24th Aug 2026 09:20
(Alliance News) - GSK PLC on Monday reported two positive regulatory developments for its treatments of hepatitis and rectal cancer.
Japan's Ministry of Health, Labour & Welfare has approved Hibsago, whose generic name is bepirovirsen, as a functional cure for chronic hepatitis B virus infections "in adult patients who have received at least six months of prior nucleos(t)ide analogue therapy and meet pre-defined viral markers".
This marks "the first global approval for bepirovirsen, and the first and only functional cure treatment for CHB approved in Japan," GSK noted.
The Japanese approval was supported by results from the B-Well phase 3 trials, which showed an "unprecedented functional cure rates of 19%", compared to standard of care alone, which typically achieves only a 1% cure rate after one year of treatment, GSK said.
The London-based pharmaceuticals maker said it is advancing bepirovirsen across multiple jurisdictions, including the US, with decisions expected in coming months.
Separately, the US Food & Drug Administration has accepted GSK's supplemental biologics license application for Jemperli, or dostarlimab, for priority review.
The indication is for previously untreated stage 2 and 3 mismatch repair deficient/microsatellite instability-high locally advanced rectal cancer. Jemperli could eliminate the need for chemotherapy, radiation, and surgery for some patients, GSK said.
The FDA has set an action date of February 2027 for the application, which also is eligible for expedited review through the National Priority Voucher programme. This could result in an earlier FDA decision, GSK said.
GSK says the sBLA is based on positive data from the phase 2, single-arm AZUR-1 trial. This met its primary objective of a meaningful and sustained clinical complete response rate for 12 months with no detectable signs of cancer for at least one year.
GSK shares were down 0.5% to 1,909.50 pence early Monday in London.
By Tom Waite, Alliance News editor
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