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Getting the latest healthcare news for you
Getting the latest healthcare news for you
GSK's bepirovirsen (Hibsago) just became the first functional cure for chronic hepatitis B approved in Japan, while its cancer drug dostarlimab (Jemperli) scored FDA priority review for locally advanced rectal cancer. The hepatitis B approval is based on late-stage data showing nearly 1 in 5 patients achieved a functional cure. Both milestones mark significant steps forward for GSK's growing drug pipeline.
GSK is riding a wave of regulatory momentum. The British pharma giant announced that bepirovirsen — to be branded Hibsago — has been approved in Japan as the country's first and only functional cure for chronic hepatitis B. The approval is based on late-stage trial data showing the drug helped nearly one in five patients achieve a functional cure, offering a potential finite treatment course as an alternative to lifelong antiviral therapy.
Bepirovirsen works on three fronts: blocking viral DNA replication, reducing hepatitis B surface antigen levels in the blood, and boosting the immune response for longer-lasting disease control. GSK projects the drug could generate over £2 billion in peak annual sales, pushing the company closer to its £40 billion annual revenue target by 2031.
On the oncology front, GSK's dostarlimab (Jemperli) received FDA priority review as a potential treatment for locally advanced rectal cancer, with an action date set for February 2027 — though a decision could come sooner. Jemperli has also received both Breakthrough Therapy and Fast Track designations from the FDA for this indication.
By the Numbers:
Why it matters: A functional cure for hepatitis B — a disease affecting hundreds of millions globally — would be a landmark shift from lifelong management to finite treatment. Meanwhile, priority FDA review for dostarlimab in rectal cancer could open a new immunotherapy option for a cancer with limited treatment advances.
