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中國生物製藥(01177.HK):抗血栓藥“替格瑞洛片”獲藥品註冊批件
格隆匯 12-20 18:14

格隆匯12月20日丨中國生物製藥(01177.HK)發佈公告,由公司附屬公司正大天晴藥業集團股份有限公司開發的抗血栓藥“替格瑞洛片”,已獲國家藥品監督管理局頒發藥品註冊批件。該產品適用於治療急性冠脈綜合症(ACS)患者或有心肌梗死病史且伴有至少一種動脈粥樣硬化血栓形成事件高危因素的患者,降低心血管死亡、心肌梗死和卒中的發生率。該產品是按照化藥新4類申報,視同通過仿製藥質量和療效一致性評價。

披露顯示,替格瑞洛是一種新型抗血栓藥,通過可逆性結合到血小板P2Y12ADP(二磷酸腺苷)受體,阻斷血小板活化,臨牀上主要用於ACS及心腦血管血栓事件的預防和治療。替格瑞洛無需經過肝臟代謝活化,具有快速、強效的特點,受到多個國內外治療指南的推薦,極具市場潛力。替格瑞洛作為重磅抗凝血藥物,國內仿製者眾多;隨着公司兩家附屬公司南京正大天晴製藥有限公司和正大天晴藥業集團股份有限公司開發的替格瑞洛片於本年內相繼獲批上市,集團有望攻佔其中的市場份額。

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