GSK's Hibsago Wins Japanese Approval for Chronic Hepatitis B Treatment

02:30 AM EDT, 08/24/2026 (MT Newswires) -- GSK (GSK.L) said Monday it received clearance in Japan for the use of Hibsago as a functional cure for chronic hepatitis B in adult patients, marking the drug's first-ever global approval. The pharmaceutical giant added that the approval from the Japanese Ministry of Health, Labour and Welfare was based on its B-Well phase 3 trials, in which patients who used Hibsago showed a statistically significant and clinically meaningful 19% functional cure response rate, compared with 1% for those treated with the current standard of care. Hibsago, or bepirovirsen, is indicated for patients who have received at least six months of analogue therapy and have pre-defined viral markers.