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恒瑞医药九款药物临床试验获批
Bei Jing Shang Bao· 2025-11-21 10:33
Core Viewpoint - Heng Rui Medicine announced the approval of multiple clinical trial applications for new drugs by the National Medical Products Administration, indicating a significant advancement in its drug development pipeline [1] Group 1: Clinical Trials - The company and its subsidiaries received approval for clinical trials of several injectable drugs, including SHR-9839(sc), SHR-A2009, SHR-1826, HRS-4642, and others [1] - A specific focus is on the Phase I/II study of SHR-9839(sc) in combination with anti-tumor drugs for safety, tolerability, and efficacy in solid tumor patients [1]
恒瑞医药SHR-1139注射液临床试验获批
Bei Jing Shang Bao· 2025-11-21 10:33
Core Viewpoint - Heng Rui Medicine's subsidiary, Guangdong Heng Rui Medicine Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of SHR-1139 injection, aimed at treating necrotizing pyoderma, marking a significant step in the company's drug development efforts [1] Group 1 - SHR-1139 injection is a biopharmaceutical independently developed by Heng Rui Medicine [1] - There are currently no similar drugs approved for market in both domestic and international markets [1]
恒瑞医药(600276) - H股公告-翌日披露报表
2025-11-21 10:30
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11月21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 ...
恒瑞医药(600276) - 恒瑞医药关于回购公司A股股份的进展公告
2025-11-21 10:17
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。 重要内容提示: | 回购方案首次披露日 | 2025/8/21 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 回购方案实施期限 | 2025 年 月 8 | 8 | 20 | 日~2026 | 年 | 月 | 19 日 | | 预计回购金额 | 100,000万元~200,000万元 | | | | | | | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 | | | | | | | | | □用于转换公司可转债 □为维护公司价值及股东权益 | | | | | | | | 累计已回购股数 | 889.87万股 | | | | | | | | 累计已回购股数占总股本比例 | 0.13% | | | | | | | | 累计已回购金额 | 59,521.63万元 | | | | | | | | 实际回购价格区间 | 59.32元/股~70.00/元/股 | | | | | | | ...
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
2025-11-21 10:15
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-183 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")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、上海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")核准签发关于注射用 SHR-9839(sc)、 注射用 SHR-A2009、注射用 SHR-1826、HRS-4642 注射液、阿得贝利单抗注射液、 注射用瑞康曲妥珠单抗、注射用 SHR-A2102、HRS-7058 胶囊和 HRS-7058 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: 药品 名称 注射用 SHR-9839(sc) 注射用 SHR-A2009 注射用 SHR-1826 HRS-4642 注射液 阿得贝利单 抗注射液 注射用瑞康 曲妥珠单抗 注射用 SHR-A2102 HRS-7058 胶囊 HRS-7058 片 剂 ...
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
2025-11-21 10:15
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。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-182 剂 型:注射剂 申请事项:临床试验 受 理 号:CXSL2500704 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 8 月 15 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 意本品开展坏疽性脓皮病的临床试验。 二、药物的其他情况 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:SHR-1139 注射液 SHR-1139 注射液是公司自主研发的一种治疗用生物制品,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 ...
恒瑞医药(01276.HK)11月21日耗资1488万元回购25万股A股
Ge Long Hui· 2025-11-21 10:09
格隆汇11月21日丨恒瑞医药(01276.HK)发布公告,2025年11月21日耗资人民币1488万元回购25万股A 股,回购价格每股59.32-59.72元。 ...
恒瑞医药11月21日耗资约1487.99万港元回购25万股
Zhi Tong Cai Jing· 2025-11-21 10:09
恒瑞医药(600276)(01276)公布,2025年11月21日耗资约1487.99万港元回购25万股股份。 ...
恒瑞医药(01276)11月21日耗资约1487.99万港元回购25万股
智通财经网· 2025-11-21 10:07
智通财经APP讯,恒瑞医药(01276)公布,2025年11月21日耗资约1487.99万港元回购25万股股份。 ...
医药生物行业双周报(2025、11、7-2025、11、20)-20251121
Dongguan Securities· 2025-11-21 07:26
Investment Rating - The report maintains an "overweight" rating for the pharmaceutical and biotechnology industry, expecting the industry index to outperform the market index by more than 10% in the next six months [4][25]. Core Insights - The SW pharmaceutical and biotechnology industry outperformed the CSI 300 index during the period from November 7 to November 20, 2025, with a decline of 1.51%, which is approximately 1.23 percentage points better than the CSI 300 index [11]. - Most sub-sectors within the industry recorded negative returns, with in vitro diagnostics and pharmaceutical distribution showing the highest gains of 2.37% and 2.27%, respectively, while medical R&D outsourcing and medical consumables experienced declines of 3.67% and 2.93% [12]. - Approximately 43% of stocks in the industry recorded positive returns during the same period, with the top performer, Hezhong China, seeing a weekly increase of 82.57% [16]. - The overall price-to-earnings (PE) ratio for the SW pharmaceutical and biotechnology industry as of November 20, 2025, was approximately 51.84 times, indicating a decrease in industry valuation [19]. Summary by Sections 1. Market Review - The SW pharmaceutical and biotechnology industry outperformed the CSI 300 index, with a decline of 1.51% compared to the index's performance [11]. - Most sub-sectors recorded negative returns, with in vitro diagnostics and pharmaceutical distribution leading in gains [12]. - About 43% of stocks in the industry had positive returns, with significant variations in individual stock performance [16]. 2. Industry News - The report highlights the announcement from the Hebei Provincial Medical Products Procurement Center regarding the centralized procurement of 25 types of medical consumables, including biopsy needles and infusion ports [23]. 3. Company Announcements - Ningbo Tianyi Medical Devices Co., Ltd. received a medical device registration certificate for its blood dialysis concentrate products [24]. 4. Industry Outlook - The report suggests focusing on investment opportunities in the flu-related sector due to the onset of the flu season, recommending several companies across various segments, including medical devices, pharmaceutical commerce, and innovative drugs [25][27].