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華潤雙鶴(600062.SH):華潤賽科“纈沙坦氫氯噻嗪片”通過仿製藥質量和療效一致性評價
格隆匯 09-14 16:42

格隆匯 9 月 14日丨華潤雙鶴(600062.SH)公告,近日,公司全資子公司華潤賽科藥業有限責任公司(以下簡稱“華潤賽科”)收到了國家藥品監督管理局(以下簡稱“國家藥監局”)頒發的纈沙坦氫氯噻嗪片(纈沙坦80mg/氫氯噻嗪12.5mg)(以下簡稱“該藥品”)《藥品補充申請批准通知書》(通知書編號:2020B04553),批准該藥品通過仿製藥質量和療效一致性評價。

適應症:治療單一藥物不能充分控制血壓的輕-中度原發性高血壓。

華潤賽科自2017年11月啟動該藥品的一致性評價工作,於2019年11月5日向國家藥監局提交一致性評價申請,於2019年11月20日獲得受理通知書,並於2020年9月3日通過國家藥監局審批,是第2家通過該藥品一致性評價的公司。

截止公告日,華潤賽科就該藥品開展一致性評價累計研發投入為人民幣1725.33萬元(未經審計)。

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,本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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