羅欣藥業(002793.SZ):替格瑞洛片獲批上市
格隆匯2月8日丨羅欣藥業(002793.SZ)公佈,公司下屬子公司山東羅欣藥業集團股份有限公司(“山東羅欣”)於近日收到國家藥品監督管理局核准簽發的替格瑞洛片《藥品註冊證書》。
替格瑞洛是一種直接作用、可逆結合的P2Y12血小板抑制劑,用於急性冠狀動脈綜合徵(不穩定性心絞痛、非ST段抬高心肌梗死或ST段抬高心肌梗死,ACS)患者,包括接受藥物治療和PCI治療的患者,降低血栓性心血管事件的發生率,至少在ACS發病後最初12個月內,替格瑞洛的療效優於氯吡格雷。
替格瑞洛片(商品名:Brilinta®)是阿斯利康研製開發的用於治療ACS的新藥,於2011年7月20日在FDA批准上市,2012年11月22日在中國獲批上市。
山東羅欣於2016年5月獲得替格瑞洛片臨牀試驗批件,2018年4月完成生物等效性試驗,於2019年1月向國家藥品監督管理局藥品審評中心按照化學藥品新註冊分類4類進行申報並獲得受理。
根據IQVIA數據,替格瑞洛片2019年度在全球的銷售金額為19.2億美元(以出廠價計算),在我國境內銷售金額為17.4億元人民幣(以招標價計算)。
替格瑞洛片是公司首個直接作用、可逆結合的P2Y12受體拮抗劑,將提高公司在抗凝血藥領域的市場競爭力。替格瑞洛片獲得藥品註冊批件,視同通過一致性評價,進一步豐富了公司的產品線,有利於提升公司的市場競爭力,對公司產生積極影響。
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