After decades of limited treatment options, the global fight against chronic hepatitis B is entering a new era. Two recent developments, including a landmark drug approval in China and promising late-stage trial results from an international collaboration, are bringing a functional cure for the 254 million people living with the virus closer than ever before. Chronic hepatitis B, which can lead to liver cirrhosis and cancer, caused an estimated 1.1 million deaths in 2022, according to the World Health Organization.
In October 2025, Chinese regulators approved Pegbing, the country’s first domestically developed drug aimed at a functional cure for hepatitis B. Developed by Amoytop Biotech, the injectable medication is designed for use alongside standard antiviral therapy. In a clinical trial, 31.4 percent of patients receiving the combination achieved a clinical cure 24 weeks after stopping all medications, a rate significantly higher than with conventional treatment. A functional cure means the virus remains undetectable in the blood and the patient clears hepatitis B surface antigens, dramatically reducing the risk of liver cancer.
Meanwhile, in the United States, the experimental therapy bepirovirsen has completed two global phase 3 trials involving more than 1,800 patients across 29 countries. Developed by Ionis Pharmaceuticals and licensed by GSK, this antisense oligonucleotide works by blocking the production of viral proteins, including the surface antigen linked to poor outcomes. Both trials met their primary endpoints, showing a statistically significant and clinically meaningful functional cure rate. GSK has announced plans to submit the drug for regulatory approval in early 2025, and if successful, bepirovirsen could become the first finite, six-month therapeutic option for chronic hepatitis B. A third candidate, AHB-137 from AusperBio, also entered phase 3 testing in China in July 2025.
These advances are driven by a better scientific understanding of the virus. Unlike hepatitis C, which is now curable in over 95 percent of cases, hepatitis B has proven stubborn because it leaves a persistent genetic template called cccDNA inside liver cells. The new wave of therapies aims to silence or eliminate this template, mimicking the natural resolution seen in patients who clear the virus on their own. Researchers are also developing lab techniques to track drug-resistant variants more accurately, which could speed up future drug discovery.
China’s national action plan aims to raise antiviral treatment rates for newly reported cases to at least 80 percent by 2030, while intensifying research into functional cures. With multiple candidates now in late-stage testing and one already approved, the prospect of a finite, curative treatment for chronic hepatitis B is no longer a distant hope. For the millions living with the physical and psychological burden of this disease, the path forward looks brighter than ever.