GSK has received its first global approval for its chronic hepatitis B drug and key support for a potential rectal cancer therapy, it announced on Monday.
The British pharmaceutical giant shared that bepirovirsen, to be branded as Hibsago, has been approved as the first and only functional cure for chronic hepatitis B in Japan – where it is estimated over 800,000 people live with the disease, according to the WHO.
The approval comes after successful late-stage trials proved the drug to be successful in helping one in five patients reach a functional cure for hepatitis B.
Bepirovirsen works by blocking viral DNA replication, lowing hepatitis B surface antigen levels in the blood and boosting the immune response for longer lasting control of the virus, tackling the disease three-fold.
As the first approved finite treatment course that can be used as an alternative to lifelong antiviral pills to achieve functional cure, it leads the way for a new wave of next-generation therapies.
GSK has predicted that the new drug could bring in over £2bn ($2.73bn) in peak annual sales, bringing it closer to its annual revenue goal of over £40bnby 2031.
The firm also announced that the FDA has committed to carrying out a priority review of another of its drugs, Jemperli (dostarlimab), as a potential treatment for a type of rectal cancer, alongside its existing approvals for specific endometrial cancer subtypes.
The FDA has assigned February 2027 as the action date for the rectal cancer review, with the program structure possibly yielding a decision earlier.
Jemperli, which is not currently approved anywhere in the world for the treatment of locally advanced rectal cancer, also received Breakthrough Therapy and Fast Track designations by the FDA.
These two regulatory wins for the company come just weeks after it launched a £1.9bn ($2.52bn) cost-savings effort to help fund its expanded late-stage study roster and deliver on CEO Luke Miels’ promise for faster drug development.
The restructuring is a major step by the company’s boss to reassure investors that GSK can navigate a looming patent deadline for its blockbuster HIV drug, dolutegravir, between 2028 and 2030.
HIV is currently the company’s leading specialty therapy area by revenue, but GSK said it now expects to start 25 late-stage studies by the end of 2026 in an effort to continue to expand pipelines in oncology and respiratory, immunology and inflammation.
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