New hepatitis D treatment gets green light

China has approved a first-of-its-kind treatment for chronic hepatitis D, marking both a clinical breakthrough and a symbolic milestone for the country's push to develop globally competitive original medicines.

The National Medical Products Administration on Friday granted conditional approval to Libevitug, a monoclonal antibody developed by Beijing-based Huahui Health, for adult patients with chronic hepatitis D virus infection, including those with compensated cirrhosis. The drug targets a disease long regarded as one of the most severe and least treatable forms of viral hepatitis.

Libevitug works by blocking hepatitis B and D viruses from entering liver cells, targeting the PreS1 domain of the viral envelope. Because HDV depends on the hepatitis B virus to replicate, chronic hepatitis D occurs only in HBV carriers and is associated with accelerated liver damage and a sharply higher risk of cirrhosis and liver cancer.

The World Health Organization estimates that around 12 million people globally are coinfected with HBV and HDV, yet effective treatment options have remained limited.

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 in November.

The drug had previously received breakthrough therapy designation from China's drug regulator and the US Food and Drug Administration, underscoring its clinical potential.

Beyond its immediate medical impact, Libevitug is drawing attention as a marker of China's evolving innovation capacity. From identifying the viral infection mechanism to selecting the drug target and developing the antibody, the entire research and development process was led domestically.

The scientific roots of the drug date back to 2012, when a team led by Li Wenhui at the National Institute of Biological Sciences, Beijing, identified the sodium taurocholate cotransporting polypeptide as the key receptor allowing both HBV and HDV to enter liver cells. The discovery solved a question that had challenged scientists worldwide for nearly half a century and opened a new pathway for drug development.

Building on that breakthrough, Li teamed up with antibody engineering specialist Sui Jianhua from the institute to translate the finding into a therapeutic candidate. The prototype antibody was developed in 2015, and Huahui Health was subsequently established to push the program into clinical development. After more than a decade of sustained research, the drug has now reached the market.

Wang Xiaodong, director of the National Institute of Biological Sciences, Beijing, and a cofounder of BeOne Medicines, described Libevitug as a rare example of full-chain innovation, in which a single team led the process from fundamental discovery through to clinical application. Such "from zero to one, and from one to market" breakthroughs remain uncommon globally, he said.

Libevitug's approval comes as China's innovative drug sector gathers pace. In 2025, the NMPA approved 76 innovative drugs, a record high, spanning chemical medicines, biologics and traditional Chinese medicines. Access has also expanded, with about 70 percent of eligible new drugs approved in the first half of the year successfully entering the national reimbursement list.

Industry observers attribute the momentum to years of regulatory reform aimed at prioritizing innovation. Fast-track pathways — including breakthrough therapy designation, conditional approval and priority review — have shortened review timelines and reduced uncertainty for developers.

Zhang Fangning, a partner at McKinsey & Company, said in a previous interview with China Daily that "China's innovation system has proved effective in advancing drug development in a fast and cost-efficient way, supported by an innovation-conducive macro environment, a dense local ecosystem and a strong talent base".

She, however, said that first-in-class innovation still depends on deeper translational research, long-term investment and stronger links between academia and industry — areas that are still evolving.

lijing@chinadaily.com.cn