复星医药(02196.HK)子公司红旗制药异烟肼片通过仿制药一致性评价
格隆汇7月16日丨复星医药(02196.HK)公布,近日,公司控股子公司沈阳红旗制药有限公司收到国家药品监督管理局颁发的关于异烟肼片(规格:0.3g)的《药品补充申请批件》,该药品通过仿制药一致性评价。
异烟肼片主要与其他抗结核药联合使用,适用于各型结核病的治疗。2019年3月,红旗制药异烟肼片(规格:0.1g)通过仿制药一致性评价。2018年度,沈阳红旗异烟肼片(规格:0.1g)于中国境内(不包括港澳台地区,下同)销售额约为人民币2909万元(未经审计)、异烟肼片(规格:0.3g)未有销售额。
截至本公告日,于中国境内已上市的异烟肼片包括杭州民生药业有限公司的异烟肼片、成都锦华药业有限责任公司的异烟肼片等。根据IQVIACHPA最新数据,2018年度,异烟肼片于中国境内销售额约为人民币9436万元。
截至2019年6月,该集团现阶段针对异烟肼片(包括0.1g及0.3g规格)一致性评价累计研发投入人民币约563万元(未经审计)。
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