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上海医药:关于溴吡斯的明缓释片获得批准生产的公告
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of bromperidol sustained-release tablets, indicating a significant advancement in its product portfolio [1] Company Summary - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Shiyu Chinese and Western Medicine Co., Ltd., has obtained the Drug Registration Certificate for bromperidol sustained-release tablets, with the certificate number 2025S03175 [1]
上海医药溴吡斯的明缓释片获批生产
Bei Jing Shang Bao· 2025-10-28 10:48
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of Bromidespamine sustained-release tablets, which are indicated for the treatment of myasthenia gravis [1] Group 1 - The product, Bromidespamine sustained-release tablets, was originally developed by BAUSCH and was first launched in the United States in 1959 [1] - The registration certificate number for the approved drug is 2025S03175 [1]
上海医药(02607):溴吡斯的明缓释片获得批准生产
智通财经网· 2025-10-28 09:44
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of Bromidespasm, a sustained-release tablet used to treat myasthenia gravis, marking a significant milestone for the company in expanding its product portfolio [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has been granted a Drug Registration Certificate for Bromidespasm, with the certificate number 2025S03175 [1] - The drug was originally developed by BAUSCH and was first launched in the United States in 1959 [1] - The company submitted the registration application for this drug to the National Medical Products Administration in March 2024, which has been accepted [1] - As of the date of the announcement, the company has invested approximately RMB 16.09 million in research and development for this drug [1]
上海医药(02607.HK):溴吡斯的明缓释片获得批准生产
Ge Long Hui· 2025-10-28 09:41
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of Bromperidol Sustained-Release Tablets, indicating a significant advancement in its product portfolio [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has been granted a drug registration certificate (Certificate No. 2025S03175) for Bromperidol Sustained-Release Tablets, allowing the company to commence production [1]
上海医药(02607) - 海外监管公告
2025-10-28 09:33
香港交易及結算所有限公司和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,概不對因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 上 海 醫 藥 集 團 股 份 有 限 公 司 Shanghai Pharmaceuticals Holding Co., Ltd. * (於中華人民共和國註冊成立的股份有限公司) (股份代碼:02607) 海外監管公告 中國上海,2025 年 10 月 29 日 於本公告日期,本公司的執行董事為楊秋華先生、沈波先生、李永忠先生及董明 先生;非執行董事為張文學先生;以及獨立非執行董事為顧朝陽先生、霍文遜先 生、王忠先生及萬鈞女士。 * 僅供識別 证券代码:601607 证券简称:上海医药 编号:临 2025-094 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 條而作出。 茲載列上海醫藥集團股份有限公司(「本公司」)在上海證券交易所網站(http://www.sse.com.cn) 刊登的《上海醫藥集團股份有限公司關於溴吡斯的明緩釋片獲得批准生產的公告》、《上海醫 藥集團股份有限公司關 ...
上海医药(601607) - 上海医药集团股份有限公司关于溴吡斯的明缓释片获得批准生产的公告
2025-10-28 07:50
剂型:片剂 规格:0.18g 注册分类:化学药品 3 类 上海医药集团股份有限公司 关于溴吡斯的明缓释片获得批准生产的公告 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个别及连带责任。 近日,上海医药集团股份有限公司(以下简称"公司")下属上海上药中西 制药有限公司(以下简称"上药中西")的溴吡斯的明缓释片(以下简称"该药 品")收到国家药品监督管理局(以下简称"国家药监局")颁发的《药品注册 证书》(证书编号:2025S03175),该药品获得批准生产。 一、该药品基本情况 药物名称:溴吡斯的明缓释片 证券代码:601607 证券简称:上海医药 编号:临 2025-094 药品批准文号:国药准字 H20255730 1 三、对上市公司影响及风险提示 根据国家相关政策,按新注册分类获批仿制药的品种在医保支付及医疗机构 采购等领域将获得更大的支持力度。因此上药中西的溴吡斯的明缓释片获得批准 生产,有利于扩大该药品的市场份额,提升市场竞争力,同时为公司后续产品开 展仿制药申报积累了宝贵的经验。 因受国家政策、市场环境等不确定因素影响,该药 ...
上海医药(601607) - 上海医药集团股份有限公司关于召开2025年第三季度业绩说明会的公告
2025-10-28 07:50
证券代码:601607 证券简称:上海医药 公告编号:临 2025-095 上海医药集团股份有限公司 关于召开 2025 年第三季度业绩说明会的公告 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。 重要内容提示: 投资者可于 2025 年 10 月 29 日(星期三)至 11 月 04 日(星期二)16:00 前登录上证路演中心网站首页点击"提问预征集"栏目进行提问。公司将在说明 会上对投资者普遍关注的问题进行回答。 上海医药集团股份有限公司(以下简称"公司")将于 2025 年 10 月 30 日盘 后发布公司 2025 年第三季度报告,为便于广大投资者更全面深入地了解公司 20 25 年第三季度经营成果、财务状况,公司计划于 2025 年 11 月 05 日(星期三) 10:00-11:00 举行 2025 年第三季度业绩说明会,就投资者关心的问题进行交流。 一、 说明会类型 (二) 会议召开地点:上证路演中心 (三) 会议召开方式:上证路演中心网络互动 三、 参加人员 钟 涛 副总裁、董事会秘书 上述参会人员将视实际情况 ...
上海医药(601607.SH):子公司成为氨磺必利口崩片上市许可持有人
Ge Long Hui· 2025-10-25 21:07
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) has received approval from the National Medical Products Administration to change the marketing authorization holder for Amisulpride Orally Disintegrating Tablets to its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd, enhancing its product line and market competitiveness [1] Group 1 - The National Medical Products Administration issued a notification approving the change of marketing authorization holder for Amisulpride Orally Disintegrating Tablets [1] - Amisulpride Orally Disintegrating Tablets are an improved formulation of Amisulpride Tablets, originally launched by Sanofi in France in 1986, used for treating adult schizophrenia [1] - The change in marketing authorization holder to Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd will further enrich the company's product offerings [1]
上海医药集团股份有限公司关于子公司成为氨磺必利口崩片上市许可持有人的公告
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration to change the marketing authorization holder for Amisulpride Orally Disintegrating Tablets to its subsidiary, Shanghai Pharmaceutical Zhongxi Pharmaceutical Co., Ltd [1][2]. Group 1: Drug Information - Drug Name: Amisulpride Orally Disintegrating Tablets - Dosage Form: Tablet - Specifications: 50mg, 0.2g - Registration Classification: Chemical Drug - Approval Numbers: National Drug Approval Code H20250041, H20250042 - Approval Conclusion: Change of marketing authorization holder from "Shanghai Zezheng Pharmaceutical Technology Co., Ltd." to "Shanghai Pharmaceutical Zhongxi Pharmaceutical Co., Ltd." [2]. Group 2: Market Context - Amisulpride Orally Disintegrating Tablets is an improved formulation of Amisulpride Tablets, which was launched by Sanofi in France in 1986 for the treatment of adult schizophrenia [3]. - As of the date of the announcement, there are no other companies in China that have listed Amisulpride Orally Disintegrating Tablets [4]. - According to IQVIA data, the hospital procurement amount for Amisulpride oral formulations in 2024 is projected to be RMB 168.41 million [5]. Group 3: Company Impact - The change in marketing authorization holder for Amisulpride Orally Disintegrating Tablets enhances the product line of Shanghai Pharmaceuticals and is expected to improve the company's market competitiveness [6].
上海医药:关于子公司成为氨磺必利口崩片上市许可持有人的公告
Core Viewpoint - Shanghai Pharmaceuticals announced the approval of a change in the marketing authorization holder for Amisulpride orally disintegrating tablets to its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd. [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., received the approval from the National Medical Products Administration for the change of marketing authorization holder [1]