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国药现代子公司法莫替丁注射液通过仿制药一致性评价
Bei Jing Shang Bao· 2025-10-17 10:35
Core Viewpoint - The announcement by China National Pharmaceutical Group Modern (国药现代) regarding the approval of Famotidine injection by the National Medical Products Administration highlights a significant development in the company's product portfolio and its potential impact on the market for gastrointestinal medications [1]. Company Summary - China National Pharmaceutical Group Modern's wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., has received the approval for Famotidine injection, which has passed the consistency evaluation of generic drug quality and efficacy [1]. - Famotidine is classified as a histamine H2 receptor antagonist, primarily used for treating upper gastrointestinal bleeding caused by peptic ulcers and other non-tumor-related conditions leading to gastric and duodenal mucosal erosion and bleeding [1].
国药现代(600420) - 关于公开挂牌转让控股子公司股权进展暨交易结果的公告
2025-10-17 10:15
证券代码:600420 证券简称:国药现代 公告编号:2025-079 上海现代制药股份有限公司 (一)本次交易的基本情况 1、本次交易概况 关于公开挂牌转让控股子公司股权进展暨交易结果的公告 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: 上海现代制药股份有限公司(以下简称公司或国药现代)通过公开挂牌 方式,转让控股子公司上海现代哈森(商丘)药业有限公司(以下简称国药哈森) 51%股权。近日,河南洋森药业集团有限公司(以下简称河南洋森)按当前挂牌 价人民币 10,968.00 万元摘牌,交易双方签署了《上海市产权交易合同》。本次交 易完成后,公司不再持有国药哈森股权。 本次交易不构成关联交易,亦不构成重大资产重组。 公司不存在为国药哈森提供担保、委托其理财等情况,国药哈森不存在 占用公司资金的情况。 一、交易概述 2025 年 7 月 1 日,公司披露了《关于拟公开转让控股子公司股权预挂牌的 提示性公告》,为推进实施公司中长期战略规划,优化资源配置,提高公司资产 的运营效率,公司拟公开挂牌转让控股子公司国药哈 ...
国药现代(600420) - 关于全资子公司药品通过仿制药一致性评价的自愿性信息披露公告
2025-10-17 10:15
证券代码:600420 证券简称:国药现代 公告编号:2025-080 药品名称:法莫替丁注射液 通知书编号:2025B04693 剂型:注射剂 规格:2ml:20mg 注册分类:化学药品 上海现代制药股份有限公司 原药品批准文号:国药准字 H20033269 关于全资子公司药品通过仿制药一致性评价的自愿性信息 披露公告 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。 近日,上海现代制药股份有限公司(以下简称公司)全资子公司国药集团容 生制药有限公司(以下简称国药容生)收到国家药品监督管理局核准签发的《药 品补充申请批准通知书》,批准法莫替丁注射液通过仿制药质量和疗效一致性评 价(以下简称一致性评价)。现将相关情况公告如下: 一、药品基本信息 上市许可持有人:国药集团容生制药有限公司 药品生产企业:国药集团容生制药有限公司 审批结论:根据《中华人民共和国药品管理法》《国务院关于改革药品医疗 器械审评审批制度的意见》(国发〔2015〕44 号)、《关于仿制药质量和疗效 一致性评价工作有关事项的公告》(2017 年第 100 号) ...
国药现代(600420.SH):子公司药品法莫替丁注射液通过仿制药一致性评价
Ge Long Hui A P P· 2025-10-17 10:13
Core Viewpoint - China National Pharmaceutical Group Modern (600420.SH) announced that its wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the supplementary application of Famotidine injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approval allows Famotidine injection to be used for treating upper gastrointestinal bleeding caused by peptic ulcers and other non-tumor related conditions [1] - Famotidine is classified as a histamine H2 receptor antagonist [1] - The drug is indicated for various causes of gastric and duodenal mucosal erosion bleeding, excluding those related to tumors and esophageal or gastric varices [1]
国药现代:法莫替丁注射液通过仿制药一致性评价
Core Viewpoint - The announcement by China National Pharmaceutical Group Modern (国药现代) regarding the approval of Famotidine injection by the National Medical Products Administration signifies a significant advancement in the company's product portfolio and its ability to meet market demands for gastrointestinal treatments [1] Group 1 - China National Pharmaceutical Group Modern's wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., has received the approval notice for the supplementary application of Famotidine injection [1] - Famotidine is classified as a histamine H2 receptor antagonist, primarily used for treating upper gastrointestinal bleeding caused by peptic ulcers and other non-tumor-related conditions [1] - The approval indicates that Famotidine injection has passed the consistency evaluation of generic drug quality and efficacy, enhancing its market competitiveness [1]
国药现代(600420) - 关于全资子公司获得化学原料药上市申请批准通知书的公告
2025-10-10 09:45
近日,上海现代制药股份有限公司(以下简称公司)全资子公司国药集团威 奇达药业有限公司(以下简称国药威奇达)收到国家药品监督管理局关于原料药 磷酸西格列汀的《化学原料药上市申请批准通知书》。现将相关情况公告如下: 一、化学原料药基本信息 化学原料药名称:磷酸西格列汀 证券代码:600420 证券简称:国药现代 公告编号:2025-078 上海现代制药股份有限公司 关于全资子公司获得化学原料药上市申请批准通知书 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。 生产企业:国药集团威奇达药业有限公司 企业地址:山西省大同市经济技术开发区医药工业园区 申请事项:境内生产化学原料药上市申请 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准注册。 二、药品研发及市场情况 磷酸西格列汀为 DPP-4 抑制剂,临床上主要用于改善 2 型糖尿病患者的血 糖控制。 根据 CDE 网站显示,目前磷酸西格列汀原料药登记状态为"A"的国内企 业还有山东新时代药业有限公司、重庆圣华曦药业股份有限公司、 ...
国药现代(600420.SH)子公司磷酸西格列汀原料药获上市申请批准通知书
智通财经网· 2025-10-10 09:38
Core Viewpoint - The announcement indicates that China National Pharmaceutical Group Modern (国药现代) has received approval for the active pharmaceutical ingredient (API) phosphoric acid sitagliptin, which is primarily used for improving blood sugar control in patients with type 2 diabetes [1] Group 1: Company Developments - The company's wholly-owned subsidiary, China National Pharmaceutical Group Weichida Pharmaceutical Co., Ltd. (国药威奇达), has received the "Approval Notice for Chemical Raw Material Drug Listing Application" from the National Medical Products Administration [1] - The approval signifies that the phosphoric acid sitagliptin API meets the regulatory requirements for drug registration in China, allowing it to be marketed domestically [1] - This development will further enrich the company's specialized API product portfolio [1]
国药现代(600420.SH):子公司获得化学原料药上市申请批准通知书
Ge Long Hui A P P· 2025-10-10 09:38
Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing application of the active pharmaceutical ingredient, Sitagliptin Phosphate, which is primarily used for improving blood sugar control in patients with type 2 diabetes [1] Company Summary - The company involved is Sinopharm Modern (国药现代), which is a subsidiary of Sinopharm Group [1] - The approved product, Sitagliptin Phosphate, is classified as a DPP-4 inhibitor [1] Industry Summary - Sitagliptin Phosphate is utilized in the clinical management of type 2 diabetes, indicating a focus on diabetes treatment within the pharmaceutical industry [1]
国药现代子公司磷酸西格列汀原料药获上市申请批准通知书
Zhi Tong Cai Jing· 2025-10-10 09:36
Core Viewpoint - The approval of the active pharmaceutical ingredient (API) Sitagliptin Phosphate by the National Medical Products Administration (NMPA) signifies a significant advancement for the company, enhancing its portfolio in specialty APIs for diabetes treatment [1] Company Summary - The company, through its wholly-owned subsidiary China National Pharmaceutical Group Weichida Pharmaceutical Co., Ltd. (referred to as Weichida), has received the approval notice for the marketing application of Sitagliptin Phosphate [1] - Sitagliptin Phosphate is classified as a DPP-4 inhibitor, primarily used for improving blood sugar control in patients with type 2 diabetes [1] - The approval indicates that the API meets the regulatory requirements for drug registration in China, allowing it to be marketed domestically [1] Industry Summary - The approval of Sitagliptin Phosphate will contribute to the diversification of the company's specialty API product offerings, particularly in the diabetes treatment sector [1]
国药现代:全资子公司国药威奇达收到磷酸西格列汀化学原料药上市申请批准通知书
Xin Lang Cai Jing· 2025-10-10 09:31
Core Insights - The company Guoyao Modern has received approval for the listing application of the chemical raw material drug, phosphate sitagliptin, from the National Medical Products Administration [1] Company Summary - Guoyao Modern's wholly-owned subsidiary, Guoyao Weiqida, is responsible for the development of phosphate sitagliptin, which is a DPP-4 inhibitor primarily used for improving blood sugar control in patients with type 2 diabetes [1] - The total research and development investment for the phosphate sitagliptin raw material drug has reached approximately 5.29 million yuan [1]