• The Phase III OptiTROP-Lung06 study supporting this application showed that sac-TMT plus pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with pembrolizumab plus pemetrexed and platinum-based chemotherapy.
• OptiTROP-Lung06 is the world's first Phase III study of an ADC combined with an immune checkpoint inhibitor to meet its primary endpoint in first-line treatment of driver gene‑negative and PD‑L1‑negative non-squamous NSCLC.
• The detailed results of this study had been presented as a LBA oral report at the 2026 ESMO Congress.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that a new indication application ("the application") for its trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱^®) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, in combination with MSD^[1]'s anti-programmed cell death protein 1 (PD-1) monoclonal antibody pembrolizumab (KEYTRUDA^®[2]) as first-line treatment for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) <1% and are epidermal growth factor receptor (EGFR)-negative and anaplastic lymphoma kinase (ALK)-negative. This marks the seventh indication application for sac-TMT accepted for review by the NMPA.

This application is based on positive results from the Phase III registrational OptiTROP-Lung06 study evaluating the efficacy and safety of sac-TMT in combination with pembrolizumab compared with pembrolizumab plus chemotherapy as first-line treatment for patients with PD-L1-negative locally advanced or metastatic non-squamous NSCLC. This study directly compared two treatment strategies— "ADC plus immunotherapy" versus "immunotherapy plus chemotherapy".

At a prespecified interim analysis, sac-TMT plus pembrolizumab 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-based chemotherapy; a positive trend was also observed in the secondary endpoint of overall survival (OS). The safety profile of this combination regimen was consistent with that reported in previous studies, with no new safety signals observed.

The OptiTROP-Lung06 study has been selected as a late-breaking abstract (LBA) at the 2026 European Society for Medical Oncology (ESMO) Congress, and the detailed results had been presented as an oral report during the congress.

Dr. Michael Ge, Chief Executive Officer of Kelun-Biotech, said: "Following the acceptance for review of the new indication application for sac-TMT in combination with pembrolizumab as first-line treatment for PD-L1-positive NSCLC, this combination has demonstrated encouraging progress in the more challenging setting of PD-L1-negative non-squamous NSCLC, highlighting the therapeutic potential of this ADC plus pembrolizumab combination across a broad lung cancer population, and its potential to reshape the current first-line treatment landscape with improved efficacy. We will continue to work with our partners to advance the clinical development and combination strategies of sac-TMT, with the goal of delivering meaningful benefits to cancer patients and improving clinical outcomes."