智通财经APP讯，永泰生物-B(06978)发布公告，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。
根据《药品注册管理办法》及《国家药监局关于发布〈突破性治疗药物审评工作程序(试行)〉等三个文件的公告》(2020年第82号)，药品审评中心在沟通和指导中会优先处理获颁突破性疗法认定的药物，以促进药物开发进度。
药品审评中心的突破性疗法认定旨在加快具有显著临床优势的创新药物的临床开发。获得突破性疗法认定的在研药物在提交新药申请时，可被考虑给予有条件批准及优先审评。据药品审评中心表示，获得突破性疗法认定的在研药物在临床试验及开发战略方面有机会获得药品审评中心更深入的指导及讨论，并在稍后获得优先审评。
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