GSK scores regulatory wins for chronic hepatitis B drug, cancer therapy

GSK

24/08/2026 08:05

Aug 24 (Reuters) - GSK GSK.L said on Monday its experimental chronic hepatitis B drug received its first global approval in Japan, and a key cancer therapy was granted a priority U.S. regulatory review as a possible rectal cancer treatment.   

Here are some details: 
The British drugmaker said bepirovirsen, to be branded as Hibsago, has been approved in Japan as the first and only functional cure for chronic hepatitis B in the country.
GSK said the approval was based on late-stage studies, which showed that the drug helped nearly one-in-five patients achieve a functional cure and raised hopes for a finite treatment course as an alternative to lifelong antiviral ​pills.
Bepirovirsen is designed to tackle hepatitis B in three ways: by blocking viral DNA replication, lowering hepatitis B surface antigen levels in the blood, and boosting immune response for longer-lasting control of the disease.
GSK has predicted bepirovirsen could bring in over £2 billion ($2.73 billion) in peak annual sales, taking it closer to its annual revenue target of more than £40 billion by 2031 as its pipeline development comes into focus.
Separately, GSK said the U.S. FDA will conduct a priority review of dostarlimab, marketed as Jemperli, as a potential treatment for a type of rectal cancer alongside existing approvals of specific endometrial ​cancer subtypes.
The FDA has assigned a February 2027 action date for the rectal cancer review, with the program structure possibly yielding a decision earlier as well. 
Jemperli, which had also received both Breakthrough Therapy and Fast Track designations by the FDA, is not currently approved anywhere in the world for locally advanced rectal cancer.
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 (Reporting by Ankita Bora in Bengaluru; Editing by Mrigank Dhaniwala)
 ((Ankita.Bora@thomsonreuters.com;))