CSPC PHARMA (01093): SYS 6010 Granted Breakthrough Therapy Designation by China's NMPA for the Treatment of Patients with Driver Gene-Negative Non-Squamous Non-Small Cell Lung Cancer

CSPC PHARMA (01093) announced that SYS 6010 (the "Product"), developed by the Group, has recently been granted Breakthrough Therapy Designation by the National Medical Products Administration (the "NMPA") of the People's Republic of China. The proposed indication is for the treatment of patients with recurrent or metastatic driver gene-negative non-squamous non-small cell lung cancer who have failed prior immunotherapy and platinum-containing chemotherapy. The Product is an antibody-drug conjugate (ADC) targeting epidermal growth factor receptor ("EGFR") developed by the Group, composed of a humanized anti-EGFR monoclonal antibody conjugated via a cleavable linker to a topoisomerase I inhibitor as the payload. The Product is able to specifically bind to EGFR on the surface of tumor cells, and upon internalization, releases the cytotoxic payload intracellularly, thereby exerting an anti-tumor effect. Lung cancer is one of the leading causes of cancer incidence and mortality worldwide. According to the "Analysis of Malignant Tumor Epidemiology by Region in China, 2024" published by the National Cancer Center of China, there were approximately 1.176 million new lung cancer cases and approximately 743,000 deaths in China in 2024, with both incidence and mortality rates ranking first globally. Non-small cell lung cancer ("NSCLC") is the predominant pathological subtype of lung cancer, accounting for approximately 85% of all lung cancer cases. Among NSCLC patients, driver gene-negative patients account for approximately 40%, and the incidence in this population is increasing year by year. Immunotherapy combined with platinum-containing chemotherapy is the first-line standard treatment for driver gene-negative NSCLC; after failure of first-line treatment, second-line standard treatment remains primarily single-agent chemotherapy, with overall poor clinical efficacy and limited survival benefit for patients. The Product significantly improves the objective response rate in patients with driver gene-negative non-squamous NSCLC and has a durable duration of response, with progression-free survival (PFS) more than doubled compared to standard treatment, suggesting that patients receiving the Product have significant survival benefits, with clinical efficacy significantly superior to existing standard treatments. The Product demonstrates outstanding clinical value and is expected to provide patients with a better treatment option upon approval and launch, with good market potential. Currently, a randomized, open-label, multicenter Phase III clinical trial evaluating the Product as monotherapy for driver gene-negative locally advanced or metastatic non-squamous non-small cell lung cancer that has failed standard treatment is ongoing. Previously, the Product has been granted three Breakthrough Therapy Designations by the NMPA, with proposed indications as follows: monotherapy for EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) that has failed EGFR-TKI and platinum-containing chemotherapy; unresectable locally advanced or metastatic esophageal squamous cell carcinoma that has failed prior first-line platinum-containing chemotherapy and immune checkpoint inhibitor (ICI) therapy; and recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) that has failed immunotherapy and platinum-containing chemotherapy.