CSPC PHARMA (01093.HK): ADC candidate SYS6010 receives another Breakthrough Therapy designation in China for recurrent or metastatic head and neck squamous cell carcinoma

NewTimeSpace News: On 1 September 2026, CSPC Pharmaceutical Group Limited (stock code: 01093) announced that SYS6010, developed by the Group, has recently been granted another Breakthrough Therapy designation by the National Medical Products Administration (NMPA) of China, with the intended indication of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in patients who have failed prior immunotherapy and platinum-based chemotherapy.

SYS6010 is an antibody-drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), composed of a humanized anti-EGFR monoclonal antibody conjugated via a cleavable linker to a topoisomerase I inhibitor payload. It specifically binds to EGFR on tumor cell surfaces and releases the cytotoxic payload intracellularly after internalization. According to the GLOBOCAN 2024 global cancer statistics report by the International Agency for Research on Cancer of the World Health Organization, head and neck squamous cell carcinoma records approximately 845,000 new cases and 392,000 deaths globally each year, with approximately 87,000 new cases and 48,000 deaths annually in China, and a five-year overall survival rate of only 40% to 50%.

The announcement stated that the product has markedly improved the objective response rate in patients with recurrent or metastatic HNSCC who failed prior immunotherapy and platinum-based chemotherapy, with durable responses, and a pivotal Phase III clinical trial of the product as monotherapy for the indication is underway. The product has previously received two Breakthrough Therapy designations from the NMPA, for EGFR-mutant 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 cell carcinoma after failure of first-line platinum-based chemotherapy and immune checkpoint inhibitors.

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