证券代码：600420 证券简称：国药现代 公告编号：2025-074 上海现代制药股份有限公司 关于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）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》，批准马来酸依那普利片（5mg）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 药品名称：马来酸依那普利片 通知书编号：2025B04287 剂型：片剂 规格：5mg 注册分类：化学药品 原药品批准文号：国药准字 H31021937 上市许可持有人：上海现代制药股份有限公司 药品生产企业：上海现代制药股份有限公司 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）和《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）规定，经审查，本品通 过仿制药质量和疗效一致性评价。 二、药品 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for the supplementary application of Maleate Enalapril Tablets (5mg), which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval and Market Potential - The approval allows for the expansion of the product's market and sales potential, with projected sales in 2024 for the drug estimated at RMB 164 million in public medical institutions and urban pharmacies [1] - The company has invested approximately RMB 15.3657 million in the research and development of this project [1] Group 2: Product Information - Maleate Enalapril Tablets are an angiotensin-converting enzyme inhibitor primarily used for treating primary hypertension, renovascular hypertension, and symptomatic heart failure [1] - The company’s Maleate Enalapril Tablets (10mg) had already passed the consistency evaluation in January 2022, indicating a strong foundation for the new 5mg formulation [1]

Core Viewpoint - The company, China National Pharmaceutical Group Modern (国药现代), has received approval from the National Medical Products Administration for the supplementary application of Enalapril Maleate Tablets (5mg), which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approved drug, Enalapril Maleate Tablets, is an angiotensin-converting enzyme (ACE) inhibitor [1] - The primary indications for Enalapril Maleate Tablets include the treatment of essential hypertension, renovascular hypertension, and symptomatic heart failure [1]

Core Viewpoint - The company, China National Pharmaceutical Group Modern (国药现代), has received approval from the National Medical Products Administration for the supplementary application of Enalapril Maleate Tablets (5mg), which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The approved drug, Enalapril Maleate Tablets, is an angiotensin-converting enzyme (ACE) inhibitor [1] - The primary indications for Enalapril Maleate Tablets include the treatment of essential hypertension, renovascular hypertension, and symptomatic heart failure [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the supplementary application of Enalapril Maleate Tablets (5mg), which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Company Summary - The approved product, Enalapril Maleate Tablets, is an angiotensin-converting enzyme (ACE) inhibitor used primarily for the treatment of essential hypertension, renovascular hypertension, and symptomatic heart failure [1]

Core Viewpoint - The company, China National Pharmaceutical Group Modern (国药现代), has received approval from the National Medical Products Administration for the supplementary application of Enalapril Maleate Tablets (5mg), which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The approved drug, Enalapril Maleate Tablets, is an angiotensin-converting enzyme (ACE) inhibitor [1] - The primary indications for Enalapril Maleate Tablets include the treatment of essential hypertension, renovascular hypertension, and symptomatic heart failure [1]

（文章来源：证券日报） 证券日报网讯 9月16日晚间，国药现代发布公告称，近日，公司全资子公司国药集团工业有限公司收到 国家药品监督管理局核准签发的盐酸戊乙奎醚注射液《药品注册证书》。 ...

证券代码：600420 证券简称：国药现代 公告编号：2025-073 上海现代制药股份有限公司 关于全资子公司获得药品注册证书的公告 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。 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工 业有限公司（以下简称国药工业）收到国家药品监督管理局核准签发的盐酸戊乙 奎醚注射液《药品注册证书》。现将相关情况公告如下： 一、药品基本信息 药品名称：盐酸戊乙奎醚注射液 证书编号：2025S02759 剂型：注射剂 规格：1ml:1mg 注册分类：化学药品 4 类 药品生产企业：国药集团工业有限公司廊坊分公司 企业地址：廊坊经济技术开发区创业路 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，发给药品注册证书。 二、药品研发及市场情况 盐酸戊乙奎醚注射液为选择性抗胆碱药，主要用于麻醉前给药以抑制唾液腺 和气道腺体分泌，以及用于有机磷毒物（农药）中毒急救治疗和中毒后期或胆碱 酯酶（ChE）老化后维持阿托品化。 根据米内网数据库 ...

Core Viewpoint - The company Guoyao Modern has received approval from the National Medical Products Administration for its product, "Pentazocine Hydrochloride Injection," which may enhance its market position and revenue potential in the pharmaceutical sector [1]. Company Summary - Guoyao Modern's subsidiary, Shanghai Modern Pharmaceutical Co., Ltd., has obtained a drug registration certificate for Pentazocine Hydrochloride Injection [1]. - As of the latest report, Guoyao Modern's market capitalization stands at 14.8 billion yuan [1]. Revenue Composition - For the year 2024, Guoyao Modern's revenue composition is as follows: - Formulations account for 49.84% - Intermediates and raw materials account for 47.53% - Other businesses account for 2.44% - Health-related products account for 0.19% [1].

国药现代9月16日公告，公司全资子公司国药集团工业有限公司收到国家药品监督管理局核准签发的盐 酸戊乙奎醚注射液《药品注册证书》。盐酸戊乙奎醚注射液为选择性抗胆碱药，主要用于麻醉前给药以 抑制唾液腺和气道腺体分泌，以及用于有机磷毒物（农药）中毒急救治疗和中毒后期或胆碱酯酶 （ChE）老化后维持阿托品化。本次国药工业的盐酸戊乙奎醚注射液（1ml:1mg）获得药品注册证书并 视同通过一致性评价，将进一步丰富公司产品群，有利于进一步增强公司的综合市场竞争力，为公司未 来发展带来积极影响。上述事项对公司目前经营业绩不会产生重大影响。因药品销售易受到行业政策、 招标采购、市场环境等因素影响，存在不确定性。 ...