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信达生物(01801.HK)抑制剂IBI376获药监局突破性治疗药物认定
阿思达克 03-31 15:08
信达生物(01801.HK)公布,旗下特异性抑制剂产品Parsaclisib(IBI376)已通过国家药品监督管理局药品审评中心公示期,获纳入突破性治疗药物品种,拟定适应症为复发/难治性滤泡性淋巴瘤(r/r FL)。

Parsaclisib由信达生物和Incyte在中国共同开发,信达生物拥有Parsaclisib在大中华地区的开发和商业化权利。信达生物医学科学与战略肿瘤部副总裁周辉表示,Parsaclisib在海外研究中已经受到多项临床认证,此次能够被纳入CDE突破性治疗药物程序,期待够加速Parsaclisib在中国内地的研发和审批速度。

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