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以嶺藥業(002603.SZ):伐昔洛韋片獲得美國FDA批准文號
格隆匯 03-19 19:08

格隆匯3月19日丨以嶺藥業(002603.SZ)公佈,近日,公司收到美國食品藥品監督管理局(“美國FDA”)的通知,公司全資子公司以嶺萬洲國際製藥有限公司(“以嶺萬洲”)向美國FDA申報的伐昔洛韋片的新藥簡略申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。

伐昔洛韋主要用於治療帶狀皰疹、單純皰疹病毒感染、預防(抑制)單純皰疹病毒感染的復發。伐昔洛韋片由葛蘭素史克公司研發,於1995年在美國上市。當前,美國境內伐昔洛韋片的主要生產廠商有Sandoz,Mylan、Teva等。伐昔洛韋片美國市場2018年度銷售額約為1.86億美元(數據均來源於IMS數據庫)。

截至目前,公司在伐昔洛韋片研發項目上已投入研發費用約2025萬元人民幣。

此次伐昔洛韋片獲得美國FDA批准文號,標誌着以嶺萬洲具備了在美國市場銷售該產品的資格,公司預計該產品在美國市場上市後將給公司帶來新的利潤增長點,公司將積極推動該產品在美國市場的上市準備。

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