证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-180 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 HRS-6209 是一种新型选择性 CDK4 抑制剂，能够强效抑制 CDK4/cyclinD 复 合物及下游信号，诱导肿瘤细胞阻滞在 G1 期，进而发挥抗肿瘤作用，临床拟用 于治疗晚期恶性实体瘤。与 CDK4/6 抑制剂相比，提高了对 CDK6/cyclinD3 信号 通路的选择性，可改善 CDK4/6 抑制剂相关的血液毒性。经查询，国内外尚无同 类产品获批上市。截至目前，HRS-6209 相关项目累计研发投入约 8,037 万元。 HRS-2189 是一种新型的 KAT6 抑制剂，通过抑制组蛋白赖氨酸乙酰化水平， 调控下游多种癌基因表达进而发挥抗肿瘤作用，拟用于治疗晚期恶性肿瘤。目前 国内外暂无同靶点药物获批上市。截至目前，HRS-2189 相关项目累计研发投入 约 4,900 万元。 三、风险提示 根据我国药品注册相关的法律法规要求，药物 ...

SHR-1701 注射液是公司自主研发并具有知识产权的抗 PD-L1/TGF-βRII 双 功能融合蛋白，可以促进效应性 T 细胞的活化，同时还可有效改善肿瘤微环境中 的免疫调节作用，最终有效促进免疫系统对于肿瘤细胞的杀伤。经查询，国内外 尚无同类产品获批上市。截至目前，SHR-1701 注射液相关项目累计研发投入约 68,570 万元。 SHR-7367 注射液为公司自主研发的靶向人 FAP 和 CD40 的 IgG1 亚型双特异 性抗体，可以通过与肿瘤相关抗原特异性结合，激活免疫共刺激分子，从而激活 肿瘤微环境中的多种免疫细胞发挥抗肿瘤作用。经查询,目前国内外暂无同类产 品获批上市。截至目前，SHR-7367 相关项目累计研发投入约 4,310 万元。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-179 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 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 ...

Core Viewpoint - 恒瑞医药 has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant advancement in its drug development pipeline [1][2]. Group 1: Company Developments - 恒瑞医药 and its subsidiaries have been granted clinical trial approval for several products, including HRS-4642 injection, SHR-1701 injection, and others, which will commence trials soon [1]. - The company's revenue composition for the year 2024 is projected to be 89.37% from pharmaceutical manufacturing and 10.63% from other businesses [1]. Group 2: Market Position - As of the latest report, 恒瑞医药's market capitalization stands at 410.2 billion yuan [2].

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of two new drugs, HRS-6209 and HRS-2189, which are aimed at treating advanced malignant tumors [2] Group 1: Drug Development - HRS-6209 is a novel selective CDK4 inhibitor intended for the treatment of advanced malignant solid tumors, with no similar products approved for market domestically or internationally [2] - HRS-2189 is a new KAT6 inhibitor also aimed at treating advanced malignant tumors, with no drugs targeting the same pathway approved for market domestically or internationally [2]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant advancement in its drug development pipeline [1] Group 1: Clinical Trials - The company and its subsidiaries, including Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Heng Rui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd., have been granted clinical trial approval for several drugs [1] - The approved drugs include HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, Adebali monoclonal antibody injection, Bevacizumab injection, SHR-A2102 for injection, Appleseed Famitinib capsules, and Hydroxyethyl sulfonic acid Darsilil tablets [1] - A specific trial will focus on the safety, tolerability, and efficacy of HRS-4642 in combination with anti-tumor drugs in solid tumor subjects, categorized as a Phase I/II study [1]

每经AI快讯，11月17日，恒瑞医药（600276）(600276.SH)公告称，公司收到国家药品监督管理局核准 签发关于富马酸泰吉利定注射液的《药物临床试验批准通知书》，将于近期开展临床试验。该药品是μ 阿片受体(MOR)偏向性小分子激动剂，2024年1月于国内获批上市，是中国首个自主研发的1类阿片类镇 痛创新药。 ...

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant advancement in its drug development pipeline [1] Group 1: Clinical Trials - The company and its subsidiaries have received approval for clinical trials of HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, Adebali monoclonal antibody injection, Bevacizumab injection, SHR-A2102 for injection, Apalutamide capsules, and Darsylis sulfate tablets [1] - A specific trial for HRS-4642 will focus on its safety, tolerability, and efficacy in combination with anti-tumor drugs in solid tumor subjects, categorized as a Phase I/II study [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant advancement in its drug development pipeline [1] Group 1: Clinical Trial Approvals - The company and its subsidiaries have been granted clinical trial approval for several products, including HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, Adalimumab injection, Bevacizumab injection, SHR-A2102 for injection, Apalutamide capsules, and Darsylis sulfate tablets [1] - Notably, HRS-4642 injection, SHR-1701 injection, and SHR-7367 injection have no similar products approved for market in both domestic and international markets [1]

Core Viewpoint - Heng Rui Medicine announced that the company and its subsidiaries have received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for HRS-4642 injection and eight other drugs, which will soon enter clinical trials [1] Group 1: Drug Development - HRS-4642, SHR-1701, and SHR-7367 have no similar products approved for sale domestically or internationally [1] - The remaining drugs have similar products already on the market [1] - The total research and development investment for the nine drug projects ranges from 43.1 million to 1.287 billion yuan [1] Group 2: Market Considerations - The drug development process from research to market launch is lengthy and involves multiple stages, which introduces uncertainty [1]

Core Insights - The company and its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., have received approval from the National Medical Products Administration for clinical trials of HRS-6209 capsules and HRS-2189 tablets [1] Group 1: Product Development - HRS-6209 is a novel selective CDK4 inhibitor intended for the treatment of advanced malignant solid tumors [1] - HRS-2189 is a new KAT6 inhibitor aimed at treating advanced malignant tumors [1] Group 2: Research and Development Investment - Cumulative R&D investment for the HRS-6209 project is approximately 80.37 million yuan [1] - Cumulative R&D investment for the HRS-2189 project is around 49 million yuan [1]