According to a report in China Daily on January 27, 2026
BEIJING — China has approved a first-of-its-kind treatment for chronic hepatitis D, a move widely seen as both a medical breakthrough and a milestone in the country’s ambition to develop globally competitive original medicines.
China’s National Medical Products Administration (NMPA) on Friday granted conditional approval to Libevitug, a monoclonal antibody developed by Beijing-based Huahui Health, for adult patients infected with the hepatitis D virus (HDV), including those with compensated cirrhosis. Chronic hepatitis D is considered the most severe form of viral hepatitis and has long lacked effective treatment options.
Libevitug works by blocking hepatitis B and D viruses from entering liver cells, targeting the PreS1 domain of the viral envelope. Because HDV relies on hepatitis B virus (HBV) to replicate, the disease occurs only in HBV carriers and is associated with accelerated liver damage and sharply elevated risks of cirrhosis and liver cancer.
According to the World Health Organization, an estimated 12 million people worldwide are coinfected with HBV and HDV, yet therapeutic options have remained extremely limited.
Strong Clinical Results and International Recognition
Huahui Health said clinical trials showed Libevitug significantly outperformed the control group across key indicators, including viral suppression, normalization of liver enzymes and improvement in liver stiffness.
After 48 weeks of treatment, the combined response rate reached 44.1%, while the virological response rate stood at 60%. The results were presented at the 2025 annual meeting of the American Association for the Study of Liver Diseases (AASLD) in November.
The drug had previously received breakthrough therapy designation from both China’s NMPA and the US Food and Drug Administration, underscoring its clinical potential and international relevance.
From Basic Science to Market: A Full-Chain Innovation
Beyond its immediate medical impact, Libevitug has attracted attention as a rare example of full-chain pharmaceutical innovation originating entirely in China — from fundamental discovery to clinical application and regulatory approval.
The scientific roots of the drug trace back to 2012, when a research team led by Li Wenhui at the National Institute of Biological Sciences (NIBS) in Beijing identified the sodium taurocholate cotransporting polypeptide (NTCP) as the key receptor enabling both HBV and HDV to enter liver cells. The discovery solved a question that had challenged scientists globally for nearly half a century and opened a new pathway for antiviral drug development.
Building on this breakthrough, Li partnered with antibody engineering specialist Sui Jianhua to translate the discovery into a therapeutic candidate. A prototype antibody was developed in 2015, and Huahui Health was later established to advance the program into clinical trials.
After more than a decade of sustained research and development, the drug has now reached the market.
Wang Xiaodong, director of NIBS Beijing and cofounder of BeOne Medicines, described Libevitug as a rare case in which a single team led the entire process “from zero to one, and from one to market.” Such end-to-end innovation, he said, remains uncommon even in mature pharmaceutical ecosystems.
A Broader Shift in China’s Drug Innovation Landscape
Libevitug’s approval comes amid accelerating momentum in China’s innovative drug sector. In 2025, the NMPA approved 76 innovative drugs, a record high, spanning chemical medicines, biologics and traditional Chinese medicines. About 70% of eligible new drugs approved in the first half of the year were subsequently included in China’s national reimbursement list, expanding patient access.
Industry observers attribute the surge to years of regulatory reform aimed at prioritizing innovation. Fast-track mechanisms — including breakthrough therapy designation, conditional approval and priority review — have shortened review timelines and reduced development uncertainty.
“China’s innovation system has proved effective in advancing drug development in a fast and cost-efficient way,” said Zhang Fangning, a partner at McKinsey & Company, citing a supportive macro environment, dense local ecosystems and a growing talent pool.
She cautioned, however, that first-in-class innovation still requires deeper translational research, long-term capital commitment and stronger links between academia and industry — areas that continue to evolve.
Global Implications
For global investors and pharmaceutical companies, Libevitug’s approval signals that China is no longer merely a fast follower in drug development but is increasingly capable of delivering original therapies with global clinical relevance.
As China seeks to move up the pharmaceutical value chain, cases like Libevitug suggest that the country’s life sciences sector is entering a new phase — one defined less by imitation and more by genuine scientific discovery and commercialization.