证券代码：601607 证券简称：上海医药 编号：临2025-080 上海医药集团股份有限公司 关于盐酸维拉帕米注射液通过仿制药一致性评价的公告 注册分类：化学药品 申请人：上海禾丰制药有限公司 药品批准文号：国药准字H31021343 审批结论：本品通过仿制药质量和疗效一致性评价。 二、该药品相关的信息 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"）下属上海禾丰制药有限公司（以下简称"上药禾 丰"）的盐酸维拉帕米注射液（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《药品补充申请批准通知书》（通知书编号：2025B03892），该药品通过仿制药质量和疗 效一致性评价。 一、该药品基本情况 药品名称：盐酸维拉帕米注射液 剂型：注射剂 规格：2ml:5mg 根据国家相关政策，通过一致性评价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。 因此上药禾丰的盐酸维拉帕米注射液通过仿制药一致性评价，有利于扩大该药品的市场份额，提升市场 竞争 ...

Group 1 - Shanghai Pharmaceutical Group Co., Ltd. announced that its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the consistency evaluation of the quality and efficacy of Verapamil Hydrochloride Injection [1][2] - The drug is primarily used for the rapid conversion of paroxysmal supraventricular tachycardia and for temporary control of ventricular rate in atrial flutter or atrial fibrillation [1][2] - The company has invested approximately RMB 3.29 million in research and development for this drug's consistency evaluation [1] Group 2 - As of the announcement date, there is one other company, Sichuan Meida Kangjiale Pharmaceutical Co., Ltd., that has also been deemed to have passed the consistency evaluation for this drug in China [2] - The IQVIA database indicates that the total procurement amount for Verapamil Hydrochloride Injection in hospitals in mainland China for 2024 is RMB 148.51 million [2] - The approval for consistency evaluation is expected to enhance the market share and competitiveness of Shanghai Hefeng's Verapamil Hydrochloride Injection, while also providing valuable experience for future product evaluations [2]

证券日报网讯 9月1日晚间，上海医药发布公告称，近日，公司下属上海禾丰制药有限公司的盐酸维拉 帕米注射液（简称"该药品"）收到国家药品监督管理局颁发的《药品补充申请批准通知书》，该药品通 过仿制药质量和疗效一致性评价。 （编辑 任世碧） ...

Group 1 - The core point of the article is that Shanghai Pharmaceuticals announced the approval of its Verapamil Hydrochloride Injection by the National Medical Products Administration, indicating that the drug has passed the consistency evaluation of quality and efficacy for generic drugs [3]. - The Verapamil Hydrochloride Injection is primarily used for the rapid conversion of paroxysmal supraventricular tachycardia and for the temporary control of ventricular rate in atrial flutter or atrial fibrillation [1].

盐酸维拉帕米注射液主要用于：1．快速阵发性室上性心动过速的转复。应用维拉帕米之前应首选抑制 迷走神经的手法治疗(如 Valsalva 法)。2．心房扑动或心房颤动心室率的暂时控制。心房扑动或心房颤 动合并房室旁路通道(预激综合症和 LGL 综合症)时除外。 格隆汇9月1日丨上海医药(02607.HK)发布公告，近日，公司下属上海禾丰制药有限公司(以下简称"上药 禾丰")的盐酸维拉帕米注射液收到国家药品监督管理局颁发的《药品补充申请批准通知书》(通知书编 号：2025B03892)，该药品通过仿制药质量和疗效一致性评价。 ...

Core Viewpoint - Shanghai Pharmaceuticals (02607) announced that its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd. (referred to as "Hefeng"), has received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration for its Verapamil Hydrochloride Injection, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The Verapamil Hydrochloride Injection is primarily used for the rapid conversion of paroxysmal supraventricular tachycardia and for temporary control of ventricular rate in atrial flutter or atrial fibrillation [1] - The company submitted a supplementary application for the consistency evaluation of this drug to the National Medical Products Administration in April 2024, which has been accepted [1] - As of the date of the announcement, the company has invested approximately RMB 3.29 million in research and development costs for the consistency evaluation of this drug [1]

格隆汇9月1日丨上海医药(601607.SH)公布，下属上海禾丰制药有限公司（简称"上药禾丰"）的盐酸维 拉帕米注射液收到国家药品监督管理局颁发的《药品补充申请批准通知书》，该药品通过仿制药质量和 疗效一致性评价。盐酸维拉帕米注射液主要用于：1．快速阵发性室上性心动过速的转复。应用维拉帕 米之前应首选抑制迷走神经的手法治疗（如Valsalva法）。2．心房扑动或心房颤动心室率的暂时控制。 心房扑动或心房颤动合并房室旁路通道（预激综合症和LGL综合症）时除外。 ...

人民财讯9月1日电，上海医药（601607）9月1日晚间公告，近日，公司下属上海禾丰制药有限公司的盐 酸维拉帕米注射液收到国家药监局颁发的《药品补充申请批准通知书》，该药品通过仿制药质量和疗效 一致性评价。 该药品主要用于：1．快速阵发性室上性心动过速的转复。应用维拉帕米之前应首选抑制迷走神经的手 法治疗。2．心房扑动或心房颤动心室率的暂时控制。心房扑动或心房颤动合并房室旁路通道（预激综 合症和LGL综合症）时除外。 ...