Core Viewpoint - The company, Kelun-Botai Biopharmaceutical-B (06990.HK), has received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) sac-TMT in combination with Merck's PD-1 monoclonal antibody, pembrolizumab, for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥ 1% and negative for EGFR mutations and ALK [1][2] Group 1 - The Breakthrough Therapy Designation is granted to drugs that provide effective treatment options where none exist or offer significant clinical advantages over existing therapies [1] - Drugs included in the Breakthrough Therapy program can apply for conditional approval and priority review during the drug licensing application process if they meet relevant criteria [1] Group 2 - The company previously announced results from the Phase 3 OptiTROP-Lung05 clinical trial, which demonstrated statistically and clinically significant improvements in progression-free survival (PFS) as the primary endpoint, with a trend towards benefits in overall survival (OS) [2] - The OptiTROP-Lung05 study is the first Phase 3 clinical trial to achieve its primary endpoint with an immune combination ADC in the first-line treatment of NSCLC [2] - The Breakthrough Therapy Designation for sac-TMT in treating PD-L1 positive NSCLC will facilitate the review and approval process for this indication [2]
科伦博泰生物-B(06990.HK)：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