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 ...

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 ...

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]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-147 特此公告。 江苏恒瑞医药股份有限公司董事会 2024 年 12 月 9 日 附件：周纪恩先生简历 江苏恒瑞医药股份有限公司 关于增选公司第九届董事会独立董事的公告 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。 江苏恒瑞医药股份有限公司（以下简称"公司"）于 2024 年 12 月 9 日召开 第九届董事会第十二次会议，审议通过了《关于增选独立董事并确定董事角色的 议案》，具体情况如下： 为进一步完善公司发行 H 股并上市后的公司治理结构，根据《香港联合交易 所有限公司证券上市规则》等有关法律、法规及《公司章程》的规定，经公司提 名委员会资格审核通过，董事会同意推选周纪恩（Chow Kyan Mervyn）先生（简 历见附件）为公司第九届董事会独立董事，任期自公司本次发行的 H 股股票在香 港联交所上市之日至第九届董事会任期届满为止。 根据相关规定，上述独立董事候选人需经上海证券交易所审核无异议后方可 提交公司股东会审议。 本事项尚需提交公司 2024 ...

江苏恒瑞医药股份有限公司 关于筹划发行 H 股股票并上市相关事项 的提示性公告 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-145 根据相关规定，公司本次发行并上市事项尚需提交公司股东会审议，并需要 取得中国证券监督管理委员会和香港联交所等相关政府机关、监管机构、证券交 易所批准、核准或备案，本次发行并上市能否通过审议、备案和审核程序并最终 实施具有重大不确定性。公司将依据相关法规的规定，根据本次发行并上市的后 续进展情况及时履行信息披露义务。 具体内容详见公司在上海证券交易所网站（http://www.sse.com.cn）披露 的《恒瑞医药第九届董事会第十二次会议决议公告》等相关公告。本次发行并上 市尚存在较大不确定性，敬请广大投资者关注后续公告，注意投资风险。 特此公告。 江苏恒瑞医药股份有限公司董事会 2024 年 12 月 9 日 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。 为深入推动科技创新和国际化双轮驱动战略，进一步助力公司国际化业务的 发展，江苏恒瑞医药股份有限公司（以下简称"公司" ...

江苏恒瑞医药股份有限公司 境外发行证券及上市相关保密和档案管理工 作制度 第一条 为保障国家经济安全，保护社会公共利益江苏恒瑞医药股份有限公 司（以下简称"公司"）的利益，维护公司在境外发行证券及上市过程中的信息 安全，规范公司及各证券服务机构在公司境外发行证券及上市过程中的档案管理， 根据《中华人民共和国证券法》《中华人民共和国保守国家秘密法》《中华人民共 和国档案法》《中华人民共和国会计法》《中华人民共和国注册会计师法》《中华人 民共和国国家安全法》和《境内企业境外发行证券和上市管理试行办法》《关于加 强境内企业境外发行证券和上市相关保密和档案管理工作的规定》等有关法律、法 规、规范性文件及《江苏恒瑞医药股份有限公司章程》（以下简称"《公司章程》" ）的规定，结合公司情况，制定本制度。 第五条 在公司境外发行证券及上市过程中，公司向有关证券公司、证券服务 机构、境外监管机构等单位和个人提供或者公开披露，或者通过其境外上市主体 等提供、公开披露涉及国家秘密、国家机关工作秘密的文件、资料的，应当依法报 有审批权限的主管部门批准，并报同级保密行政管理部门备案后方可对外提供或 者公开披露。 公司对所提供或者公开披 ...