科伦药业:子公司SKB518新药临床试验申请获FDA批准

美港电讯
21 Apr

【科伦药业:子公司SKB518新药临床试验申请获FDA批准】金十数据4月21日讯,科伦药业公告,控股子公司科伦博泰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。2024年6月,科伦博泰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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