美諾華(603538.SH)：合資公司的瑞舒伐他汀鈣片、阿託伐他汀鈣片獲藥品註冊批件
格隆匯8月9日丨美諾華(603538.SH)公佈，公司合資公司寧波科爾康美諾華藥業有限公司(“科爾康美諾華”)於近日收到國家藥品監督管理局核准簽發的瑞舒伐他汀鈣片、阿託伐他汀鈣片《藥品註冊證書》。
瑞舒伐他汀鈣片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或混合型血脂異常症。阿託伐他汀鈣片用於治療高膽固醇血癥和混合型高脂血症；冠心病和腦中風的防治。
根據IQVIA數據顯示，阿託伐他汀鈣片2020年全球銷售額約46億美元，中國銷售額約35.40億元人民幣。該藥品已被列入《國家基本醫療保險、工傷保險和生育保險藥品目錄(2020年版)》和《國家基本藥物目錄(2018年版)》。
截至公吿日，國內阿託伐他汀鈣片已批准上市的生產廠商主要有輝瑞製藥公司、北京漢典制藥有限公司、北京嘉林藥業股份有限公司等。
根據IQVIA數據顯示，瑞舒伐他汀鈣片2020年全球銷售額約31億美元，中國銷售額約16.19億元人民幣。該藥品已被列入《國家基本醫療保險、工傷保險和生育保險藥品目錄(2020年版)》和《國家基本藥物目錄(2018年版)》。
截至公吿日，國內瑞舒伐他汀鈣片已批准上市的生產廠商主要有阿斯利康製藥公司、浙江京新藥業股份有限公司、南京正大天晴製藥有限公司等。
此次兩款藥品的獲批主體科爾康美諾華是公司與戰略客户KRKA本着資源共享、優勢互補、互利互惠、長遠戰略合作的原則，為深入開展製劑領域合作而在國內共同設立的合資公司，公司持股佔比40%。以合資公司為主體並作為藥品上市許可持有人(MAH)，以公司全資子公司美諾華天康為生產廠商，雙方協力將KRKA在歐洲已上市產品進行國內轉報，推動其製劑產品在國內市場的開拓。
上述合作在實現公司原料藥和製劑CMO業務持續穩定增長的同時，將拓寬豐富公司的製劑管線，加速提升自身生產、銷售與研發能力，進一步推進公司製劑一體化轉型。
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