Libevitug

Libevitug (HH-003) is a first-in-class human monoclonal antibody developed by Huahui Health for the treatment of chronic hepatitis B (CHB) and chronic hepatitis D (CHD). It specifically targets the pre-S1 domain of the hepatitis B virus (HBV) large envelope protein, which is essential for viral entry into hepatocytes via the sodium taurocholate co-transporting polypeptide (NTCP) receptor. By binding to this domain, Libevitug blocks the interaction between the virus and the NTCP receptor, thereby preventing the initiation of infection and the spread of both HBV and HDV. In January 2026, Libevitug received conditional approval from China's NMPA for the treatment of chronic HDV infection in adults, making it the first approved HDV treatment in China. For chronic HBV, Libevitug is currently in Phase IIa clinical trials, where it is being evaluated in HBeAg-negative patients and those with low-level viremia who are receiving background therapy with nucleos(t)ide reverse transcriptase inhibitors (NRTIs). The drug has been granted Breakthrough Therapy Designation by both the U.S. FDA and China's NMPA.

Other names

anti-PreS1 human monoclonal antibodyanti-PreS-1 human monoclonal antibodyanti-PreS 1 human monoclonal antibodyLibevitug injectionNRTIs-Huahui Health-chronic hepatitis B