山东新华制药股份(00719)获得富马酸伏诺拉生化学原料药上市申请批准通知书

智通财经网
Nov 17, 2025

智通财经APP讯,山东新华制药股份(00719)发布公告,近日,山东新华制药股份有限公司(“新华制药”或“本公司”)收到国家药品监督管理局核准签发的富马酸伏诺拉生(“本品”)《化学原料药上市申请批准通知书》。

2024年3月,新华制药向国家药品监督管理局CDE递交富马酸伏诺拉生境内生产化学原料药上市申请注册申报资料并获受理,2025年11月获得《化学原料药上市申请批准通知书》,审评结论为批准生产本品。

本品主要用于反流性食管炎,属于《国家基本医疗保险、工伤保险和生育保险药品目录(2025年)》乙类品种。根据相关统计数据,2024年中国公立医疗机构富马酸伏诺拉生相关制剂销售额约人民币8.25亿元。

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