東陽光藥(01558.HK):利伐沙班片獲批准上市
格隆匯5月25日丨東陽光藥(01558.HK)公佈,公司自廣東東陽光藥業有限公司收購的產品利伐沙班片(10mg、15mg及20mg)已獲中國國家藥品監督管理局審批完畢並獲准上市。該產品的上市許可持有人為公司全資子公司東莞市陽之康醫藥有限責任公司。
利伐沙班屬於抗凝血藥物,用於擇期髖關節或膝關節置換手術成年患者,以預防靜脈血栓形成(VTE);用於治療成人靜脈血栓形成(DVT),降低急性DVT後DVT復發和肺栓塞(PE)的風險;及用於具有一種或多種危險因素(例如:充血性心力衰竭、高血壓、年齡≥75歲、糖尿病、卒中或短暫性腦缺血發作病史)的非瓣膜性房顫成年患者,以降低卒中和全身性栓塞的風險。利伐沙班通過抑制因子Xa可以中斷凝血瀑布的內源性和外源性途徑,抑制凝血酶的產生和血栓形成。
利伐沙班是《國家基本醫療保險、工傷保險和生育保險藥品目錄》2020年版中乙類品種,同時是《國家基本藥物目錄》2018年版中品種。根據艾昆緯數據,2020年中國利伐沙班藥物的銷售額約為3.47億美元,較2019年增長約49.04%。
該產品為中國境內獲批准上市的仿製藥,獲批准上市後即為視同通過仿製藥質量和療效一致性評價的產品;該產品具有良好的臨牀應用價值和市場前景,上市後將成為公司在心血管疾病治療領域的產品之一,在進一步豐富集團的產品組合的同時,也為廣大患者提供質價雙優的用藥選擇。
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