GlaxoSmithKline said on Monday it received the first global approval for its experimental hepatitis B drug bepirovirsen in Japan, where it will be marketed as Hibsago. The approval marks the first functional cure for chronic hepatitis B available in the country, based on late-stage trials showing nearly one in five patients achieved a functional cure.
Separately, the U.S. Food and Drug Administration assigned a priority review to GSK's cancer therapy dostarlimab, branded as Jemperli, for the treatment of locally advanced rectal cancer. The FDA set a target action date of February 2027, though an earlier decision is possible under the program's structure. Jemperli is already approved in specific endometrial cancer subtypes but has no global approvals for rectal cancer.
The FDA previously granted dostarlimab both Breakthrough Therapy and Fast Track designations for the rectal cancer indication. GSK did not disclose the review's classification status in its announcement.
Bepirovirsen is projected to generate peak annual sales exceeding £2 billion, or roughly $2.73 billion, according to GSK's forecasts. The company targets total annual revenue of more than £40 billion by 2031, though it did not link the projections to the new approvals or review decisions.
GSK, listed on the London Stock Exchange under ticker LON:GSK, did not provide additional details on commercialization timelines for Hibsago or the regulatory pathway for dostarlimab in the rectal cancer indication.
