China approves world's 1st domestic drug for hepatitis B cure

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 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 functional cure for hepatitis B, ushering in a new stage in the global battle against the infectious disease.

Globally, hepatitis B affects about 254 million people and causes over 1 million related deaths annually. 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 cessation, in contrast to conventional therapies that suppress viral replication but do not eliminate the virus entirely.