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上海醫藥(02607.HK)子公司抗癲癇藥獲得美國FDA暫時批准文號
格隆匯 06-18 17:03

格隆匯 6 月 18日丨上海醫藥(02607.HK)公佈,近日,公司下屬控股子公司上海上藥中西製藥有限公司(以下簡稱"上藥中西")收到美國食品藥品監督管理局(以下簡稱"美國FDA")的通知,醋酸艾司利卡西平片(以下簡稱"該藥物")200mg、400mg、600mg及800mg的簡略新藥申請("ANDA",即美國仿製藥申請)已獲得暫時批准("Tentative Approval")。

據悉,該藥物是新一代抗癲癇藥,主要通過阻斷電壓門控鈉離子通道發揮抗癲癇作用,長期給藥耐受性好,安全性高。

上藥中西於2017年向美國FDA提交了ANDA申請,並於近日獲得美國FDA對於該藥物四個規格的ANDA暫時批准。美國FDA已認定該藥物具備與參比製劑的生物等效性與治療等效性,相關申報材料足以支持FDA得出該藥物滿足ANDA審批要求的結論,由於該藥物在美國的專利權和獨佔權的問題尚未最終解決,因此簽發暫時批准。上藥中西可以根據FDA規定適時提交正式批准申請。同時上藥中西在該藥物的專利挑戰案中與原研公司達成了有利的和解協議,原研公司對於該藥物的專利侵權訴訟已撤銷

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