Hengrui Pharma(600276)
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恒瑞医药:重新提交注射用卡瑞利珠单抗的生物制品许可申请获FDA受理
Xin Lang Cai Jing· 2026-02-02 08:59
Core Viewpoint - The company has resubmitted its Biologics License Application (BLA) for injection of Carrelizumab in combination with Apatinib for the first-line treatment of unresectable or metastatic hepatocellular carcinoma, which has been accepted by the FDA [1] Group 1 - The target review date set by the FDA for the injection of Carrelizumab is July 23, 2026, according to the Prescription Drug User Fee Act (PDUFA) [1]
恒瑞医药(01276) - 翌日披露报表

2026-02-02 08:52
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 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 | 佔有關事件前的現有已發 | 行股份(不包括庫存股 ...
恒瑞医药(01276) - 海外监管公告 - 关於重新提交注射用卡瑞利珠单抗的生物製品许可申请获FD...

2026-02-02 08:50
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。 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) (股份代號:1276) 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。 根據中華人民共和國的有關法例規定,江蘇恒瑞醫藥股份有限公司(「本公司」)在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下,僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 药品名称:注射用卡瑞利珠单抗 剂型:注射剂 中國上海 2026年2月2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 ...
恒瑞医药重新提交注射用卡瑞利珠单抗的生物制品许可申请获FDA受理
Zhi Tong Cai Jing· 2026-02-02 08:43
Core Viewpoint - Heng Rui Medicine has received a confirmation letter from the FDA regarding its biologics license application (BLA) for injectable carrelizumab combined with apatinib mesylate for first-line treatment of unresectable or metastatic hepatocellular carcinoma patients, with a target review date set for July 23, 2026 [1] Group 1 - The FDA has accepted the BLA for injectable carrelizumab [1] - The application is intended for use in patients with unresectable or metastatic hepatocellular carcinoma [1] - The target review date under the Prescription Drug User Fee Act (PDUFA) is July 23, 2026 [1]
恒瑞医药(600276.SH)重新提交注射用卡瑞利珠单抗的生物制品许可申请获FDA受理
智通财经网· 2026-02-02 08:40
Core Viewpoint - Heng Rui Medicine has received a confirmation letter from the FDA regarding the acceptance of its Biologics License Application (BLA) for injection of Carrelizumab combined with Apatinib for first-line treatment of unresectable or metastatic hepatocellular carcinoma patients [1] Group 1 - The FDA has accepted the BLA submitted by Heng Rui Medicine for Carrelizumab [1] - The target review date set by the FDA under the Prescription Drug User Fee Act (PDUFA) is July 23, 2026 [1]
恒瑞医药:累计回购978.84万股,金额达6.46亿元
Xin Lang Cai Jing· 2026-02-02 08:39
恒瑞医药公告称,公司于2025年8月20日起实施股份回购计划,预计金额10亿元 - 20亿元,用于员工持 股计划或股权激励。截至2026年1月31日,累计回购股份978.84万股,占总股本0.15%,已支付总金额 64,628.87万元,回购价格区间为56.10 - 70.00元/股。2026年1月回购88.97万股,占总股本0.013%,支付 5,107.24万元。 ...
AI医疗:暴力破解创新药,人类突破长寿极限
泽平宏观· 2026-02-01 16:05
Core Viewpoint - AI is revolutionizing the life sciences and pharmaceutical research, significantly improving efficiency and reducing costs associated with drug development [3][4][7]. Group 1: Global AI Medical Market Expansion - The global AI medical market is rapidly expanding, characterized by the entry of major tech companies like NVIDIA, Google, and Microsoft, which are restructuring medical infrastructure [3][4]. - AI technology is deeply integrating with biotechnology, leading to unprecedented levels of financing and mergers in the AI medical sector, with projections indicating a record high in 2025 [4][5]. - Major pharmaceutical companies are investing billions in partnerships with AI startups, exemplified by Sanofi's $2.5 billion collaboration with Earendil and other significant deals with Atomwise and Dren Bio [5][6]. Group 2: AI Drug Development and Applications - AI is transforming drug development by addressing various diseases, including cancer, neurodegenerative diseases, metabolic disorders, autoimmune diseases, infectious diseases, and rare diseases, significantly lowering trial costs and improving success rates [7][8][9]. - The efficiency of AI in drug development is highlighted by its ability to reduce the traditional 10-year, $1 billion timeline with only a 10% success rate, enhancing the overall drug discovery process [8][9]. - AI's role in drug discovery is expanding from initial target identification to clinical trial design and patient recruitment, covering the entire industry spectrum [8][9]. Group 3: Policy Support for AI in Healthcare - National strategies are being implemented to support AI applications in healthcare, including the 2025 guidelines promoting AI in drug development to reduce costs and time [9][10]. - Local governments are providing financial incentives for AI drug development, with subsidies for computational costs and support for companies achieving regulatory approvals [11][12]. - Policies are encouraging the internationalization of innovative drugs, with significant support for local companies conducting global clinical trials [11][12]. Group 4: Future Opportunities in AI Healthcare - The first major opportunity lies in AI-assisted drug discovery, which is expected to have a trillion-dollar market potential, particularly in treating diseases like cancer and Alzheimer's [25][26]. - AI is set to enhance diagnostic accuracy in medical imaging, addressing resource distribution issues and integrating diagnostic capabilities into imaging devices [28][29]. - AI will drive advancements in clinical decision support and healthcare information systems, improving data utilization and patient care efficiency [30][31]. - AI-powered surgical robots are expected to redefine surgical precision and enable remote medical procedures, breaking geographical barriers in healthcare delivery [32][33].
医药行业周报:技术加持稳定原料药出口竞争力-20260201
Huaxin Securities· 2026-02-01 15:09
证 券 研 究 报 告 行业周报 技术加持稳定原料药出口竞争力 医药行业周报 分析师:胡博新 SAC编号:S1050522120002 分析师:吴景欢 SAC编号:S1050523070004 医 药 行 业 观 点 2 诚信、专业、稳健、高效 请阅读最后一页重要免责声明 医 药 行 业 观 点 投资评级: 报告日期: 推荐 ( 维持 ) 2026年02月01日 1.技术加持稳定原料药出口竞争力,重视供给变量 根据医保商会数据,2025年中国医药保健品出口额1113.41亿美元,增长3.14%,其中西药原料出口额428.67亿美元,占西 药总出口的76.8%,同比微降0.27%。原料药出口能保持出口总量的相对稳定,是克服全球贸易变局和内部价格竞争内卷下 实现的,是中国原料药产业竞争力的体现。受关税贸易影响,2025年中国对美国医药出口下降了10.6%,而非美市场,欧 盟增长11.38%,新兴市场增长4.49%。展望2026年原料药贸易依然存在较多的不确定性,中国与印度之间原料药竞争合作 将进一步演绎。价格方面,价格竞争内卷是一方面,另一方面合成生物学等新技术加持,新工艺新产能的投产,单位成本 下降是重要一面。 ...
国泰海通医药2026年2月月报:持续推荐创新药械产业链
GUOTAI HAITONG SECURITIES· 2026-02-01 13:20
股票研究 /[Table_Date] 2026.02.01 持续推荐创新药械产业链 [Table_Industry] 医药 ——国泰海通医药 2026 年 2 月月报 | [姓名table_Authors] | 电话 | 邮箱 | 登记编号 | | --- | --- | --- | --- | | 余文心(分析师) | 021-38676666 | yuwenxin@gtht.com | S0880525040111 | | 郑琴(分析师) | 021-23219808 | zhengqin@gtht.com | S0880525040108 | | 谈嘉程(分析师) | 021-38038429 | tanjiacheng@gtht.com | S0880523070004 | 本报告导读: 持续推荐创新药械及产业链。 投资要点: | [Table_Invest] | | | --- | --- | | 评级: | 增持 | [Table_Report] 相关报告 医药《V940 五年随访数据披露,mRNA 肿瘤疫 苗长期价值验证》2026.01.30 医药《支持政策不断,持续推荐创新药械产业 链》202 ...
国泰海通医药2026年2月月报:持续推荐创新药械产业链-20260201
GUOTAI HAITONG SECURITIES· 2026-02-01 12:48
股票研究 /[Table_Date] 2026.02.01 持续推荐创新药械产业链 [Table_Industry] 医药 ——国泰海通医药 2026 年 2 月月报 | [姓名table_Authors] | 电话 | 邮箱 | 登记编号 | | --- | --- | --- | --- | | 余文心(分析师) | 021-38676666 | yuwenxin@gtht.com | S0880525040111 | | 郑琴(分析师) | 021-23219808 | zhengqin@gtht.com | S0880525040108 | | 谈嘉程(分析师) | 021-38038429 | tanjiacheng@gtht.com | S0880523070004 | 本报告导读: 持续推荐创新药械及产业链。 投资要点: | [Table_Invest] | | | --- | --- | | 评级: | 增持 | [Table_Report] 相关报告 医药《V940 五年随访数据披露,mRNA 肿瘤疫 苗长期价值验证》2026.01.30 医药《支持政策不断,持续推荐创新药械产业 链》202 ...