永泰生物(06978)CAR-T–19注射液获得国家药监局突破性疗法认定

金吾财讯
11 Dec 2024

金吾财讯 | 永泰生物(06978)公布,集团的产品CAR-T–19注射液(一种抗CD19单链抗体嵌合抗原受体T细胞注射液)获得国家药品监督管理局药品审评中心颁发的突破性疗法认定,用于治疗25岁及以下复发╱难治B细胞急性淋巴细胞白血病(“B-ALL”)患者。该认定乃基于CAR-T–19注射液可靠的临床疗效及安全性数据。其将加快CAR-T–19注射液的临床开发,并加速其早日与患者见面。

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