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恒瑞医药(01276) - 海外监管公告 - 关於获得药物临床试验批准通知书的公告
2026-01-20 11:24
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 (股份代號:1276) Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 中國上海 2026年1月20日 於本公告日期,董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生;(ii)非執行董事郭叢照女士;及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-009 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 ...
恒瑞医药:公司获批两款药物临床试验将开展
Hua Er Jie Jian Wen· 2026-01-20 09:43
Core Viewpoint - The company and its subsidiary have received approval from the National Medical Products Administration for two drug clinical trial notifications, which will commence shortly [1] Drug Details - **Injection SHR-9839 (sc)** - Indication: Advanced colorectal cancer - Mechanism: Humanized antibody that simultaneously blocks two key tumor signaling pathways - Progress: Initiating Phase Ib/II clinical study in combination with anti-tumor therapy - Competitive Landscape: One drug targeting the same pathway has been approved globally - Cumulative R&D Investment: Approximately 93.9 million [1] - **HRS-4642 Injection** - Indication: KRAS G12D mutation tumors - Mechanism: KRAS G12D inhibitor (liposome formulation) - Competitive Landscape: No similar drugs have been approved for marketing domestically or internationally - Cumulative R&D Investment: Approximately 254.2 million [1]
恒瑞医药:收到药物临床试验批准通知书
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]
恒瑞医药(600276) - 恒瑞医药关于获得药物临床试验批准通知书的公告
2026-01-20 09:15
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 ...
恒瑞医药(600276) - 恒瑞医药关于获得药物临床试验批准通知书的公告
2026-01-20 09:15
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 ...
恒瑞医药:HRS-2141片获准开展2型糖尿病适应症的临床试验,目前国内外尚无同类药物获批上市
Mei Ri Jing Ji Xin Wen· 2026-01-20 08:56
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]
恒瑞医药:HRS-2141片获准开展2型糖尿病适应症的临床试验
Xin Lang Cai Jing· 2026-01-20 08:52
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]
恒瑞医药:注射用SHR-9839(sc)、HRS-4642注射液获临床试验批准
Xin Lang Cai Jing· 2026-01-20 08:50
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]
智通AH统计|1月20日
智通财经网· 2026-01-20 08:20
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].
智通AH统计|1月19日
智通财经网· 2026-01-19 08:17
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]