Huahui Health announced that China’s National Medical Products Administration (NMPA) has granted conditional approval for Libevitug, a human monoclonal antibody developed for adults with chronic hepatitis D virus (HDV) infection, with or without compensated cirrhosis. Libevitug targets the PreS1 domain of the large envelope protein shared by hepatitis B virus (HBV) and HDV, thereby blocking viral entry into hepatocytes. It is the first antibody therapy for viral hepatitis and the first approved treatment for HDV in China, marking a major advance in the management of a disease for which no authorized therapies previously existed. The drug has also received Breakthrough Therapy Designation from both the China NMPA’s Center for Drug Evaluation and the U.S. FDA.
International 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 aggressive form of chronic viral hepatitis, characterized by rapid progression to cirrhosis, hepatocellular carcinoma, and liver-related mortality. HDV is a satellite virus that requires HBV envelope proteins to replicate and infects only individuals already infected with HBV. Globally, co-infection is responsible for about one in six cases of cirrhosis and one in five cases of liver cancer among individuals with chronic HBV.
WHO estimates that around 12 million people—approximately 5 percent of those with chronic HBV—are infected with HDV. Given the high disease burden and poor clinical outcomes, WHO’s 2024 guidelines recommend anti-HDV antibody testing for all HBsAg-positive individuals to expand access to diagnosis and timely care. In China, where more than 75 million people live with chronic HBV, limited awareness of HDV, low testing rates, and an absence of approved treatment options have created a substantial unmet medical need.
Libevitug entered clinical development in 2018. Results from its pivotal Phase IIb registrational trial (HH003-204)—an international, multicenter, randomized, controlled, open-label study—were presented as a Late-Breaker at the 2025 AASLD Annual Meeting. The trial showed that Libevitug was significantly superior to the control arm across all primary and secondary endpoints, including combined response, HDV virological response, ALT normalization, and improvement in liver stiffness, while demonstrating favorable safety and tolerability. At Week 48, the combined response rate reached 44.1%, the HDV virological response 60%, ALT normalization 70%, and improvements in liver stiffness were both significant and sustained.
“Libevitug delivers robust antiviral efficacy and marked improvements in liver stiffness, with especially notable benefits for patients with HBV/HDV-related cirrhosis,” said Professor Niu Junqi, principal investigator of the HH003-204 trial at the First Hospital of Jilin University. “Its approval supports national goals outlined in China’s Action Plan for the Prevention and Control of Viral Hepatitis (2025–2030)—improving diagnosis and treatment rates, reducing liver cancer incidence and mortality, and accelerating progress toward eliminating viral hepatitis as a public health threat by 2030.”
Libevitug’s development is rooted in a landmark scientific discovery. In 2012, a team led by Dr. Li Wenhui at the National Institute of Biological Sciences, Beijing (NIBS) identified NTCP as the functional receptor for HBV and HDV—resolving a decades-long research challenge and laying the foundation for new therapeutic strategies. This discovery earned Dr. Li several prestigious awards, including the Baruch S. Blumberg Prize, the Future Science Prize, and the Distinguished Award in Hepatitis B Research. In 2015, Dr. Li and Dr. Sui Jianhua, co-founder of Huahui Health and an expert in antibody engineering, developed the lead molecule that evolved into Libevitug.
“HDV–HBV co-infection represents the most severe form of chronic viral hepatitis,” noted Dr. Sui. “We are proud that Libevitug stands as the first monoclonal antibody approved in this domain.” Dr. Li added that completing the full continuum from fundamental mechanistic discovery to drug development illustrates “China’s growing capacity to address major global health challenges.”
Huahui Health CEO Dr. Chen Bin emphasized that Libevitug’s approval reflects the company’s commitment to building a comprehensive translational and clinical development platform. Huahui now maintains an integrated R&D pipeline spanning HDV, HBV, oncology, and other liver diseases, with eight core therapeutic candidates in development. “Our mission,” he stated, “is to pursue innovation ‘Originated in China, Benefiting the Globe,’ advancing science-driven solutions for infectious and liver diseases worldwide.”
