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 ...

Market Overview - The Hang Seng Index closed down by 0.29% at 26,487.51 points, while the Hang Seng Tech Index fell by 1.16% to 5,683.44 points [1][2] - The total trading volume for the Hang Seng Index was 2,378 billion, and for the Hang Seng Tech Index, it was 663 billion [2] Sector Performance Technology Sector - Major tech stocks led the decline, with SMIC and Sunny Optical falling over 3%, and Xiaomi, BYD Electronics, SenseTime, and Hua Hong Semiconductor also experiencing losses [2] Biotech Sector - The biotech sector continued its downward trend, with major companies like Hengrui Medicine and WuXi AppTec dropping over 4% [3] New Consumption Sector - The new consumption sector showed strength, with Pop Mart and Heytea rising by 9%, and Blukoo increasing by nearly 4% [5] Gold Sector - The gold sector saw significant gains, with the International Gold Group rising over 7%, and Zijin Mining and King Precious Metals increasing by over 5% [7][8]

Market Overview - The Hang Seng Index closed down 0.29%, while the Hang Seng Tech Index fell by 1.16% [1] Technology Sector - Tech stocks led the decline, with notable drops including SMIC and Sunny Optical Technology, both down over 3%. Other companies like Xiaomi, BYD Electronics, SenseTime, and Hua Hong Semiconductor also experienced declines [2] Pharmaceutical Sector - The pharmaceutical sector continued its adjustment, with companies such as Hengrui Medicine and WuXi AppTec dropping over 4%. Other significant declines included: - BAKANGSHIYUN-B down 15.61% - YIMINGANGKE-B down 10.53% - JINGFANGYAO-B down 7.56% [2][3] New Consumption Sector - The new consumption sector showed strength, with Pop Mart and Hu Shang A Yi rising by 9%, and Blukoo increasing nearly 4% [3] Gold Sector - The gold sector saw significant gains, with companies like: - 万国黄金集团 up over 7% - 紫金黄金国际 and 金至尊集团 both up over 5% - 周生生 up over 4% [4][5]

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]

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 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 Insights - In 2025, the National Medical Products Administration approved 76 innovative drugs, marking a record high and showcasing a trend of diversified innovative therapies accelerating in China, significantly enriching clinical treatment options for domestic patients [1] Group 1: Drug Approval Overview - Among the approved drugs, 47 are chemical drugs, 23 are biological products (including 10 antibody drugs, 4 recombinant proteins, 3 cell gene therapies, 3 antibody-drug conjugates, 1 gene therapy, and 1 peptide), and 6 are traditional Chinese medicines [1] - The oncology sector remains the most concentrated area for new drug approvals, with 34 new drugs, including various types such as small molecules, monoclonal antibodies, and cell therapies [3] Group 2: Disease-Specific Drug Approvals - Breast cancer leads with 9 new drugs, including 3 CDK4/6 inhibitors and 2 CDK2/4/6 inhibitors, along with the first domestic AKT inhibitor and two antibody-drug conjugates targeting Trop2 and HER2 [3] - The field of infectious diseases saw significant approvals, including 4 influenza treatment drugs that target the influenza virus RNA polymerase PA subunit, which can alleviate medication shortages during peak flu seasons [6] - Immunological and metabolic diseases also saw a concentration of new approvals, with 8 and 7 new drugs respectively, including treatments for plaque psoriasis and type 2 diabetes [6] Group 3: Breakthrough Therapies - The quality of innovative drugs in the Chinese market has improved, with 17 of the approved drugs recognized as breakthrough therapies, indicating a significant advancement in both quantity and quality [7][11] - Notably, 12 of the new drugs are ranked first globally in their respective categories, and 31 are in the top three, reflecting China's leading position in drug development [7] Group 4: Insurance Coverage and Accessibility - The National Healthcare Security Administration has accelerated the inclusion of innovative drugs into the national insurance catalog, with 30 out of 43 new drugs approved in the first half of 2025 successfully entering the insurance directory, achieving a coverage rate of 70% [13] - This rapid inclusion is particularly significant for drugs addressing unmet clinical needs, such as the high-selectivity MEK1/2 inhibitor that covers rare tumors lacking standard treatment options [14][15] - The establishment of a commercial health insurance directory for innovative drugs further enhances accessibility, with two drugs from the 2025 approvals included, reducing out-of-pocket expenses for patients [16]