千金药业(600479.SH):缬沙坦胶囊通过仿制药一致性评价
格隆汇4月21日丨千金药业(600479.SH)公布,2020年4月20日,公司控股子公司湖南千金湘江药业股份有限公司(以下简称“千金湘江药业”)收到国家药品监督管理局核准签发缬沙坦胶囊的《药品补充申请批件》,该药品通过仿制药质量和疗效一致性评价。
缬沙坦胶囊为特异性血管紧张素II受体拮抗剂,用于治疗轻、中度原发性高血压。缬沙坦胶囊为2018年版国家基本药物目录、2019年版国家医保目录甲类品种。
缬沙坦胶囊最早由诺华制药开发,于1996年获得美国FDA批准上市,对心衰有一定治疗作用,在沙坦类药物中获FDA批准适应症最多。截至公告日,千金湘江药业针对该药品一致性评价已投入研发费用约人民币1250万元。2019年度,千金湘江药业该药品销售收入为2.11亿元(经审计)。
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