复星医药(600196.SH):Tenapanor片用于便秘性肠易激综合症治疗的临床试验申请获受理
格隆汇9月10日丨复星医药(600196.SH)公布,近日,公司控股子公司上海复星医药产业发展有限公司(“复星医药产业”)收到《受理通知书》(受理号:JXHL1900227国),其获许可的Tenapanor片用于便秘性肠易激综合症治疗的临床试验申请获国家药品监督管理局注册审评受理。
2017年12月,复星医药产业获Ardelyx, Inc.(“Ardelyx”)关于该新药在区域内(包括中国大陆、香港及澳门特别行政区,下同)的独家临床开发和商业化等许可,Ardelyx仍为该新药在区域内的权利人。该新药为化学药品,主要用于治疗便秘性肠易激综合症和终末期肾病透析患者高磷血症。
截至公告日,Ardelyx的Tenapanor尚处于美国上市注册申请阶段;于全球上市的用于治疗便秘性肠易激综合症的药品主要包括Trulance®(Plecanatide,普卡那肽)、Amitiza®(Lubiprostone,鲁比前列酮)、Linzess®(Linaclotide,利那洛肽)。根据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),上述药品于全球的销售额约为22.2亿美元(于中国境内尚未有销售额)。
截至2019年8月,集团现阶段针对该新药累计研发投入为人民币约7768万元(未经审计)。
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