信達生物(01801.HK)抑制劑IBI376獲藥監局突破性治療藥物認定
信達生物(01801.HK)公佈,旗下特異性抑制劑產品Parsaclisib(IBI376)已通過國家藥品監督管理局藥品審評中心公示期,獲納入突破性治療藥物品種,擬定適應症為復發/難治性濾泡性淋巴瘤(r/r FL)。
Parsaclisib由信達生物和Incyte在中國共同開發,信達生物擁有Parsaclisib在大中華地區的開發和商業化權利。信達生物醫學科學與戰略腫瘤部副總裁周輝表示,Parsaclisib在海外研究中已經受到多項臨床認證,此次能夠被納入CDE突破性治療藥物程序,期待夠加速Parsaclisib在中國內地的研發和審批速度。
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