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華潤雙鶴(600062.SH):纈沙坦膠囊(80mg)通過仿製藥質量和療效一致性評價
格隆匯 04-16 17:15

格隆匯4月16日丨華潤雙鶴(600062.SH)公佈,近日,華潤雙鶴藥業股份有限公司全資子公司華潤賽科藥業有限責任公司(“華潤賽科”)收到了國家藥品監督管理局(“國家藥監局”)頒發的纈沙坦膠囊(80mg)《藥品補充申請批件》(批件號:2020B02753),批准該藥品通過仿製藥質量和療效一致性評價(“一致性評價”)。

該藥品主要用於治療輕、中度原發性高血壓。

華潤賽科自2016年5月啟動該藥品的一致性評價工作,於2019年4月28日向國家藥監局提交一致性評價申請,於2019年5月7日獲得受理通知書,並於2020年4月1日通過國家藥監局審批。

根據國家相關政策,對於通過一致性評價的藥品品種,在醫保支付方面予以適當支持,醫療機構應優先採購併在臨牀中優先選用,同品種藥品通過一致性評價的生產企業達到3家以上的,在藥品集中採購等方面不再選用未通過一致性評價的品種。因此,此次通過一致性評價將有利於該藥品未來的市場銷售和市場競爭,併為後續其他產品開展仿製藥一致性評價積累了寶貴的經驗,將會對公司的經營業績產生積極影響。

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