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上海醫藥(601607.SH):瑞舒伐他汀鈣片獲藥品註冊證書
格隆匯 09-22 17:16

格隆匯9月22日丨上海醫藥(601607.SH)公佈,近日,公司控股子公司常州製藥廠有限公司(以下簡稱“常州製藥”)收到國家藥監局頒發的關於瑞舒伐他汀鈣片的《藥品註冊證書》。

瑞舒伐他汀鈣片主要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)。該藥品也適用於純合子家族性高膽固醇血癥的患者,作為飲食控制和其它降脂措施(如LDL去除療法)的輔助治療,或在這些方法不適用時使用。

瑞舒伐他汀鈣片由Astra Zeneca研發,最早於2002年在荷蘭上市。2019年7月,常州製藥向國家藥監局提出註冊申請並獲受理。2019年,常州製藥該藥品海外銷售收入為人民幣3533萬元。

截至目前,中國境內該藥品的主要生產廠家為阿斯利康藥業(中國)有限公司、魯南貝特製藥有限公司、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。經查詢IQVIA數據庫,2019年該藥品醫院採購金額為人民幣39.43億元。

截至目前,該藥品已投入研發費用約人民幣1042萬元。

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