上海医药(601607.SH):二羟丙茶碱注射液通过仿制药一致性评价

智通财经
Sep 04

智通财经APP讯,上海医药(601607.SH)发布公告,近日,公司下属上海信谊金朱药业有限公司(简称“信谊金朱”)的二羟丙茶碱注射液收到国家药品监督管理局(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:2025B04012),该药品通过仿制药质量和疗效一致性评价。

二羟丙茶碱注射液适用于支气管哮喘、喘息型支气管炎、阻塞性肺气肿等缓解喘息症状。也可用于因心源性肺水肿而致的喘息。二羟丙茶碱注射液由卫材株式会社开发,于1952年10月在日本上市。2024年8月,信谊金朱就该药品新增规格合并仿制药一致性评价向国家药监局提出补充申请并获受理。截至本公告日,公司针对该药品已投入的研发费用约人民币305万元。

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