Hengrui Pharma(600276)
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恒瑞医药:两款产品获得药物临床试验批准通知书
Zheng Quan Shi Bao Wang· 2026-01-05 09:40
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-4357 injection and HRS-5041 tablets, marking a significant step in the development of innovative cancer treatments [1] Group 1: Product Development - HRS-4357 injection is a first-class radioactive therapy drug developed by the company, which will now undergo clinical trials for a new indication in combination with HRS-5041 for treating prostate cancer patients who are positive for prostate-specific membrane antigen (PSMA) [1] - HRS-5041 is a novel, efficient, and selective ARPROTAC small molecule developed by the company, aimed at treating prostate cancer [1] - There are currently no similar products approved for marketing in both domestic and international markets, indicating a unique position for the company's offerings [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
2026-01-05 09:15
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-002 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 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 HRS9531 注射液、HRS-5817 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: HRS9531 注射液是以 HRS9531 为主要活性成分,具有全球自主知识产权的新 型靶向胰高血糖素样肽-1 受体(GLP-1R)和葡萄糖依赖性促胰岛素肽受体(GIPR) 的双激动剂,可在体内调节糖脂代谢、抑制食欲和增强胰岛素敏感性,从而起到 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。 | 药物名称 | HRS9531 注射液 HRS-5817 注射液 | | --- | --- | | 剂型 | 注射剂 | | 事项 | 临床试验 | | 受理号 | CXHL2501098、CXHL2501100、 CXHL250110 ...
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
2026-01-05 09:15
HRS-5041 是公司开发的新型、高效、选择性的 AR PROTAC(雄激素受体-蛋 白降解靶向嵌合体)小分子,拟用于治疗前列腺癌。HRS-5041 对野生型及绝大 多数突变体的 AR 蛋白有显著的降解作用,与二代 AR 抑制剂相比,有克服耐药的 潜力。经查询,目前国内外暂无同类产品获批上市。截至目前,HRS-5041 片相 关项目累计研发投入约 9,266 万元。 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上市。药品 从研制、临床试验报批到投产的周期长、环节多,药品研发及至上市容易受到一 些不确定性因素的影响,敬请广大投资者谨慎决策,注意防范投资风险。公司将 按国家有关规定积极推进上述研发项目,并及时对项目后续进展情况履行信息披 露义务。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-003 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。 ...
恒瑞医药(600276) - H股公告-证券变动月报表
2026-01-05 09:00
FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 江蘇恒瑞醫藥股份有限公司 呈交日期: 2026年1月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01276 | 說明 | H股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 258,197,600 | RMB | | | 1 RMB | | 258,197,600 | | 增加 / 減少 (-) | | | | | | | RMB | | | | 本月底結存 | | | 258,197,600 | RMB | | | 1 RMB | | 258,197,600 | | 2. 股份分 ...
恒瑞医药:HRS-4357注射液联合HRS-5041片获临床试验批准
2 1 Shi Ji Jing Ji Bao Dao· 2026-01-05 08:57
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-4357 injection and HRS-5041 tablets, aimed at treating PSMA-positive prostate cancer [1] Group 1: Clinical Trial Approval - The approval includes an open, multi-center, Phase Ib/II clinical study to evaluate the safety, tolerability, and preliminary efficacy of HRS-4357 in combination with HRS-5041 for adult patients with PSMA-positive prostate cancer [1] - HRS-4357 is an innovative Class 1 radioactive therapeutic drug independently developed by the company [1] - HRS-5041 is a new, highly efficient, selective ARPROTAC small molecule developed by the company, intended for prostate cancer treatment [1] Group 2: Financial Investment - The cumulative R&D investment for the HRS-4357 injection project is approximately 67.55 million yuan [1] - The cumulative R&D investment for the HRS-5041 tablet project is approximately 92.66 million yuan [1] Group 3: Market Context - There are currently no approved products of the same kind available in both domestic and international markets [1]
大和:升信达生物(01801)目标价至112港元 与恒瑞医药(600276.SH)同为生物医药首选
智通财经网· 2026-01-05 07:59
Core Viewpoint - Daiwa has released a report recommending specific pharmaceutical stocks, highlighting the preference for Innovent Biologics (01801) and Hengrui Medicine (600276.SH) while maintaining a "sell" rating on CSPC Pharmaceutical Group (01093) [1] Group 1: Stock Recommendations - Innovent Biologics' target price has been raised from HKD 95 to HKD 112 [1] - Hengrui Medicine's target price remains at RMB 80 [1] - CSPC Pharmaceutical Group's target price is maintained at HKD 6.6 with a "sell" rating [1] Group 2: Market Outlook - The Chinese biopharmaceutical sector is expected to experience a comprehensive increase in 2025 [1] - For 2026, Daiwa suggests a more selective stock-picking strategy focusing on high-quality targets [1] Group 3: Key Focus Areas for 2026 - Daiwa plans to outline key clinical data release timelines [1] - The report will identify significant stock price catalysts [1] - Key areas of analysis will include PD-(L)1/VEGF, GLP-1, and siRNA [1]
大和:升信达生物目标价至112港元 与恒瑞医药同为生物医药首选
Zhi Tong Cai Jing· 2026-01-05 07:57
Core Viewpoint - Daiwa has released a report recommending specific pharmaceutical stocks, highlighting Innovent Biologics (01801) and Heng Rui Medicine (600276) as top picks, with target price adjustments and ratings for other companies in the sector [1] Company Recommendations - Innovent Biologics' target price has been raised from HKD 95 to HKD 112 [1] - Heng Rui Medicine's target price remains at RMB 80 [1] - CSPC Pharmaceutical Group (01093) is rated "Sell" with a target price maintained at HKD 6.6 [1] Industry Outlook - The Chinese biopharmaceutical sector is expected to experience a comprehensive increase in 2025 [1] - For 2026, Daiwa suggests a more selective stock-picking strategy focusing on high-quality targets [1] - Key clinical data release timelines and significant stock price catalysts will be outlined for 2026 [1] - Important areas of analysis include PD-(L)1/VEGF, GLP-1, and siRNA [1]
HTI 医药 2026 年 1 月月报:景气延续,持续重点推荐创新药械产业链-20260105
Haitong Securities International· 2026-01-05 07:14
Investment Rating - The report maintains an "Outperform" rating for the following A-share targets: Jiangsu Heng Rui Medicine, Sichuan Kelun Pharmaceutical, Huadong Medicine, Jiangsu Nhwa Pharmaceutical, Xiamen Amoytop Biotech, Zhejiang Jingxin Pharmaceutical, Innovent Biologics, WuXi AppTec, Hangzhou Tigermed Consulting, Lepu Medical, MicroPort EP MedTech [5][36][8] - The report also maintains an "Outperform" rating for the following H-share targets: Hansoh Pharmaceutical Group, 3SBio, PATEO Biotech, Akeso, and related targets: Innovent Biologics, WuXi AppTec [8][36] Core Insights - The report continues to recommend the innovative drug and device industry and its supply chains, indicating a positive outlook for this sector [1][36] - In December 2025, the pharmaceutical sector underperformed the market, with the SW Pharmaceutical and Biological index falling by 4.1%, while the SHCOMP rose by 2.1%, ranking 26th among Shenwan primary industries [15][37] - The report highlights that the premium level of the pharmaceutical sector relative to all A-shares is currently at a normal level, with a relative premium rate of 63.2% as of the end of December 2025 [25][37] Summary by Sections A-Share Targets - The report includes a monthly portfolio of A-share targets that outperformed the pharmaceutical index, with a monthly average decline of 1.8% compared to the overall pharmaceutical index decline of 3.9% in December 2025 [11][36] - The top three stock gains in December 2025 were Luyan Pharma (+118.8%), CareRay Digital Medical Technology Co., Ltd. (+36.6%), and Hubei Hongyuan Pharmaceutical Technology Co., Ltd. (+34.0%) [24][37] H-Share Targets - The report notes that the Hong Kong stock pharmaceutical sector also underperformed the market, with the Hang Seng Healthcare index falling by 9.5% and the Hong Kong Biological Technology index falling by 10.6% in December 2025 [26][38] U.S. Market Performance - In December 2025, the U.S. pharmaceutical sector underperformed the market, with the S&P 500 Healthcare Select Sector declining by 1.5% while the S&P 500 fell by only 0.1% [26][39]
大行评级|大和:今年中国生物医药板块首选是信达生物与恒瑞医药
Ge Long Hui· 2026-01-05 06:28
Group 1 - The core viewpoint of the report is that the Chinese biopharmaceutical sector experienced a comprehensive increase in 2025, and for 2026, a more selective stock-picking strategy is recommended, focusing on high-quality targets [1] Group 2 - Daiwa's top picks include Innovent Biologics and Hengrui Medicine, with Innovent's target price raised from HKD 95 to HKD 112, while Hengrui's target price remains at HKD 80 [1] - The rating for CanSino Biologics has been downgraded from "Buy" to "Hold," with its target price increased from HKD 100 to HKD 116 [1] - The rating for CSPC Pharmaceutical Group is maintained at "Sell," with a target price of HKD 6.6 [1]
2025年港股IPO募资额超2800亿港元,诞生8家百亿级融资企业
Huan Qiu Wang· 2026-01-05 01:35
报道还提到,港股市场2025年全年诞生8家百亿级港元融资企业,分别为宁德时代、紫金黄金国际、三一重工、赛力 斯、恒瑞医药、三花智控、海天味业、奇瑞汽车。8家企业合计募资达1424.6亿港元,占全年募资总额的52.75%,龙头 效应显著,成为港股IPO市场复苏的"压舱石"。 另据港交所数据显示,截至2025年12月31日,共有逾612件上市申请,其中包括549家主板、11家GEM(原创业板), 还有52家根据"主板上市规则"第20章及第21章递交的上市申请,仍在排队处理的还有321件。 【环球网财经综合报道】据Wind资讯初步统计,截至2025年12月末,包括聚辰股份、天孚通信等在内的超20家A股上 市公司,披露赴港上市相关公告。对此有机构认为,港股"含A量"提高,释放出两地市场协同发力的积极信 号,"A+H"模式预计将持续火热。 联合新闻网近日发文称,2025年全年港股IPO募资额达2856.9亿港元,较2024年大幅增长224%,募资规模成功重返全 球榜首,排名超越纽交所、纳斯达克及印度股市;全年共有117家公司在港上市,较2024年增长67.14%。 ...