SYS6010 has received another BTD in China for the treatment of patients with locally advanced or metastatic ESCC

CAR-T Digest - August 2020

11 May 2026: SYS6010 has received another BTD in China for the treatment of patients with locally advanced or metastatic ESCC

CSPC Pharmaceutical has secured another Breakthrough Therapy Designation from China’s NMPA for SYS6010, its EGFR-targeted ADC, this time in patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed platinum-based chemotherapy and immunotherapy
The designation highlights the urgent need for better therapies in advanced ESCC, especially after failure of first-line chemo-immunotherapy, where existing chemotherapy options continue to deliver limited efficacy and poor survival outcomes
SYS6010 has shown encouraging efficacy and a favorable safety profile in clinical studies, positioning the ADC as a potentially differentiated option compared with existing second-line standards for relapsed or refractory ESCC patients
CSPC has already initiated a Phase 3 confirmatory study for ESCC while simultaneously advancing multiple other Phase 3 trials for NSCLC and breast cancer, reflecting the company’s broader strategy to position SYS6010 across several solid tumor indications
With a previous BTD already granted in EGFR-mutant resistant NSCLC, the latest regulatory milestone further strengthens SYS6010’s profile as a key next-generation ADC asset within CSPC’s expanding oncology pipeline