CSPC PHARMA (01093) has announced that its innovative drug candidate, SYS 6010, has been included in the Breakthrough Therapy Designation list by China's National Medical Products Administration (NMPA). The proposed indication covers patients with recurrent or metastatic driver-gene-negative non-squamous non-small cell lung cancer who have previously failed immunotherapy and platinum-based chemotherapy.

SYS 6010 is an antibody-drug conjugate (ADC) developed by the company, specifically targeting the epidermal growth factor receptor (EGFR). This investigational therapy consists of a humanized anti-EGFR monoclonal antibody conjugated to a topoisomerase I inhibitor payload via a cleavable linker. The drug works by selectively binding to EGFR on tumor cell surfaces, after which it undergoes internalization and releases its cytotoxic payload within the cells to exert its anti-tumor effect.

Lung cancer remains one of the leading causes of cancer incidence and mortality worldwide. According to the "2024 Regional Malignant Tumor Prevalence Analysis in China" published by the National Cancer Center, approximately 1.176 million new lung cancer cases and 743,000 deaths were recorded in China in 2024, with both incidence and mortality rates ranking highest globally. Non-small cell lung cancer (NSCLC) represents the predominant pathological subtype of lung cancer, accounting for roughly 85% of all cases. Among NSCLC patients, those with driver-gene-negative status constitute about 40% of the population, and this group's incidence has been rising year over year.

Immunotherapy combined with platinum-based chemotherapy serves as the current first-line standard treatment for driver-gene-negative NSCLC. Following first-line treatment failure, second-line standard therapy still relies primarily on single-agent chemotherapy, which yields generally unsatisfactory clinical outcomes and provides limited survival benefits. SYS 6010 has demonstrated a significant improvement in objective response rates for patients with driver-gene-negative non-squamous NSCLC, accompanied by durable remission periods. Its progression-free survival (PFS) surpasses that of standard therapy by more than twofold, indicating that patients receiving this treatment experience notable survival advantages and that its clinical efficacy is markedly superior to existing standard care.

Given its pronounced clinical value, SYS 6010 is anticipated to provide patients with a superior therapeutic option upon market approval and possesses strong market potential. Currently, a randomized, open-label, multicenter Phase III clinical trial is underway to evaluate SYS 6010 as a monotherapy for patients with driver-gene-negative locally advanced or metastatic non-squamous NSCLC who have progressed following standard treatment.

Previously, SYS 6010 has already received three Breakthrough Therapy Designations from the NMPA for the following proposed indications: as a monotherapy for advanced NSCLC with EGFR mutation positivity who have failed EGFR-TKI and platinum-based chemotherapy; for patients with unresectable locally advanced or metastatic esophageal squamous cell carcinoma who have failed prior first-line treatment with platinum-based chemotherapy and immune checkpoint inhibitors (ICIs); and for recurrent or metastatic head and neck squamous cell carcinoma (R/MHNSCC) after failure of immunotherapy and platinum-based chemotherapy.