The world’s first prescription for a monoclonal antibody treatment for hepatitis D has been issued in Beijing, filling a major treatment gap for the severe viral infection.
BEIJING: The world’s first prescription for a groundbreaking monoclonal antibody treatment for the hepatitis D virus has been issued at a Beijing hospital, marking a milestone in global viral hepatitis care.
Developed by a team from Tsinghua University and the Beijing-based biopharmaceutical company Huahui Health, the drug Libevitug is the first monoclonal antibody ever approved for viral hepatitis worldwide.
China’s National Medical Products Administration granted the drug conditional approval in January 2026 following a priority review.
The treatment fills a long-standing gap for one of the most severe forms of the disease, which affects patients co-infected with hepatitis B and D.
Of the over 254 million chronic hepatitis B carriers worldwide, approximately 5% are co-infected with the hepatitis D virus, and these patients have long lacked effective targeted therapies.
Libevitug is a monoclonal antibody that works by blocking hepatitis B and D viruses from entering liver cells.
Clinical trials for this drug began in 2018, with an international multi-centre study launched in 2023 among patients with chronic co-infection.
Clinical results demonstrated significant efficacy in virological response and normalisation of liver function, with particularly notable benefits for patients with cirrhosis.
This year, 10 innovative drugs have been approved for marketing in China.
