Kangtai bio gets approval for hepatitis b vaccine clinical trials

Shenzhen Kangtai Biological Products Co., Ltd. announced today that its recombinant hepatitis B vaccine (Saccharomyces cerevisiae) (60µg) has received approval from the National Medical Products Administration for a new indication. The approval allows for clinical trials to prevent HBsAg recurrence in individuals functionally (clinically) cured of chronic hepatitis B. The company will proceed with the clinical trial, which is valid for three years.

This new application targets 16-64 year olds who are clinically cured of chronic hepatitis B, aiming to increase their HBsAb seroconversion rate and antibody levels, thereby preventing the recurrence of hepatitis B surface antigen after clearance. This initiative addresses the risk of recurrence observed in clinically cured patients despite advancements in hepatitis B treatment. Currently, no other hepatitis B vaccine approved globally specifically targets the prevention of HBsAg recurrence in functionally cured chronic hepatitis B patients.

The company stated that the successful development of this vaccine would enrich its product portfolio, enhance its core competitiveness, and solidify its market position. However, vaccine development is a complex and lengthy process with inherent uncertainties regarding clinical trial progress, results, and eventual market launch.