退市、召回,一款FIC肿瘤药的落幕

氨基观察
Mar 10

FIC药物,遇到了意想不到的波折。3月9日,和黄医药公告,同步益普生全球决策,启动达唯珂在中国内地、港澳地区的撤市与产品召回,停止全部在研临床试验。这款2025年3月才获NMPA附条件批准的全球首创EZH2抑制剂,上市不足一年便黯然退场。而退市的原因,并非价格、医保或商业化失利,而是安全天平彻底倾斜——SYMPHONY1关键III期的独立数据监察委员会(IDMC)判定:达唯珂联合R²方案治疗滤泡性...

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