九典制藥(300705.SZ):瑞舒伐他汀鈣片獲批上市
格隆匯7月23日丨九典制藥(300705.SZ)公佈,公司於近日收到國家藥監局下發的關於瑞舒伐他汀鈣片(10mg)的《藥品註冊證書》。經審查,瑞舒伐他汀鈣片符合仿製藥審批的有關規定,批准生產瑞舒伐他汀鈣片,同時發給藥品批准文號。
瑞舒伐他汀是羥甲基戊二酰輔酶A還原酶抑制劑(HMG-CoA),不僅具有較好的降低血脂、抑制血栓的形成、減少心腦血管疾病危險因素等作用,還有較好的抗炎、抗氧化和改善血管內皮功能的作用。主要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)。在降脂治療的同時,可延緩成人患者的動脈粥樣硬化進展。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。
瑞舒伐他汀鈣是20世紀80年代末由日本鹽野義公司研發,代號為S-4522。1998年4月日本鹽野義公司將除在日本之外的專利轉讓給英國的阿斯利康公司。2002年11月首次在荷蘭上市瑞舒伐他汀鈣片,2003年8月獲得美國FDA批准上市,2005年1月日本上市。2007年在中國上市,商品名為Crestor,規格:5mg、10mg及20mg,目前己經在德國、意大利、澳大利亞、丹麥、葡萄牙等六十幾個國家上市。
截至該公吿日,瑞舒伐他汀鈣片(10mg)國內共有24家(含公司和原研)企業取得了藥品註冊證書,公司該品種按照新註冊分類4申報,為國內第22家通過或視同通過仿製藥質量和療效一致性評價的企業。該藥品註冊證書的取得進一步豐富了公司製劑產品品種,對進一步優化公司產品結構有着積極意義。
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