China approves pioneering treatment for hepatitis D

China's drug regulator has granted conditional approval to Huahui Health's Libevitug injection for the treatment of the chronic hepatitis D virus infection in adults, the company said on Friday.

The drug, which could fill a long-standing treatment gap for one of the most severe forms of viral hepatitis, has been approved for patients with or without compensated cirrhosis. Libevitug is a monoclonal antibody that works by blocking hepatitis B and D viruses from entering liver cells, targeting the PreS1 domain of the viral envelope.

The World Health Organization estimates that nearly 5 percent, or approximately 12 million people, of the 254 million people living with chronic Hepatitis B worldwide are also infected with Hepatitis D.

HDV is a "defective" virus that requires HBV to replicate, making chronic HDV only occur in HBV carriers. This co-infection significantly accelerates liver disease, increasing the risk of cirrhosis and liver cancer.

Huahui Health said clinical trial data showed Libevitug significantly outperformed a control group across key indicators, including viral response, normalization of liver enzymes and improvement in liver stiffness. At 48 weeks, the combined response rate reached 44.1 percent, with a virological response rate of 60 percent. The results were presented at the 2025 annual meeting of the American Association for the Study of Liver Diseases.

The drug had previously received breakthrough therapy designation from both China's National Medical Products Administration and the US Food and Drug Administration, the company said, underscoring its potential role in improving hepatitis diagnosis and treatment and supporting broader efforts to reduce liver disease and related deaths.