2026/ 06/27

CSPC Innovation Initiates Phase III Clinical Trial of SYS6010

On June 26, CSPC Innovation Pharmaceutical Co., Ltd. (stock code: 300765.SZ) released an announcement stating that its holding subsidiary CSPC Jushi Biopharmaceutical Co., Ltd. (hereinafter referred to as "Jushi Bio") has recently initiated a randomized, open-label, multicenter Phase III clinical trial of SYS6010 combined with Enlangumab as first-line therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) with negative driver genes and positive PD-L1 expression.


SYS6010 is an antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) developed by Jushi Bio. It consists of a humanized anti-EGFR monoclonal antibody conjugated via a cleavable linker to a topoisomerase I inhibitor payload. The agent can specifically bind to EGFR receptors on the surface of tumor cells; after internalization, cytotoxic payloads are released intracellularly to exert anti-tumor efficacy.


Enlangumab Injection (Recombinant Fully Human Anti-PD-1 Monoclonal Antibody Injection) is a humanized IgG4 variant monoclonal antibody targeting human programmed cell death protein 1 (PD-1), indicated for the treatment of malignant tumors in multiple human organs and tissues.


In May 2026, Jushi Bio received review comments from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), which approved the initiation of clinical trial SYS6010-022 (SYNSTAR-04). This randomized, open-label, multicenter Phase III study is designed to evaluate the efficacy and safety of SYS6010 plus Enlangumab as first-line treatment in subjects with locally advanced or metastatic NSCLC featuring negative driver genes and positive PD-L1 expression. Subject recruitment and screening are currently in active progress.