CSPC PHARMA(01093.HK): Phase Ib/II Clinical Trial of SYS6090 Injection for Colorectal Cancer Initiated at First Study Centre in China

NewTimeSpace News: CSPC Pharmaceutical Group Limited (01093.HK) announced that the Phase Ib/II clinical trial (SYS6090-008) evaluating the combination therapy of SYS6090 Injection for colorectal cancer developed by the Group has officially been initiated at the first study centre in China. The product is a recombinant fully human anti-PD-1 fusion protein fused with IL-15, classified as Class 1 therapeutic biological product.

NewTimeSpace News: CSPC Pharmaceutical Group Limited (01093.HK) released a voluntary announcement on 3 August 2026. The Phase Ib/II clinical trial (SYS6090-008) investigating the combination regimen of SYS6090 Injection for colorectal cancer developed by the Group has been officially launched at the first study centre in China.

SYS6090 is a recombinant fully human anti-programmed cell death protein 1 (PD-1) fusion protein fused with interleukin-15 (IL-15), categorized as Class 1 therapeutic biological product. Its left arm targets PD-1-positive tumour-infiltrating immune cells to block immune suppression induced by PD-1/PD-L1 interaction. Meanwhile, the right arm binds to IL-15 receptors to activate downstream signalling pathways and further boost the activation and proliferation of relevant immune cells. Preclinical studies demonstrate that the candidate can significantly inhibit tumour growth with favourable safety and tolerability, and exhibits superior pharmacological activity compared with other PD-1 monoclonal antibodies and IL-15 agents.

The Group obtained the Clinical Trial Approval Notice issued by the NMPA in March 2026. The approved trial SYS6090-008 is an open-label, multi-centre Phase Ib/II study designed to assess the safety, tolerability and efficacy of the product combination regimen in participants with colorectal cancer. The Group will advance pivotal Phase III confirmatory clinical trials based on the study outcomes.

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