NMPA (China) approves Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection

Beyfortus is anticipated to be available during the upcoming 2024-2025 RSV season.

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 approval by The National Medical Products Administration (NMPA) is based on three Beyfortus pivotal late-stage clinical trials and an extensive local clinical development programme. Across all clinical endpoints, a single dose of Beyfortus demonstrated consistent efficacy against RSV lower respiratory tract disease (LRTD) extending through five months, the duration of a typical RSV season.

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. This approval represents a crucial contribution to the prevention and control of RSV disease in China.”