Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-3045 injection, a self-developed biological product aimed at treating rheumatoid arthritis [1] Group 1: Product Development - SHR-3045 injection is designed to inhibit immune cell function, reduce inflammation, and improve clinical symptoms in rheumatoid arthritis treatment [1] - The company has invested approximately 35.54 million yuan in the research and development of SHR-3045 injection to date [1] Group 2: Market Position - Currently, there are no similar drugs approved for market in both domestic and international markets [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临2025-149 江苏恒瑞医药股份有限公司 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"）子公司上海恒瑞医药 有限公司的注射用SHR-1501被国家药品监督管理局药品审评中心（以下简称"药 审中心"）纳入拟突破性治疗品种公示名单，公示期7日。现将相关情况公告如下： 一、药物的基本情况 药物名称：注射用SHR-1501 受理号：CXSL2101496 药物类型：治疗用生物制品 注册分类：1类 申请日期：2025年7月23日 拟定适应症（或功能主治）：注射用SHR-1501联合卡介苗（BCG）用于BCG无 应答的非肌层浸润性原位癌（CIS）患者。 关于药物纳入拟突破性治疗品种公示名单的公告 理由及依据：经审核，本申请符合《药品注册管理办法》和《国家药监局关 于发布＜突破性治疗药物审评工作程序（试行）＞等三个文件的公告》（2020年 第82号）有关要求，同意纳入突破性治疗药物程序。 二、药物的其他相关情况 SHR-1501为公 ...

一、药物的基本情况 药物名称：SHR-3045 注射液 申请事项：临床试验 受 理 号：CXSL2500533 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 7 月 2 日受理的 SHR-3045 注射液临床试验申请符合药品注册的有关要求，同 意本品开展类风湿关节炎临床试验。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-147 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 二、药物的其他情况 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"）子公司广东恒瑞医 药有限公司和上海恒瑞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 SHR-3045 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下： 剂 型：注射剂 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 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-148 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。 剂 型：注射剂 申请事项：临床试验 受 理 号：CXSL2500536 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 7 月 3 日受理的 SHR-1139 注射液临床试验申请符合药品注册的有关要求，同 意本品开展溃疡性结肠炎的临床试验。 二、药物的其他情况 SHR-1139 注射液是公司自主研发的一种治疗用生物制品，预期可在溃疡性 结肠炎治疗过程中,通过抑制炎症反应和维持上皮屏障等机制协同增效。经查询， 目前国内外尚无同类药物获批上市。截至目前，SHR-1139 注射液相关项目累计 研发投入约 7,128 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"）子公司广东恒瑞医 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 SHR-1139 注射液的《药物临床试验批准通 ...

Group 1 - The core point of the article is that 恒瑞医药 has received approval from the National Medical Products Administration for clinical trials of SHR-3045 injection, a self-developed biological product aimed at treating rheumatoid arthritis [1] - SHR-3045 injection is expected to suppress immune cell function, reduce inflammation, and improve clinical symptoms during rheumatoid arthritis treatment [1] - Currently, there are no similar drugs approved for market in both domestic and international markets [1] Group 2 - The total research and development investment for the SHR-3045 injection project has reached approximately 35.54 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-3045 injection, a self-developed biological product aimed at treating rheumatoid arthritis [1] Company Summary - The company’s subsidiary, Guangdong Heng Rui Medicine Co., Ltd. and Shanghai Heng Rui Medicine Co., Ltd. are involved in the clinical trial process for SHR-3045 injection [1] - SHR-3045 injection is expected to suppress immune cell function, reduce inflammation, and improve clinical symptoms in rheumatoid arthritis treatment [1] - The total research and development investment for SHR-3045 injection has reached approximately 35.54 million yuan [1] Industry Summary - Currently, there are no similar drugs approved for market use domestically or internationally, indicating a potential market opportunity for SHR-3045 injection [1]

SHR-1139注射液是公司自主研发的一种治疗用生物制品，预期可在溃疡性结肠炎治疗过程中,通过抑制 炎症反应和维持上皮屏障等机制协同增效。经查询，目前国内外尚无同类药物获批上市。截至目前， SHR-1139注射液相关项目累计研发投入约7,128万元。 智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，公司子公司广东恒瑞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SHR-1139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。 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of SHR-1139 injection, a self-developed biological product aimed at treating ulcerative colitis [1] Group 1: Product Development - SHR-1139 injection is designed to inhibit inflammatory responses and maintain epithelial barriers, potentially enhancing treatment efficacy for ulcerative colitis [1] - Currently, there are no similar drugs approved for market in both domestic and international markets [1] - The total research and development investment for the SHR-1139 injection project has reached approximately 71.28 million yuan [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Shanghai Heng Rui Medicine Co., Ltd., has announced that its injectable SHR-1501 has been included in the list of proposed breakthrough therapeutic products by the National Medical Products Administration, with a public announcement period of 7 days [1] Group 1: Product Development - SHR-1501 is a self-developed interleukin-15 (IL-15) fusion protein that stimulates the proliferation of T cells, B cells, and NK cells, enhancing the immune response to eliminate foreign substances such as tumors [1] - The proposed indication for SHR-1501 is in combination with Bacillus Calmette-Guérin (BCG) for patients with non-muscle invasive carcinoma in situ (CIS) who do not respond to BCG [1] - The combination of SHR-1501 with BCG is expected to significantly enhance the immune response in the bladder, achieving a synergistic anti-tumor effect [1] Group 2: Market Context - Currently, there are no approved products in China targeting the same mechanism as SHR-1501, while a similar product, Nogapendekin Alfa Inbakicept (marketed as Anktiva), has been approved for sale in the United States [1] - The cumulative research and development investment for SHR-1501 has reached approximately 10.218 million yuan [1]

【恒瑞医药：子公司收到SHR-1139注射液临床试验批准通知书】智通财经9月18日电，恒瑞医药 (600276.SH)公告称，公司子公司广东恒瑞医药有限公司收到国家药监局核准签发关于SHR-1139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。SHR-1139注射液是公司自主研发的一种治 疗用生物制品，预期可在溃疡性结肠炎治疗过程中,通过抑制炎症反应和维持上皮屏障等机制协同增 效。经查询，目前国内外尚无同类药物获批上市。 转自：智通财经 ...