Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) disclosed on Monday that it has received Japan's first global approval for Hibsago (bepirovirsen) as a functional cure for chronic hepatitis B in adults who have received at least six months of prior nucleos(t)ide analogue therapy and meet specified viral markers.

This approval makes Hibsago the first and only functional cure for chronic hepatitis B approved in Japan.

Approval was supported by phase III B-Well trials, which showed a 19% functional cure rate after six months of treatment among adults with HBsAg levels of up to 3,000 IU/ml, compared with no functional cures in the placebo group. A 26% functional cure rate was recorded among participants with HBsAg levels of up to 1,000 IU/ml.

The approval was accelerated through Japan's SENKU designation for innovative medicines addressing high unmet medical need. GSK is continuing regulatory submissions for bepirovirsen in other markets, including the US, with further decisions expected in the coming months.