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]

Core Viewpoint - The Chinese innovative drug sector is experiencing rapid growth, positioning itself as a global leader in drug development, with significant investments and collaborations from major pharmaceutical companies [2][8][30]. Group 1: Market Dynamics - The price of experimental monkeys has surged from 3,000 yuan to 100,000 yuan, indicating a high demand in the innovative drug sector [1]. - By 2025, China is projected to rank second globally in new drug clinical trials, with its pipeline accounting for 30% of the global total [2]. - In 2024, Chinese innovative drug companies completed 94 overseas licensing transactions, representing 44% of the national total, with over 100 transactions exceeding $100 billion in the first ten months of 2025 [6][30]. Group 2: Challenges in Traditional Pharmaceutical Sector - The generic drug sector is facing significant challenges, with a projected 5.5% decline in revenue for 2024 and over 30% of companies experiencing losses [5]. - Major pharmaceutical companies are increasingly collaborating with Chinese innovative drug firms to mitigate the risks associated with patent expirations, which could lead to a revenue gap exceeding $300 billion in the next five years [10][30]. Group 3: Advantages of Chinese Innovative Drugs - China offers a cost-effective and efficient environment for drug development, with clinical trial costs significantly lower than in the U.S. [20][21]. - The average time for clinical trial approvals in China has been reduced from 60 to 30 working days, and the average new drug application approval time has decreased to approximately 130 days [14]. - Chinese pharmaceutical companies are increasingly moving from "me-too" and "me-better" drugs to original innovations, with a notable increase in the number of innovative drug projects [27]. Group 4: Global Positioning and Future Outlook - Despite the rapid growth of Chinese innovative drugs, the overall market value of Chinese biotech companies remains significantly lower than their U.S. counterparts, capturing only 5% to 10% of global new drug revenues [30][31]. - Chinese companies are establishing commercial centers in global pharmaceutical hubs to enhance their commercialization capabilities, marking a shift towards becoming major players in the global market [37][38]. - The transition from biotech firms to large multinational pharmaceutical companies is seen as a critical step in the global battle for market share and innovation [38].

Core Insights - The article discusses the recent meeting held by the National Healthcare Security Administration (NHSA) in Beijing, focusing on how to better utilize the medical insurance drug and device procurement platform to support the international expansion of Chinese pharmaceuticals and medical devices [1] - Chinese innovative pharmaceuticals and medical devices are gaining recognition in developed markets like Europe and the US, establishing a strong "China Creation" label in the global healthcare sector [1] Regulatory Support - The rapid development of China's pharmaceutical and medical device industry is attributed to the support from regulatory bodies, which have optimized approval processes and established quality standards aligned with international norms [2] - NHSA's Director Wang Xiaoning emphasized the importance of improving mechanisms, innovating methods, and promoting system collaboration to support the internationalization of Chinese pharmaceuticals [2] Pricing and Evaluation Systems - NHSA is working on a unified medical service pricing system to facilitate patient reimbursement and remove barriers for innovative medical technologies [3] - The establishment of the China Drug Price Registration System aims to provide a transparent pricing framework for Chinese drugs in international markets, enhancing their competitiveness [3][8] International Collaboration - Various government departments, including the Ministry of Industry and Information Technology and the Ministry of Commerce, are implementing policies to enhance the international competitiveness of the pharmaceutical industry [5][6] - The National Medical Products Administration is reforming drug lifecycle supervision to stimulate innovation and facilitate international market entry for Chinese drugs [7] Company Strategies - Companies like Heng Rui Medicine and United Imaging Healthcare are exploring diverse paths for international expansion, focusing on core technology development and strategic partnerships [10][11] - Heng Rui Medicine has established a significant presence in over 40 countries, leveraging a collaborative model to enhance its international footprint [10] - United Imaging Healthcare emphasizes a comprehensive approach to internationalization, integrating R&D, production, and service to adapt to local markets [11] Future Directions - NHSA plans to enhance the international procurement model for medical devices and pharmaceuticals, focusing on regional advantages and tailored development strategies [8] - The China Drug Price Registration System is expected to play a crucial role in providing a "price passport" for innovative drugs, facilitating their entry into global markets [9]