China OKs world's first functional cure for hepatitis B

China has approved the world's first domestically developed drug designed to achieve a functional cure for hepatitis B, marking a significant step in the global fight against the chronic liver infection.

The injectable drug, named Pegbing, was developed by Amoytop Biotech based in Xiamen, Fujian province. It has been approved for use in combination with antiviral medication to achieve sustained clearance of the hepatitis B surface antigen in adults with chronic hepatitis B, according to a notice recently released by the National Medical Products Administration.

The Chinese Foundation for Hepatitis Prevention and Control said the approval represents the world's first market authorization for a drug aimed at achieving a functional cure for hepatitis B, ushering in a new stage in the global battle against the viral infection.

Globally, hepatitis B affects about 254 million people and causes more than 1 million related deaths each year. China has about 75 million chronic hepatitis B patients.

A functional cure for hepatitis B is defined as the sustained loss of the hepatitis B surface antigen after treatment ends, in contrast to conventional therapies that suppress viral replication but do not eliminate the virus entirely.

Data from the foundation shows that more than 92 percent of liver cancer cases in China are caused by hepatitis B infection.

The incidence of liver cancer can be reduced to 10.7 percent among patients receiving antiviral treatment, compared with nearly 15 percent among those who do not. For those who achieve a clinical cure, the rate drops to just 1 percent.

"Such a significant difference underscores the critical importance of achieving clinical cure for hepatitis B patients," the foundation said.

Amoytop Biotech said that in a clinical trial evaluating the efficacy and safety of the injection combined with antiviral treatment, 31.4 percent of patients receiving the combination therapy achieved a clinical cure 24 weeks after discontinuing all medications. This rate is significantly higher than that observed in patients following conventional treatment regimens.

According to an action plan released last month by the National Disease Control and Prevention Administration and eight other government departments, China aims to raise the antiviral treatment rate for newly reported cases to at least 80 percent by 2030. The plan also emphasized intensified efforts in innovative drug research and development and the exploration of new solutions for the functional cure of hepatitis B.