海思科(002653.SZ)旗下替格瑞洛片獲得《藥品註冊證書》
格隆匯 1 月 31日丨海思科(002653.SZ)公佈,公司全資子公司四川海思科製藥有限公司旗下全資子公司海思科製藥(眉山)有限公司於近日收到國家藥品監督管理局下發的《藥品註冊證書》。
2018年9月,四川海思科製藥有限公司向國家藥品監督管理提交替格瑞洛片報產申請並獲受理。2021年1月,海思科製藥(眉山)有限公司正式獲批生產,獲得本品《藥品註冊證書》。
替格瑞洛是一種新型的環戊基三唑嘧啶類(CPTP)口服抗血小板藥物,它能夠可逆性阻斷血小板P2Y12受體。替格瑞洛是第一個證實可以顯著降低急性冠狀動脈綜合徵患者心血管死亡和總病死率的口服抗血小板藥物,同時顯著降低心血管事件風險,而不增加出血。
經查詢,替格瑞洛片原研製劑由瑞典阿斯利康(AstraZeneca)公司研發,於2010年12月獲得歐盟(EMA)批准在歐洲上市,商品名為BRILIQUE®,規格為90mg,2016年2月獲得EMA批准上市60mg規格;替格瑞洛片原研製劑2011年7月獲美國FDA批准在美國上市,商品名為BRILINTA®,規格為90mg;2015年9月60mg規格獲得批准上市。
2013年3月,替格瑞洛片獲得批准進口(國藥準字H20120486),規格為90mg,商品名為倍林達®。2017年6月60mg規格獲得批准進口(國藥準字H20171037)。我公司該產品按照仿製藥質量與療效一致性評價註冊申報,批准即視同通過一致性評價。該產品目前國內除原研廠家(AstraZeneca AB)上市外,另有深圳信立泰藥業股份有限公司等8家藥企上市。
據米內網數據顯示,替格瑞洛在城市公立及縣級公立醫院2019年銷售額超過15億元,2020年上半年銷售額近9億元。
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