Biokangtai’s 60 μg Hepatitis B Vaccine Approved for Clinical Trial in Relapse Prevention

Biokangtai has received NMPA approval to initiate a clinical trial of its 60 μg recombinant hepatitis B vaccine in patients who have achieved functional cure of chronic hepatitis B, aiming to prevent HBsAg relapse after treatment cessation.

By inducing high and durable anti-HBs antibody responses, the vaccine is designed to reinforce immune memory and help sustain functional cure, addressing a key unmet need in current HBV management.

With nearly 300 million people living with chronic hepatitis B globally, relapse prevention remains a critical gap. This program explores a potential post-treatment maintenance strategy that could complement existing therapies and expand long-term patient benefit worldwide——an approach expected to become a global innovative strategy.