基石药业(02616.HK):舒格利单抗获中国突破性治疗药物认定
基石药业(02616.HK)公布,舒格利单抗(抗PD-L1单抗)被国家药品监督管理局药品审评中心纳入突破性治疗药物认定,拟定适应症为复发或难治性(「R/R」)结外自然杀伤细胞/T 细胞淋巴瘤(「ENKTL」)。
这是继2020年10月美国食品药品监督管理局分别授予舒格利单抗孤儿药资格用於治疗T细胞淋巴瘤和突破性疗法认定用於治疗成人R/R ENKTL後,舒格利单抗取得的又一个重要进展。
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