基石藥業(02616.HK):舒格利單抗獲中國突破性治療藥物認定
基石藥業(02616.HK)公布,舒格利單抗(抗PD-L1單抗)被國家藥品監督管理局藥品審評中心納入突破性治療藥物認定,擬定適應症為復發或難治性(「R/R」)結外自然殺傷細胞/T 細胞淋巴瘤(「ENKTL」)。
這是繼2020年10月美國食品藥品監督管理局分別授予舒格利單抗孤兒藥資格用於治療T細胞淋巴瘤和突破性療法認定用於治療成人R/R ENKTL後,舒格利單抗取得的又一個重要進展。
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