At a Glance
- China’s CDE accepted Arexvy for regulatory review
- Designed to prevent RSV-related lower respiratory disease in adults 60+
- Phase III China study showed strong immune response with acceptable safety
- Approval decision anticipated in 2027
Written By: Pharmacally Medical News Desk
GSK announced that China’s Center for Drug Evaluation has accepted its regulatory application for Arexvy, the company’s recombinant, adjuvanted respiratory syncytial virus (RSV) vaccine, for review. The submission seeks approval for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older. If approved, Arexvy would become the first RSV vaccine available for this population in China.
The application is supported by a comprehensive clinical data package, including positive results from a Phase III immuno-bridging study conducted in China (NCT06551181). The trial met all primary endpoints, demonstrating non-inferior immune responses against RSV-A and RSV-B strains compared with overseas participants. The vaccine also showed an acceptable safety profile. A regulatory decision is anticipated in 2027.
RSV represents a substantial health burden among older adults in China. Estimates suggest the virus affects more than six million individuals aged 60 years and older annually, leading to over 350,000 RSV-related hospitalisations.
Arexvy contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3), combined with GSK’s proprietary AS01E adjuvant system. The adjuvant is designed to enhance immune response, particularly important in older adults where immune function may be reduced. As with all vaccines, individual immune responses may vary.
Arexvy has already secured approvals in more than 65 countries for adults aged 60 years and older. The vaccine is also authorized in multiple regions for adults aged 50–59 at increased risk due to underlying medical conditions, while broader approvals exist in select markets, including the European Economic Area.
RSV is a common respiratory virus that can lead to serious complications in older adults, particularly those with comorbidities such as COPD, asthma, and chronic heart failure. Severe cases may result in pneumonia, hospitalization, and increased mortality risk. The true disease burden is often underestimated due to limited routine testing in adults.
Reference
GSK’s RSV vaccine, Arexvy, accepted for regulatory review in China for adults aged 60 years and older, 10 February 2026, GSK’s RSV vaccine, Arexvy, accepted for regulatory review in China for adults aged 60 years and older | GSK
A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older, ClinicalTrials.gov ID NCT06551181, https://clinicaltrials.gov/study/NCT06551181