萊美藥業(300006.SZ):仿製藥瑪巴洛沙韋片獲得倫理批件
格隆匯6月26日丨萊美藥業(300006.SZ)公佈,近日,重慶萊美藥業股份有限公司委託外部機構研發的仿製藥瑪巴洛沙韋片(規格:20mg)通過了岳陽市人民醫院藥物/醫療器械臨牀試驗倫理審查委員會的審批,獲得倫理批件,正式進入BE(生物等效性)試驗階段。
瑪巴洛沙韋用於治療流感,是一種帽狀結構依賴性內切酶抑制劑,抑制mRNA合成的啟動。瑪巴洛沙韋具有以下獨特的優勢:①獨特的作用機制:可阻斷病毒基因的轉錄起始階段,在流感早期即可發揮作用;①瑪巴洛沙韋治療流感只需服一次藥,就能在24小時內有效抑制流感病毒,縮短傳染期並大幅減少流感症狀的持續時間,且瑪巴洛沙韋療程短,大大提高了患者依從性;①對奧司他韋耐藥的患者,瑪巴洛沙韋仍然有效。
截至目前,國內僅有 2家企業取得瑪巴洛沙韋片藥品註冊證書。根據藥融雲數據顯示:瑪巴洛沙韋片2022-2024年上半年在中國醫院(全終端)市場銷售額分別為0.49億元、4.29億元、3.23億元。
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