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HLX10 (serplulimab) in combination with nucleoside or nucleotide analogues (NAs) is an investigational therapeutic regimen developed by Shanghai Henlius Biotech for the treatment of chronic hepatitis B (CHB). Serplulimab is a recombinant humanized IgG4 monoclonal antibody that binds to the programmed cell death protein 1 (PD-1) receptor, blocking its interaction with PD-L1 and PD-L2 to revitalize exhausted T-cells. Nucleoside and nucleotide analogues, such as entecavir or tenofovir, are standard antiviral agents that inhibit the HBV DNA polymerase/reverse transcriptase, thereby suppressing viral replication. The combination is designed to address the immune tolerance characteristic of CHB, aiming to induce HBsAg seroconversion and a functional cure. Clinical development has progressed to Phase 2 trials evaluating safety and efficacy in patients with CHB who are already receiving stable NA therapy.
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