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華潤雙鶴(600062.SH):馬來酸依那普利片通過仿製藥質量和療效一致性評價
格隆匯 12-15 16:35

格隆匯12月15日丨華潤雙鶴(600062.SH)公佈,近日,公司全資子公司華潤雙鶴利民藥業(濟南)有限公司(“雙鶴利民)收到了國家藥品監督管理局頒發的馬來酸依那普利片《藥品補充申請批准通知書》(通知書編號: 2021B04415),該藥品通過仿製藥質量和療效一致性評價。

該藥品用於治療各期原發性高血壓、腎血管性高血壓、各級心力衰竭、預防症狀性心衰、預防左心室功能不全病人冠狀動脈缺血事件。

雙鶴利民自2019年啟動該藥品的一致性評價工作,於2020年10月9日向國家藥品監督管理局提交一致性評價申請,於2020年10月15日獲得受理通知書,並於2021年11月29日獲得國家藥品監督管理局批准通過一致性評價。

截至公吿日,雙鶴利民就該藥品開展一致性評價累計研發投入為人民幣653.5萬元(未經審計)。

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