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海正藥業(600267.SH):法維拉韋片獲藥品註冊批件和藥物臨牀試驗批件
格隆匯 02-16 21:41

格隆匯2月16日丨海正藥業(600267.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的法維拉韋片(又稱:法匹拉韋片)的《藥品註冊批件》和《藥物臨牀試驗批件》。

法維拉韋片(又稱:法匹拉韋片)於2014年3月獲批在日本上市,為廣譜抗病毒藥物,適應症為用於治療成人新型或再次流行的流感(僅限於其它抗流感病毒藥物治療無效或效果不佳時使用)。富山化學工業株式會社於1999年8月對法匹拉韋進行了最早的化合物專利申請,期限20年。公司與日本富山化學工業株式會社在2016年6月簽定了化合物專利獨家授權協議。經核實,該化合物專利已於2019年8月到期,公司研發生產該藥品符合相關規定。此前公司該藥品未實現商業化生產。

經查詢IMS數據庫,未查詢到該品種在國內外市場的銷量數據。截至目前,公司在法維拉韋研發項目上已投入約4003萬元。

此次公司獲得法維拉韋片的《藥品註冊批件》,僅適用於治療成人新型或再次流行的流感。

此次獲得的《藥物臨牀試驗批件》針對新適應症,目前臨牀試驗尚待開展,後續待完成一系列臨牀試驗步驟後還需提交審評審批,臨牀試驗結果存在不確定性,能否取得新適應症的生產註冊存在不確定性。

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