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永太科技(002326.SZ):瑞舒伐他汀鈣片的ANDA獲得美國FDA批准
格隆匯 11-05 17:11

格隆匯11月5日丨永太科技(002326.SZ)公佈,近日,公司全資子公司浙江永太藥業有限公司(“永太藥業”)收到美國食品藥品監督管理局(“FDA”)的通知,永太藥業向美國FDA申報的瑞舒伐他汀鈣片簡略新藥申請(ANDA,即美國仿製藥申請)獲得批准。這是公司ANDA申請首次獲得美國FDA批准。

藥品名稱:瑞舒伐他汀鈣片;劑型:片劑;規格:5mg,10mg,20mg,40mg;註冊分類:仿製藥;申請事項:ANDA。

瑞舒伐他汀鈣片原研藥由英國阿斯利康開發,於2003年在美國上市,是一種治療高血脂藥物,適用於治療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)。

經查詢IMS數據庫,瑞舒伐他汀鈣片2017年7月至2018年6月全球銷售額約為39.78億美元,其中美國市場銷售額約為4.12億美元;2018年7月至2019年6月全球銷售額約為34.61億美元,其中美國市場銷售額約為2.95億美元。

此次瑞舒伐他汀鈣片的ANDA獲得美國FDA的批准標誌着公司具備了在美國市場銷售該產品的資格,也標誌着公司在挑戰專利產品領域業務的穩步推進,這將對公司拓展美國市場、提升公司業績帶來積極的影響,同時也為公司後續產品開展仿製藥申請工作積累了寶貴的經驗。

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