SYS6010 granted BTD by the NMPA in China for the treatment of patients with recurrent or metastatic HNSCC

CAR-T Digest - August 2020

01 September 2026: SYS6010 granted BTD by the NMPA in China for the treatment of patients with recurrent or metastatic HNSCC

CSPC Pharmaceutical Group announced that SYS6010 has received Breakthrough Therapy Designation from China’s NMPA for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma following failure of prior immunotherapy and platinum-based chemotherapy
The designation is supported by clinical data demonstrating a significant improvement in objective response rate, with durable clinical responses observed in patients with R/M HNSCC who had failed prior immunotherapy and platinum-based chemotherapy
The BTD addresses a major unmet need in R/M HNSCC, where treatment options after failure of immunotherapy and platinum-based chemotherapy remain limited and prognosis is poor, highlighting the need for more effective therapies
SYS6010 is an EGFR-targeting ADC comprising a humanized anti-EGFR monoclonal antibody conjugated to a topoisomerase I inhibitor payload through a cleavable linker, enabling targeted delivery and intracellular release of the cytotoxic payload
Strategically, this marks SYS6010’s third NMPA Breakthrough Therapy Designation, following designations in EGFR mutation-positive advanced NSCLC and unresectable locally advanced or metastatic ESCC, further expanding its development potential across multiple EGFR-expressing solid tumors