東陽光藥(01558.HK)治療高尿酸血症仿製藥獲內地批准上市
東陽光藥(01558.HK)公布,公司自廣東東陽光藥業收購之產品非布司他片(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之全資子公司東莞市陽之康醫藥。
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。
集團指,非布司他適用於具有痛風症狀的高尿酸血症的長期治療,不推薦用於無臨床症狀的高尿酸血症。非布司他屬於黃嘌呤氧化(酉每)(XO)抑制劑,通過抑制尿酸合成降低血清尿酸濃度,從而達到臨床治療效果。(ek/u)
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