科伦博泰生物-B(06990):创新ADC药物SKB518新药临床试验申请获美国食品药品监督管理局批准

智通财经
21 Apr

智通财经APP讯,科伦博泰生物-B(06990)发布公告,公司已获得美国食品药品监督管理局(FDA)批准启动其创新抗体偶联药物(ADC)药物SKB518临床研究的新药临床试验(IND)申请。

于2024年6月,公司收到国家药品监督管理局(NMPA)药品审评中心(CDE) 批准SKB518用于晚期实体瘤的IND申请的临床试验通知书。SKB518的1期临床试验正在中国进行中。

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