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东阳光药(01558.HK):利伐沙班片获批准上市
格隆汇 05-25 18:13

格隆汇5月25日丨东阳光药(01558.HK)公布,公司自广东东阳光药业有限公司收购的产品利伐沙班片(10mg、15mg及20mg)已获中国国家药品监督管理局审批完毕并获准上市。该产品的上市许可持有人为公司全资子公司东莞市阳之康医药有限责任公司。

利伐沙班属于抗凝血药物,用于择期髋关节或膝关节置换手术成年患者,以预防静脉血栓形成(VTE);用于治疗成人静脉血栓形成(DVT),降低急性DVT后DVT复发和肺栓塞(PE)的风险;及用于具有一种或多种危险因素(例如:充血性心力衰竭、高血压、年龄≥75岁、糖尿病、卒中或短暂性脑缺血发作病史)的非瓣膜性房颤成年患者,以降低卒中和全身性栓塞的风险。利伐沙班通过抑制因子Xa可以中断凝血瀑布的内源性和外源性途径,抑制凝血酶的产生和血栓形成。

利伐沙班是《国家基本医疗保险、工伤保险和生育保险药品目录》2020年版中乙类品种,同时是《国家基本药物目录》2018年版中品种。根据艾昆纬数据,2020年中国利伐沙班药物的销售额约为3.47亿美元,较2019年增长约49.04%。

该产品为中国境内获批准上市的仿制药,获批准上市后即为视同通过仿制药质量和疗效一致性评价的产品;该产品具有良好的临床应用价值和市场前景,上市后将成为公司在心血管疾病治疗领域的产品之一,在进一步丰富集团的产品组合的同时,也为广大患者提供质价双优的用药选择。

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