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GSK's Hibsago Wins Japan Approval as First Functional Cure for Chronic Hepatitis B

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GSK secured Japan's first global approval for Hibsago (bepirovirsen), an antisense oligonucleotide treatment offering a functional cure for chronic hepatitis B, according to a statement on Monday.

The approval, accelerated under Japan's SENKU designation, was supported by phase III trials showing a 19% functional cure rate versus 1% with standard care.

Functional cure, which is defined as undetectable viral DNA and protein for at least 24 weeks, is associated with up to 89% lower liver cancer risk and 62% lower all-cause mortality.

GSK plans further regulatory filings in other markets, including the U.S., in the coming months.

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