科倫藥業(002422.SZ):鹽酸替羅非班氯化鈉注射液通過仿製藥一致性評價
格隆匯 3 月 3日丨科倫藥業(002422.SZ)公佈,公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“鹽酸替羅非班氯化鈉注射液”的《藥品補充申請批准通知書》。
近日我公司的抗血小板藥物鹽酸替羅非班氯化鈉注射液通過一致性評價並獲得藥品補充申請批准通知書,主要用於末次胸痛發作12小時之內且伴有心電圖改變和/或心肌酶升高的非ST段抬高型急性冠脈綜合徵成年患者,預防早期心肌梗死;及計劃進行直接PCI(經皮冠狀動脈介入治療)的急性心肌梗死患者,以減少重大心血管事件的發生。
替羅非班為血小板糖蛋白IIb/IIIa受體拮抗劑,臨牀使用具有起效迅速、療效確切、停藥後快速恢復血小板功能的優勢,目前已被歐洲《心肌血運重建指南(2018)》、中國《急性ST段抬高型心肌梗死診斷和治療指南(2019)》、中國《急性ST段抬高型心肌梗死溶栓治療的合理用藥指南(2019)》等國內外權威指南推薦使用。鹽酸替羅非班氯化鈉注射液為2020年國家醫保乙類品種,2019年中國銷售額約為1.9億元。
目前公司在心血管領域已有3個產品獲批,且後續還有多個品種申報與在研,將逐漸在該領域形成優勢產品集羣。此外,本次我公司鹽酸替羅非班氯化鈉注射液國內第2家通過一致性評價,將進一步提升該產品的市場競爭力。
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