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東陽光藥(01558.HK):瑞舒伐他汀鈣片獲批准上市
格隆匯 12-21 17:53

格隆匯 12 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瑞舒伐他汀鈣片(5mg及10mg)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。

瑞舒伐他汀鈣適用於經飲食控制和其它非藥物治療(如運動治療,減輕體重)仍不能適當控制血脂異常的原發性高膽固醇血癥(IIa型,包括雜合子家族性高膽固醇血癥)或混合型血脂異常症(IIb型)。瑞舒伐他汀鈣是選擇性3-羥基-3-甲基戊二醯輔酶A(HMG-CoA)還原酶抑制劑,通過抑制HMG-CoA還原酶,減少肝細胞合成及儲存膽固醇,從而降低血中總膽固醇(TC)和低密度脂蛋白膽固醇(LDL-C)水平。

公司瑞舒伐他汀鈣片按照中國藥品註冊分類化學藥品4類申報。瑞舒伐他汀是2019年版《國家基本醫療保險、工傷保險和生育保險藥品目錄》乙類品種,同時是2018年版《國家基本藥物目錄》品種。根據艾美仕數據顯示,2019年中國瑞舒伐他汀藥物銷售金額約為5.03億美元。

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系統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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