GSK News & Events

GSK announced that that China's National Medical Products Administration, NMPA, has approved Exdensur as add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older. The approval of Exdensur in severe asthma is based on data from the SWIFT-1 and SWIFT-2 phase III trials. In these studies, depemokimab demonstrated sustained exacerbation reduction with two doses per year versus placebo, both plus standard of care.

GSK announced that the China National Medical Products Administration, NMPA, has accepted for review a new drug application, NDA, for bepirovirsen, an investigational antisense oligonucleotide, for the treatment of adults with chronic hepatitis B. The regulatory submission is supported by positive results from the B-Well 1 and B-Well 2 Phase III trials, where bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone across all ranked endpoints, including in patients with lower baseline HBsAg levels where an even greater effect was observed. Bepirovirsen demonstrated an acceptable safety and tolerability profile consistent with previous studies. These data will be presented at a congress and submitted for scientific peer-reviewed publication in 2026.

GSK announced that the European Medicines Agency, EMA, has accepted for review the marketing authorisation application, MAA, for the use of bepirovirsen, an investigational antisense oligonucleotide, ASO, in the treatment of adults with chronic hepatitis B. The regulatory submission to EMA is based on positive results from the B-Well 1 and B-Well 2 Phase III trials. Both trials met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone. Results were statistically significant across all ranked endpoints. The trials demonstrated an acceptable safety and tolerability profile consistent with what was reported in other studies. These data will be presented at a congress and submitted for scientific peer-reviewed publication in 2026.

GSK announced that risvutatug rezetecan, a B7-H3-targeted antibody-drug conjugate, has received Orphan Drug Designation, ODD, from Japan's Ministry of Health, Labour and Welfare for the treatment of small-cell lung cancer, SCLC. The ODD was supported by preliminary clinical data showing durable responses in patients with extensive-stage SCLC who were treated with Ris-Rez in the phase I ARTEMIS-001 clinical trial. This is the sixth regulatory designation for Ris-Rez, which is being developed in a range of solid tumours, including lung, prostate and colorectal cancers.