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GC5103
- Development stage
- Phase 3
- Lead developer
- GC Biopharma
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
- Administration
- Intravenous
01
Overview
**GC5103 (Lenvervimab)** is a recombinant hepatitis B immunoglobulin developed by GC Biopharma for preventing hepatitis B virus reinfection in post-liver transplant patients. It functions as a human monoclonal antibody that neutralizes HBV by binding to hepatitis B surface antigen (HBsAg), providing passive immunity through intravenous administration. Currently under investigation in a Phase 3 trial (NCT05686759) comparing undiluted versus diluted infusion, focusing on safety endpoints like adverse events and efficacy measures such as HBsAg positivity rates and anti-HBs titers.[1][5][7][9]
- Brand names
- I.V.-Hepabig injHepabig
- Other names
- LenvervimabGC-1102GC1102GC 1102HepaBig GeneRecombinant Hepatitis B Human Immunoglobulin - Green-Cross
02
Targets
HBsAg (Hepatitis B surface antigen)
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