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海正药业(600267.SH):抗感染药利奈唑胺片获批上市
格隆汇 06-08 16:17

格隆汇6月8日丨海正药业(600267.SH)宣布,公司于近日收到国家药监局核准签发的利奈唑胺片(0.6g)的《药品注册证书》。公司利奈唑胺片按新4类获得国家药监局批准上市,视同通过一致性评价。

利奈唑胺片适用于治疗由特定微生物敏感株引起的:院内获得性肺炎;社区获得性肺炎;复杂性皮肤和皮肤软组织感染,包括未并发骨髓炎的糖尿病足部感染;非复杂性皮肤和皮肤软组织感染;万古霉素耐药的屎肠球菌感染等。

利奈唑胺片原研药由法玛西亚普强公司研发,目前,利奈唑胺片国内主要生产厂家有重庆华邦制药有限公司、江苏豪森药业集团有限公司等。经查询IMS数据库,利奈唑胺片2019年全球销售额约为2.67亿美元,其中国内市场销售额约为2647.93万美元;2020年全球销售额约为2.76亿美元,其中国内市场销售额约为3244.01万美元。

2019年5月29日,国家药监局受理了公司向其递交的利奈唑胺片药品注册申请。截至目前,公司在该药品研发项目上已投入约2869万元人民币。

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