中國生物製藥(01177.HK)抗血栓藥“替格瑞洛片”獲美國 FDA ANDA 批准
格隆匯10月14日丨中國生物製藥(01177.HK)發佈公告,由公司附屬公司北京泰德製藥股份有限公司開發的抗血栓藥“替格瑞洛片”已獲美國食品藥品監督管理局(“FDA”)的新藥簡略申請(“ANDA”,即美國仿製藥申請)暫定批准。這再次表明集團的藥品生產和管理能力達到國際水平,對未來拓展海外市場帶來積極的影響。
根據披露,替格瑞洛是一種新型抗血栓藥,通過可逆性結合到血小板 P2Y12 ADP(二磷酸腺苷)受體,阻斷血小板活化,用於急性冠脈綜合症患者,減少血栓性心血管事件的發生。替格瑞洛無需經過肝臟代謝活化,具有快速、強效的特點;憑藉其臨牀優勢,已被多個國際治療指南推薦。
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