GSK notches major regulatory milestones in Japan and US

(Sharecast News) - Drugmaker GSK notched two major regulatory milestones on Monday, with Japan granting the first global approval for its hepatitis B therapy Hibsago and US regulators accepting a priority review for Jemperli in previously untreated locally advanced rectal cancer. GSK said Japan's Ministry of Health, Labour and Welfare had cleared Hibsago (bepirovirsen) as the world's first functional‑cure treatment for chronic hepatitis B in adults who have received at least six months of nucleos(t)ide analogue therapy and meet specific viral criteria.

The decision marks the first approval for the antisense oligonucleotide and comes as Japan faces almost one million CHB cases and around 4,000 related deaths annually.

GSK said the green light was backed by phase III data showing functional cure rates of 19% in patients with ≤3,000 IU/ml HBsAg, far above the roughly 1% typically achieved with standard therapy. It also highlighted that he approval was accelerated under Japan's SENKU designation for medicines addressing high unmet need.

Separately, the US Food and Drug Administration accepted a priority review for a supplemental biologics licence application for Jemperli (dostarlimab) in mismatch‑repair‑deficient/microsatellite‑instability‑high stage II and III rectal cancer.

The FDA set a February 2027 PDUFA date, with the filing also eligible for expedited assessment via the National Priority Voucher programme and reviewed under Project Orbis.

GSK added that the submission was supported by positive phase II AZUR‑1 data showing a sustained 12‑month clinical complete response with no detectable cancer for at least a year, with safety broadly consistent with prior experience. It said the results point to the potential for Jemperli, if approved, to become the first immunotherapy capable of eliminating or delaying the need for chemotherapy, radiation or surgery for some patients.

As of 0850 BST, GSK shares were down 0.55% at 1,908p.









Reporting by Iain Gilbert at Sharecast.com

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