GSK has secured its first global regulatory approval for bepirovirsen, branded Hibsago, in Japan as a functional cure for chronic hepatitis B, marking a historic milestone for the drug in that country.

Phase III B-Well results show about 19% of adults with low HBsAg levels achieved a functional cure after bepirovirsen treatment, versus roughly 1% with current standard therapies after one year.

This approval represents bepirovirsen7s first global regulatory clearance and the first and only functional cure approved for CHB in Japan, underpinned by B-Well trial data demonstrating a 19% functional cure rate in a subset of patients compared with standard care.

The global regulatory landscape includes Fast Track/Breakthrough Designations from the US FDA and Breakthrough/Priority Designations in China, with US decisions anticipated in the coming months.

GSK continues to build its hepatology portfolio around CHB, MASH, and ALD, leveraging immune-system biology and advanced technologies.

GSK projects peak annual sales for bepirovirsen exceeding $2.7 billion, contributing to a broader goal of over $40 billion in annual revenue by 2031 as the pipeline develops.

GSK is pursuing additional regulatory decisions in other countries and positions bepirovirsen as part of an expanding hepatology portfolio.

Globally, about 240 million people live with CHB, with significant mortality from cirrhosis and liver cancer; in 2024, only 27% were diagnosed and 4.3% treated, according to WHO data in the Global Hepatitis Report 2026.

Ionis Pharmaceuticals, based in Carlsbad, California, co-develops and licenses bepirovirsen, combining Ionis7 antisense technology with GSK7s development and commercialization strength.

In the US, dostarlimab (Jemperli) has received a priority review for a type of locally advanced rectal cancer, with an FDA action date set for February 2027, though it is not approved for this indication anywhere yet.

Jemperli previously secured Breakthrough Therapy and Fast Track designations but has no current approval for locally advanced rectal cancer.

GSK notes ongoing regulatory submissions for bepirovirsen across multiple regions, with China aiming for rapid rollout if approved, supported by Sino Biopharm via CTTQ.