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百奧泰(688177.SH):巴替非班注射液(BAT2094)上市許可申請獲受理
格隆匯 10-14 17:46

格隆匯10月14日丨百奧泰(688177.SH)宣佈,公司於近日收到國家藥監局核准簽發的關於公司在研藥品巴替非班注射液(BAT2094)上市許可申請的《受理通知書》。

巴替非班注射液(BAT2094)是人工合成的血小板糖蛋白IIb/IIIa(即“GPIIb/IIIa”)受體拮抗劑,可特異性地結合GPIIb/IIIa受體,能通過阻止纖維蛋白原、VonWillebrand因子和其它粘附配體與GPIIb/IIIa的結合來抑制血小板聚集。巴替非班不僅對靶點的親和力強(即能抑制血小板聚集),還能通過抑制玻璃基蛋白(Vitronectin)受體而抑制血管平滑肌生長,從而阻止動脈血管再阻塞。

巴替非班注射液(BAT2094)為百奧泰自主開發的擁有自主知識產權的1.1類化學藥品,截至該公告發布日,國內已有替羅非班等IIb/IIIa受體拮抗劑上市,另有2家公司正在開展臨牀I研究,未來競品的上市或將對巴替非班注射液(BAT2094)商業化後的定價以及市場份額產生不利影響。

巴替非班注射液(BAT2094)經審評審批通過後可獲發藥品批准證書並可投入生產、銷售,因為審評審批的辦結時間無法預估,所以此次獲得藥品註冊受理通知書對公司近期業績不會產生影響。

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