证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-010 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 HRS-4642 注射液能特异性结合 KRAS G12D，抑制 MEK、ERK 蛋白的磷酸化，发挥 抗肿瘤作用。经查询，目前国内外尚无同类药物获批上市。截至目前，HRS-4642 注射液相关项目累计研发投入约 25,420 万元（未经审计）。 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，并及时对项目后续进展情况履行信息披 露义务。 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、上海恒瑞医药有限公司收到国家药品监督管理 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-009 一、药物的基本情况 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-2141 片（Ⅰ）、（Ⅱ）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： 药物名称：HRS-2141 片（Ⅰ）、（Ⅱ） 剂 型：片剂 申请事项：临床试验 受 理 号：CXHL2501153、CXHL2501154 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，2025 年 10 月 21 日受理的 HRS-2141 片（Ⅰ）、（Ⅱ）符合药品注册的有关要求，同 意开展 2 型糖尿病适应症的临床试验。 二、药物的其他情况 HRS-2141 片（Ⅰ）、（Ⅱ）是固定剂量复方制剂，通过药理机制互补协同 降血糖。经查询，目前国内外尚无同类药物获 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of HRS-2141 tablets for type 2 diabetes, marking a significant step in its drug development pipeline [1] Group 1: Drug Development - HRS-2141 is a fixed-dose combination formulation that utilizes complementary pharmacological mechanisms to lower blood sugar levels [1] - Currently, there are no similar drugs approved for market in both domestic and international markets [1] Group 2: Regulatory Approval - The approval includes the issuance of a "Clinical Trial Approval Notice" for phases I and II of the drug [1] - This regulatory milestone is crucial for the advancement of the drug towards potential market entry [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of HRS-2141 tablets for type 2 diabetes, marking a significant step in the company's drug development efforts [1] Group 1: Drug Development - HRS-2141 is a fixed-dose combination formulation that utilizes complementary pharmacological mechanisms to lower blood sugar levels [1] - Currently, there are no similar drugs approved for market release domestically or internationally, indicating a potential competitive advantage for the company [1] Group 2: Regulatory Approval - The approval includes a clinical trial notification for both phases I and II, allowing the company to advance its research and development process [1] - The regulatory approval is a critical milestone that may enhance investor confidence in the company's future prospects [1] Group 3: Market Considerations - The development and market introduction of the drug may face uncertainties, which necessitates cautious decision-making from investors [1]

Core Viewpoint - The company and its subsidiaries have received approval from the National Medical Products Administration for clinical trial notifications for two injectable drugs, SHR-9839 and HRS-4642, indicating progress in their drug development pipeline [1] Group 1: Drug Approvals - The company has received the clinical trial approval notice for SHR-9839, a humanized antibody drug aimed at treating advanced solid tumors by blocking two key signaling pathways related to tumor development [1] - HRS-4642 is a KRAS G12D inhibitor developed by the company, formulated as a liposome injection [1]

Core Viewpoint - The report highlights the premium rates of AH shares, with Northeast Electric, Zhejiang Shibao, and Junda Co. leading in premium rates, while CATL, China Merchants Bank, and Hansoh Pharmaceutical have the lowest premium rates [1]. Premium Rate Rankings - The top three AH shares by premium rate are: - Northeast Electric (00042) with a premium rate of 815.25% - Zhejiang Shibao (01057) with a premium rate of 386.24% - Junda Co. (02865) with a premium rate of 369.87% [1]. - The bottom three AH shares by premium rate are: - CATL (03750) with a premium rate of -12.69% - China Merchants Bank (03968) with a premium rate of -0.92% - Hansoh Pharmaceutical (01276) with a premium rate of -0.12% [1]. Deviation Values - The top three shares by deviation value are: - Junda Co. (02865) with a deviation value of 138.55% - Goldwind Technology (02208) with a deviation value of 35.44% - Sanhua Intelligent Control (02050) with a deviation value of 18.71% [1]. - The bottom three shares by deviation value are: - Northeast Electric (00042) with a deviation value of -39.75% - Chenming Paper (01812) with a deviation value of -27.60% - China Life (02628) with a deviation value of -19.12% [1]. Additional Premium Rate and Deviation Data - The report includes detailed tables showing the premium rates and deviation values for various AH shares, indicating significant variations among different companies [2].

Group 1 - The article highlights the top three and bottom three AH premium rates for various companies, with Northeast Electric (00042) leading at 815.25% and Ningde Times (03750) at -11.36% [1] - The top three companies with the highest deviation values are Junda Co., Ltd. (02865) at 129.73%, Goldwind Technology (02208) at 38.82%, and Sanhua Intelligent Control (02050) at 18.64% [1] - The bottom three companies with the lowest deviation values include Northeast Electric (00042) at -42.57%, Chenming Paper (01812) at -21.05%, and Nanhua Futures (02691) at -20.64% [1] Group 2 - The top ten AH stocks by premium rate include Zhejiang Shibao (01057) at 384.97% and Junda Co., Ltd. (02865) at 355.07% [2] - The bottom ten AH stocks by premium rate include China Merchants Bank (03968) at -0.84% and Hengrui Medicine (01276) at -4.80% [2] - The deviation values for the bottom ten AH stocks show significant negative values for Northeast Electric (00042) and Chenming Paper (01812), indicating a potential mispricing in the market [2]

Core Viewpoint - The 44th J.P. Morgan Healthcare Conference highlighted the global pharmaceutical industry's focus on innovation, with HengRui Medicine showcasing its capabilities as a global pharmaceutical company from China, emphasizing platform-based R&D, business development (BD), and international clinical and registration systems [1][3]. Group 1: R&D and Innovation - HengRui has established a "dual-drive" model, investing over 25% annually in R&D and supporting a robust pipeline with over 100 new molecular entities (NMEs) and more than 400 clinical trials [3][4]. - The company’s "All-in Strategy" encompasses all major treatment modalities, including small molecules, large molecules, and peptides, demonstrating a comprehensive and iterative innovation engine [4][6]. - HengRui focuses on first-in-class (FIC) and best-in-class (BIC) therapies, with significant breakthroughs in challenging targets, such as the KRAS G12D inhibitor HRS-4642, which has shown a 63.3% objective response rate in clinical trials [6][7]. Group 2: Business Development and Internationalization - The trend at the conference indicated a shift towards BD as a mainstream strategy, with companies needing to demonstrate continuous innovation and stable delivery capabilities to attract investment [8][9]. - HengRui has completed 12 external licensing deals since 2023, valued at over $27 billion, showcasing its R&D strength and innovation quality recognized by top multinational corporations (MNCs) [12]. - The company is building a global capability system alongside its BD efforts, with significant progress in establishing R&D centers and teams, including a new center in Boston [13]. Group 3: Future Growth and Market Position - In 2026, HengRui is expected to achieve over 10 new drug approvals, submit more than 20 NDA/BLA applications, and report data from 25 Phase III studies, indicating a clear growth trajectory [14]. - The company anticipates a more than 25% year-on-year increase in innovative drug revenue, driven by the inclusion of 10 new products in the national medical insurance catalog [14]. - HengRui aims to enhance its global partnerships and accelerate international clinical trials, reflecting its commitment to a robust internationalization strategy [14][15].

Core Insights - The 44th J.P. Morgan Healthcare Conference highlighted the global pharmaceutical industry's focus on innovation and the search for next-generation pipelines, with HengRui Pharma presenting its global strategy and capabilities [1][2]. Group 1: Company Strategy and Development - HengRui Pharma has established a "dual-engine" model, investing over 25% of its annual revenue in R&D, which supports its position as the second-largest in global original drug pipelines [2]. - The company is advancing its internationalization through flexible BD collaborations and a solid overseas team, aiming to accelerate the realization of innovative value [2][3]. - HengRui's R&D framework includes over 100 new molecular entities (NMEs) and more than 400 clinical trials across key therapeutic areas such as oncology, cardiovascular, metabolism, immunology, and neuroscience [3][7]. Group 2: Innovation and Pipeline - HengRui's pipeline is structured to provide comprehensive solutions in critical disease areas, focusing on synergy, iterative innovation, and addressing unmet medical needs [7]. - The company has demonstrated breakthrough capabilities in challenging targets, such as the KRAS G12D inhibitor HRS-4642, which has shown a 63.3% objective response rate in clinical trials [8]. - In the metabolic disease sector, HengRui is targeting the $100 billion obesity market with its GLP-1 asset portfolio, including the dual agonist HRS9531, which has shown significant weight loss results in clinical trials [8]. Group 3: Business Development and Internationalization - Since 2023, HengRui has completed 12 licensing deals worth over $27 billion, securing $1.3 billion in cash and equity investments, showcasing its R&D strength and innovation quality [12]. - The company aims to push approximately 20 new molecular entities into clinical trials annually, indicating a robust and efficient R&D pipeline [9][12]. - HengRui's internationalization strategy includes establishing a global capability system, with 15 R&D centers and a team of over 5,600, enhancing its global presence and operational capacity [13]. Group 4: Future Outlook - In 2026, HengRui is expected to achieve significant milestones, including over 10 new drug approvals and more than 20 NDA/BLA submissions, with key data from its pipeline assets anticipated [14]. - The company projects a revenue growth of over 25% year-on-year from its innovative drugs, supported by new products entering the national medical insurance directory [15]. - HengRui is committed to becoming a global leader in pharmaceuticals, focusing on delivering innovative drugs to patients worldwide, reflecting the broader trend of Chinese innovation in the pharmaceutical industry [16].

Core Insights - The J.P. Morgan Healthcare Conference highlighted the weight loss market as a key focus, with major pharmaceutical companies like Eli Lilly, Novo Nordisk, and Pfizer emphasizing their commitment to this sector [1] - Pfizer plans to launch weight loss assets acquired from Metzera by mid-2028, indicating a long-term strategy in the weight loss market [1] - Eli Lilly's Orforglipron has been submitted for approval in China, following its inclusion in the FDA's expedited approval list in November 2025 [1] Pricing Strategies - Novo Nordisk announced a significantly lower price for its oral version of semaglutide (Wegovy) compared to its injectable counterpart, with monthly costs starting at approximately $149 for self-paying patients [2] - The price of injectable semaglutide (Ozempic) was previously set at $969 per month, while Wegovy was priced at $1,349 per month [2] - Agreements with the U.S. government will lead to price reductions for semaglutide and Orforglipron starting in 2026, with some products capped at $50 per month [3] Market Competition - The GLP-1 market is experiencing intense competition, with 88 small molecule GLP-1 drugs currently in development, including six in Phase III trials [3] - A price war has erupted in the GLP-1 injection market, driven by increased supply and the expiration of patents for key products [4] - The introduction of new competitors and the expansion of indications for GLP-1 drugs are reshaping the market landscape [5] Domestic Market Dynamics - The new national medical insurance directory in China has initiated a price competition era for GLP-1 products, with significant discounts being offered on e-commerce platforms [4][6] - The price of semaglutide and other competing products has seen drastic reductions, with some prices dropping to as low as 20% of their original costs [5][6] - The entry of multiple domestic companies into the GLP-1 market is intensifying the price competition, particularly as patents expire [9][19] Future Outlook - The GLP-1 market is expected to grow significantly, with projections indicating a potential market size exceeding $100 billion by 2030 [16] - The competition is shifting from price-based to innovation-based, focusing on multi-target therapies and expanded indications [16] - The expiration of key patents is likely to lead to an influx of generic competitors, further intensifying the price competition [17][19]