The drug, named Beyfortus, is intended for the prevention of RSV in neonates and infants for their first RSV season and has already been greenlit in the U.S. and European Union.
The latest approval by China's National Medical Products Administration is based on three late-stage clinical studies and an ‘extensive’ local clinical development programme, the drugmaker said.
AstraZeneca anticipates that the vaccine will be available for the upcoming 2024/25 RSV period.
"Beyfortus is the first approved preventive option to protect against RSV in a broad infant population, including protecting those infants born healthy at term, or preterm, or with specific health conditions that make them vulnerable to severe RSV disease," the company said.
In March 2017, AstraZeneca and Sanofi announced an agreement to develop and commercialize Beyfortus.
Under the terms of the collaboration, AstraZeneca leads development and manufacturing activities while Sanofi is in charge of commercialization activities.
Respiratory syncytial virus (RSV) is a seasonal, highly contagious respiratory virus that often feels like a common cold.
It is a leading cause of hospitalization in children and the elderly, with most hospitalisations for RSV occurring in healthy infants born at term.
China currently ranks among countries with a high prevalence of RSV infections.
Professor Liu Hanmin, president of West China Second University Hospital, Sichuan University, said: “There is currently no specific treatment for RSV disease in infants, and the potential long-term consequences of severe infections in infancy underscore the importance of prevention.
“As an innovative long-acting monoclonal antibody, Beyfortus can protect infants across the RSV season with a single dose. Its approval in China has the potential to alleviate the disease burden on children and their families and mitigate pressure on the medical system due to pediatric respiratory diseases.”
AstraZeneca added that regulatory applications are currently under review in Japan and several other countries.
