Beijing:The world's first prescription for a groundbreaking monoclonal antibody treatment for the hepatitis D virus has been issued recently at a Beijing hospital, marking a milestone in global viral hepatitis care, Science and Technology Daily reported.
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, filling a long-standing treatment gap for one of the most severe forms of the disease.
China's National Medical Products Administration granted conditional approval in January 2026 following priority review.
Of the over 254 million chronic hepatitis B carriers worldwide, approximately 5 percent are co-infected with the hepatitis D virus, and patients with co-infection 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-center study launched in 2023 among patients with chronic co-infection.
Clinical results demonstrated significant efficacy in virological response and normalization of liver function, with particularly notable benefits for patients with cirrhosis.
This year, 10 innovative drugs have been approved for marketing in China.
