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東陽光藥(01558.HK)抗病毒藥物恩替卡韋片獲批准上市
格隆匯 05-21 18:46

格隆匯5月21日丨東陽光藥(01558.HK)發佈公告,公司從廣東東陽光藥業有限公司收購的產品恩替卡韋片(0.5mg及1mg)已獲國家藥品監督管理局審批完畢並獲准上市。後續通過補充申請,該產品的上市許可持有人將變更為公司或公司控股子公司。

恩替卡韋為鳥嘌呤核苷類似物,對乙肝病毒逆轉錄酶具有抑制作用,且具有良好安全性和耐受性的優勢,獲全世界多個權威乙肝診療指南推薦為一線抗病毒藥物。

根據艾美仕中國市場資料,2019年恩替卡韋片總銷售額為人民幣39.6億元。恩替卡韋片在國內現有9個品種產品通過仿製藥質量和療效一致性評價,另有20個醫藥廠商已提交上市申請。該產品獲批上市後即為視同通過一致性評價的產品。該產品的獲批上市進一步豐富了集團抗病毒領域產品線,同時,集團也將持續推進抗病毒產品管線的研發進程,致力於補充尚未滿足的臨牀用藥需求。

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