Shijiazhuang Pharma Group (01093.HK) Launches Phase III Clinical Trial of SYS6010 in Combination with Enlansubai Monoclonal Antibody as Adjuvant Therapy for Resected Stage II–IIIB EGFR Wild-Type, Non-MPR Non-Small Cell Lung Cancer in China

Zhitong Finance APP News: CSPC (01093) announced that the Group has officially launched a randomized, controlled, open-label Phase III clinical study in China (SYS 6010–015). This study aims to evaluate the safety and efficacy of SYS 6010 in combination with the PD-1 monoclonal antibody (enrangubai monoclonal antibody) versus PD-(L)-1 monoclonal antibody as adjuvant therapy for participants with resected Stage II–IIIB, driver gene-negative non-small cell lung cancer (NSCLC) who did not achieve major pathological response (MPR). The first patient enrollment is planned to be completed by July 2026.

SYS6010 is an antibody-drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), developed by CSPC Pharmaceutical Group Limited. It consists of a humanized anti-EGFR monoclonal antibody conjugated via a cleavable linker to a topoisomerase I inhibitor payload. The drug specifically binds to EGFR receptors on the surface of tumor cells, and upon internalization, releases the cytotoxic payload intracellularly, thereby exerting antitumor effects. Enlunsumab Injection (Recombinant Fully Human Anti-PD-1 Monoclonal Antibody Injection) is a humanized IgG4 variant monoclonal antibody that targets human programmed cell death protein-1 (PD-1) for the treatment of malignant tumors in various human 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 enlanrubartab as adjuvant therapy for patients with resected stage II–IIIB driver gene-negative non-small cell lung cancer (NSCLC) who have not achieved major pathological response (MPR). Previously, in June 2026, the Group received approval from the Center for Drug Evaluation of the National Medical Products Administration of the People's Republic of China to conduct this clinical trial. Currently, recruitment and screening of participants are actively underway.