GSK has secured its first global regulatory approval for Hibsago(bepirovirsen), marking the debut of a functional cure option for chronic hepatitis B (CHB) anywhere in the world. Japan’s Ministry of Health, Labour and Welfare cleared the antisense oligonucleotide for adults who have completed at least six months of prior nucleoside/nucleotide analogue therapy and meet specific viral marker criteria.
The approval carries significant weight for Japan, where nearly a million people live with CHB and the disease drives roughly 4,000 deaths each year. Review was fast-tracked under the country’s SENKU pathway, reserved for therapies addressing serious unmet medical needs.
Backing the decision, pooled results from the B-Well Phase III program showed a 19% functional cure rate among patients with baseline HBsAglevels at or below 3000 IU/ml — a sharp contrast to the roughly 1% typically seen with standard antiviral suppression alone. Among a narrower subgroup with lower baseline antigen levels, cure rates climbed to 26%. Functional cure is defined as sustained loss of detectable virus and surface antigen for six months after stopping treatment, meaning patients could potentially be freed from indefinite drug dependence.
GSK, which licensed the compound from Ionis, said filings are progressing in additional markets, including the United States, with outcomes anticipated in coming months. Company leadership described the milestone as a turning point for hepatitis B care and its broader liver-disease pipeline, which also spans MASH and alcohol-related liver conditions.
Written By: Sayan Das
Graphics by: Pramit Hazra
