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HLX13 is a biosimilar of ipilimumab (Yervoy®) developed by Shanghai Henlius Biotech. It is a fully human, anti-CTLA-4, IgG1 monoclonal antibody with kappa light chain. HLX13 works by blocking T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumor cells. It can also reduce T-regulatory cell function and selectively deplete T-regulatory cells at the tumor site, leading to an increase in the intratumoral T-effector/T-regulatory cell ratio which drives tumor cell death. HLX13 is being developed for multiple indications including unresectable or metastatic melanoma, adjuvant treatment of melanoma, advanced renal cell carcinoma, and microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, and hepatocellular carcinoma.
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