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

On August 7, the CDE official website announced that the application for a new indication of Sanofi's (SNY.US) Nirsevimab injection has been accepted, with a registration classification of Class 3.1. Based on publicly available information and clinical trial progress, the Insight database speculates that this application is aimed at preventing lower respiratory tract infections caused by respiratory syncytial virus (RSV) in infants: specifically, newborns and infants who will soon be born or are born during the second RSV infection season. Source of the screenshot: CDE official website Nirsevimab is a single-dose long-acting antibody vaccine jointly developed by Sanofi and AstraZeneca PLC Sponsored ADR, which provides rapid protection through antibodies with just one dose, helping to prevent lower respiratory tract diseases caused by RSV without activating the immune system.