Sanofi (SNY.US) applies for the market approval of a new indication for its long-acting RSV monoclonal antibody.

On August 7, the CDE official website announced that Sanofi (SNY.US) has received acceptance for a new indication marketing application for Nirsevimab Injection, classified under Category 3.1. According to public information and clinical trial progress, the Insight database speculates that this application is for the prevention of lower respiratory tract infections caused by respiratory syncytial virus (RSV) in infants: specifically, newborns and infants who are about to enter or are born during the second RSV infection season.