SYS6010 received NMPA BTD in China for actionable genomic alteration-negative non-squamous NSCLC

CAR-T Digest - August 2020

15 September 2026: SYS6010 received NMPA BTD in China for actionable genomic alteration-negative non-squamous NSCLC

CSPC Pharmaceutical Group announced that SYS6010 has received BTD from China’s NMPA for recurrent or metastatic actionable genomic alteration-negative non-squamous non-small cell lung cancer following failure of prior immunotherapy and platinum-based chemotherapy
The designation is supported by clinical data showing a significant improvement in objective response rate and durable responses, with progression-free survival more than twice as long as standard treatment; a randomized, open-label, multicenter phase 3 trial is currently evaluating SYS6010 monotherapy in this setting
The designation addresses a major unmet need in actionable genomic alteration-negative non-squamous NSCLC, where patients who progress after first-line immunotherapy plus platinum-based chemotherapy predominantly rely on single-agent chemotherapy, which provides limited clinical benefit and survival improvement

SYS6010 is an EGFR-directed 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 in EGFR-expressing tumor cells
Strategically, this marks SYS6010’s fourth NMPA Breakthrough Therapy Designation, following designations in EGFR mutation-positive NSCLC, ESCC and R/M HNSCC, further broadening its development potential across multiple EGFR-expressing solid tumor indications