Hengrui Pharma(600276)
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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
2025-09-30 10:01
受 理 号:CXHL2500682、CXHL2500683、CXHL2500684 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-157 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。 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 10 日受理的 HRS-2329 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 RAS 突变或扩增的晚期实体瘤患者中开展临床试验。 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-2329 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-2329 片 剂 型:片剂 申请事项:临床试验 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 ...
恒瑞医药:收到两份药物临床试验批准通知书
Zheng Quan Shi Bao Wang· 2025-09-30 09:58
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-2329 tablets and SHR-4298 injection, indicating progress in its drug development pipeline [1] Group 1: Clinical Trial Approvals - The company announced that it has received the clinical trial approval notice for HRS-2329 tablets from the National Medical Products Administration [1] - Its subsidiary, Suzhou Sediya Biopharmaceutical Co., Ltd., has also received approval for SHR-4298 injection [1] Group 2: Drug Registration Application - Heng Rui Medicine announced that its innovative drug, a combination of injectable Carrelizumab and Apalutamide capsules, has had its drug registration application accepted for the first-line treatment of recurrent or metastatic cervical cancer patients [1]
恒瑞医药:子公司收到SHR-4298注射液药物临床试验批准通知书
Mei Ri Jing Ji Xin Wen· 2025-09-30 09:58
Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-4298 injection, aimed at treating advanced solid tumors [1] Company Summary - SHR-4298 injection is a Class 1 therapeutic biological product independently developed by the company [1] - The total research and development investment for the related project has reached approximately 28.79 million yuan [1] - The drug must undergo clinical trials and receive further review and approval from the National Medical Products Administration before it can be produced and marketed [1] Industry Summary - The approval for clinical trials indicates a potential advancement in the treatment options available for advanced solid tumors within the biopharmaceutical industry [1] - The development of innovative therapies like SHR-4298 reflects ongoing investment and research efforts in the biopharmaceutical sector [1]
恒瑞医药:孙杰平已减持0.004%股份
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-30 09:55
Core Points - Heng Rui Medicine announced that its director and senior vice president, Sun Jieping, reduced his holdings by 237,000 shares from July 9, 2025, to September 25, 2025, accounting for 0.004% of the company's total share capital [1] - The total amount of the reduction was 15.6332 million yuan, with the share price ranging from 57.01 to 73.95 yuan per share [1]
恒瑞医药:孙杰平减持0.004%
Xin Lang Cai Jing· 2025-09-30 09:51
恒瑞医药公告,公司董事、高级副总裁孙杰平已于2025年7月9日至2025年9月25日通过集中竞价减持 23.7万股,减持比例0.004%,成交价57.01~73.95元/股,套现1563.32万元。本次减持计划已完成,原拟 减持不超47.67万股;减持后其持股167万股,占0.025%。 ...
恒瑞医药(600276) - H股公告-翌日披露报表
2025-09-30 09:46
FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別: 股票 狀態: 新提交 公司名稱: 江蘇恒瑞醫藥股份有限公司 呈交日期: 2025年9月30日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 A | | 於香港聯交所上市 | 否 | | | 證券代號 (如上市) | 600276 | 說明 | A股(於上海證券交易所上市) | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份(不包括庫存股份)數 目 | 佔有關事件 ...
恒瑞医药(01276.HK)9月30日耗资69.45万元回购1万股A股
Ge Long Hui· 2025-09-30 09:03
格隆汇9月30日丨恒瑞医药(01276.HK)发布公告,2025年9月30日耗资人民币69.45万元回购1万股A股, 回购价格每股69.45-69.45元。 ...
恒瑞医药(01276)9月30日斥资69.45万元回购1万股A股
智通财经网· 2025-09-30 08:53
智通财经APP讯,恒瑞医药(01276)发布公告,该公司于2025年9月30日斥资69.45万元人民币回购1万股A 股,每股回购价格为69.45元人民币。 ...
恒瑞医药9月30日斥资69.45万元回购1万股A股
Zhi Tong Cai Jing· 2025-09-30 08:52
恒瑞医药(600276)(01276)发布公告,该公司于2025年9月30日斥资69.45万元人民币回购1万股A股, 每股回购价格为69.45元人民币。 ...
医药生物行业今日涨1.40%,主力资金净流入9.84亿元
Zheng Quan Shi Bao Wang· 2025-09-30 08:50
Market Overview - The Shanghai Composite Index rose by 0.52% on September 30, with 19 out of 28 sectors experiencing gains, led by the non-ferrous metals and defense industries, which increased by 3.22% and 2.59% respectively [1] - The pharmaceutical and biological industry saw an increase of 1.40% [1] - The sectors with the largest declines were telecommunications and non-bank financials, which fell by 1.83% and 1.14% respectively [1] Capital Flow Analysis - The main capital outflow from the two markets totaled 32.303 billion yuan, with only four sectors seeing net inflows [1] - The defense industry had the highest net inflow of 2.059 billion yuan, while the non-ferrous metals sector followed with a net inflow of 1.984 billion yuan [1] - The non-bank financial sector experienced the largest net outflow, totaling 11.405 billion yuan, followed by telecommunications with a net outflow of 5.936 billion yuan [1] Pharmaceutical and Biological Sector Performance - The pharmaceutical and biological sector had a net inflow of 984 million yuan, with 310 out of 475 stocks rising, including two hitting the daily limit [2] - The top three stocks by net inflow were WuXi AppTec with 1.113 billion yuan, followed by Hengrui Medicine and Yong'an Pharmaceutical with 431 million yuan and 134 million yuan respectively [2] - Nine stocks in this sector saw net outflows exceeding 50 million yuan, with C Jianfa Zhi leading at 896.727 million yuan [3] Top Gainers in Pharmaceutical Sector - WuXi AppTec increased by 6.42% with a turnover rate of 2.86% and a main capital flow of 1.112 billion yuan [2] - Hengrui Medicine rose by 3.40% with a turnover rate of 0.91% and a main capital flow of 431 million yuan [2] - Yong'an Pharmaceutical saw a rise of 6.92% with a turnover rate of 16.56% and a main capital flow of 134 million yuan [2] Top Losers in Pharmaceutical Sector - C Jianfa Zhi decreased by 15.04% with a turnover rate of 52.49% and a main capital flow of -896.727 million yuan [3] - Xiangrikui rose by 2.00% but had a net outflow of 854.806 million yuan [3] - Jilin Aodong fell by 1.91% with a net outflow of 797.945 million yuan [3]