Zhitong App learned today that Astrazeneca and Sanofi have announced the official approval and launch of their jointly developed and commercialized long-acting monoclonal antibody, Nirsevimab, by the China National Medical Products Administration.
This drug is used to prevent lower respiratory tract infections (LRTIs) caused by respiratory syncytial virus (RSV) in newborns and infants. RSV is a common and highly contagious seasonal virus that is the most common cause of lower respiratory tract infections in infants, such as bronchiolitis and pneumonia, and is also one of the main reasons for infant hospitalization. Data shows that RSV ranks among the top three pathogens causing viral respiratory infections in children and may lead to mixed outbreaks of various respiratory viruses.
It is reported that China is one of the countries with a high prevalence of RSV worldwide. Nirsevimab is expected to be launched in China during the RSV infection season in 2024-2025.
Nirsevimab was approved in the European Union in October 2022 and subsequently received approval from the U.S. Food and Drug Administration (FDA) in July 2023 based on the unanimous recommendation of the Antimicrobial Drugs Advisory Committee. Currently, the marketing applications for Nirsevimab submitted in Japan and several other markets are also under review.
AstraZeneca and Sanofi announced their collaboration on the development and commercialization of Nirsevimab in March 2017. Under the terms of the agreement, AstraZeneca is responsible for product development and production, while Sanofi is responsible for commercialization and revenue measurement. Both companies share costs and profits in all regions except the United States. The revenue AstraZeneca receives based on this agreement is classified as alliance revenue and collaboration revenue in the company's financial statements.

SNYNF

TBIO

The drug Levoi® (nirsevimab), jointly developed by AstraZeneca and Sanofi, has been approved for market by the China National Medical Products Administration. This drug can prevent infant RSV infection, which is one of the main causes of infant hospitalization. Nirsevimab has already been approved in the European Union and the United States, and is expected to be launched in China in 2024-2025. AstraZeneca and Sanofi have collaborated on the development, production, and commercialization of this drug.

Zhitong

Today, the drugs developed by Astrazeneca and Sanofi for the prevention of infant RSV infection have been approved in China.