科伦药业(002422.SZ)子公司核心产品TROP2 ADC芦康沙妥珠单抗(sac-TMT)联合免疫疗法帕博利珠单抗一线治疗PD-L1阳性局部晚期或转移性非小细胞肺癌获国家药监局突破性疗法认定

Core Viewpoint - The company, Kelun Pharmaceutical, has received breakthrough therapy designation from the National Medical Products Administration (NMPA) in China for its antibody-drug conjugate (ADC) SKB264/MK-2870, in combination with Merck's PD-1 monoclonal antibody, for the treatment of specific types of non-small cell lung cancer (NSCLC) [1]. Group 1 - Kelun Pharmaceutical's subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., is involved in the development of the ADC targeting TROP2 [1]. - The combination therapy is aimed at patients with locally advanced or metastatic NSCLC who are negative for EGFR gene mutations and ALK [1]. - The therapy is specifically for patients with a tumor proportion score (TPS) of ≥1% for PD-L1 [1].