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中国生物制药(01177.HK):抗血栓药“替格瑞洛片”获药品注册批件
格隆汇 12-20 18:14

格隆汇12月20日丨中国生物制药(01177.HK)发布公告,由公司附属公司正大天晴药业集团股份有限公司开发的抗血栓药“替格瑞洛片”,已获国家药品监督管理局颁发药品注册批件。该产品适用于治疗急性冠脉综合症(ACS)患者或有心肌梗死病史且伴有至少一种动脉粥样硬化血栓形成事件高危因素的患者,降低心血管死亡、心肌梗死和卒中的发生率。该产品是按照化药新4类申报,视同通过仿制药质量和疗效一致性评价。

披露显示,替格瑞洛是一种新型抗血栓药,通过可逆性结合到血小板P2Y12ADP(二磷酸腺苷)受体,阻断血小板活化,临床上主要用于ACS及心脑血管血栓事件的预防和治疗。替格瑞洛无需经过肝脏代谢活化,具有快速、强效的特点,受到多个国内外治疗指南的推荐,极具市场潜力。替格瑞洛作为重磅抗凝血药物,国内仿制者众多;随着公司两家附属公司南京正大天晴制药有限公司和正大天晴药业集团股份有限公司开发的替格瑞洛片于本年内相继获批上市,集团有望攻占其中的市场份额。

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