GSK plcGSK's hepatitis B drug Hibsago received first global approval in Japan and FDA granted priority review to Jemperli, both regulatory milestones.

GSK plc has reached two regulatory milestones: its hepatitis B treatment Hibsago, also known as bepirovirsen, received its first global approval in Japan, and the FDA granted priority review to its cancer therapy Jemperli for locally advanced rectal cancer. Hibsago is the first and only treatment approved in Japan to deliver a functional cure for chronic hepatitis B, with late-stage studies showing nearly one in five patients achieved that outcome. GSK forecasts peak annual sales of more than £2 billion, approximately $2.73 billion, for Hibsago, contributing to its goal of over £40 billion in annual revenue by 2031. The FDA has set an action date for Jemperli in February 2027, though GSK notes the program's structure may allow an earlier decision. Jemperli already holds Breakthrough Therapy and Fast Track designations for this use, and an approval would expand its indications beyond endometrial cancer subtypes.
GSK plcGSK's hepatitis B drug Hibsago received first global approval in Japan and FDA granted priority review to Jemperli, both regulatory milestones.