Alphamab 皮下 PD-1 药物 envafolimab 在中国获得有条件批准

StephenW

Alphamab 皮下 PD-1 药物 envafolimab 在中国获得有条件批准
2021 年 11 月 30 日
大卫·何
Alphamab Oncology Co. Ltd. 的 KN-035（envafolimab）已获得中国 NMPA 的有条件上市许可，这是世界上第一个通过皮下注射给药的 PD-1/PD-L1 抗体。 该药物被批准用于治疗患有不可切除或转移性晚期微卫星不稳定性高表型/错配修复缺陷的晚期实体瘤成年患者。 这包括先前接受氟尿嘧啶、奥沙利铂和伊立替康治疗后疾病进展的晚期结直肠癌患者。
Alphamab’s subcutaneous PD-1 drug envafolimab wins conditional approval in China
Nov. 30, 2021
By David Ho
Alphamab Oncology Co. Ltd. has won conditional marketing approval from China’s NMPA for KN-035 (envafolimab), the world’s first PD-1/PD-L1 antibody to be administered by subcutaneous injection. The drug was cleared for use in treating adult patients with advanced solid tumors who have unresectable or metastatic advanced microsatellite instability-high phenotype/mismatch-repair deficiency. That includes patients with advanced colorectal cancer who have experienced disease progression after previous therapy with fluorouracil, oxaliplatin and irinotecan.