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恒瑞医药:帕立骨化醇软胶囊获得药品注册批准
Zhi Tong Cai Jing· 2025-11-24 10:32
Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for the market launch of Paricalcitol soft capsules, aimed at treating secondary hyperparathyroidism (SHPT) in adults with chronic kidney disease (CKD) stages 3-4 [1] Company Summary - The approved indication for Paricalcitol soft capsules is for the prevention and treatment of secondary hyperparathyroidism in adults suffering from chronic kidney disease stages 3-4 [1]
11月24日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-24 10:21
Group 1 - Huafeng Co., Ltd. announced a stock suspension due to a potential change in control after signing a share transfer intention agreement [1] - Keshida plans to reduce its shareholding by up to 424,000 shares, representing 0.07% of its total share capital [1] - Jinqilin intends to distribute a cash dividend of 0.10 yuan per share, totaling 19.61 million yuan [1] Group 2 - Rejingshi Biotech has repurchased 904,100 shares, accounting for 0.98% of its total share capital, with a total expenditure of 150 million yuan [2] - Yishitong has repurchased 1,236,500 shares, representing 0.619% of its total share capital, with a total expenditure of approximately 33.49 million yuan [2] Group 3 - Hanjia Design announced the release of a detention on its subsidiary's chairman, allowing him to resume duties [4] - Qingmu Technology plans to acquire 65.83% of Vitalis Pharma AS for 300 million Norwegian Krone (approximately 212 million yuan) [4] - Anda Intelligent's shareholder plans to reduce its stake by up to 2.74% [4] Group 4 - Wansheng Intelligent is a candidate for a project with a pre-bid amount of approximately 42.99 million yuan, representing 4.56% of its audited revenue for 2024 [4] - Yipin Hong received a drug registration certificate for a medication used to treat Alzheimer's symptoms [4] Group 5 - *ST Sansheng received a total of 254 million yuan from restructuring investors [4] - Haichuang Pharmaceutical received approval for clinical trials of HP518 tablets for advanced prostate cancer treatment [4] Group 6 - Ningbo Huaxiang's subsidiary plans to invest 5 million yuan in a venture capital fund focusing on intelligent industries [4] - Petty Co. plans to repurchase shares worth 50 to 70 million yuan [4] Group 7 - Tongji Technology's subsidiary won a construction project with a bid price of 866 million yuan [4] - Prolo Pharmaceutical received a drug registration certificate for a generic drug [4] Group 8 - Jingyan Technology plans to use up to 1.6 billion yuan of idle funds for financial management [4] - Furan De received government subsidies totaling 34.65 million yuan [4] Group 9 - David Medical's subsidiary's medical device registration has been accepted [4] - Jusaylong plans to increase its subsidiary's capital by 170 million yuan through debt-to-equity conversion [4] Group 10 - Heng Rui Pharmaceutical's application for a drug license has been accepted by the National Medical Products Administration [4] - Lege Co. plans to increase its stake in the company by 40 to 80 million yuan [4] Group 11 - New Beiyang's subsidiary won a project with the Bank of Communications [4] - Jiangxi Changyun plans to publicly transfer land use rights and buildings with a starting price of 7.79 million yuan [4] Group 12 - Shenqi Pharmaceutical's subsidiary has paid approximately 16.67 million yuan in tax and penalties [4] - Panjiang Co. plans to invest 1.334 billion yuan in a power plant project [4] Group 13 - Fashilong's vice president resigned for personal reasons [4] - Chunxue Food received government subsidies of 3.79 million yuan [4] Group 14 - China Galaxy completed the repayment of a short-term financing bond totaling 3.025 billion yuan [4] - Jiuzhou Pharmaceutical received approval for a chemical raw material drug [4] Group 15 - Longqi Technology's subsidiary plans to invest 30 million yuan in a venture capital fund [4]
恒瑞医药:硫酸艾玛昔替尼片上市许可申请获受理
Zhi Tong Cai Jing· 2025-11-24 09:48
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。 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。 ...
恒瑞医药(600276.SH):硫酸艾玛昔替尼片药品上市许可申请获受理
Ge Long Hui A P P· 2025-11-24 09:41
拟定适应症(或功能主治):本品适用于对非甾体抗炎药(NSAID)应答不佳或不耐受且存在客观炎 症征象(表现为C反应蛋白[CRP]升高和/或磁共振成像[MRI]异常)的活动性放射学阴性中轴型脊柱关 节炎成人患者。 格隆汇11月24日丨恒瑞医药(600276.SH)公布,公司收到国家药品监督管理局下发的《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。 ...
恒瑞医药(600276) - 恒瑞医药关于获得药品注册批准的公告
2025-11-24 09:15
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 ...
恒瑞医药(600276) - 恒瑞医药关于药品上市许可申请获受理的提示性公告
2025-11-24 09:15
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 ...
恒瑞医药(600276.SH):帕立骨化醇软胶囊获得药品注册批准
智通财经网· 2025-11-24 09:14
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]
恒瑞医药(600276.SH):硫酸艾玛昔替尼片上市许可申请获受理
智通财经网· 2025-11-24 09:14
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。 ...
持续推荐创新药械产业链
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].
恒瑞医药:子公司帕立骨化醇软胶囊获批上市
Xin Lang Cai Jing· 2025-11-24 09:02
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]