China Approves First Hepatitis D Drug After 13-Year Quest

After more than a decade of research, scientists in China have delivered a breakthrough for a disease that has stumped doctors worldwide for nearly 50 years.

China's drug regulator approved Libevitug on Friday, the first treatment of its kind for chronic hepatitis D. The disease affects 12 million people globally and is considered one of the most severe forms of viral hepatitis, often leading to rapid liver damage, cirrhosis, and cancer.

The new drug works by stopping hepatitis B and D viruses from entering liver cells. Because hepatitis D depends on hepatitis B to replicate, people with both infections face accelerated liver damage and dramatically higher cancer risks.

Clinical trials showed impressive results. At 48 weeks, 60 percent of patients had a viral response, and 44 percent showed combined improvements across multiple health markers including normalized liver enzymes and reduced liver stiffness.

The journey started in 2012 when scientist Li Wenhui and his team at the National Institute of Biological Sciences in Beijing identified the exact receptor that allows these viruses to enter liver cells. That discovery solved a mystery that had puzzled researchers worldwide for half a century.

Li partnered with antibody specialist Sui Jianhua to turn that finding into an actual medicine. They developed the prototype antibody in 2015, founded Huahui Health to bring it to patients, and pushed through years of testing and development.

Why This Inspires

This story represents something rare in medical innovation: a complete journey from laboratory discovery to patient treatment, all led by a single team. Wang Xiaodong, director of the National Institute of Biological Sciences, calls it a "from zero to one, and from one to market" breakthrough that remains uncommon anywhere in the world.

The approval signals China's growing strength in developing original medicines, not just copying existing ones. In 2025, China approved a record 76 innovative drugs, and about 70 percent of new drugs approved in the first half of the year made it onto the national reimbursement list, making them accessible to patients who need them.

Both Chinese regulators and the U.S. Food and Drug Administration had previously granted Libevitug breakthrough therapy status, recognizing its potential to help patients with limited options.

For millions living with hepatitis D, a disease that once meant watching their liver deteriorate with few weapons to fight back, effective treatment is finally within reach.