CSPC PHARMA (01093): SYS6010 has been included again in the list of breakthrough therapy varieties by the National Medical Products Administration of China for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.

CSPC PHARMA (01093) announced that SYS6010 (the product) developed by the Group has recently been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration (NMPA) of China. The intended indication is for relapsed or metastatic head and neck squamous cell carcinoma (R/MHNSCC) in patients who have previously failed immunotherapy and platinum-based chemotherapy. This product is an antibody-drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), composed of a humanized anti-EGFR monoclonal antibody linked to a topoisomerase I inhibitor as an effective payload through a cleavable linker. The product can specifically bind to EGFR on the tumor cell surface, and upon internalization, it releases the cytotoxic payload inside the cell, thereby exerting an antitumor effect. Head and neck squamous cell carcinoma (HNSCC) is an epithelial-derived malignant tumor located in the oral cavity, oropharynx, hypopharynx, and larynx. According to the GLOBOCAN 2024 global cancer statistics report released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there are approximately 845,000 new cases and about 392,000 deaths globally each year, while in China, there are about 87,000 new cases and approximately 48,000 deaths annually. This indicates that this type of tumor has a high malignancy grade and poses significant treatment challenges, with a 5-year overall survival rate of only 40% to 50%. HNSCC is a serious and life-threatening disease; despite the existence of standard treatment options, the therapeutic effect is limited and the prognosis for patients is poor. This product significantly improves the objective response rate in patients with relapsed or metastatic head and neck squamous cell carcinoma previously treated unsuccessfully with immunotherapy and platinum-based chemotherapy, and the responses are durable. The product demonstrates outstanding clinical value and is expected to provide better treatment options for patients upon approval for market release, showing good market potential. Currently, a pivotal Phase III clinical trial is underway evaluating this product as a monotherapy for relapsed or metastatic head and neck squamous cell carcinoma after failure of immunotherapy and platinum-based chemotherapy. Previously, this product had already received two designations of breakthrough therapy from the NMPA (excluding the current one), with the intended indications being: as a monotherapy for EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) after failure of EGFR-TKI and platinum-based chemotherapy; and for unresectable locally advanced or metastatic esophageal squamous carcinoma after failure of first-line treatment with platinum-based chemotherapy and immune checkpoint inhibitors (ICIs).