BEIJING, Jan. 27, 2026 /PRNewswire/ — Huahui Health announced that China’s National Medical Products Administration (NMPA) has granted conditional approval to its Libevitug injection for chronic hepatitis D virus (HDV) infection in adults with or without compensated cirrhosis. Libevitug is a human monoclonal antibody targeting the PreS1 domain of hepatitis B virus (HBV) and HDV envelope proteins, blocking viral entry into hepatocytes. As a groundbreaking advance in viral hepatitis care, it is China’s first approved HDV therapy and a first-in-class antibody for viral hepatitis, addressing a critical clinical gap.
Libevitug Injection
According to the World Health Organization (WHO), HDV affects nearly 5% (an estimated 12 million) of people with chronic HBV infection. HDV–HBV co-infection is considered the most severe form of chronic viral hepatitis due to more rapid progression towards hepatocellular carcinoma and liver-related death.
Libevitug was previously granted “Breakthrough Therapy Designation” by China’s NMPA and the U.S. FDA. Data from its pivotal registrational study (HH003-204) were presented as a Late-Breaker Abstract 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, virological response, alanine aminotransferase (ALT) normalization rate, and improvement in liver stiffness. The drug also showed favorable tolerability and a satisfactory safety profile. At Week 48, the combined response rate reached 44.1%, along with an HDV RNA virological response rate of 60% and an ALT normalization rate of 70%, and a significant, sustained improvement in liver stiffness. Libevitug is poised to provide a novel and accessible treatment option for hepatitis D patients worldwide.
Huahui Health is dedicated to developing first-in-class and best-in-class therapies, with a strategic focus on viral hepatitis, liver diseases, and oncology. It has established an integrated R&D system covering the entire drug development process, enabling it to continuously deliver breakthrough therapies for patients across the globe.
About Huahui Health
Huahui Health is a biopharmaceutical company headquartered in Beijing, dedicated to innovating breakthrough therapies in virology, hepatology and oncology through its proprietary, world-class drug development platforms.
For more information, please visit www.huahuihealth.com.
