港股异动 | 永泰生物-B(06978)午后涨超9% CAR-T-19注射液获授予突破性疗法认定

智通财经
19 Dec 2024

智通财经APP获悉,永泰生物-B(06978)午后涨超9%,截至发稿,涨9.65%,报2.5港元,成交额66.03万港元。

消息面上,永泰生物近期公布,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。

据悉,目前全球只有一款CAR-T产品获批用于治疗儿童及青少年复发/难治B细胞急性淋巴细胞白血病(25岁及以下),国内尚无针对治疗儿童及青少年该适应症的CAR-T产品上市。此外,永泰生物具备符合GMP体系的质粒和慢病毒载体生产技术平台和质量检验平台,生产的第三代慢病毒载体基因修饰系统,技术水平和生产工艺处于国内领先水平。自主可控且成本相对较低。

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