CSPC Pharmaceutical Group Limited (HKEX: 01093) has announced the official initiation in China of a Phase III clinical study for its drug candidate SYS6010 in combination with Enlangsuba monoclonal antibody, targeting driver gene-negative non-small cell lung cancer (NSCLC).
The trial, designated SYS6010–022 (SYNSTAR-04), plans to enroll its first patient by July 2026.
SYS6010 is an antibody-drug conjugate (ADC) developed by the group that targets the epidermal growth factor receptor (EGFR). It is composed of a humanized anti-EGFR monoclonal antibody linked via a cleavable linker to a topoisomerase I inhibitor payload. The drug is designed to specifically bind to EGFR receptors on the surface of tumor cells, internalize, and then release its cytotoxic payload inside the cell to exert an anti-tumor effect.
Enlangsuba monoclonal antibody injection (recombinant anti-PD-1 fully human monoclonal antibody injection) is a humanized IgG4 variant monoclonal antibody that targets human programmed cell death protein-1 (PD-1) and is intended for the treatment of various malignant tumors in human organs and tissues.
The SYS6010–022 (SYNSTAR-04) study is a randomized, open-label, multi-center Phase III trial. Its primary objective is to evaluate the efficacy and safety of SYS6010 combined with Enlangsuba monoclonal antibody, compared to standard immunotherapy plus platinum-based chemotherapy, in patients with driver gene-negative, PD-L1 positive locally advanced or metastatic NSCLC.
Prior to this launch, the group received feedback in May 2026 from the Center for Drug Evaluation of China's National Medical Products Administration, agreeing to proceed with this clinical trial. Patient recruitment and screening activities are currently underway and progressing actively.
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