GlaxoSmithKline announced that bepirovirsen, its investigational antisense oligonucleotide for chronic hepatitis B, met the primary endpoint in two global Phase III trials, B-Well 1 and B-Well 2. The randomized, double-blind, placebo-controlled studies enrolled over 1,800 patients across 29 countries and evaluated bepirovirsen added to standard nucleos(t)ide analogue therapy. GSK reported a statistically significant and clinically meaningful functional cure rate—defined as sustained loss of hepatitis B surface antigen and undetectable viral DNA for at least 24 weeks after treatment—in both trials. In the subgroup with baseline HBsAg ≤1,000 IU/ml, cure rates were even higher versus standard of care alone. The safety profile was consistent with earlier studies, with most adverse events being mild to moderate. GSK plans to submit full data to regulatory authorities and present at an upcoming scientific congress, aiming for approval of a finite six-month treatment regimen.

Japan’s Ministry of Health, Labour and Welfare has approved Exdensur (depemokimab), GSK’s twice-yearly monoclonal antibody therapy for severe or refractory bronchial asthma and chronic rhinosinusitis with nasal polyps. Approval was granted following positive top-line results from two Phase III trials, SWIFT and ANCHOR, which showed that biannual injections of depemokimab on top of standard of care significantly reduced annualized severe asthma exacerbation rates and improved nasal polyp scores compared with placebo. The decision marks GSK’s eighth biologic approval for respiratory indications and strengthens its position in the global respiratory market. The therapy will be launched in Japan later this year, with pricing negotiations under way to facilitate patient access.