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

According to Golden Ten Data APP, on August 7, the official CDE website announced that the new indication listing application for Sanofi (SNY.US)'s Nirsevimab Injection has been accepted, with a registration classification of category 3.1. Based on publicly available information and clinical trial progress, the Insight database speculates that the indication for this application is the prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV) in infants and young children: specifically, newborns and infants entering or born during their second RSV season.

Nirsevimab is a single-dose, long-acting monoclonal antibody vaccine developed jointly by Sanofi and AstraZeneca. With just one dose, it provides rapid protection against RSV-induced lower respiratory tract diseases through antibodies, without needing to activate the immune system.