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白云山(00874.HK)枸橼酸西地那非片通过仿制药一致性评价
格隆汇 01-20 17:13

格隆汇1月20日丨白云山(00874.HK)发布公告,今日,公司分公司广州白云山医药集团股份有限公司白云山制药总厂通过国家药品监督管理局药品评审中心(“CDE”)网站获悉,枸橼酸西地那非片已通过仿制药质量和疗效一致性评价。

枸橼酸西地那非片于2014年10月在国内正式上市,并于2018年8月30日向国家药品监督管理局递交一致性评价申请,于2018年9月6日获得受理。枸橼酸西地那非片适应症为勃起功能障碍,是一种5型磷酸二酯酶(PDE5)选择性抑制剂。

白云山制药总厂成为该品种国内首家通过一致性评价的企业。目前中国境内上市的枸橼酸西地那非片的生产厂家还包括辉瑞制药有限公司、江苏亚邦爱普森药业有限公司、成都地奥制药集团有限公司、常山生化药业(江苏)有限公司、吉林金恒制药股份有限公司等。根据米内网数据显示,2018年枸橼酸西地那非片在中国公立医院和城市零售药店的销售额分别为人民币11,445万元和人民币220,690万元。

截至公告日,白云山制药总厂针对该药品一致性评价已投入研发费用约人民币2,006.17万元(未经审计)。2018年度白云山制药总厂该药品的销售收入为人民币66,205.78万元,约占白云山制药总厂2018年度的营业收入的19.97%,约占公司2018年度的营业收入的1.57%。

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