GSK plc has announced that China’s Centre for Drug Evaluation (CDE) has accepted its regulatory application for Arexvy, the company’s Respiratory Syncytial Virus (RSV) vaccine, for review. The vaccine is indicated 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 age group in China.

The submission is supported by a comprehensive data package, including positive results from a Phase III clinical trial conducted in adults aged 60 years and older in China. The study met all primary endpoints, demonstrating non-inferior immune responses against RSV-A and RSV-B strains compared to participants outside China. The vaccine also showed an acceptable safety profile. A regulatory decision is anticipated in 2027.

RSV poses a significant health burden among older adults in China, with more than six million cases estimated annually in individuals aged 60 and above, leading to over 350,000 hospitalisations each year.

Arexvy contains a recombinant RSV glycoprotein F antigen stabilised in the prefusion conformation (RSVPreF3), combined with GSK’s proprietary AS01E adjuvant system. The AS01 adjuvant includes STIMULON QS-21, licensed from Antigenics LLC, a subsidiary of Agenus Inc. As with all vaccines, immune protection may vary among individuals.

The Phase III trial was a randomised, controlled, partially blinded immuno-bridging study conducted across 41 locations in seven countries. It enrolled approximately 1,200 participants in the China vaccinated group, 800 in the overseas vaccinated group and 600 participants in a placebo group in China. The co-primary endpoints assessed the non-inferiority of humoral immune responses to RSV-A and RSV-B strains.

Globally, RSV affects an estimated 64 million people annually. Older adults and individuals with underlying conditions such as Chronic Obstructive Pulmonary Disease (COPD), asthma, chronic heart failure, or compromised immunity face a higher risk of severe disease. RSV infection can lead to pneumonia, hospitalisation and death, with older adults often experiencing more severe complications and higher fatality rates compared to children.

Arexvy is currently approved for adults aged 60 years and older in more than 65 countries. It is also authorised for individuals aged 50–59 at increased risk in over 60 countries, including the United States and Japan. In the European Economic Area, it is approved for adults aged 18 years and older.