证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-186 江苏恒瑞医药股份有限公司 关于获得药品注册批准的公告 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。 注册分类：化学药品 3 类 受理号：CYHS2400770、CYHS2400772 处方药/非处方药：处方药 批准的适应症：用于预防和治疗成人慢性肾脏病（CKD）3-4 期继发性甲状 旁腺功能亢进症（SHPT）。 二、药品的其他情况 SHPT 是 CKD 患者常见的严重并发症之一，在 CKD 早期（肾小球滤过率<80 mL/[min·1.73m 2]）即可出现，并随着肾功能的恶化而加重。帕立骨化醇是一种 合成的维生素 D 类似物，通过与维生素 D 受体结合抑制甲状旁腺激素（PTH）的 分泌，从而降低血清 PTH 水平。帕立骨化醇软胶囊由 Abbvie 公司研制开发，于 2005 年 5 月获 FDA 批准上市，尚未在国内上市。公司为该品种在国内的首家仿 制药企业，本次获批视同通过仿制药质量和疗效一致性评价。截至目前，帕立骨 化醇软胶囊项目累计研发投入约 ...

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"）下发的《受理通知书》，公司提交的硫酸艾 玛昔替尼片药品上市许可申请获国家药监局受理。现将相关情况公告如下： 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-185 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理的提示性公告 一、药品的基本情况 药品名称：硫酸艾玛昔替尼片 剂型：片剂 受理号：CXHS2500141 申报阶段：上市 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。 三、药品的已获批适应症情况 硫酸艾玛昔替尼片已在国内获批上市四个适应症，分别为：用于对一种或多 种 TNF 抑制剂疗效不佳或不耐受的活动性强直性脊柱炎成人患者；用于对一种或 多种 TNF 抑制剂疗效不佳或不耐受的中重度活动性类风湿关节炎成人患者；用于 对局部外用治疗或其他系统性治疗应答不充分或不耐受的中重度特应性皮炎成 人患者；用于成人重度斑秃患者。 四、药品的其他情况 中轴型脊柱关节炎是以中轴关节及关节周围组织慢性进展性炎症为主 ...

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the launch of Paricalcitol soft capsules, aimed at treating secondary hyperparathyroidism in adults with chronic kidney disease stages 3-4 [1] Group 1 - The approved indication for Paricalcitol soft capsules is for the prevention and treatment of secondary hyperparathyroidism in adults with chronic kidney disease [1]

智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，公司收到国家药品监督管理局(简称"国家药监 局")下发的《受理通知书》，公司提交的硫酸艾玛昔替尼片药品上市许可申请获国家药监局受理。 硫酸艾玛昔替尼片已在国内获批上市四个适应症，分别为：用于对一种或多种TNF抑制剂疗效不佳或不 耐受的活动性强直性脊柱炎成人患者;用于对一种或多种TNF抑制剂疗效不佳或不耐受的中重度活动性 类风湿关节炎成人患者;用于对局部外用治疗或其他系统性治疗应答不充分或不耐受的中重度特应性皮 炎成人患者;用于成人重度斑秃患者。 ...

Investment Rating - The report maintains an "Outperform" rating for several companies including Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, 3SBio, Sichuan Kelun Pharmaceutical, and Jiangsu Nhwa Pharmaceutical [6][7]. Core Insights - The report continues to recommend innovative pharmaceuticals and the industry chain, highlighting the high prosperity in innovative drugs and the potential for value re-evaluation [6][26]. - The A-share pharmaceutical sector underperformed the market in the third week of November 2025, with the SW Pharmaceutical and Biological index falling by 6.9% compared to a 3.9% drop in the SHCOMP [9][19]. - The report identifies top gainers and losers in the A-share market, with Hainan Haiyao (+23.8%) and Remed (+13.9%) being the top gainers, while GDK (-25.5%) and Nanjing Hicin Pharmaceutical (-23.2%) were the biggest losers [16][19]. - The premium level of the pharmaceutical sector relative to all A-shares is currently at a normal level, with a relative premium rate of 71.8% as of November 21, 2025 [18][22]. Summary by Sections 1. Continued Recommendation for Innovative Pharmaceuticals and Industry Chain - The report emphasizes the ongoing recommendation for innovative drugs and the industry chain, maintaining "Outperform" ratings for various companies in the pharmaceutical and biotech sectors [6][26]. 2. A-share Pharmaceutical Sector Performance - In the third week of November 2025, the A-share pharmaceutical sector underperformed the broader market, ranking 23rd among Shenwan primary industries [9][19]. 3. Hong Kong and U.S. Market Performance - The Hong Kong pharmaceutical sector also underperformed, with the Hang Seng Healthcare index falling by 7.5%, while the U.S. pharmaceutical sector outperformed, with the S&P Healthcare Select Sector rising by 1.8% [19][26].

Core Viewpoint - Heng Rui Medicine announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. received notification from the National Medical Products Administration, approving the market launch of Paricalcitol soft capsules [1] Group 1: Product Details - The drug specifications are 1μg and 2μg, intended for the prevention and treatment of secondary hyperparathyroidism in adults with chronic kidney disease stages 3-4 [1] - Paricalcitol soft capsules have not been previously launched in the domestic market, making the company the first generic drug enterprise in the country to receive approval, which is considered equivalent to passing the consistency evaluation [1] Group 2: Financial and Development Insights - Cumulative research and development investment for this project amounts to approximately 57.94 million yuan [1] - The production and sales of the drug post-approval may be influenced by uncertain factors [1]

Investment Rating - The report maintains a "Buy" rating for several companies including Tian Shi Li, Xin Da Biology, and WuXi AppTec, with a focus on the innovative drug industry and high-end medical devices [3][25]. Core Insights - The small nucleic acid drug sector is experiencing significant advancements, marking the dawn of a new wave of innovative drugs. The industry is entering a golden development period driven by technological breakthroughs and commercial validation, with a recommendation to focus on leading innovative drug companies and those benefiting from the overall industry upturn [1][20][24]. Summary by Sections Market Review - The A-share pharmaceutical and biotechnology index fell by 4.32%, underperforming the CSI 300 index by 0.54 percentage points, while outperforming the ChiNext index by 1.92 percentage points, ranking 30th among 31 sub-industries. The H-share Hang Seng Healthcare Index dropped by 7.5%, underperforming the Hang Seng Index by 2.41 percentage points [1][15][9]. R&D Progress - Recent IND applications have been initiated for Heng Rui Medicine's HRS-1358 and HRS-3738, and clinical applications for SHR-9539 and JS207 have also been newly undertaken. Additionally, Zheng Da Tian Qing's TQB2934 is in Phase I clinical trials, while Gan Li Pharmaceutical's Bo Fan Gu Lu Tai is in Phase III [1][28]. Key Company Recommendations - The report highlights key companies to watch, including Heng Rui Medicine (A+H), Xin Da Biology (H), WuXi AppTec (A+H), Qian Yan Biology, Chengdu Xian Dao, and Jian Kai Technology, focusing on those with leading technology platforms and differentiated pipelines [1][25][24]. Investment Strategy - The report emphasizes the importance of clinical value in the pharmaceutical sector, suggesting that investments should focus on innovative drug chains and medical devices that meet clinical needs. The strategy is based on a three-stage clinical value framework [2][24]. Financial Forecasts - The report provides earnings per share (EPS) forecasts for key companies, with Tian Shi Li projected at 0.64 CNY for 2024, Xin Da Biology at -0.06 CNY, and WuXi AppTec at 3.27 CNY for 2024, indicating a positive outlook for several firms [3].

Core Viewpoint - Heng Rui Medicine (1276.HK) experienced a significant stock price increase, rising approximately 7% to HKD 69.6, with a total market capitalization of HKD 461.9 billion, following the announcement of multiple drug clinical trial approvals by the National Medical Products Administration [1] Group 1: Drug Approvals - The company and its subsidiaries received approval for clinical trials for several drugs, including SHR-9839, SHR-A2009, SHR-1826, HRS-4642 injection, Adalimumab injection, Trastuzumab, SHR-A2102, and HRS-7058 capsules and tablets [1] - The approval of nine drugs (excluding SHR-1139) in a single announcement highlights the company's strong research and development efficiency and a rich product pipeline, which are core components of its long-term competitiveness [1]

Core Viewpoint - Heng Rui Pharmaceutical (1276.HK) experienced a significant stock price increase, rising approximately 7% to a current price of 69.6 HKD, with a total market capitalization of 461.9 billion HKD following the announcement of multiple drug clinical trial approvals by the National Medical Products Administration [1] Group 1: Drug Approvals - The company and its subsidiaries recently received approval for clinical trials for several drugs, including SHR-9839 (sc) and SHR-A2009, among others [1] - A total of nine drugs were approved for clinical trials, demonstrating the company's strong research and development efficiency and a rich product pipeline [1] Group 2: Market Implications - The approval of multiple drugs is seen as a testament to the company's long-term competitive advantage in the pharmaceutical industry [1]

| | | 港股通创新药ETF (520880) 标的指数 | | | --- | --- | --- | --- | | | | 前十成份股权重高达71.51%，龙头优势显著 | | | 代码 | 简称 | 权重(%) | 总市值(亿港元) | | 6160.HK | 三济神州 | 10.74 | 3,022 | | 1177.HK | 中国生物制药 | 9.76 | 1,326 | | 1801.HK | 信达 参物 | 9.68 | 1,491 | | 9926.HK | 康方生物 | 8.53 | 1,045 | | 1093.HK | 有分量团 | 8.43 | 881 | | 1530.HK | 三生制药 | 8.34 | 749 | | 3692.HK | 翰森制药 | 6.04 | 2,158 | | 6990 HK | 科伦博泰生物-B | 4.16 | 1,045 | | 9688.HK | 电間居然 | 3.18 | ટટક | | 6855.HK | 亚盛医药-B | 2.65 | 248 | | 100 40 -- 10 -- 1 -- 1 -- 1 -- | 合计 | 71.51 ...