GSK’s Arexvy RSV vaccine accepted for regulatory review in China
#GSK #Arexvy #RSV vaccine #China NMPA #Infectious diseases #Healthcare regulation #Elderly care
📌 Key Takeaways
- China's NMPA has accepted the marketing application for GSK's RSV vaccine, Arexvy.
- The vaccine is intended for adults aged 60 and older to prevent lower respiratory tract disease.
- The application is backed by Phase III clinical trial data showing high efficacy in the elderly population.
- Arexvy was the first RSV vaccine to receive global approvals, including in the US and EU.
📖 Full Retelling
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.
🏷️ Themes
Pharmaceuticals, Public Health, Global Trade
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Respiratory syncytial virus vaccine
Vaccine against respiratory syncytial virus
A respiratory syncytial virus vaccine, or RSV vaccine, is a vaccine that protects against respiratory syncytial virus. RSV affects an estimated 64 million people and causes 160,000 deaths worldwide each year. The RSV vaccines Arexvy (GSK), Abrysvo (Pfizer), and Mresvia (Moderna) are approved for med...
Infection
Invasion of an organism's body by pathogenic agents
An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable disease, is an illness resulting from an infection. Infection...
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try{ var _=i o; . if(!_||_&&typeof _==="object"&&_.expiry As Claude disrupts stock market, Anthropic researcher warns ’world is in peril’ Gold, silver prices rise amid U.S.-Iran tensions, blowout January payrolls data Dow halts three-day win streak as blowout jobs data curbs rate cut bets Citi pushes back Fed rate cuts to May after blowout January jobs report (South Africa Philippines Nigeria) GSK’s Arexvy RSV vaccine accepted for regulatory review in China SEC Filings Published 02/10/2026, 11:52 AM GSK’s Arexvy RSV vaccine accepted for regulatory review in China 0 GSK -0.83% GSK -0.56% GSK plc (LSE/NYSE:GSK) announced Monday that China’s Center for Drug Evaluation has accepted its regulatory application for Arexvy, the company’s respiratory syncytial virus vaccine, for adults aged 60 years and older. If approved, Arexvy would become the first vaccine available in China for the prevention of lower respiratory tract disease caused by RSV in this age group. According to the press release statement, RSV affects more than six million adults aged 60 and older in China each year, resulting in over 350,000 hospitalizations annually. The regulatory submission is supported by data from a Phase III trial (NCT06551181) conducted in China, which evaluated the safety and immunogenicity of Arexvy in adults 60 and older. The trial met all primary endpoints, and the vaccine demonstrated an acceptable safety profile. Arexvy is a recombinant, adjuvanted RSV vaccine that contains a stabilized prefusion RSV glycoprotein F antigen combined with GSK’s proprietary AS01 adjuvant. The vaccine has already been approved for the prevention of RSV-related lower respiratory tract disease in individuals aged 60 years and older in more than 65 countries. It is also approved for use in people aged 50-59 with certain underlying medical conditions in over 60 countries, including the United States and Japan, and for adults aged 18 years and older in the European Economic Area. A regulatory decision in...