Sanofi Launches Beyfortus (Nirsevimab) in China, the First and Only RSV Preventive for All Infants

China Finance Online, July 3rd: Today, Sanofi announced the official commercial launch in China of its respiratory syncytial virus (RSV) prevention solution for all infants — the long-acting monoclonal antibody Leqviu (nirsevimab injection).

As the first and currently only innovative method approved in China for preventing lower respiratory tract infections caused by respiratory syncytial virus (RSV) in infants, Beyfortus has filled a gap in RSV prevention in China. The new drug application for this product was approved by the National Medical Products Administration in December 2023. With its current market launch, it is expected to provide immune protection for Chinese babies while potentially alleviating the diagnostic and treatment burden on the healthcare system during the RSV infection season.

According to reports, Levechu, through passive immunization, requires only a single injection to provide timely, rapid, and direct protection for newborns and infants about to enter or born during the first Respiratory Syncytial Virus (RSV) infection season, thereby preventing lower respiratory tract infections caused by RSV.

Professor Liu Hanmin, President of West China Second University Hospital, Sichuan University, and the principal investigator of the Phase III clinical trial of Levecri in China, stated that both clinical trials and real-world data consistently confirm that Levecri demonstrates high protective efficacy and good safety in preventing lower respiratory tract infections caused by the respiratory syncytial virus. "Severe respiratory syncytial virus infection during infancy is associated with recurrent wheezing and asthma in childhood. Preventing respiratory syncytial virus not only benefits current disease control but may also positively impact the maintenance of healthy lung function during childhood."

According to Dr. Zhang Yonghui, a public health expert, the respiratory syncytial virus (RSV) is a long-standing and highly common respiratory virus, for which China has lacked effective preventive measures. "As a country with high incidence of RSV, the disease burden from lower respiratory tract RSV infections in children under five years old in China is very heavy. We hope the launch of Nirsevimab will help reduce the diagnostic and treatment burden on China's healthcare system during the RSV season, and push forward an important step in building a preventive system for infant diseases."

"As an innovative product that fills the gap in disease prevention, we believe that the successful commercial launch of Levechu will help protect the health of more Chinese babies. Sanofi has a profound foundation of over a hundred years in the field of immune prevention. In the future, we also look forward to continuously introducing more innovative products in the field of immune prevention, enriching the company's product portfolio from prevention to treatment, and better fulfilling our commitment to China," said Wang Shi, President of Sanofi Greater China.

Data show that respiratory syncytial virus (RSV) is a common and highly contagious respiratory virus. It is the leading detected pathogen causing hospitalization for lower respiratory tract infections in infants and young children, primarily pneumonia and bronchiolitis. Due to weaker immune systems and narrower airways, infants within their first year are at higher risk of developing severe illness from RSV compared to other age groups. Infants with severe RSV infections may experience recurrent wheezing or asthma.

Since the fall of 2023, Beyfortus has been launched and used in multiple countries worldwide, including the United States, Canada, France, the United Kingdom, Switzerland, Spain, and Chile. Not only has it seen a peak in vaccinations, but it has also been recommended by authoritative institutions in these countries for the prevention of respiratory syncytial virus in infants. Additionally, it has been included in the immunization schedule for children and adolescents by the U.S. Centers for Disease Control and Prevention. According to recent real-world data from Spain published in The Lancet, compared with no intervention, Beyfortus can effectively reduce the risk of hospitalization due to lower respiratory tract infections caused by respiratory syncytial virus in infants by 82%.