AZ’s Beyfortus authorized as first RSV treatment in China

Beyfortus aims to prevent lower respiratory tract infections (LRTIs) caused by RSV in newborns and babies who are entering or are experiencing their first season. According to the firm, this is the first and only RSV preventive option authorized for use in China, and it will be accessible in time for the 2024–2025 RSV season. 

It is designed to protect infants born during or entering their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

“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 […] 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,” said Liu Hanmin, president of West China Second University Hospital, Sichuan University. 

A single dose long-acting antibody, Beyfortus is given to newborns and infants in a single dose, offering rapid protection via an antibody to help prevent LRTD caused by RSV, without requiring activation of the immune system. 

“Beyfortus represents the first opportunity to prevent serious respiratory disease due to RSV for all infants in China. The science that Beyfortus is built on demonstrates AstraZeneca’s leadership in addressing the needs of the most vulnerable populations and reducing the infectious disease burden on healthcare systems. We look forward to making Beyfortus available for the 2024/5 season,” said Iskra Reic, executive vice president, vaccines and immune therapies, AstraZeneca. 

Beyfortus is being considered for approval in Japan and other countries as a one-dose preventive treatment from LRTIs caused by the virus. It has also been approved in the US, Canada, EU, and GB. 

AstraZeneca and Sanofi announced that they had reached a deal to develop and market nirsevimab in March 2017. As per the agreement, AstraZeneca oversees development and production, while Sanofi oversees commercialization and revenue recording. 

Recently, AstraZeneca acquired Icosovax adding a virus-like particle vaccine technology and a Phase II respiratory syncytial virus (RSV) for $838 million upfront, while the deal is expected to reach $1.1 billion.

The approval is the latest achievement for AstraZeneca in China after the firm acquired Gracell Biotechnologies for $1.2 billion with an aim to further its cell therapy ambitions, along with chimeric antigen receptor (CAR-T) and T-cell receptor therapies (TCR-Ts) in solid tumors.