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复星医药(600196.SH):江苏万邦非布司他片通过仿制药一致性评价
格隆汇 04-16 17:58

格隆汇4月16日丨复星医药(600196.SH)公布,近日,公司控股子公司江苏万邦生化医药集团有限责任公司(以下简称“江苏万邦”)收到国家药品监督管理局颁发的关于非布司他片(商品名称:优立通®;以下简称“该药品”)的《药品补充申请批件》(批件号:2020B02785、2020B02786),该药品通过仿制药一致性评价。

非布司他片主要用于痛风患者高尿酸血症的长期治疗。2019年度,江苏万邦非布司他片于中国境内(不包括港澳台地区,下同)的销售额约为人民币11.26亿元。

截至本公告日,于中国境内已上市的非布司他片主要包括江苏恒瑞医药股份有限公司的瑞扬®、江苏万邦的优立通®、杭州朱养心药业有限公司的风定宁®、安斯泰来制药(中国)有限公司的菲布力?等。根据IQVIACHPA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;IQVIACHPA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IQVIACHPA数据存在不同程度的差异),2019年度,非布司他片于中国境内销售额约为人民币12.75亿元。

截至2020年3月,江苏万邦现阶段针对该药品一致性评价累计研发投入人民币约2142万元(未经审计)。

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