GlaxoSmithKline (GSK) reported two major regulatory milestones on Monday. The British pharmaceutical company said its experimental chronic hepatitis B treatment, bepirovirsen, has been approved in Japan under the brand name Hibsago. This marks the first functional cure for chronic hepatitis B approved in the country.

Late‑stage studies showed that roughly one in five patients treated with bepirovirsen achieved a functional cure, offering the prospect of a finite therapy that could replace lifelong antiviral pills. The drug works by blocking viral DNA replication, lowering hepatitis B surface antigen levels, and enhancing the immune response for longer‑term disease control.

GSK projects that bepirovirsen could generate peak annual sales of more than £2 billion (about $2.73 billion), helping the company move toward its target of over £40 billion in revenue by 2031 as its pipeline expands.

U.S. priority review for cancer therapy

In a separate announcement, GSK said the U.S. Food and Drug Administration will conduct a priority review of its cancer immunotherapy dostarlimab, marketed as Jemperli, for a type of rectal cancer. The FDA set a February 2027 action date, though the agency may decide earlier.

Dostarlimab already holds Breakthrough Therapy and Fast Track designations for certain endometrial cancer subtypes, but it is not yet approved anywhere for locally advanced rectal cancer.

These regulatory advances highlight GSK’s focus on innovative treatments that address unmet medical needs, from chronic viral infections to challenging cancers.

Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.