Sanofi (SNY.US) applies for market approval for new indication of long-acting RSV monoclonal antibody
On August 7, according to the CDE official website, the marketing application for a new indication of Sanofi (SNY.US)'s nirsevimab injection has been accepted, with a registration classification of Category 3.1.
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.
Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.
You may also like
Swiss Franc gains ground as easing US Yields pressures Greenback
Korean media: Delivery times for key semiconductor equipment components have more than doubled
According to reports, there is a severe shortage of core components for semiconductor equipment in South Korea. Delivery cycles have generally doubled, and waiting times for some Japanese-made parts are as long as 40 months, with components unavailable even at a premium price. Japanese suppliers are cautious about expanding production capacity, resulting in serious delays that have impacted downstream businesses. Major construction projects like Samsung’s Pyeongtaek and SK Hynix’s Yongin face the risk of postponement, with AI chip expansion plans running into a “hard wall” in the supply chain.
New Zealand Dollar steadies as softer US bond yields keep USD on the defensive
Japanese stocks rise 1.83%, breaking through 65,000 points
Crypto prices
More
