SKB BIO (06990): Marketing application for a new indication of core product TROP2 ADC sac-TMT accepted by the National Medical Products Administration

SKB BIO (06990) announced that the marketing application for a new indication of the company's antibody-drug conjugate (ADC) targeting human trophoblast cell-surface antigen 2 (TROP2), sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (), has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The new indication is for use in combination with Merck's anti-programmed cell death protein 1 (PD-1) monoclonal antibody pembrolizumab (Keytruda) for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) with tumor proportion score (TPS) <1%, and who are negative for epidermal growth factor receptor (EGFR) gene mutations and negative for anaplastic lymphoma kinase (ALK). This application is the seventh marketing application for an indication of sacituzumab tirumotecan (sac-TMT) accepted by the NMPA. This application is based on the positive results of the Phase 3 registrational OptiTROP-Lung06 study, which was designed to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT) in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab for the first-line treatment of patients with PD-L1-negative locally advanced or metastatic non-squamous NSCLC. The study directly compared two treatment strategies: "ADC combined with immunotherapy" versus "immunotherapy combined with chemotherapy." In the prespecified interim analysis, the sacituzumab tirumotecan (sac-TMT) plus pembrolizumab regimen demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by blinded independent central review (BICR) compared with pembrolizumab plus pemetrexed and platinum-containing chemotherapy, and a trend toward benefit was also observed in the secondary endpoint of overall survival (OS). The safety profile of the combination regimen was consistent with that reported in previous studies, with no new safety signals observed.