CSPC PHARMA (01093): SYS 6010 in combination with Enrosumab used for adjuvant treatment of resected II-IIIB stage driver gene-negative, unresectable MPR non-small cell lung cancer Phase III clinical trial officially launched in China.

CSPC PHARMA (01093) announced that the group has officially initiated a randomized, open-label Phase III clinical study (SYS 6010-015) in China evaluating the combination of SYS 6010, an antibody-drug conjugate targeting epidermal growth factor receptor (EGFR), with PD-1 monoclonal antibody (camrelizumab) as adjuvant therapy in resected stage II-III B driver gene-negative, non-small cell lung cancer participants who did not achieve major pathological response. The study is scheduled to complete the enrollment of the first subject in July 2026. SYS 6010 is an ADC developed by the group, composed of a humanized anti-EGFR monoclonal antibody linked with a topoisomerase I inhibitor payload through a cleavable linker. This drug specifically binds to EGFR receptors on the surface of tumor cells, releasing cytotoxic payload upon internalization to exert its anti-tumor effect. Camrelizumab injection (recombinant anti-PD-1 humanized monoclonal antibody injection) is a humanized IgG4 variant monoclonal antibody targeting human programmed cell death protein-1 (PD-1) for the treatment of various malignant tumors in multiple organs and tissues. SYS 6010-015 is a randomized, open-label, multicenter, Phase III clinical study designed to evaluate the safety and efficacy of SYS 6010 in combination with camrelizumab as adjuvant therapy in resected stage II-III B driver gene-negative, non-small cell lung cancer participants who did not achieve major pathological response. The group has received approval from the National Medical Products Administration of the People's Republic of China for this clinical trial in June 2026. Currently, subject recruitment and screening are actively underway.