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GSK plc announced that Japan's Ministry of Health, Labour and Welfare approved Hibsago (bepirovirsen) as a functional…
GLAXFGSK plc
GSK plc announced that Japan's Ministry of Health, Labour and Welfare approved Hibsago (bepirovirsen) as a functional cure for chronic hepatitis B in adult patients. This marks the first global approval for bepirovirsen and is the only such treatment approved in Japan. The approval was accelerated by SENKU designation. Clinical data from the B-Well phase III trials showed a 19% functional cure rate in adults with ≤3000 IU/ml HBsAg, compared to 1% for standard care. GSK expects regulatory decisions in other geographies, including the US, in the coming months. GSK plc is a global biopharmaceutical company focused on vaccines, specialty medicines, and consumer healthcare.