证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-154 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"）子公司广东恒瑞医 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 SHR-2173 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。现 将相关情况公告如下： 一、 药物的基本情况 三、风险提示 根据我国药品注册相关的法律法规要求，药物在获得药物临床试验批准通知 书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。 药物名称：SHR-2173 注射液 剂 型：注射剂 申请事项：临床试验 受 理 号：CXSL2400643 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，2024 年 9 月 24 日受理的 SHR-2173 注射液临床试验申请符合药品注册的有关要求，同 意本品开展临床试验。申请的适应症为狼疮肾炎（LN）。 二、药物的其 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-153 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"）及子公司福建盛迪 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-4729 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。 现将相关情况公告如下： 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，2024 年 9 月 29 日受理的 HRS-4729 注射液临床试验申请符合药品注册的有关要求，同 意本品在肥胖或超重患者中开展临床试验。 二、药物的其他情况 HRS-4729 注射液是公司自主研发的多肽类药物，是一种胰高血糖素样肽-1 受体（GLP-1R）/葡萄糖依赖性促胰岛素多肽受体（GIPR）/胰高血糖素受体（GCGR） 三激动剂。与 GLP-1/GIP 双靶点相比，三重受体激动剂通过在体内调节糖脂代谢、 抑制食欲的基础上增加 GC ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-152 江苏恒瑞医药股份有限公司 关于 2022 年员工持股计划第二个锁定期解锁 执行完毕的公告 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。 2022 年 11 月 8 日披露于上海证券交易所网站（www.sse.com.cn）的《恒瑞医药 2022 年员工持股计划第一次持有人会议决议公告》（公告编号：临 2022-121）。 4、2023 年 11 月 3 日，公司召开 2022 年员工持股计划第二次持有人会议、 第九届董事会第六次会议，审议通过《关于<江苏恒瑞医药股份有限公司 2022 年员工持股计划（修订稿）>的议案》等相关议案，对公司 2022 年员工持股计 划有关权益分配方式的相关表述由原来的"择机出售相应的标的股票"调整为 "择机出售相应的标的股票或过户至当期员工持股计划份额持有人"。其他调 整内容详见《恒瑞医药关于修订 2022 年员工持股计划及相关文件的公告》（公 告编号：临 2023-127）。 5、2023 年 11 月 4 日，公司披 ...

Group 1 - The core viewpoint of the news is that Heng Rui Medicine is planning to list H-shares on the Hong Kong Stock Exchange to enhance its internationalization strategy and attract more international investors [1][3][8] - Heng Rui Medicine's board approved the proposal for the H-share issuance and listing, indicating a strategic move to align its organizational structure with international standards [1][3] - The funds raised from the listing will be used for research and development, product commercialization, and company operations, reflecting the company's commitment to innovation [2][5] Group 2 - The Hong Kong market has seen a significant decrease in the number of biotech IPOs, down 43% year-on-year, but the total amount raised has increased by 5%, indicating a shift in investor sentiment towards larger funding rounds [2][8] - Heng Rui Medicine's financial performance shows strong growth, with a revenue of 20.189 billion yuan and a net profit of 4.620 billion yuan for the first three quarters of 2024, representing year-on-year increases of 18.67% and 32.98% respectively [4][5] - The company has invested over 40 billion yuan in R&D cumulatively, with a significant increase in R&D expenses in 2024, highlighting its focus on innovation and competitiveness in the market [5][6] Group 3 - The establishment of the Hong Kong Drug Regulatory Authority (CMPR) is anticipated, which will enhance the regulatory framework for drug approvals and support the growth of the biotech industry in Hong Kong [6][8] - The Hong Kong government has been actively supporting mainland companies to list in Hong Kong, optimizing the IPO approval process to attract more firms [7][9] - The choice of Hong Kong as a listing venue is seen as strategic for Heng Rui Medicine, as it allows for better access to international investors and enhances its global brand image [3][8][9]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-4394 and HRS-3802, both of which are innovative treatments for cancer [1][2][4]. Group 1: Product Development - SHR-4394 is a self-developed injectable biological product intended for the treatment of prostate cancer [2]. - HRS-3802 is a sustained-release tablet that can inhibit tumor cell proliferation and exert anti-tumor effects [3]. - Both products are set to commence clinical trials shortly following the approval [1][2]. Group 2: Market Context - There are currently no similar products approved for market release in both domestic and international markets [4].

Market Overview - The Shanghai Composite Index rose by 0.59% on December 10, with 23 out of the 28 sectors experiencing gains, led by retail and beauty care sectors, which increased by 2.54% and 2.25% respectively [1] - The sectors that saw declines included utilities and oil & gas, with decreases of 0.74% and 0.47% respectively [1] Capital Flow Analysis - The main capital flow showed a net outflow of 33.974 billion yuan across the two markets, with only four sectors experiencing net inflows [1] - The food and beverage sector had the highest net inflow, totaling 2.14% in growth and 2.364 billion yuan in net inflow, followed by the retail sector with a 2.54% increase and a net inflow of 1.652 billion yuan [1] Pharmaceutical and Biological Sector - The pharmaceutical and biological sector closed flat, with a net outflow of 4.394 billion yuan, comprising 475 stocks, of which 215 rose and 239 fell [2] - Among the stocks in this sector, 161 experienced net inflows, with five stocks receiving over 50 million yuan, led by Aier Eye Hospital with a net inflow of 140 million yuan, followed by Fudan-Zhangjiang and Changshan Pharmaceutical with inflows of 124 million yuan and 100 million yuan respectively [2] - The sector also saw significant outflows, with seven stocks experiencing net outflows exceeding 100 million yuan, led by Hengrui Medicine, Kangmei Pharmaceutical, and Dezhan Health with outflows of 888 million yuan, 752 million yuan, and 191 million yuan respectively [2]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-150 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。 药品从研制、临床试验报批到投产的周期长、环节多，药品研发及至上市容 申请事项：临床试验 受 理 号：CXSL2400601 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，2024 年 9 月 9 日受理的注射用 SHR-4394 临床试验申请符合药品注册的有关要求，同 意本品开展晚期前列腺癌的临床试验。 二、药物的其他情况 注射用 SHR-4394 是公司自主研发的一款治疗用生物制品，拟用于治疗前列 腺癌。经查询，国内外尚无同类产品获批上市。截至目前，注射用 SHR-4394 相 关项目累计已投入研发费用约为 1,842 万元。 三、风险提示 根据我国药品注册相关的法律法规要求，药物在获得药物临床试验批准通知 书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"） ...

剂 型：片剂 申请事项：临床试验 受 理 号：CXHL2400976、CXHL2400977 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-151 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"）子公司上海恒瑞医 药有限公司和山东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-3802 缓释片的《药物临床试验批准通知书》，将 于近期开展临床试验。现将相关情况公告如下： 一、 药物的基本情况 药物名称：HRS-3802 缓释片 根据我国药品注册相关的法律法规要求，药物在获得药物临床试验批准通知 书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。 药品从研制、临床试验报批到投产的周期长、环节多，药品研发及至上市容 易受到一些不确定性因素的影响，敬请广大投资者谨慎决策，注意防范投资风险。 公司将按国家有关规定积极推进上述研发项目，并及时对项目后 ...

财联社12月10日电，恒瑞医药公告，子公司上海恒瑞医药有限公司和山东盛迪医药有限公司收到国家药 监局签发的关于HRS-3802缓释片的《药物临床试验批准通知书》，将于近期开展临床试验。 HRS-3802缓释片是一种新型、高效、选择性的细胞周期蛋白依赖性激酶抑制剂，能够通过抑制下游蛋 白磷酸化，诱导肿瘤细胞周期阻滞，进而抑制肿瘤细胞增殖，发挥抗肿瘤作用。 国内外尚无同类产品获批上市。 截至目前，HRS-3802缓释片相关项目累计已投入研发费用约为1025万元。 药物在获得药物临床试验批准通知书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产 上市。 ...

Group 1 - The core point of the news is that Heng Rui Pharmaceutical plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its international business development and drive innovation [1][5][6] - The company aims to use the funds raised from the H-share issuance for research and development, product commercialization, and operational activities, reflecting its commitment to the "innovation + internationalization" strategy [1][3] - Heng Rui Pharmaceutical reported a revenue of 20.189 billion yuan for the first three quarters, a year-on-year increase of 18.67%, and a net profit of 4.620 billion yuan, up 32.98% year-on-year, indicating stable growth [2][3] Group 2 - The company has invested over 40 billion yuan in research and development, with annual R&D expenditures exceeding 6 billion yuan from 2021 to 2023, and 4.549 billion yuan in the first three quarters of 2024, a 22% increase year-on-year [2][3] - Heng Rui's pipeline includes 17 innovative drugs approved in China, 4 Class 2 new drugs, and over 90 self-innovated products in clinical development, showcasing its strong R&D capabilities [2][4] - The company has entered over 40 countries with its high-end formulation products, including the FDA-approved paclitaxel albumin, and is actively pursuing international clinical trials and collaborations [4][5] Group 3 - The overseas listing is expected to accelerate Heng Rui's international expansion, providing access to a diverse range of international investors and enhancing its global brand image [5][6] - Recent policy support from the Hong Kong Securities and Futures Commission and the Stock Exchange aims to facilitate the listing process for A-share companies, creating a favorable environment for Heng Rui's dual listing strategy [5][6] - The company's focus on innovation and internationalization positions it to become a globally competitive multinational pharmaceutical group through the A+H dual listing model [6]