赛诺菲(SNY)获维亚臻在研药物普乐司兰钠注射液大中华区权利

金吾财讯
01 Aug

金吾财讯 | 赛诺菲(SNY)宣布与生物技术公司Arrowhead的子公司维亚臻签署资产购买协议。维亚臻目前在大中华区开发和商业化Arrowhead的四种在研心血管代谢候选药物。根据协议,赛诺菲将获得在大中华区开发和商业化在研药物普乐司兰钠注射液的权利。

维亚臻已完成在研药物普乐司兰钠注射液治疗中国FCS患者的一项III期临床试验(CTR20231418/NCT05902598),该试验成功达到了主要疗效终点和所有关键次要终点。维亚臻随后向中国国家药品监督管理局(NMPA)提交了普乐司兰钠注射液用于治疗FCS的新药申请(NDA),并于2025年1月26日获得NMPA的正式受理。普乐司兰钠注射液用于治疗FCS患者也已获得中国NMPA的突破性疗法认定和优先审评资格。

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