Beijing has taken a major step in liver disease treatment, as doctors issued the first prescription for a hepatitis D monoclonal antibody.
The medicine, named Libevitug, marks the first time a targeted antibody therapy has been used for viral hepatitis anywhere in the world.
The drug was developed by researchers from Tsinghua University in collaboration with Huahui Health. It received conditional approval from the National Medical Products Administration in January 2026 following a priority review, allowing it to reach patients more quickly.
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Hepatitis D is considered one of the most severe forms of viral hepatitis because it occurs alongside hepatitis B, worsening liver damage and increasing the risk of complications.
Of the 254 million people with chronic hepatitis B globally, about 5 percent have hepatitis D, and these patients have long lacked treatment options. This development is significant.
Libevitug, a hepatitis D monoclonal antibody drug, works by blocking both hepatitis B and D viruses from entering liver cells. Stopping the viruses at the entry stage prevents them from multiplying and causing further damage. This mechanism sets it apart from conventional treatments that act only after infection has already progressed.
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Clinical trials began in 2018, followed by a global multi-center study in 2023. Results showed reduced viral levels and improved liver function, especially for patients with cirrhosis. Doctors gained new confidence for advanced cases.
The importance of this hepatitis D monoclonal antibody drug goes beyond immediate treatment. It offers a targeted approach for co-infected patients, helps slow disease progression, and may reduce the risk of severe complications such as liver failure.
It also signals a shift toward antibody-based therapies for viral diseases, opening the door to future innovations.
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This approval is part of a broader trend, with China clearing 10 innovative drugs for market use this year. Among them, Libevitug stands out for addressing a long-neglected condition, offering new direction and hope for patients living with hepatitis D.
