China has approved the world’s first drug aimed at a functional cure of hepatitis B — a disease that affects more than 250 million people worldwide. The new therapy, Pegbing, developed by Amoytop Biotech in Xiamen, marks a breakthrough after decades of treatments that could control the virus but rarely silence it.
A breakthrough in hepatitis-B treatment
Pegbing has been authorised by China’s National Medical Products Administration (NMPA) for use together with existing antiviral medication. The aim is to achieve a sustained loss of the hepatitis B surface antigen (HBsAg) after treatment ends — the internationally accepted definition of a functional cure.
The Chinese Foundation for Hepatitis Prevention and Control (CFHPC) describes the approval as the first of its kind globally.
Why the new drug matters
Around 254 million people worldwide live with chronic hepatitis B, including 75 million in China. Traditional therapies suppress viral activity but rarely remove viral proteins from the blood. That’s why a functional cure — an enduring disappearance of HBsAg — is considered a major step forward.
The disease burden is immense: more than 92% of liver-cancer cases in China are linked to hepatitis B.
In trials, 31.4% of patients treated with the new combination therapy achieved a functional cure 24 weeks after completing treatment — a far higher rate than existing therapies. The long-term implications are significant: liver-cancer risk could fall from nearly 15% to just 1% among patients who achieve a clinical cure.
“Such a significant difference underscores the critical importance of achieving clinical cure for hepatitis B patients,” the foundation said.
China’s public-health strategy
China has recently adopted a national action plan to scale up hepatitis-B treatment. The goal: ensure that over 80% of newly reported patients receive antiviral therapy by 2030. The plan also emphasises accelerating drug innovation and supporting research that aims for functional cures.
What this could mean for patients
If implemented widely, Pegbing could shift clinical practice from lifelong disease management to achieving durable cures in a notable share of patients. That means fewer cases progressing to cirrhosis or liver cancer, less pressure on health systems and a faster path to national elimination targets. Still open: affordability, access, international use, and long-term trial data. Those factors will determine how transformative this breakthrough becomes.
