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复星医药(600196.SH):马来酸阿伐曲泊帕片用于ITP获批临床试验
格隆汇 10-13 16:22

格隆汇10月13日丨复星医药(600196.SH)宣布,近日,公司控股子公司复星医药产业收到国家药品监督管理局关于同意其获许可的马来酸阿伐曲泊帕片用于成人慢性免疫性血小板减少症适应症(ITP)开展临床试验的通知书。复星医药产业拟于近期条件具备后于中国境内(不包括港澳台地区,下同)开展该新药针对该适应症的III期临床试验。

复星医药产业于2018年3月获美国AkaRx, Inc.(现为Swedish Orphan Biovitrum AB之控股子公司;以下简称“AkaRx”)关于该新药在区域内(即中国大陆及香港特别行政区)的独家销售代理权(包括为实现销售享有的独家注册、开发权)的许可,AkaRx仍为该新药在区域内的权利人,复星医药产业在区域内的销售将由AkaRx负责供货。

该新药为化学药品。截至该公告日,该新药适用于择期行诊断性操作或者手术的慢性肝病相关血小板减少症的成年患者已于美国、欧盟、中国境内上市,适用于慢性免疫性血小板减少症(ITP)已于美国上市。此外,该新药用于肿瘤化疗引起的血小板减少症(CIT)亦于近期完成国际多中心III期临床试验,初步分析试验结果未达到预设主要复合终点;据此,复星医药产业将结合对该临床研究试验及结果的分析,进一步评估确定该适应症于中国境内的临床开发策略、优化临床试验设计并确定注册策略。

根IQVIA MIDASTM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),2019年度,阿伐曲泊帕片于全球销售额约为343万美元。

截至2020年9月,集团现阶段针对该新药累计研发投入约为人民币1.06亿元(未经审计;包括许可转让费)。

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