According to Zhitong Financial App, Shiyao Group (01093) announced that SYS 6010 (“this product”) developed by the Group was recently included in the list of breakthrough treatment varieties by the China Drug Administration (“State Drug Administration”). The proposed indications are recurrent or metastatic negative non-squamous non-small cell lung cancer that has previously received immunotherapy and failed platinum-containing chemotherapy.
This product is an antibody-conjugated drug (ADC) that targets the epidermal growth factor receptor (“EGFR”) developed by the Group. It is formed by coupling a humanized anti-EGFR monoclonal antibody with a lyzable ligand with a topoisomerase I inhibitor as a payload. This product can specifically bind EGFR on the surface of tumor cells and release cytotoxic payloads within cells after internalization, thereby exerting an anti-tumor effect.
Lung cancer is one of the leading causes of cancer incidence and death worldwide. According to the “2024 Analysis of the Prevalence of Malignant Tumors in China by Region” published by the National Cancer Center of China, China added about 1.176,000 new cases of lung cancer and 743,000 deaths in 2024, ranking first in the world in terms of incidence rate and death rate. Non-small cell lung cancer (“NSCLC”) is the main pathological subtype of lung cancer, accounting for approximately 85% of all lung cancer cases. Among NSCLC patients, patients with negative driver genes account for about 40%, and the incidence rate of this group is increasing year by year. Immunotherapy combined with platinum-containing chemotherapy is the first-line standard treatment plan for gene-negative NSCLC; after first-line treatment failed, second-line standard treatment was still dominated by single-agent chemotherapy. Overall clinical efficacy was poor, and patient survival benefits were limited.
The product significantly improved the objective remission rate of patients with non-squamous NSCLC with negative driver genes, and had a long-lasting remission period. Its progression-free survival (PFS) was more than double that of standard treatment, suggesting that patients treated with this product had obvious survival benefits, and the clinical efficacy was significantly superior to existing standard treatments. The product has shown outstanding clinical value. It is expected that after approval for marketing, it will provide patients with better treatment options and good market potential. Currently, a randomized, open, multicenter phase III clinical trial to evaluate the use of this product as a single agent for drivergene-negative locally advanced or metastatic non-squamous non-small cell lung cancer that has failed standard treatment is ongoing.
Previously, the product has received 3 breakthrough treatment certifications granted by the National Drug Administration. The proposed indications are: single drug for EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) that failed to be treated with EGFR-TKI and platinum-containing chemotherapy; unresectable locally advanced or metastatic esophageal squamous cell carcinoma (R/MHSCC) that failed after first-line treatment with platinum-containing chemotherapy and immune checkpoint inhibitors (ICI); and recurrent or metastatic head squamous cell carcinoma (R/MHSCNC) that failed to be treated with immunotherapy and platinum-containing chemotherapy.