Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of multiple drug candidates, indicating progress in its research and development pipeline [1] Group 1: Clinical Trial Approvals - The company and its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Heng Rui Medicine Co., Ltd., have received approval for clinical trials of SHR-9839 (sc) and HRS-4642 injection [1] - The subsidiary Shandong Shengdi Medicine Co., Ltd. has also received approval for clinical trials of HRS-2141 tablets (I) and (II) [1]

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 ...

Group 1 - Recent net redemptions in A-share broad-based ETFs have drawn market attention, with significant outflows recorded on January 15 and 16, totaling 687 billion and 863 billion respectively, marking the highest single-day outflows in history [1] - As of January 19, four out of six major broad-based ETFs saw their shares decline by over 10% in the last three trading days, with the largest, Huatai-PB CSI 300 ETF, dropping to 778.63 billion shares, a scale of approximately 369.2 billion, the lowest since August 2024 [1] - The ChiNext and STAR Market ETFs also experienced significant declines, with the E Fund STAR 50 ETF and E Fund ChiNext ETF seeing share reductions of 34.55% and 20.22% respectively [3] Group 2 - In contrast to the outflows from broad-based ETFs, certain commodity, cross-border, and narrow-based ETFs attracted significant inflows, with the Southern Nonferrous ETF being the only product to receive over 10 billion in net inflows, totaling 100.87 billion, driven by rising base metal prices [3] - Other ETFs such as Yongying Satellite ETF, Harvest Software ETF, and GF Media ETF also received net inflows exceeding 6 billion [3] - According to CITIC Securities, the impact of ETF redemptions on individual stocks was significant, with main board, ChiNext, and STAR Market stocks experiencing sell-offs of 946 billion, 334 billion, and 265 billion respectively during the peak outflow days [3] Group 3 - Regulatory measures have been implemented to cool down the market following rapid price increases and overheated sentiment, including raising the minimum margin requirement for margin trading from 80% to 100% [5][6] - The China Securities Regulatory Commission emphasized the need for comprehensive market monitoring and timely counter-cyclical adjustments to maintain market stability and prevent excessive volatility [6] - There are differing views on the long-term outlook for A-shares, with some analysts suggesting the potential for a slow bull market due to reforms, while others remain skeptical about escaping historical volatility patterns [7]

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]

Group 1 - The core viewpoint of the articles indicates a mixed performance in the medical and healthcare sector, with the China Medical and Medical Device Innovation Index experiencing a decline of 0.85% as of January 20, 2026, while certain stocks like Xinhecheng and Xingqi Eye Medicine showed gains [1] - The medical innovation ETF saw a decrease of 0.80%, with the latest price at 0.37 yuan, reflecting the overall market sentiment [1] - The brain-computer interface concept is gaining traction, supported by a significant investment of over 730 billion yuan in technology loans by the China Export-Import Bank, focusing on AI, brain-computer interfaces, humanoid robots, and high-end instruments [1] Group 2 - According to J.P. Morgan's conference, over 20 Chinese companies participated, highlighting the growing global interest in domestic innovative drugs and medical devices, which is expected to boost industry sentiment [1] - The China Medical and Medical Device Innovation Index includes 30 companies with strong profitability and growth potential, with the top ten stocks accounting for 63.75% of the index [2] - Recent data shows a net inflow of 1.8727 million yuan into the medical innovation ETF, with a total of 59.7643 million yuan over the past five trading days, indicating a positive trend in investor interest [2]

Core Viewpoint - The Chinese innovative drug business development (BD) for overseas licensing reached a record high of $135.655 billion in total transaction value for 2025, with a significant increase in upfront payments and transaction numbers compared to previous years [1][2]. Group 1: Market Performance - The China Securities Hong Kong Stock Connect Pharmaceutical and Health Comprehensive Index (930965) showed mixed performance among its constituent stocks, with Times Angel leading at a 4.83% increase [1]. - The Hong Kong pharmaceutical ETF (159718) was quoted at 0.96 yuan [1]. Group 2: Industry Developments - The innovative drug BD overseas licensing transactions in China for 2025 totaled $135.655 billion, with upfront payments of $7 billion and 157 transactions, all marking historical highs [2]. - Notable collaborations include Rongchang Biopharma's PD-1/VEGF dual antibody RC148 receiving a $650 million upfront payment from AbbVie, and Yilian Biopharma's partnership with Roche on B7H3-targeted ADC [2]. - GSK's Bepirovirsen for chronic hepatitis B showed positive results in Phase III trials, and Arrowhead announced advancements in RNAi therapies for weight loss, validating the clinical value of small nucleic acid drugs [2]. Group 3: Investment Outlook - The 44th Annual J.P. Morgan Healthcare Conference revealed positive updates from leading global pharmaceutical companies, with significant BD transactions and improved forecasts from CXO companies like WuXi AppTec [2]. - The global pharmaceutical industry remains robust, with innovation in drugs and medical devices continuing to be the main investment theme [2].

Core Insights - The Chinese innovative pharmaceutical industry is experiencing a surge in overseas orders and mergers, indicating a vibrant market as companies engage in international collaborations and acquisitions [1][2] Group 1: International Collaborations - Since January, local companies like West Bioman and Rongchang Biopharmaceutical have completed at least five overseas licensing agreements with multinational pharmaceutical firms, showcasing active global transaction capabilities [1] - China's drug pipeline accounts for approximately 30% of the global total, ranking second worldwide, which signifies a shift from following to leading in the biopharmaceutical sector [2] - It is projected that by 2025, the total value of innovative drug licensing transactions from China will exceed $130 billion, with over 150 deals, significantly surpassing the previous year's figures [2] Group 2: Mergers and Acquisitions - China National Pharmaceutical announced a full acquisition of Hegia Biopharmaceutical for RMB 1.2 billion, aiming to enter the small interfering RNA (siRNA) innovative drug sector and expand its pipeline in cardiovascular and metabolic diseases [3] - WuXi AppTec plans to acquire Easton Pharmaceuticals at HKD 4.00 per share to enhance its capabilities in the commercial production of antibody-drug conjugates [3] - Aopu Mai has completed the acquisition of Pengli Biopharmaceutical, integrating it as a wholly-owned subsidiary to strengthen industry chain collaboration and achieve business integration [4] Group 3: Future Outlook - Companies like Fuhong Hanlin expect to launch over 20 products globally by 2030, with more than 15 anticipated to be approved in the US and Europe [5] - Jiangsu Hengrui Medicine has over 100 innovative products in clinical development and expects multiple milestone advancements in 2026, including approvals for over 10 innovative drugs or indications [5]