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海思科(002653.SZ):用於治療勃起功能障礙(ED)的阿伐那非片獲批上市
格隆匯 03-28 20:14

格隆匯 3 月 28日丨海思科(002653.SZ)公佈,公司資子公司四川海思科製藥有限公司旗下全資子公司海思科製藥(眉山)有限公司於近日收到國家藥品監督管理局下發的《藥品註冊證書》,藥品名稱為阿伐那非片。

阿伐那非片為海思科開發的仿製藥產品,是一種口服速效的高選擇性磷酸二酯酶-5(PDE-5)抑制劑,用於治療勃起功能障礙(ED),規格為100mg/片和200mg/片。該品種於201608月獲得國家食品藥品監督管理總局頒發的《藥物臨牀試驗批件》,在完成BE研究和III期臨牀研究後,海思科於201907月遞交了上市申請。20213海思科製藥(眉山)有限公司正式獲批生產,獲得本品《藥品注冊證書》。

根據《美國泌尿外科學會(AUA)發佈的勃起功能障礙管理指南(2018)》,推薦用於ED的口服PDE5抑制劑主要包括西地那非、他達拉非、伐地那非、阿伐那非。與其他PDE-5抑制劑相比,阿伐那非可以在最短時間內起效(15分鐘),明顯快於現有PDE-5抑制劑類藥物——他達拉非(30分鐘)、西地那非(1小時)、伐地那非(1小時)。且阿伐那非對PDE-1PDE-6有更高的選擇性,不良反應較其他幾類PDE-5抑制劑更小,安全性更高。

經查詢,阿伐那非片最初是由日本田邊三菱製藥株式會社授權美VIVUS公司開發的用於治療男性勃起功能障礙的藥物,於20124月經美國FDA批准在美國上市,商品名為Stendra20136月被批准在歐盟上市,商品名為Spedra。目前已在美國、德國、法國、意大利等多國上市,在國內尚無生產和進口,海思科開發的阿伐那非片為國內首家仿製。

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