Libevitug approved in China as First-in-Class treatment for Hepatitis D
Huahui Health announced that China National Medical Products Administration (NMPA) has granted conditional approval to its Libevitug injection for the treatment of chronic hepatitis D virus infection in adults with or without compensated cirrhosis.
Libevitug is a human monoclonal antibody targeting the PreS1 domain of the large envelope protein of hepatitis B virus (HBV) and hepatitis D virus (HDV), thereby blocking viral entry into hepatocytes.
As a groundbreaking achievement in viral hepatitis therapeutics, Libevitug is a first-in-class antibody therapeutic for viral hepatitis and the first approved treatment for HDV in China, addressing a major clinical gap in this field.
The drug previously received “Breakthrough Therapy Designation” from both the Center for Drug Evaluation (CDE) of the China NMPA and the U.S. Food and Drug Administration (FDA).
Clinical development of Libevitug began in 2018. Data from its pivotal registrational study (HH003-204) were presented as a Late-Breaker at the 2025 Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). This international, multicenter, randomized, controlled, open-label Phase IIb clinical trial demonstrated that Libevitug was significantly superior to the control group across primary and secondary efficacy endpoints including combined response rate, virological response, alanine aminotransferase (ALT) normalization, and improvement in liver stiffness. Libevitug also showed favorable tolerability and a satisfactory safety profile. At Week 48, the combined response rate reached 44.1%, along with an HDV virological response rate of 60% and an ALT normalization rate of 70%, and a significant, sustained improvement in liver stiffness.