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).

Guidelines from the World Health Organization (WHO) and the European Association for the Study of the Liver (EASL) consistently identify HDV–HBV co-infection as the most severe form of chronic viral hepatitis due to rapid progression towards liver cirrhosis, hepatocellular carcinoma and liver-related death. HDV is a satellite virus that depends on HBV's envelope proteins to complete its life cycle and therefore infects only individuals who are co-infected with HBV. Chronic HDV–HBV co-infection leads to a higher risk of cirrhosis and liver cancer compared to HBV mono-infection, accounting for approximately one in six cases of cirrhosis and one in five cases of liver cancer among people with HBV infection globally.

According to WHO, HDV affects nearly 5 percent (an estimated 12 million) of people who have a chronic infection with HBV. Given the severe consequences of HDV infection, WHO's 2024 Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection recommend that serological testing for anti-HDV antibodies may be performed for all individuals who are HBsAg positive, as the preferred approach to scale up access to HDV diagnosis and linkage to care. In China, with over 75 million patients living with chronic hepatitis B, limited HDV therapies, compounded by inadequate clinical awareness and low testing rates, have left patients with no treatment options, underscoring a pressing unmet medical need.

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 percent, along with an HDV virological response rate of 60 percent and an ALT normalization rate of 70 percent, and a significant, sustained improvement in liver stiffness.

"Libevitug demonstrates outstanding clinical efficacy and significantly improves liver stiffness, with particularly remarkable efficacy in patients with HBV/HDV-related cirrhosis," stated Professor Niu Junqi, principal investigator of the Libevitug (HH003-204) trial from the First Hospital of Jilin University. "This drug aligns with the core objectives of China's Action Plan for the Prevention and Control of Viral Hepatitis (2025–2030), which aims to improve diagnosis and treatment rates for viral hepatitis and reduce the incidence of liver cancer and mortality. We anticipate that Libevitug will help effectively lower the risk of disease progression to advanced severe diseases such as liver cancer, drive the standardization of HDV diagnosis and treatment in China, advance the goal of eliminating viral hepatitis as a public health problem by 2030, and contribute a scientifically robust and accessible solution from China to global hepatitis control efforts."

The development of Libevitug stems from a scientific breakthrough over a decade in the making. In 2012, a team at the National Institute of Biological Sciences, Beijing (NIBS) led by Dr. Li Wenhui, scientific founder of Huahui Health, identified the sodium taurocholate cotransporting polypeptide (NTCP) as the critical receptor for HBV and HDV infections—a world-first discovery solving a decades-long scientific mystery. This landmark achievement earned Dr. Li prestigious accolades, including the Baruch S. Blumberg Prize, the Future Science Prize, and the Distinguished Award in Hepatitis B Research, and opened a door for new drug development. In 2015, the lead molecule of Libevitug was developed through a collaboration between Dr. Sui Jianhua, co-founder of Huahui Health and an antibody engineering expert, and Dr. Li's team. "The global burden of viral hepatitis is immense," stated Dr. Sui. "We are pleased that Libevitug is the first monoclonal antibody approved in this field, effectively treating the most severe and progressive form of chronic viral hepatitis—HDV co-infection with HBV." Dr. Li added, "We are grateful for the invaluable support from all our partners and collaborators. The teams at Huahui Health and NIBS have worked together to complete the full-cycle of biomedical innovation from 'uncovering fundamental mechanism' to 'developing effective drugs', positioning us at the leading edge of this field and demonstrating our capability and commitment to tackling critical challenges in human health."

Dr. Chen Bin, Chief Executive Officer of Huahui Health, stated, "The successful approval of Libevitug fulfills our commitment to building a world-class translational and clinical development platform dedicated to delivering innovative therapies for patients worldwide. We have established an integrated R&D system covering the entire drug development process, with a pipeline expanding from HDV and HBV to oncology and other liver diseases, comprising eight core asset candidates. Going forward, we remain steadfastly committed to our vision of 'Original in China, Benefiting the Globe', leveraging science to safeguard global healthcare in infectious and liver diseases."