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東陽光藥(01558.HK):非布司他片獲批准上市
格隆匯 05-14 17:13

格隆匯5月14日丨東陽光藥(01558.HK)發佈公吿,公司自廣東東陽光藥業有限公司收購的產品非布司他片(40mg及80mg)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的全資子公司東莞市陽之康醫藥有限責任公司。

非布司他適用於具有痛風症狀的高尿酸血癥的長期治療,不推薦用於無臨牀症狀的高尿酸血癥。非布司他屬於黃嘌呤氧化酶(XO)抑制劑,通過抑制尿酸合成降低血清尿酸濃度,從而達到臨牀治療效果。非布司他是《國家基本醫療保險、工傷保險和生育保險藥品目錄》2020年版乙類品種,根據艾昆緯數據,2020年中國非布司他藥物銷售金額約為1.98億美元,較2019年增加6.19%。

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內分泌及代謝領域的產品之一,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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