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恒瑞医药(01276.HK)收到国家药监局核准签发关于HRS-6093片的《药物临床试验批准通知书》
Jin Rong Jie· 2025-08-25 10:04
Group 1 - The company, Heng Rui Medicine (01276.HK), has received approval from the National Medical Products Administration (NMPA) for the clinical trial of HRS-6093 tablets [1] - The clinical trials for HRS-6093 will commence shortly following the approval [1]
恒瑞医药:HRS-2162注射液获药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-08-25 09:41
Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of HRS-2162 injection, a new generation muscle relaxant antagonist, which is expected to be the first of its kind in the market [1] Company Summary - The company’s subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., will soon initiate clinical trials for HRS-2162 injection [1] - HRS-2162 injection is designed to counteract the pharmacological effects of muscle relaxants and rapidly restore muscle tone [1] - The total research and development investment for the HRS-2162 injection project has reached approximately 28.25 million yuan [1] Industry Summary - Currently, there are no similar products approved for market release domestically or internationally, indicating a potential market opportunity for HRS-2162 injection [1]
恒瑞医药(01276):HRS-2162注射液获药物临床试验批准通知书
智通财经网· 2025-08-25 09:34
Core Viewpoint - Heng Rui Medicine (01276) announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for the clinical trial of HRS-2162 injection, a new generation muscle relaxant antagonist [1] Group 1 - HRS-2162 injection is designed to counteract the pharmacological effects of muscle relaxants and rapidly restore muscle tone [1] - Currently, there are no similar products approved for marketing in both domestic and international markets [1] - The total research and development investment for the HRS-2162 injection project has reached approximately 28.25 million yuan [1]
恒瑞医药收到国家药监局核准签发关于HRS-6093片的《药物临床试验批准通知书》
Zhi Tong Cai Jing· 2025-08-25 09:30
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-6093, a novel oral KRAS G12D inhibitor, which is expected to have significant anti-tumor effects [1] Group 1: Product Development - HRS-6093 is a new, efficient, and selective oral KRAS G12D inhibitor that specifically binds to the KRAS G12D mutant protein [1] - There are currently no similar products approved for sale in both domestic and international markets [1] - The total research and development investment for HRS-6093 has reached approximately 29.84 million yuan [1]
恒瑞医药(01276.HK):HRS-6093片获国家药监局临床试验批准
Ge Long Hui· 2025-08-25 09:30
Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for the clinical trial of HRS-6093 tablets, a novel and selective oral KRAS G12D inhibitor aimed at targeting KRAS G12D mutation proteins for anti-tumor effects [1] Group 1 - The company has announced the approval of a clinical trial for HRS-6093 tablets [1] - HRS-6093 is characterized as a new, efficient, and selective oral KRAS G12D inhibitor [1] - The drug specifically binds to KRAS G12D mutated proteins to exert anti-tumor effects [1]
恒瑞医药(01276.HK):HRS-2162注射液获国家药监局临床试验批准
Ge Long Hui· 2025-08-25 09:30
Core Viewpoint - Heng Rui Medicine (01276.HK) announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of HRS-2162 injection, a new generation muscle relaxant antagonist, which will soon commence clinical trials. Currently, there are no similar products approved for sale domestically or internationally [1]. Company Summary - Heng Rui Medicine's subsidiary has received a clinical trial approval for HRS-2162 injection [1]. - HRS-2162 is identified as a new generation muscle relaxant antagonist that can counteract the pharmacological effects of muscle relaxants and rapidly restore muscle tone [1]. - The absence of similar products in the market highlights a potential competitive advantage for Heng Rui Medicine [1].
恒瑞医药(01276)收到国家药监局核准签发关于HRS-6093片的《药物临床试验批准通知书》
智通财经网· 2025-08-25 09:27
Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of HRS-6093, a novel oral KRAS G12D inhibitor, which is expected to have significant anti-tumor effects [1] Group 1 - The clinical trial approval for HRS-6093 indicates a strategic advancement in the company's oncology pipeline [1] - HRS-6093 is a selective and efficient oral inhibitor specifically targeting the KRAS G12D mutation, which is crucial for certain cancer treatments [1] - Currently, there are no similar products approved for market in both domestic and international markets, highlighting a potential competitive advantage for the company [1] Group 2 - The total research and development investment for the HRS-6093 project has reached approximately 29.84 million yuan [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
2025-08-25 09:15
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-129 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。 受 理 号:CXHL2500467 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 5 月 13 日受理的 HRS-2162 注射液临床试验申请符合药品注册的有关要求,同 意本品开展"用于拮抗罗库溴铵和顺阿曲库铵诱导的神经肌肉阻滞"适应症的临 床试验。 二、药物的其他情况 HRS-2162 注射液是新一代肌松药拮抗剂,可拮抗肌松药的药理作用,快速 恢复肌张力。目前国内外尚无同类产品获批上市。截至目前,HRS-2162 注射液 相关项目累计研发投入约 2,825 万元。 三、风险提示 近日,江苏恒瑞医药股份有限公司(以下简称"公司")子公司福建盛迪医 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-2162 注射液的《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 ...
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
2025-08-25 09:15
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-128 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")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-6093 片的《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: 一、药物的基本情况 药物名称:HRS-6093 片 剂 型:片剂 申请事项:临床试验 受 理 号:CXHL2500549、CXHL2500550 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 6 月 9 日受理的 HRS-6093 片临床试验申请符合药品注册的有关要求,同意本 品单药在携带 KRAS G12D 突变的实体瘤中开展临床试验。 二、药物的其他情况 HRS-6093 片是一种新型、高效、选择性的口服 KRAS G12D 抑制剂,能够特 异性结合 KRAS G12D 突变蛋白,发挥抗肿瘤作用。经查 ...
恒瑞医药(600276.SH):HRS-6093片获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-08-25 09:13
Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for the clinical trial of HRS-6093 tablets, a novel and efficient oral KRASG12D inhibitor that specifically targets the KRASG12D mutation protein to exert anti-tumor effects [1] Company Summary - The company is set to initiate clinical trials for HRS-6093 tablets in the near future following regulatory approval [1] - HRS-6093 is characterized as a new, selective oral medication aimed at treating tumors associated with the KRASG12D mutation [1]