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廣生堂(300436.SZ):他達拉非片生產註冊申請獲受理
格隆匯 08-07 16:56

格隆匯 8 月 7日丨廣生堂(300436.SZ)公佈,公司已完成他達拉非片與原研藥品的體外質量與體內療效的一致性評價,即與原研藥體外藥學質量一致且人體上生物等效。公司已向國家藥品監督管理局藥品審評中心遞交了生產註冊申請,並於2020年8月5日獲得受理。

他達拉非片用於治療勃起功能障礙(“ED”)和ED合併良性前列腺增生(BPH)的症狀和體徵(“ED合併BPH”),零售藥店為其主要銷售渠道,有望進一步豐富公司產品線,為公司提供新的利潤增長點,助力公司向創新藥企業轉型。

此次他達拉非片生產註冊申請獲得受理,標誌着公司該藥品研發註冊工作進入了生產審評審批階段,有望進一步豐富公司產品線。若該產品未來能順利獲批上市,將為患者提供更多的用藥選擇,為公司提供新的利潤增長點。

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