景峯醫藥(000908.SZ):鹽酸替羅非班注射用濃溶液通過一致性評價
格隆匯11月22日丨景峯醫藥(000908.SZ)公佈,近日,公司之子公司貴州景峯注射劑有限公司獲得國家藥品監督管理局核准簽發的化學藥品“鹽酸替羅非班注射用濃溶液”的《藥品補充申請批准通知書》。經審查,本品通過仿製藥質量和療效一致性評價。
鹽酸替羅非班注射用濃溶液為抗血小板聚集藥,臨牀用於末次胸痛發作12小時之內且伴有ECG改變和/或心肌酶升高的非ST段抬高急性冠脈綜合徵(NSTE-ACS)成年患者,預防早期心肌梗死。最可能受益的患者是在急性心絞痛症狀發作後頭3-4天內具有較高心肌梗死風險的患者,包括可能進行早期經皮冠狀動脈介入術(PCI)的患者。用於計劃進行直接PCI的急性心肌梗死患者(STEMI)以減少重大心血管事件的發生。本品應與普通肝素和阿司匹林一起使用。
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。鹽酸替羅非班注射用濃溶液為2021年國家醫保乙類品種,2021年中國銷售額約為1.7億元。
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