東陽光藥(01558.HK):艾司奧美拉唑鎂腸溶膠囊獲批上市
格隆匯5月26日丨東陽光藥(01558.HK)宣佈,公司從廣東東陽光藥業有限公司收購的產品艾司奧美拉唑鎂腸溶膠囊(20mg及40mg)已獲中國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的控股子公司。
據悉,艾司奧美拉唑為質子泵抑制劑類抑酸藥物,主要用於治療反流性食管炎等胃酸相關性疾病。與其它類別質子泵抑制劑藥物相比,艾司奧美拉唑具有起效更快、抑酸效果更持久等特點。根據艾美仕中國市場數據,2019年艾司奧美拉唑的銷售額約為4.9億美元,過去三年複合增長率達24%,佔質子泵抑制劑總銷售額的19%。
該產品獲批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,且為中國首家且獨家通過上述認證的仿製藥品種,具有可觀的市場潛力。該產品的獲批上市進一步豐富了集團產品線,也將為患者提供更多質價雙優的用藥選擇。同時,集團也將持續推進新產品研發管線的進程,致力於補充尚未滿足的臨牀用藥需求。
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