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复星医药(600196.SH):盐酸阿米替林片通过仿制药一致性评价
格隆汇 08-16 15:14

格隆汇8月16日丨复星医药(600196.SH)公布,近日,公司控股子公司湖南洞庭药业股份有限公司(“洞庭药业”)收国家药品监督管理局颁发的关于盐酸阿米替林的《药品补充申请批准通知书(通知书编号2020B04328),该药品通过仿制药质量与疗效一致性评价

该药品属于三环类抗抑郁药,主要用于治疗焦虑性或激动性抑郁症。2019度,洞庭药业该药品于中国境内(不包括港澳台地区,下同)的销售额约人民2233万元

公告日,于中国境内已上市的盐酸阿米替林片包括洞庭药业常州四药制药有限公司、江苏恩华药业股份有限公司的盐酸阿米替林片。根据IQVIA CHPA最新数据(由IQVIA提供,IQVIA是全球领先的医药健康产业专业信息和战略咨询服务提供商;IQVIA CHPA数据代表中国境内100张床位以上的医院药品销售市场,不同的药品因其各自销售渠道布局的不同,实际销售情况可能与IQVIA CHPA数据存在不同程度的差异)2019年度,盐酸阿米替林片于中国境内销售额约人民币795万元。

20207月,洞庭药业现阶段针对该药品一致性评价累计研发投入约为人民币983万元(未经审计)。

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