On January 2nd, AstraZeneca and Sanofi jointly announced the release of the long-acting monoclonal antibody Le Weichu& Reg; (Nisetivir monoclonal antibody) has officially been approved for marketing by the China Food and Drug Administration for the prevention of lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in newborns and infants. This drug is suitable for newborns and infants who are about to enter or are born in the first RSV infection season, and is expected to be launched in China during the RSV infection season from 2024 to 2025.
It is reported that syncytial virus is a common and highly contagious respiratory virus, which is the leading cause of pulmonary infections (such as bronchiolitis and pneumonia) in infants under the age of 1. Most hospitalizations due to RSV are in full-term healthy infants. As the first and only approved preventive measure in China to protect the vast infant population against RSV infection, the population covered by Nisevirumab includes healthy full-term infants, premature infants, and infants who are susceptible to severe RSV infection due to special health conditions.
In March 2017, AstraZeneca and Sanofi announced an agreement to collaborate on the development and commercialization of Nirsevimab. According to the terms of the agreement, AstraZeneca is responsible for product development and production, while Sanofi is responsible for product commercialization and revenue measurement. Previously, Nisevizumab was approved in the European Union in October 2022 to prevent lower respiratory tract diseases caused by RSV in newborns and infants during the first season of RSV infection; In July 2023, Nisevizumab was approved by the US Food and Drug Administration (FDA); At present, the listing applications submitted by Nisevizumab in Japan and multiple other markets are also under review.
AstraZeneca's General Manager in China, Lai Minglong, stated that Nisetumab has filled the gap in the prevention of respiratory syncytial virus in newborns and infants in China, confirming the company's unwavering commitment to the pediatric field and caring for children's health. In the future, AstraZeneca will continue to accelerate research and development innovation, further enrich its product pipeline, and strive to meet the unmet needs of the vulnerable population in China in the field of health.
"Leweichu® is another significant innovation brought by Sanofi since introducing the pentavalent vaccine for Chinese babies. In the future, we will continue to accelerate the launch of innovative drugs and vaccines in China based on the rich global research and development pipeline," said Shi Wang, President of Sanofi Greater China. (He Xinyi)