Core Insights - The company Keren Biotechnology (06990.HK) has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) sac-TMT, targeting TROP2, for a third indication in treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) [1][2] Group 1 - The approval is based on a randomized, open-label, multi-center Phase III clinical study (OptiTROP-Lung04), which will be presented at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study evaluates the efficacy and safety of sac-TMT administered every two weeks at a dose of 5 mg/kg compared to pemetrexed combined with platinum-based therapy in patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who have failed EGFR-TKI treatment [2] - Sac-TMT is the first and only ADC to show significant overall survival (OS) benefits compared to standard platinum-based doublet chemotherapy in this patient population [1][2] Group 2 - In March 2025, sac-TMT was approved by NMPA for use in patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who have progressed after EGFR-TKI and platinum-based chemotherapy [2] - The single-agent therapy with sac-TMT significantly extends the overall survival of these patients compared to standard treatment [2] - Another Phase III registration study of sac-TMT combined with osimertinib as first-line treatment for EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC has completed patient enrollment in China [2]
科伦博泰生物-B(06990.HK)核心产品TROP2ADC芦康沙妥珠单抗(SAC-TMT)获国家药品监督管理局批准第三项适应症上市，用于治疗EGFR-TKI治疗后进展的EGFR突变非小细胞肺癌