Core Viewpoint - Heng Rui Medicine (1276.HK) experienced a significant stock price increase, rising approximately 7% to HKD 69.6, with a total market capitalization of HKD 461.9 billion, following the announcement of multiple drug clinical trial approvals by the National Medical Products Administration [1] Group 1: Drug Approvals - The company and its subsidiaries received approval for clinical trials for several drugs, including SHR-9839, SHR-A2009, SHR-1826, HRS-4642 injection, Adalimumab injection, Trastuzumab, SHR-A2102, and HRS-7058 capsules and tablets [1] - The approval of nine drugs (excluding SHR-1139) in a single announcement highlights the company's strong research and development efficiency and a rich product pipeline, which are core components of its long-term competitiveness [1]

注射用瑞康曲妥珠单抗可通过与HER2表达的肿瘤细胞结合并内吞，在肿瘤细胞溶酶体内通过蛋白酶剪 切释放毒素，诱导细胞周期阻滞从而诱导肿瘤细胞凋亡。公司注射用瑞康曲妥珠单抗已于2025年5月在 国内获批上市，适用于治疗存在HER2(ERBB2)激活突变且既往接受过至少一种系统治疗的不可切除的 局部晚期或转移性非小细胞肺癌(NSCLC)成人患者。经查询，目前国外已上市的同类产品有罗氏公司研 发的Ado-trastuzumab emtansine及阿斯利康与第一三共合作研发的Fam-trastuzumab deruxtecan，且均已在 国内上市。除此之外，荣昌生物研发的维迪西妥单抗于2021年在国内获批上市，科伦博泰研发的博度曲 妥珠单抗于2025年在国内获批上市。经查询EvaluatePharma数据库，2024年以上同类产品全球销售额合 计约为65.57亿美元。截至目前，注射用瑞康曲妥珠单抗相关项目累计研发投入约14.15亿元。 注射用SHR-A2102为公司自主研发且具有知识产权的靶向Nectin-4的抗体药物偶联物(ADC)，其有效载 荷是拓扑异构酶Ⅰ抑制剂(TOP1i)。多种研究表明Nectin-4在肿瘤 ...

Core Viewpoint - 恒瑞医药 has received approval from the National Medical Products Administration for multiple clinical trial applications for new drug candidates, indicating a significant advancement in its oncology pipeline [1][2][3][4][5] Group 1: New Drug Approvals - The company has received clinical trial approval for SHR-9839, a humanized antibody drug targeting advanced solid tumors, with a cumulative R&D investment of approximately 72.31 million [1] - SHR-A2009, an antibody-drug conjugate targeting HER3, has a cumulative R&D investment of about 227 million [2] - SHR-1826, targeting c-MET, has a cumulative R&D investment of around 101 million [2] - HRS-4642, a KRAS G12D inhibitor, has a cumulative R&D investment of approximately 191 million [2] - 阿得贝利单抗, a humanized anti-PD-L1 monoclonal antibody, has been approved for use in extensive-stage small cell lung cancer, with a cumulative R&D investment of about 969 million [3] - 注射用瑞康曲妥珠单抗, targeting HER2, has been approved for use in non-small cell lung cancer, with a cumulative R&D investment of around 1.415 billion [4] - SHR-A2102, an ADC targeting Nectin-4, has a cumulative R&D investment of approximately 248 million [5] - HRS-7058, a selective small molecule inhibitor for KRAS G12C mutations, has a cumulative R&D investment of about 69.57 million [5] Group 2: Market Context and Competitors - SHR-9839 is the only drug in its class currently in development, with one similar drug already approved globally [1] - SHR-A2009 is the first of its kind, with no similar drugs approved globally [2] - SHR-1826 has a competitor, ABBV399, which received accelerated approval in the U.S. for specific lung cancer patients [2] - 阿得贝利单抗 has several competitors, including Atezolizumab and Durvalumab, which collectively generated approximately 9.648 billion in global sales in 2024 [3] - 注射用瑞康曲妥珠单抗 has competitors like Ado-trastuzumab emtansine and Fam-trastuzumab deruxtecan, with a combined global sales forecast of about 6.557 billion in 2024 [4] - SHR-A2102 has one competitor, Enfortumab vedotin, with a projected global sales of approximately 1.949 billion in 2024 [5] - HRS-7058 faces competition from Sotorasib and Adagrasib, which are expected to generate around 485 million in global sales in 2024 [5]

Core Viewpoint - 恒瑞医药 and its subsidiaries have received approval from the National Medical Products Administration for multiple clinical trials of new drug candidates, indicating a strong pipeline and ongoing investment in innovative therapies [1] Group 1: Clinical Trial Approvals - The company has received approval for clinical trials for several drugs, including SHR-9839, SHR-A2009, SHR-1826, HRS-4642, and others [1] - SHR-9839 is a humanized antibody drug aimed at treating advanced solid tumors, with a cumulative R&D investment of approximately 72.31 million yuan [1] - SHR-A2009 is a HER3-targeted antibody-drug conjugate, with no similar drugs approved globally, and a cumulative R&D investment of about 227 million yuan [1] Group 2: Market Potential and R&D Investments - SHR-1826 is a c-MET-targeted antibody-drug conjugate, with a cumulative R&D investment of around 101 million yuan [1] - HRS-4642 is a KRASG12D inhibitor, with a cumulative R&D investment of approximately 191 million yuan [1] - The approved drug, 阿得贝利单抗, is indicated for first-line treatment of extensive-stage small cell lung cancer, with a projected global sales of similar products totaling about 9.648 billion USD in 2024 and a cumulative R&D investment of approximately 969 million yuan [1] Group 3: Future Drug Approvals and Sales Projections - 注射用瑞康曲妥珠单抗 is expected to be approved in China by May 2025 for HER2-mutant non-small cell lung cancer, with projected global sales of similar products totaling around 6.557 billion USD in 2024 and a cumulative R&D investment of about 1.415 billion yuan [1] - SHR-A2102 is a Nectin-4-targeted antibody-drug conjugate, with projected global sales of about 1.949 billion USD in 2024 and a cumulative R&D investment of approximately 248 million yuan [1] - HRS-7058 is a KRASG12C inhibitor, with projected global sales of similar products totaling around 485 million USD in 2024 and a cumulative R&D investment of about 69.57 million yuan [1]

审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025年8月8日受理的注射用 SHR-9839(sc)、 注射用 SHR-A2009、注射用 SHR-1826、HRS-4642 注射液、阿得贝利单抗注射液、注 射用瑞康曲妥珠单抗、 注射用 SHR-A2102、HRS-7058 胶囊和 HRS-7058 片符合药品注册的有关要求， 同意开展临床试验。具体为： 一项注射用 SHR-9839(sc)联合抗肿瘤药物在实体瘤受试者中的安全性、 耐受性及有效性的 IB/Ⅱ期研究 方案。 格隆汇11月21日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司及子公司苏州盛迪亚生 物医药有限公司、上海恒瑞医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局(以下简 称"国家药监局")核准签发关于注射用SHR-9839(sc)、注射用SHR-A2009、注射用SHR-1826、HRS-4642 注射液、阿得贝利单抗注射液、注射用瑞康曲妥珠单抗、注射用SHR-A2102、HRS-7058胶囊和HRS- 7058片的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，公司及子公司苏州盛迪亚生物医药有限公 司、上海恒瑞医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局(以下简称"国家药监局") 核准签发关于注射用SHR-9839(sc)、注射用SHR-A2009、注射用SHR-1826、HRS-4642 注射液、阿得贝 利单抗注射液、注射用瑞康曲妥珠单抗、注射用SHR-A2102、HRS-7058胶囊和HRS-7058片的《药物临 床试验批准通知书》，将于近期开展临床试验。具体为：一项注射用SHR-9839(sc)联合抗肿瘤药物在实 体瘤受试者中的安全性、耐受性及有效性的IB/Ⅱ期研究方案。 ...

智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，公司及子公司苏州盛迪亚生物医药有限公 司、上海恒瑞医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局(以下简称"国家药监局") 核准签发关于注射用SHR-9839(sc)、注射用SHR-A2009、注射用SHR-1826、HRS-4642 注射液、阿得贝 利单抗注射液、注射用瑞康曲妥珠单抗、注射用SHR-A2102、HRS-7058胶囊和HRS-7058片的《药物临 床试验批准通知书》，将于近期开展临床试验。具体为：一项注射用SHR-9839(sc)联合抗肿瘤药物在实 体瘤受试者中的安全性、耐受性及有效性的IB/Ⅱ期研究方案。 ...

恒瑞医药（600276）(600276.SH)发布公告，近日，公司及子公司苏州盛迪亚生物医药有限公司、上海 恒瑞医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发 关于注射用SHR-9839(sc)、注射用SHR-A2009、注射用SHR-1826、HRS-4642注射液、阿得贝利单抗注 射液、注射用瑞康曲妥珠单抗、注射用SHR-A2102、HRS-7058胶囊和HRS-7058片的《药物临床试验批 准通知书》，将于近期开展临床试验。具体为：一项注射用SHR-9839(sc)联合抗肿瘤药物在实体瘤受试 者中的安全性、耐受性及有效性的IB/Ⅱ期研究方案。 ...

北京商报讯（记者 王寅浩 宋雨盈）11月21日，恒瑞医药发布公告称，公司及子公司苏州盛迪亚生物医 药有限公司、上海恒瑞医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局核准签发关于注 射用SHR-9839(sc)、注射用SHR-A2009、注射用SHR-1826、HRS-4642注射液、阿得贝利单抗注射液、 注射用瑞康曲妥珠单抗、注射用SHR-A2102、HRS-7058胶囊和HRS-7058片的《药物临床试验批准通知 书》，将于近期开展临床试验。具体为一项注射用SHR-9839(sc)联合抗肿瘤药物在实体瘤受试者中的安 全性、耐受性及有效性的IB/Ⅱ期研究方案。 ...

恒瑞医药(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")及子公司苏州盛迪亚生 物医药有限公司、上海恒瑞医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局(以下简 称"国家药监局")核准签发关于 HRS-4642 注射液、 SHR-1701 注射液、SHR-7367 注射液、SHR-8068 注 射液、阿得贝利单抗注射液、贝伐珠单抗注射液、注射用 SHR-A2102、苹果酸法米替尼胶囊和羟乙磺 酸达尔西利片的《药物临床试验批准通知书》，将于近期开展临床试验。 ...