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GSK announces Canadian authorization of bepirovirsen for a defined chronic hepatitis B population

Company / institutional announcement · GSK Canada

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Site published: 2026-11-08 · Updated: 2026-11-08

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What changed

GSK announced Canadian authorization of Hibsago (bepirovirsen), an antisense oligonucleotide, for noncirrhotic adults with chronic hepatitis B after at least six months of nucleos(t)ide analogue therapy, HBV DNA below 90 IU/mL, and HBsAg at or below 3,000 IU/mL. The company expects Canadian supply in early 2027. Functional cure denotes sustained off-treatment viral suppression, rather than eradication of all viral material.

Why it may matter

Potential business implication: the authorization expands ASO commercialization opportunities and highlights the importance of quantitative viral-marker testing for patient selection.

The interpretation above is analysis, not a conclusion attributed to the original source.

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