监局GMP符合性检查，涉及注射用卡瑞利珠单抗（艾瑞卡）的10000L不锈钢生物反应器生产线。
Dividend distribution分红派息
2 · 2024-07-07 → 2026-05-20
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Cash dividend of RMB 0.2 per share for 2023 and 2024.2023年和2024年每10股派发现金红利2元。
2024-07-07Hengrui Medicine announced 2023 annual profit distribution: RMB 0.2 per share (tax included), total cash dividend of RMB 1.274 billion, with record date July 11 and ex-dividend date July 12, 2024.恒瑞医药公告2023年度利润分配：每股派发现金红利0.2元（含税），合计派发现金红利12.74亿元，股权登记日2024年7月11日，除权除息日2024年7月12日。
2026-05-20Hengrui announced its 2025 annual profit distribution plan: RMB 0.2 per share (tax included) cash dividend, totaling RMB 1.274 billion, with the record date on May 26, 2026.恒瑞医药发布2025年年度权益分派实施公告，每股派发现金红利0.2元（含税），共计派发现金红利12.74亿元，股权登记日为2026年5月26日。
HRS9531 (GLP-1/GIP dual agonist)HRS9531 (GLP-1/GIP双激动剂)
8 · 2024-07-13 → 2026-04-17
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Positive Phase II/III data in obesity and T2DM, NDA submission for weight management, licensed to Kailera.在肥胖和2型糖尿病中取得阳性II/III期数据，提交减重NDA，授权给Kailera。
2024-07-13Hengrui Medicine disclosed Phase II data for GLP-1/GIP dual receptor agonist HRS9531 in obesity: after 24 weeks, weight loss up to 16.8% vs 0.1% for placebo.恒瑞医药披露GLP-1/GIP双受体激动剂HRS9531在肥胖中的II期数据：治疗24周后体重下降最高达16.8%，安慰剂组仅下降0.1%。
2024-09-13Hengrui presented Phase II data for HRS9531 (GLP-1/GIP dual agonist) in type 2 diabetes at EASD 2024, showing HbA1c reduction up to 2.7% and weight loss up to 7.1% over 20 weeks.恒瑞医药在EASD 2024公布HRS9531（GLP-1/GIP双受体激动剂）治疗2型糖尿病Ⅱ期数据，20周后HbA1c降低达2.7%，体重降低达7.1%。
2025-01-14Hengrui announced positive Phase II results for HRS9531 injection (GLP-1/GIP dual agonist) in weight loss: 8mg group achieved 22.8% mean weight reduction from baseline at 36 weeks (placebo-adjusted 21.1%), with 59% of subjects achieving ≥20% weight loss.恒瑞医药公布HRS9531注射液（GLP-1/GIP双受体激动剂）减重II期临床阳性结果：8mg组治疗36周后平均体重较基线降低22.8%（安慰剂校正后21.1%），59%受试者体重降低≥20%。
2025-04-18Hengrui's subsidiary Fujian Shengdi receives NMPA clinical trial approval for HRS-9531 injection (oral GIPR/GLP-1R dual agonist) for obstructive sleep apnea with obesity; cumulative R&D investment ~RMB 256 million.恒瑞子公司福建盛迪收到国家药监局关于HRS-9531注射液（口服GIPR/GLP-1R双激动剂）的临床试验批准，用于阻塞性睡眠呼吸暂停合并肥胖；累计研发投入约2.56亿元。
2025-07-15Hengrui and US partner Kailera Therapeutics announced positive Phase 3 top-line results for GLP-1/GIP dual agonist HRS9531 in Chinese obese/overweight subjects; Hengrui plans to file NDA for long-term weight management in China soon.恒瑞医药与美国Kailera Therapeutics公司共同宣布，GLP-1/GIP双重受体激动剂HRS9531注射液在中国肥胖/超重受试者中的Ⅲ期临床试验获得积极顶线结果；恒瑞计划近期在中国递交长期体重管理的新药上市申请。
2025-09-01Hengrui's HRS9531 injection (GLP-1R/GIPR dual agonist) marketing authorization application was accepted by the NMPA for weight management in obese/overweight adults.恒瑞HRS9531注射液（GLP-1R/GIPR双激动剂）上市许可申请获国家药监局受理，用于肥胖/超重成人长期体重管理。
2025-10-16Hengrui's NewCo Kailera Therapeutics (formerly Hercules) announced completion of a $600M Series B financing to advance global Phase III trials of KAI-9531 (HRS9531, GLP-1/GIP dual agonist) for obesity.恒瑞医药NewCo公司Kailera Therapeutics（前Hercules）宣布完成6亿美元B轮融资，用于推动KAI-9531（HRS9531，GLP-1/GIP双受体激动剂）全球III期肥胖症临床试验。
2026-04-17Hengrui's partner Kailera Therapeutics (KLRA) listed on Nasdaq, raising $625 million, with core assets being Hengrui's GLP-1/GIP dual agonist HRS9531, oral GLP-1 agonist HRS-7535, and triple agonist HRS-4729.恒瑞医药合作伙伴Kailera Therapeutics在纳斯达克上市，募资6.25亿美元，核心资产为恒瑞医药的GLP-1/GIP双激动剂HRS9531、口服GLP-1激动剂HRS-7535和三重激动剂HRS-4729。
PMDA GMP approval (Lianyungang API)PMDA GMP批准 (连云港原料药)
1 · 2024-07-17
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Passed Japan PMDA GMP inspection for dexmedetomidine hydrochloride API.盐酸右美托咪定原料药通过日本PMDA GMP检查。
2024-07-17Hengrui Medicine's Lianyungang API subsidiary passed Japan PMDA GMP compliance inspection for dexmedetomidine hydrochloride API.恒瑞医药连云港原料药分公司通过日本PMDA对盐酸右美托咪定原料药的GMP符合性检查。
Medicilon strategic cooperation美迪西战略合作
2 · 2024-07-24 → 2024-08-01
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Preclinical evaluation partnership for ADC/siRNA/CGT novel molecular drugs.就ADC/siRNA/CGT新型分子药物临床前评估达成合作。
2024-07-24Hengrui Medicine and Medicilon (美迪西) reached a strategic cooperation for preclinical evaluation of novel molecular drugs (ADC/siRNA/CGT), covering efficacy, pharmacokinetics, and toxicology services.恒瑞医药与美迪西达成新分子药物（ADC/小核酸/CGT）临床前评价战略合作，涵盖药效、药代、毒理等研发服务。
2024-08-01Hengrui Medicine and Medicilon (Shanghai Medicilon Inc.) reached a strategic cooperation on preclinical evaluation of new molecular drugs (ADC/small nucleic acid/CGT) to jointly promote innovation and internationalization of China's biomedical industry.恒瑞医药与美迪西达成新分子药物（ADC/小核酸/CGT）临床前评价战略合作，共同推动中国生物医药产业创新与国际化。
Executive appointments & changes高管任命与变更
7 · 2024-07-29 → 2026-04-16
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Appointment of Chief Quality Officer, resignation of VPs, election of new board, and appointment of President.任命首席质量官、副总裁辞职、选举新董事会、任命总裁。
2024-07-29Hengrui Medicine appointed Dr. Xu Xuejian as Vice President and Chief Quality Officer, responsible for overall quality management. Xu previously served as CQO at WuXi Biologics and VP at WuXi AppTec.恒瑞医药聘任徐学健博士为副总经理、首席质量官，全面负责质量管理工作。徐学健此前曾任药明生物首席质量官和药明康德副总裁。
2024-08-21Hengrui's vice presidents Jiang Sumei and Wang Hongsen resigned due to personal reasons but remain in other roles at the company.恒瑞医药副总经理蒋素梅和王洪森因个人原因辞职，但仍留任公司其他岗位。
2025-04-02Hengrui appoints Feng Ji as President and COO; former President Dai Hongbin is elected Vice Chairman, a post re-established after years.恒瑞医药任命冯佶为总裁、首席运营官；原总裁戴洪斌升任副董事长，该职位时隔多年重新设立。
2025-12-03Hengrui Medicine appoints Zhu Guoxin (former VP at Eli Lilly's R&D center) as Senior Vice President to strengthen R&D leadership in small molecules and multi-modality drug discovery.恒瑞医药聘任朱国新（前礼来新药研发中心副总裁）为高级副总裁，以加强小分子及多模态药物发现的研发领导力。
2026-03-02Hengrui Medicine nominated Zhou Jien, Lou Liguang, Zeng Qingsheng, and Sun Jinyun as independent director candidates for the 10th board; Sun Jieping elected as employee representative director.恒瑞医药提名周纪恩、楼丽广、曾庆生、孙金云为第十届董事会独立董事候选人；孙杰平当选职工代表董事。
2026-03-03Hengrui Medicine nominated Sun Piaoyang, Dai Hongbin, Feng Ji, Zhang Lianshan, and Jiang Ningjun as executive director candidates; Guo Congzhao as non-executive director candidate for the 10th board.恒瑞医药提名孙飘扬、戴洪斌、冯佶、张连山、江宁军为第十届董事会执行董事候选人；郭丛照为非执行董事候选人。
2026-04-16Hengrui held its 10th board meeting, electing Sun Piaoyang as chairman, Dai Hongbin as vice chairman, appointing Feng Ji as president and COO, Liu Xiaohan as board secretary, and other executives.恒瑞医药召开第十届董事会第一次会议，选举孙飘扬为董事长，戴洪斌为副董事长，聘任冯佶为总裁兼首席运营官，刘笑含为董事会秘书等。
Employee stock ownership plans员工持股计划
3 · 2024-08-21 → 2025-08-20
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2024 and 2025 employee stock ownership plans with innovation drug revenue targets.2024年和2025年员工持股计划，设有创新药收入目标。
2024-08-21Hengrui announced 2024 employee stock ownership plan: up to 12.20 million shares (0.19% of total) at 21.20 yuan/share, sourced from repurchased shares, for up to 1,203 participants.恒瑞医药公布2024年员工持股计划：不超过1220万股（占总股本0.19%），受让价格21.20元/股，来源为回购股份，参与人数不超过1203人。
2024-09-08Hengrui announced 2024 employee stock ownership plan for up to 1,203 participants, with a transfer price of 21.20 yuan per share and a 2024 innovation drug revenue target of no less than 13 billion yuan.恒瑞医药公布2024年员工持股计划，参与人数不超过1203人，受让价21.20元/股，考核目标2024年创新药收入不低于130亿元。
2025-08-20Hengrui announced a 2025 A-share employee stock ownership plan for up to 1,316 participants, with share transfer price of ¥30.95/share.恒瑞医药公布2025年A股员工持股计划，参加对象不超过1316人，受让价格为30.95元/股。
Entrusted wealth management委托理财
2 · 2024-08-21 → 2025-08-20
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Board approved up to RMB 6 billion for low-to-medium risk wealth management.董事会批准使用不超过60亿元进行中低风险委托理财。
2024-08-21Hengrui board approved using up to 6 billion yuan of idle自有资金 for entrusted wealth management.恒瑞医药董事会批准使用最高额不超过60亿元自有闲置资金进行委托理财。
2025-08-20Hengrui plans to use up to ¥6B of idle自有资金 for entrusted wealth management in low-to-medium risk products.恒瑞医药拟使用不超过60亿元自有闲置资金进行中低风险委托理财。
SHR0302 / Ivarmacitinib (JAK1 inhibitor)SHR0302 / 艾玛昔替尼 (JAK1抑制剂)
9 · 2024-09-05 → 2026-06-23
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Approved for ankylosing spondylitis, rheumatoid arthritis, atopic dermatitis, alopecia areata; NDA for vitiligo.获批用于强直性脊柱炎、类风湿关节炎、特应性皮炎、斑秃；白癜风NDA。
2024-09-05Hengrui's marketing authorization application for Ivarmacitinib sulfate tablets (SHR0302), a JAK1 inhibitor for severe alopecia areata, was accepted by the NMPA; Phase III trial met primary endpoint; R&D investment ~1.00373 billion yuan.恒瑞医药硫酸艾玛昔替尼片（SHR0302）上市许可申请获国家药监局受理，用于成人重度斑秃，Ⅲ期达主要终点，研发投入约10.0373亿元。
2025-02-16Hengrui Medicine's marketing authorization application for ivarmacitinib ointment (JAK1 inhibitor, SHR0302) for mild-to-moderate atopic dermatitis was accepted by the NMPA; cumulative R&D investment ~1.068 billion yuan.恒瑞医药艾玛昔替尼软膏（JAK1抑制剂，SHR0302）用于轻中度特应性皮炎的上市许可申请获国家药监局受理；累计研发投入约10.68亿元。
2025-03-211st-in-class JAK1 inhibitor ivarmacitinib (SHR0302) tablets approved by NMPA for active ankylosing spondylitis in adults.1类创新药硫酸艾玛昔替尼片（SHR0302，JAK1抑制剂）获NMPA批准用于活动性强直性脊柱炎成人患者。
2025-03-31Ivarmacitinib (SHR0302) tablets approved by NMPA for new indication: moderate-to-severe active rheumatoid arthritis in adults.硫酸艾玛昔替尼片（SHR0302）获NMPA批准新增适应症：中重度活动性类风湿关节炎成人患者。
2025-04-09Hengrui receives NMPA drug registration certificate for ivarmacitinib sulfate tablets (JAK1 inhibitor) for a new indication: moderate-to-severe atopic dermatitis in adults; cumulative R&D investment ~RMB 1.071 billion.恒瑞医药收到国家药监局药品注册证书，硫酸艾玛昔替尼片（JAK1抑制剂）新增适应症：中重度特应性皮炎成人患者；累计研发投入约10.71亿元。
2025-06-30Hengrui received NMPA approval for new indication of self-developed class 1 innovative drug Ivarmacitinib sulfate tablets (SHR0302) for severe alopecia areata in adults.恒瑞医药自主研发的1类创新药硫酸艾玛昔替尼片（SHR0302）新增适应症获批，用于成人重度斑秃。
2025-07-01Hengrui's self-developed Class 1 innovative drug ivarmacitinib sulfate tablets (SHR0302, brand name Aisuda) approved for a new indication: severe alopecia areata in adults.恒瑞医药自主研发的1类创新药硫酸艾玛昔替尼片（SHR0302片，商品名：艾速达®）新增适应症获批：成人重度斑秃。
2025-11-24Hengrui received NMPA acceptance of marketing authorization application for Sulfate Ivarmacitinib Tablets (JAK1 inhibitor) for active non-radiographic axial spondyloarthritis. The drug already has 4 approved indications in China; global sales of similar drug upadacitinib reached ~$5.971 billion in 2024.恒瑞医药提交的硫酸艾玛昔替尼片（JAK1抑制剂）药品上市许可申请获国家药监局受理，用于活动性放射学阴性中轴型脊柱关节炎。该药已在国内获批4个适应症，同类药物乌帕替尼2024年全球销售额约59.71亿美元。
2026-06-23Hengrui voluntarily withdrew its NDA for Ivarmacitinib ointment (艾玛昔替尼软膏), a topical JAK1 inhibitor for mild-to-moderate atopic dermatitis, after NMPA agreed to terminate the application due to need for further data refinement.恒瑞医药撤回艾玛昔替尼软膏的药品注册申请，该药为外用高选择性JAK1抑制剂，适用于成人轻度至中度特应性皮炎，因需进一步完善申报资料，经与国家药监局沟通后决定撤回。
SHR2554 / Zemeituosita (EZH2 inhibitor)SHR2554 / 泽美妥司他 (EZH2抑制剂)
3 · 2024-10-11 → 2025-10-27
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NDA accepted with priority review, conditional approval for relapsed/refractory PTCL.NDA获受理并优先审评，有条件批准用于复发/难治性PTCL。
2024-10-11Hengrui's NDA for SHR2554 (oral EZH2 inhibitor) was accepted by NMPA and included in priority review for relapsed/refractory peripheral T-cell lymphoma; R&D cost ~151 million yuan.恒瑞医药SHR2554片（口服EZH2抑制剂）的药品上市许可申请获国家药监局受理并被纳入拟优先审评品种，用于复发/难治外周T细胞淋巴瘤；累计研发费用约1.51亿元。
2025-09-01Hengrui's self-developed Class 1 innovative drug Zemeituosita Tablets (SHR2554), China's first self-developed EZH2 inhibitor, received conditional approval from the NMPA for relapsed/refractory peripheral T-cell lymphoma.恒瑞自主研发的1类创新药泽美妥司他片（SHR2554），中国首个自主研发的EZH2抑制剂，获国家药监局附条件批准用于复发/难治外周T细胞淋巴瘤。
2025-10-27Hengrui's first self-developed EZH2 inhibitor, Zemeituosita tablets (Airuijing), a Class 1 innovative drug, was launched for relapsed/refractory peripheral T-cell lymphoma.恒瑞医药自主研发的首个EZH2抑制剂泽美妥司他片（艾瑞璟）上市，为1类创新药，用于复发或难治外周T细胞淋巴瘤。
Hong Kong IPO & international financing香港上市与国际融资
17 · 2024-10-24 → 2025-06-20
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Preparation, approval, pricing, listing, and post-IPO activities for H-share listing on HKEX.H股在香港联交所上市的筹备、审批、定价、上市及后续活动。
2024-10-24Hengrui confirmed it is conducting preliminary research on overseas capital market financing (including Hong Kong listing) but has not finalized any plan.恒瑞医药公告确认近期对境外资本市场融资等事项开展了研究咨询等前期工作，但尚未确定具体方案。
2024-11-07Hengrui Medicine is preparing for a 2025 Hong Kong IPO, reportedly selecting Citigroup and Morgan Stanley as lead underwriters, aiming to raise about USD 2 billion.恒瑞医药正筹备2025年香港IPO，据报选定花旗和大摩牵头，拟集资约20亿美元。
2024-12-09Hengrui announced a proposal to issue H-shares and list on the Main Board of the Hong Kong Stock Exchange to advance its internationalization strategy; proceeds will be used for R&D, product commercialization, and operations.恒瑞医药公告拟发行H股并在香港联交所主板上市，以推动科技创新和国际化双轮驱动战略，募集资金将用于研发创新、产品商业化及公司运营等。
2024-12-26Hengrui's second extraordinary general meeting of shareholders in 2024 approved all proposals related to the issuance of H-shares and listing on the Hong Kong Stock Exchange with high votes.恒瑞医药2024年第二次临时股东大会高票通过了关于公司发行H股股票并在香港联交所上市的各项议案。
2025-01-06Hengrui Medicine submitted an H-share listing application to the Hong Kong Stock Exchange, with Morgan Stanley, Citigroup, and Huatai International as joint sponsors, planning to raise at least USD 2 billion.恒瑞医药向港交所递交H股上市申请，联席保荐人为摩根士丹利、花旗和华泰国际，计划募资至少20亿美元。
2025-01-17CSRC received Hengrui Medicine's overseas listing filing materials for its H-share IPO on the Hong Kong Stock Exchange.中国证监会接收恒瑞医药港股IPO备案申请材料。
2025-01-21Hengrui added UBS AG Hong Kong Branch as a global coordinator for its H-share listing on the Hong Kong Stock Exchange.恒瑞医药新增UBS AG Hong Kong Branch为港股上市整体协调人。
2025-02-14China Securities Regulatory Commission (CSRC) requested Hengrui Medicine to supplement its Hong Kong IPO filing, specifically clarifying whether its business involves foreign-investment prohibited areas (e.g., human stem cell, gene diagnosis and therapy).中国证监会对恒瑞医药港股IPO出具补充材料要求，要求说明业务是否涉及外资禁止领域（如人体干细胞、基因诊断与治疗）。
2025-04-28Hengrui receives CSRC filing notice for H-share listing on HKEX; plans to issue up to 815,094,600 H-shares.恒瑞医药收到中国证监会关于发行H股并在香港联交所上市的备案通知书；拟发行不超过8.15亿股H股。
2025-05-05Hengrui Medicine passed the HKEX listing hearing for its H-share IPO, with joint sponsors Morgan Stanley, Citigroup, and Huatai International. The CSRC approved the issuance of up to 815 million H-shares.恒瑞医药通过港交所上市聆讯，联席保荐人为摩根士丹利、花旗和华泰国际，中国证监会批准发行不超过8.15亿股H股。
2025-05-06Hengrui Medicine began evaluating investor interest for its Hong Kong IPO, with the bookbuilding process running from May 6 to May 9.恒瑞医药开始评估投资者对其香港IPO的认购意向，簿记建档过程从5月6日持续至5月9日。
2025-05-12Hengrui Medicine's board approved the global offering of H-shares and listing on the HKEX, including the publication of the prospectus and related arrangements.恒瑞医药董事会审议通过关于公司H股全球发售及在香港联交所上市的议案。
2025-05-15Hengrui Medicine launched its H-share global offering, planning to issue 224.52 million H-shares (base) at a price range of HKD 41.45-44.05 per share, with trading expected to begin on May 23, 2025.恒瑞医药启动H股全球发售，计划发行2.245亿股H股（基础），发行价区间为每股41.45-44.05港元，预计5月23日开始交易。
2025-05-21Hengrui Medicine set the final H-share IPO price at HKD 44.05 per share (the top of the range), with cornerstone investors including GIC, Invesco, UBS-GAM, Hillhouse Capital, and Boyu Capital subscribing for approximately HKD 4.131 billion.恒瑞医药确定H股IPO最终发行价为每股44.05港元（上限定价），基石投资者包括GIC、景顺、瑞银全球资管、高瓴资本、博裕资本等，认购金额约41.31亿港元。
2025-05-23Hengrui Medicine's H-shares began trading on the HKEX main board (stock code: 1276), opening at HKD 57, up 29.4% from the IPO price of HKD 44.05. The IPO raised net proceeds of approximately HKD 9.747 billion.恒瑞医药H股在港交所主板开始交易（股票代码1276），开盘价57港元，较发行价44.05港元上涨29.4%，IPO募资净额约97.47亿港元。
2025-06-19Hengrui fully exercised over-allotment option for H-share IPO, issuing additional 33,677,800 H-shares at HK$44.05 each, raising net proceeds of about HK$1.4715 billion; total H-share issuance reached 258,197,600 shares.恒瑞医药悉数行使H股超额配售权，以每股44.05港元增发33,677,800股H股，额外募集净额约14.715亿港元，H股总发行量达258,197,600股。
2025-06-20Hengrui's H-shares were included in the Shenzhen-Hong Kong Stock Connect eligible securities list effective June 20, 2025.恒瑞医药H股自2025年6月20日起被调入深港通下的港股通标的证券名单。
NRDL inclusion & volume-based procurement医保目录纳入与集采
3 · 2024-11-28 → 2025-12-07
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Inclusion of drugs in National Reimbursement Drug List and outcomes of volume-based procurement.药品纳入国家医保目录及集采结果。
2024-11-28Hengrui Medicine had 12 products included in the 2024 National Reimbursement Drug List (NRDL), including first-time inclusions of fumarate tagexifu injection, oteseconazole capsules, and henagliflozin-metformin extended-release tablets; several drugs renewed or added indications via simplified renewal rules.恒瑞医药12款产品纳入2024年国家医保目录，包括富马酸泰吉利定注射液、奥特康唑胶囊、恒格列净二甲双胍缓释片首次纳入；多款药物通过简易续约规则续约成功或新增适应症。
2024-12-12Hengrui won the bid for gadoteric acid meglumine injection as the first candidate in the 10th national volume-based procurement (VBP); sodium bicarbonate Ringer's injection failed.恒瑞医药在第十批国家药品集中采购中拟第一顺位中标钆特酸葡胺注射剂，碳酸氢钠林格注射液落选。
2025-12-07Hengrui Medicine announces 9 drugs (including injectable Ruikang Trastuzumab, Famitinib Malate capsules) are newly included in the 2025 National Reimbursement Drug List (NRDL), and 11 drugs (including Camrelizumab, Fuzuloparib capsules) have new indications added or renewed; these drugs had combined sales of ~86.60 billion yuan in 2024 and ~75.54 billion yuan in 9M 2025.恒瑞医药宣布9款药品（包括注射用瑞康曲妥珠单抗、苹果酸法米替尼胶囊等）首次纳入2025年国家医保目录，11款药品（包括注射用卡瑞利珠单抗、氟唑帕利胶囊等）新增适应症或续约成功；这些药品2024年合计销售额约86.60亿元，2025年前三季度合计约75.54亿元。
Awards & certifications奖项与认证
6 · 2025-01-18 → 2026-05-19
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Regulatory certifications, first shipments, and product launch ceremonies.监管认证、首批发货及产品上市仪式。
2025-01-18First shipment ceremony of Recaticimab (Aixin'an), Hengrui's first ultra-long-acting PCSK9 monoclonal antibody, held at the Guangzhou Knowledge City industrialization base, marking its clinical use launch.瑞卡西单抗（艾心安）首批发货仪式在广州知识城产业化基地举行，标志着该产品正式投入临床使用。
2025-01-20Subsidiary Fujian Shengdi received Drug Registration Certificate for Compound Amino Acid (16AA)/Glucose (12.6%) Electrolyte Injection, the first domestic generic, deemed passing consistency evaluation; cumulative R&D investment ~RMB 20.06 million.子公司福建盛迪收到复方氨基酸（16AA）/葡萄糖（12.6%）电解质注射液的《药品注册证书》，该产品为国内首仿，视同通过一致性评价；累计研发投入约2006万元。
2025-06-05Hengrui's subsidiary Fujian Shengdi received NMPA approval for Sodium Citrate Hemofiltration Replacement Fluid (chemical class 4, 5000ml) for CRRT; R&D investment about 8.57 million yuan.恒瑞医药子公司福建盛迪获得枸橼酸钠血滤置换液（化药4类，5000ml）上市批准，用于连续性肾脏替代治疗，研发投入约857万元。
2025-06-08Hengrui held first shipment ceremony for self-developed class 1 new drug Ruikang Trastuzumab (Aivita) injection, approved in May 2025 for HER2-mutant NSCLC, covering multiple hospitals nationwide.恒瑞医药自主研发的1类新药注射用瑞康曲妥珠单抗（艾维达）首批发货，该药于2025年5月获批用于HER2突变非小细胞肺癌，覆盖全国多家医疗机构。
2025-06-17Hengrui's class 1 innovative drug injection of Phosphoraprepitant Palonosetron (Ruitaining) received first prescription in China for prevention of chemotherapy-induced nausea and vomiting (CINV), approved in May 2025.恒瑞医药1类创新药注射用磷罗拉匹坦帕洛诺司琼（瑞坦宁）开出全国首张处方，用于预防化疗引起的恶心呕吐，2025年5月获批。
2026-05-19Hengrui's subsidiary Fujian Shengdi received NMPA approval for ω-3 triglycerides (2%)/medium-chain triglycerides/amino acids (16)/glucose (30%) injection, a generic 3-class drug for parenteral nutrition in adult patients with moderate-to-severe catabolism.恒瑞医药子公司福建盛迪医药收到国家药监局批准，ω-3甘油三酯（2%）中/长链脂肪乳/氨基酸（16）/葡萄糖（30%）注射液上市，用于中重度分解代谢成人患者的肠外营养治疗。
Subsidiaries & manufacturing bases子公司与生产基地
3 · 2025-01-21 → 2026-01-12
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Establishment of new subsidiaries, approval of manufacturing bases, and R&D center inaugurations.新子公司设立、生产基地获批及研发中心启用。
2025-01-21Hengrui established a wholly-owned subsidiary, Shandong Ruiyuan Pharmaceutical Co., Ltd., with registered capital of RMB 100 million, for drug production and commissioned manufacturing.恒瑞医药全资成立山东瑞远医药有限公司，注册资本1亿元，经营范围包括药品生产和药品委托生产。
2025-10-29Hengrui's Shanghai Innovation R&D Center in Zhangjiang, Pudong was officially inaugurated, featuring world-class molecular biology and cell biology labs, gene therapy and cell therapy R&D and pilot facilities, supporting global strategy.恒瑞医药上海创新研发中心在浦东张江正式启用，配备国际一流分子生物学和细胞生物开发实验室、基因治疗和细胞治疗研发及中试实验室，支持全球化战略。
2026-01-12Subsidiary Fujian Shengdi's high-end API base phase II construction project received environmental approval with total investment of 250 million yuan.子公司福建盛迪高端原料药基地二期建设项目环评获批，总投资额2.5亿元。
Other developments其他动态
1 · 2025-01-26
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Assorted one-off developments.零散的一次性动态。
2025-01-26Hengrui announced the pricing of Recaticimab (Aixin'an) at RMB 1,660 per vial.恒瑞医药公布瑞卡西单抗（艾心安）定价为每支1660元。
Digital transformation & AI deployment数字化转型与AI部署
1 · 2025-02-07
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Internal deployment of AI tools like DeepSeek across the organization.在全公司内部署DeepSeek等AI工具。
2025-02-07Hengrui Medicine issued an internal notice, ordered by chairman Sun Piaoyang, to fully deploy DeepSeek AI across all departments and subsidiaries, requiring application plans by Feb 25 and incorporating usage into annual executive performance reviews.恒瑞医药发布内部通知，由董事长孙飘扬指示，在全公司及子公司全面部署DeepSeek AI，要求各部门于2月25日前提交应用计划，并将其纳入干部年度考核。
Strategic cooperation & partnerships战略合作与伙伴关系
6 · 2025-08-01 → 2026-06-11
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Strategic agreements with chemical suppliers, hospitals, universities, and foundations.与化工供应商、医院、大学及基金会签署的战略协议。
2025-08-01Hengrui signed a strategic supply agreement with Yangben Chemical (300261.SZ) for pharmaceutical intermediates and APIs, effective until 2035-07-31.恒瑞医药与雅本化学（300261.SZ）签署供应战略协议，合作医药中间体及原料药，有效期至2035年7月31日。
2025-10-23Hengrui signed a strategic cooperation agreement with the National Health Commission's Population Culture and Grassroots Health Center to collaborate on 'Million Disability Reduction' initiatives, county-level medical research capacity building, and grassroots health science resource development.恒瑞医药与国家卫生健康委人口文化与基层健康中心签署战略合作协议，围绕“百万减残”强基行动、县域医疗机构科研能力提升、基层健康科普资源库建设等领域合作。
2025-11-22Hengrui signed a Named Patient Program (NPP) cooperation agreement with the Hong Kong Greater China Cancer Foundation to provide its innovative targeted drug Pyrotinib Maleate Tablets (Airuini) to breast cancer patients in Hong Kong public hospitals.恒瑞医药与香港大中华癌病基金会签署指定患者药物使用计划（NPP）合作协议，为香港公立医院乳腺癌患者提供其创新靶向药物马来酸吡咯替尼片（艾瑞妮）。
2026-04-28Hengrui Medicine signed a strategic cooperation agreement with Sun Yat-sen University in Guangzhou, focusing on oncology, autoimmune, metabolic, anti-infection, and RNA vaccines, establishing joint labs and an intelligent pilot base.恒瑞医药与中山大学在广州签署战略合作协议，聚焦肿瘤、自身免疫、代谢、抗感染、RNA疫苗等领域，共建联合实验室与智能化中试基地。
2026-05-08Hengrui officially opened its Hong Kong office and signed a charitable cooperation agreement with the Greater China Cancer Foundation (GCCF), marking a step in its global expansion and Greater Bay Area patient services.恒瑞医药香港办公室正式启用，并与大中华癌病基金会（GCCF）签署慈善合作协议，标志着公司完善港澳业务布局、强化粤港澳大湾区服务能力。
2026-06-11Hengrui signed a strategic cooperation agreement with Sun Yat-sen University in Guangzhou, covering talent training, scientific research collaboration, clinical translation, and academic exchange.恒瑞医药与中山大学在广州签署战略合作协议，涵盖人才培养、科研协同、临床转化、学术交流等领域。
R&D investment & pipeline disclosure研发投入与管线披露
3 · 2025-11-13 → 2026-03-25
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Annual R&D expenditure, pipeline updates, and future approval forecasts.年度研发支出、管线更新及未来获批预测。
2025-11-13Hengrui Global R&D President Zhang Lianshan stated at the SSE International Investor Conference that the company aims to transition from quantity to quality in innovative drugs, targeting $1-2 billion overseas revenue from innovative drugs to become a top-tier global pharma.恒瑞医药全球研发总裁张连山在上交所国际投资者大会上表示，公司将从创新药数量导向转向更高质量发展，目标实现10-20亿美元海外创新药营收，跻身国际一流梯队。
2026-03-25Hengrui Medicine's 2025 annual report disclosed that 24 Class 1 innovative drugs have been approved in China; 7 Class 1 and 1 Class 2 innovative drugs approved in 2025; 53 innovative achievements expected to be approved in 2026-2028.恒瑞医药2025年年报披露，已在中国获批上市24款1类创新药；2025年获批7款1类、1款2类创新药；预计2026-2028年约有53项创新成果获批上市。
2026-03-25Hengrui Medicine's 2025 annual report disclosed that R&D investment reached 8.724 billion yuan, accounting for 27.58% of revenue; 180 clinical trial approvals obtained in 2025.恒瑞医药2025年年报披露，全年研发投入87.24亿元，占营业收入27.58%；2025年取得药物临床批件180个。
ESG & corporate social responsibilityESG与企业社会责任
1 · 2025-11-28
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Donations, charitable cooperation, and social responsibility initiatives.捐赠、慈善合作及社会责任举措。
2025-11-28Hengrui donated 10 million HKD for emergency rescue and disaster reconstruction.恒瑞医药紧急捐赠1000万港元，用于紧急救援和灾后重建。
Industry standards & policy行业标准与政策
1 · 2026-04-23
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Participation in industry standards, policy responses, and regulatory filings.参与行业标准、政策回应及监管申报。
2026-04-23Hengrui stated that it has no commercial innovative drugs exported to the US, so the 100% tariff on imported innovative drugs has no current impact.恒瑞医药表示暂无商业化创新药出口至美国销售，美国对进口创新药加征100%关税目前对公司暂无影响。
