CSPC Group (01093): SYS6010 was once again included in the list of breakthrough treatment varieties by the State Drug Administration in China to treat patients with recurrent or metastatic head and neck squamous cell cancer

According to Zhitong Finance App News, Shiyao Group (01093) announced that SYS6010 (this product) developed by the Group was recently included in the list of breakthrough treatment varieties by the China National Drug Administration (NDRA). The proposed indications are recurrent or metastatic head and neck squamous cancer (R/MHNSCC) that has previously failed to be treated with immunization and platinum-containing chemotherapy.

This product is an antibody-conjugated drug (ADC) targeting the epidermal growth factor receptor (EGFR) developed by the Group. It is formed by combining 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.

Head and neck squamous cell carcinoma (HNSCC) is an epithelial-derived malignant tumor located in the oral cavity, oropharynx, mandible, and larynx. According to the GLOBOCAN 2024 Global Cancer Statistics Report issued by the World Health Organization's International Agency for Research on Cancer (IARC), there are about 845,000 new cases and 392,000 deaths worldwide, while China has about 87,000 new cases and 48,000 deaths a year. This suggests that this tumor type is highly malignant, difficult to treat, and the 5-year overall survival rate is only 40% to 50%. HNSCC is a serious and life-threatening disease. Although there are currently standard treatment plans, treatment results are limited, and patients have poor prognosis.

The product significantly improved the objective remission rate and long-lasting relief for patients with recurrent or metastatic head and neck squamous cell carcinoma who had previously failed immunization and platinum-containing chemotherapy. 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, critical phase III clinical trials of this single drug for recurrent or metastatic head and neck squamous cell carcinoma that have failed immunization and platinum-containing chemotherapy are ongoing.

Previously, the product has obtained 2 breakthrough treatment certifications granted by the State Drug Administration (not including this one). 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 that has failed after receiving platinum-containing chemotherapy and immune checkpoint inhibitors (ICI) on the frontline.