GSK's RSV vaccine Arexvy accepted for review in China
GSK plc announced its respiratory syncytial virus (RSV) vaccine, Arexvy, has been accepted for regulatory review by China's Center for Drug Evaluation (CDE). If approved, it would be the first vaccine in China for adults aged 60 and older to prevent RSV lower respiratory tract disease.
GSK plc's application for its respiratory syncytial virus (RSV) vaccine, Arexvy, has been accepted for review by China's Center for Drug Evaluation (CDE). The vaccine is intended for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older.
Should it receive approval, Arexvy would become the first vaccine available in China specifically for this demographic to protect against RSV disease. The company estimates that over six million adults aged 60 and older in China are affected by RSV annually, leading to more than 350,000 hospitalizations.
The submission is supported by a robust data package, including positive results from a Phase III trial conducted in China. This trial evaluated the vaccine's safety and immunogenicity in the target age group. GSK anticipates a regulatory decision in 2027.
Arexvy contains a recombinant RSV glycoprotein F antigen stabilized in the prefusion conformation, combined with GSK's proprietary AS01E adjuvant. The vaccine is already approved for individuals aged 60 and older in over 65 countries.