GSK’s Arexvy RSV vaccine accepted for regulatory review in China

The British pharmaceutical giant GSK announced on Thursday that China’s National Medical Products Administration (NMPA) has formally accepted its regulatory application for the RSV vaccine Arexvy. This submission aims to secure marketing authorization for the prevention of Respiratory Syncytial Virus (RSV) caused lower respiratory tract disease (LRTD) in adults aged 60 and older across mainland China. The move comes as GSK seeks to expand its global footprint for the world’s first approved RSV vaccine, targeting a significant demographic in one of the world's most populous nations where the burden of respiratory illness is high among the elderly. The regulatory filing is supported by positive data from the pivotal AReSVi-006 Phase III clinical trial, which demonstrated high vaccine efficacy against RSV-LRTD in older adults, including those with underlying medical conditions. If approved, Arexvy would provide a critical preventative tool for a Chinese population that currently faces limited options for RSV protection. The virus is a common cause of severe respiratory infections, often leading to hospitalization or death in vulnerable age groups, creating a substantial strain on the national healthcare infrastructure. Expansion into the Chinese market represents a strategic milestone for GSK as it competes with other major pharmaceutical firms, such as Pfizer and Moderna, in the rapidly growing RSV vaccine sector. The company has already secured approvals for Arexvy in several major jurisdictions, including the United States, Europe, and Japan. By entering the Chinese market, GSK aims to address a massive unmet medical need while strengthening its position as a leader in infectious disease prevention and respiratory medicine on a global scale.