On August 3, CSPC Innovation Pharmaceutical Co., Ltd. (Stock Code: 300765.SZ) announced that its holding subsidiary CSPC Giant Stone Biopharmaceutical Co., Ltd. (hereinafter referred to as “Giant Stone Bio”) has recently initiated a Phase Ib/II clinical trial (SYS6090‑008) to evaluate the safety, tolerability and efficacy of combination therapy with SYS6090 Injection in participants with advanced or metastatic colorectal cancer.
SYS6090 Injection is classified as Class 1 therapeutic biological product. It is a recombinant fully‑human anti‑PD‑1 fusion protein fused with IL‑15. Via its left arm, it targets PD‑1‑positive tumor‑infiltrating immune cells and blocks the immunosuppressive effect induced by the interaction between PD‑1 and PD‑L1. Via its right arm, it binds to the IL‑15 receptor to activate downstream signaling pathways, further promoting the activation and proliferation of relevant immune cells. Preclinical studies have demonstrated that SYS6090 Injection can significantly inhibit tumor growth with favorable safety and tolerability, and exhibits superior pharmacodynamic activity compared with other anti‑PD‑1 monoclonal antibodies and IL‑15‑based agents.In March 2026, Giant Stone Bio received the Drug Clinical Trial Approval Notice for SYS6090 Injection issued by the National Medical Products Administration (NMPA). Following approval, Giant Stone Bio has recently launched the SYS6090‑008 clinical trial.
The newly‑initiated clinical trial SYS6090‑008 is an open‑label, multicenter Phase Ib/II clinical trial designed to evaluate the safety, tolerability and efficacy of combination therapy with SYS6090 Injection in participants with colorectal cancer. Going forward, the Company will further advance the Phase Ⅲ confirmatory clinical study of combination therapy with SYS6090 Injection in colorectal‑cancer participants based on findings from this trial, so as to further validate the clinical value of the SYS6090 Injection combination regimen.Participant recruitment and screening for the SYS6090‑008 study are currently underway.