百利天恒(688506.SH):BL-M17D1(ADC)用于治疗晚期实体瘤患者的I期临床试验申请获得FDA许可

智通财经
07 Nov 2024

智通财金APP讯,百利天恒(688506.SH)发布公告,近日,公司的全资子公司SystImmune,Inc.收到美国食品药品监督管理局(“FDA”)的通知,BL-M17D1(ADC)用于治疗晚期实体瘤患者的I期临床试验申请已获得FDA许可。

BL-M17D1是与BL-B16D1出自同一新的小分子技术平台、与BL-B16D1共享同一新的“连接子+毒素”平台的ADC药物,其适应症为晚期实体瘤。

包括本次BL-M17D1新获得FDA许可,截至目前,公司共有6个项目已获FDA许可开展临床研究,其他5个分别是:BL-B01D1、BL-M07D1、SI-B001、BL-M05D1、BL-M11D1在美国的临床试验。

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