Core Viewpoint - Heng Rui Medicine (01276) 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 HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, Adalimumab injection, Bevacizumab injection, SHR-A2102 for injection, Famitinib malate capsules, and Darsylis sulfate tablets [1] - The approved clinical trials are set to commence in the near future, reflecting the company's ongoing commitment to expanding its product offerings [1]

Core Viewpoint - Recently, Jiangsu Hengrui Medicine Co., Ltd. and its subsidiaries received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant advancement in their drug development pipeline [1] Group 1: Clinical Trial Approvals - The company has received approval for clinical trials of HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, Abediteran injection, Bevacizumab injection, SHR-A2102 injection, Apalutamide capsules, and Darsylis sulfate tablets [1] - The approval is based on compliance with the relevant drug registration requirements as per the Drug Administration Law of the People's Republic of China [1] - The specific study includes a Phase I/II trial to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with anti-tumor drugs in subjects with solid tumors [1]

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 (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]

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]

Group 1 - Roche Pharmaceuticals announced an investment of 2.04 billion RMB to establish a biopharmaceutical production base in Shanghai, aimed at enhancing its supply chain and local production in China, with completion expected in 2029 and production starting in 2031 [1] - Hengrui Medicine's application for the market approval of its CDK4/6 inhibitor, Hydroxyethyl Sulfonate Darsilil Tablets, has been accepted by the National Medical Products Administration, targeting hormone receptor-positive, HER2-negative early or locally advanced breast cancer [2] - Sanyou Medical plans to establish a joint venture with South Korea's CGBio to research innovative cell biological materials in regenerative medicine, marking a significant step in this field [3] Group 2 - ST Kelly has elected a new chairman, Wang Chong, following the recent resignation of both the chairman and the general manager, with the board voting in favor of the appointment [4] - Yunding New Medicine's core product, Naimu Kang, has received full approval from the National Medical Products Administration for treating primary immunoglobulin A nephropathy in adults, becoming the first and only drug in China approved for this indication [5]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-016 江苏恒瑞医药股份有限公司 关于药品临床试验进展的公告 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"）自主研发的羟乙磺 酸达尔西利片联合内分泌治疗在激素受体（HR）阳性、人表皮生长因子受体 2 （HER2）阴性女性乳腺癌辅助治疗中的一项多中心、随机、双盲的Ⅲ期临床试验 （研究方案编号：SHR6390-Ⅲ-303），首次期中分析主要终点达到统计学显著性。 研究结果显示，达尔西利联合内分泌治疗，较安慰剂联合内分泌治疗，可显著降 低患者复发风险，提高患者无侵袭性疾病生存期（IDFS）[1]。公司已于近期向国 家药品监督管理局药品审评中心递交上市前沟通交流申请。 一、 药品的基本情况 药品名称：羟乙磺酸达尔西利片 剂型：片剂 二、 药品的临床试验情况 达尔西利已于国内获批两项适应症，即本品适用于激素受体（HR）阳性、人 表皮生长因子受体 2（HER2）阴性局部晚期或转移性乳腺癌患者：1.与芳香化酶 抑制剂联合使 ...