CSPC Pharmaceutical Group Limited (CSPC Pharma) announced that its investigational antibody–drug conjugate (ADC) SYS6010 has received a Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in patients who have progressed after immunotherapy and platinum-based chemotherapy.

SYS6010 is a humanised epidermal growth factor receptor (EGFR)-targeting ADC that links an anti-EGFR monoclonal antibody to a topoisomerase I inhibitor through a cleavable linker. By binding to EGFR on tumour cells and releasing its cytotoxic payload intracellularly, the candidate has shown a marked improvement in objective response rate (ORR) with durable responses in the target patient population.

HNSCC remains a high-burden malignancy: according to GLOBOCAN 2024 data, global incidence reaches approximately 0.85 million new cases and 0.39 million deaths annually, while China accounts for about 0.09 million new cases and 0.05 million deaths each year. Five-year overall survival for this cancer type is estimated at 40%–50%, underscoring the need for more effective therapies.

The newly granted BTD is the third for SYS6010. Previous NMPA designations cover: 1) Monotherapy in EGFR mutation–positive advanced non-small cell lung cancer post-failure of EGFR tyrosine kinase inhibitors and platinum chemotherapy. 2) Treatment of unresectable locally advanced or metastatic esophageal squamous cell carcinoma after first-line platinum chemotherapy and immune checkpoint inhibitors.

A pivotal Phase III trial evaluating SYS6010 as monotherapy in R/M HNSCC patients who have failed both immunotherapy and platinum chemotherapy is currently in progress. Approval of SYS6010 could establish an additional treatment option for this hard-to-treat patient segment and expand CSPC Pharma’s oncology portfolio.