今年,美国FDA批准了2款siRNA新药,至此全球已有8款RNAi产品获得监管批准。回顾RNAi的监管历程,从2018年8月首款siRNA药物patisiran(Onpattro)获得FDA批准,打破了RNAi技术在递送难题凸显和资本相继退出的黑暗时期,到如今2025年,7年多的时间,已经有8款siRNA新药获得监管批准——siRNA药物已经成为创新药中重要的组成部分,给多种亟待治疗选择的患者提供...
Source Link今年,美国FDA批准了2款siRNA新药,至此全球已有8款RNAi产品获得监管批准。回顾RNAi的监管历程,从2018年8月首款siRNA药物patisiran(Onpattro)获得FDA批准,打破了RNAi技术在递送难题凸显和资本相继退出的黑暗时期,到如今2025年,7年多的时间,已经有8款siRNA新药获得监管批准——siRNA药物已经成为创新药中重要的组成部分,给多种亟待治疗选择的患者提供...
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