The Board of CSPC Pharmaceutical Group Limited (CSPC) has announced the formal initiation of a Phase Ib/II clinical trial (Protocol SYS6090-007) evaluating SYS6090 Injection in hepatocellular carcinoma at the first study centre in China.

SYS6090 is classified as a Class 1 therapeutic biological product. The recombinant, fully human fusion protein combines an anti-programmed cell death receptor-1 (PD-1) antibody with interleukin-15 (IL-15). The left arm blocks the PD-1/PD-L1 pathway, while the right arm engages IL-15 receptors, stimulating downstream signalling to activate and expand immune cells. Pre-clinical studies showed significant tumour-growth inhibition, favourable safety and tolerability, and stronger pharmacodynamic activity versus existing PD-1 monoclonal antibodies and IL-15 agents.

Regulatory approval to begin clinical studies was granted by China’s National Medical Products Administration in July 2026. The open-label, multi-centre Phase Ib/II trial will assess safety, tolerability and preliminary efficacy of SYS6090 combination therapy in patients with hepatocellular carcinoma. Subject recruitment and screening are underway.

Based on outcomes from this study, CSPC plans to advance SYS6090 into a Phase III trial to further confirm efficacy and safety in the same indication. The company is currently coordinating additional centres to expand patient enrolment across China.