一、药物的基本情况 药物名称：SHR-4610 注射液 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 SHR-4610 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： 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-175 三、风险提示 剂 型：注射剂 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 申请事项：临床试验 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，并及时对项目后续进展情况履行信息披 露义务。 受 理 号：CXSL2500686 特 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of HRS-2430 injection, a new intravenous general anesthetic [1] Group 1: Product Development - HRS-2430 injection is designed for intravenous general anesthesia, competing with existing products such as etomidate, midazolam, and remimazolam [1] - The total global sales of etomidate, midazolam, and remimazolam are approximately $773 million in 2024 [1] - The cumulative R&D investment for the HRS-2430 injection project has reached approximately 24.6 million yuan [1]

Core Viewpoint - The Medical Health R Index (480016) closed at 7535.01 points, down 0.39%, with a trading volume of 21.869 billion yuan and a turnover rate of 0.89% on November 7 [1] Group 1: Index Performance - The index had 26 stocks rising, with Xinhecheng leading at a 4.9% increase, while 23 stocks fell, with Zaiqing Pharmaceutical leading the decline at 4.35% [1] - The top ten constituent stocks of the Medical Health R Index are primarily in the pharmaceutical and medical sectors, with notable weights and market capitalizations [1] Group 2: Key Constituents - WuXi AppTec (sh603259) holds a weight of 13.66% with a market cap of 282.98 billion yuan, closing at 94.84 yuan, down 0.89% [1] - Hengrui Medicine (sh600276) has an 11.00% weight, a market cap of 408.72 billion yuan, and closed at 61.58 yuan, down 1.35% [1] - Mindray Medical (sz300760) has a weight of 7.57%, a market cap of 249.51 billion yuan, and closed at 205.79 yuan, down 0.27% [1] - Other notable constituents include United Imaging Healthcare (sh688271), Pianzai Shou (sh600436), and Xinhecheng (sz002001), which saw a 4.9% increase [1] Group 3: Capital Flow - The Medical Health R Index constituents experienced a net outflow of 240 million yuan from institutional investors and 119 million yuan from retail investors, while retail investors saw a net inflow of 359 million yuan [1] - Specific stocks like Huazhong Pharmaceutical (000999) and Yuyue Medical (002223) showed significant net inflows and outflows among different investor types [2]

Core Viewpoint - Heng Rui Medicine's subsidiary has received approval for clinical trials of SHR-4610 injection, an innovative anti-tumor drug developed by the company [1] Group 1: Company Developments - The subsidiary, Shanghai Shengdi Pharmaceutical Co., Ltd., received the clinical trial approval notice from the National Medical Products Administration for SHR-4610 injection [1] - SHR-4610 injection is intended for use in clinical trials for late-stage solid tumors [1] - The total research and development investment for the related project has reached approximately 7.36 million yuan [1] Group 2: Regulatory and Market Context - Following the approval notice, the drug must undergo clinical trials and receive further review and approval from the National Medical Products Administration before it can be manufactured and marketed [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of its innovative anti-tumor drug SHR-4610 injection, which shows promising anti-tumor activity in preclinical animal models and is intended for the treatment of advanced solid tumors [1] Company Summary - The company’s subsidiary, Shanghai Shengdi Pharmaceutical Co., Ltd., is responsible for the clinical trial of SHR-4610 injection [1] - The total research and development investment for the SHR-4610 injection project has reached approximately 7.36 million yuan [1] Industry Summary - The approval of SHR-4610 injection for clinical trials indicates a positive development in the field of innovative anti-tumor therapies, potentially enhancing the company's position in the pharmaceutical industry [1]

Core Viewpoint - Heng Rui Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of HRS-2430 injection, a new intravenous general anesthetic [1] Company Summary - HRS-2430 injection is positioned as a competitor to existing products such as etomidate, midazolam, and remimazolam [1] - The total global sales of etomidate, midazolam, and remimazolam are approximately $773 million for the year 2024 [1] - The cumulative R&D investment for the HRS-2430 injection project has reached approximately 24.6 million yuan [1]

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Shanghai Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-4610 injection, an innovative anti-tumor drug developed by the company, aimed at treating advanced solid tumors [1] Summary by Categories - **Clinical Trial Approval** - The National Medical Products Administration has issued a clinical trial approval notice for SHR-4610 injection [1] - The clinical trials are set to commence in the near future [1] - **Product Development** - SHR-4610 injection is an innovative anti-tumor drug independently developed by the company [1] - The drug is intended for the treatment of advanced solid tumors [1] - **Research and Development Investment** - The cumulative R&D investment for the SHR-4610 injection project has reached approximately 7.36 million yuan [1]

Core Insights - The rapid development of China's biopharmaceutical sector is prompting multinational pharmaceutical companies (MNCs) to adjust their strategies, focusing on increasing investment in the Chinese market and accelerating the introduction of global innovative products into China [1][2] - MNCs are adopting a dual strategy of enhancing local market engagement while leveraging Chinese innovations to expand globally, as highlighted by GSK and Kelsey Group's approaches [1][2][3] Group 1: Investment and Collaboration - The top 20 MNCs have steadily increased the number and value of assets introduced from China since 2021, with a total of $39.4 billion in innovative drug assets introduced in the first eight months of 2025, accounting for 37.4% of global transaction totals [2] - In the first three quarters of 2025, the total amount for Chinese license-out transactions reached $92.03 billion, indicating a vibrant BD transaction environment for domestic innovative drugs [2] - GSK's strategic partnership with Heng Rui Pharmaceutical involves the joint development of up to 12 innovative drugs, with GSK committing a total of $500 million in upfront payments and potential milestone payments of approximately $12 billion [2][3] Group 2: Market Dynamics and Growth - Kelsey Group's strategy includes three pillars: China to China, Global to China, and China to Global, emphasizing increased investment in the Chinese market and the integration of Chinese innovations into its global system [1][2] - Kelsey Group's recent collaboration with Haisco on the innovative drug HSK31858 represents a significant step in bringing Chinese innovations to global markets, particularly in treating chronic airway diseases [3] - The Chinese market is becoming a key growth engine for GSK, with expectations that approximately 18 new products and indications will be approved in China over the next three years [9] Group 3: Strategic Initiatives and Future Outlook - MNCs are increasingly focusing on enhancing their R&D presence in China, with Kelsey Group planning to increase its R&D personnel and strengthen its engagement with the local innovation ecosystem [4][6] - Boehringer Ingelheim's strategy includes a planned investment of over 5 billion RMB in R&D in China over the next five years, focusing on areas such as metabolism, inflammation, eye health, and oncology [8] - The China International Import Expo (CIIE) is recognized as a vital platform for MNCs to showcase innovations and deepen collaborations, with Boehringer Ingelheim highlighting its commitment to open innovation through this event [7][8]

Core Viewpoint - The article discusses the performance of the Hu-Shen 300 ESG ETF managed by Southern Fund Management, highlighting its recent market activity and returns since inception [1]. Group 1: Fund Performance - The Hu-Shen 300 ESG ETF (560180) opened at 1.182 yuan, experiencing a decline of 0.34% [1]. - Since its inception on April 13, 2023, the fund has achieved a return of 18.78%, with a monthly return of 1.07% [1]. Group 2: Major Holdings - Key stocks in the fund include: - Ningde Times: down 0.30% - Kweichow Moutai: unchanged at 0.00% - China Merchants Bank: up 0.14% - Zhongji Xuchuang: down 1.18% - Changjiang Power: up 0.04% - Midea Group: up 0.31% - BYD: down 0.53% - Industrial Bank: up 0.57% - Industrial and Commercial Bank of China: unchanged at 0.00% - Heng Rui Pharmaceutical: down 0.67% [1].

Core Insights - Wellington Management Group LLP increased its stake in Heng Rui Medicine (恒瑞医药) by purchasing 855,600 shares at an average price of HKD 72.6411 per share, totaling approximately HKD 62.15 million [1] - Following this transaction, Wellington Management's total shareholding in Heng Rui Medicine rose to 18,462,687 shares, increasing its ownership percentage from 6.82% to 7.15% [1] Summary by Category Shareholding Changes - Wellington Management Group LLP acquired 855,600 shares of Heng Rui Medicine, raising its total holdings to 18,462,687 shares [1] - The ownership percentage increased from 6.82% to 7.15% after the purchase [1] Financial Details - The total investment for the share purchase was approximately HKD 62.15 million [1] - The average purchase price per share was HKD 72.6411 [1]