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啟明醫療(2500.HK)高開3.86% 核心產品VenusP-Valve獲英國特殊使用許可
格隆匯 03-22 09:24
格隆匯3月22日丨啟明醫療(2500.HK)高開3.86%報64.5港元,盤前成交6.5萬港元,最新市值284億港元。公司宣佈其核心產品——經導管人工肺動脈瓣膜系統VenusP-Valve,已獲得英國藥品監管局(MHRA)特殊使用(special use)許可,可在指定醫療機構進行使用。VenusP-Valve已於2019年在歐洲申報了CE認證,目前處於審評階段。此次特殊使用許可意味着,VenusP-Valve在尚未獲得CE認證的情況下,可以提前進入英國市場。注:VenusP-Valve是全球首個由中國公司開發,並獲准在中國及歐洲進入臨牀試驗的自膨脹式經導管肺動脈置換術(TPVR)產品,也是全球首個用於治療接受跨瓣環修補(TAP)後出現右心室流出道障礙(RVOTD)患者的產品。

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