默沙东创新药物欣瑞来®(注射用索特西普)在华获批

格隆汇
Jan 05

默沙东宣布,全球首个且目前唯一[1]突破性疗法激活素信号传导抑制剂(ASI)欣瑞来®(注射用索特西普)已获得中国国家药品监督管理局(NMPA)批准,适用于治疗WHO功能分级(FC)II-III级的肺动脉高压(PAH,WHO第1组)成年患者,以改善患者的运动能力和WHO功能分级。ASI是针对PAH病因治疗的新型生物制剂,此次获批是基于III期临床试验STELLAR的研究数据。

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