On January 2nd, AstraZeneca and Sanofi jointly developed a long-acting monoclonal antibody called Nirsevimab, which was officially approved for marketing by the National Medical Products Administration of China. It is used to prevent lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants. The drug is expected to be launched in China during the 2024-2025 RSV infection season.
Respiratory syncytial virus (RSV) is a common respiratory virus. Due to the fact that cells infected with the virus fuse together, forming a large cell structure similar to a "syncytial body", they are vividly referred to as respiratory "syncytial" viruses. RSV is more prevalent in winter and early spring, and the epidemic season in the Northern Hemisphere usually starts in October or November, and can last until April or May of the following year. The peak period usually occurs in January or February.
China is one of the countries with a high incidence of RSV worldwide. Research shows that from 2009 to 2019, influenza virus and RSV ranked among the top two pathogens detected in the total population of acute respiratory infections in China, with proportions of 28.5% and 16.8%, respectively.
Research has shown that over 60% of acute lower respiratory tract infections in young children and 80% of infections in infants under 1 year old are caused by RSV. According to data from the World Health Organization, syncytial virus infection is the leading cause of hospitalization or even death in children under the age of five due to virus infection, hence the nickname "winter baby killer".
The newly approved Nissevir monoclonal antibody is the first and only approved preventive measure in China to protect the general infant population against RSV infection, covering healthy full-term infants, premature infants, and infants who are susceptible to severe RSV infection due to special health conditions. The approval of niseverumab in China is mainly based on the results of three key clinical trials and clinical research and development projects in China. For all clinical trial endpoints, a single injection of niseverumab has shown consistent efficacy in treating lower respiratory tract diseases caused by respiratory syncytial virus, with a sustainable protection period of five months, which is a typical RSV infection season.
In response, Professor Liu Hanmin, Dean of West China Second Hospital of Sichuan University and Principal Investigator (PI) of Phase III Clinical Trials of Nisevirumab in China, said, "This approval for marketing in China not only reduces the disease burden caused by syncytial virus infection in children and families, but also hopes to reduce the burden on the medical system caused by respiratory diseases in pediatrics. This will contribute an important force to the prevention and control of syncytial virus in China."
It is worth noting that as early as March 2017, AstraZeneca and Sanofi announced a cooperation agreement for the development and commercialization of nisetizumab. 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. The two companies share costs and profits in all regions except the United States. The revenue generated by AstraZeneca based on this agreement is classified as alliance revenue and partnership revenue in the company's financial statements.
AstraZeneca's General Manager in China, Lai Minglong, pointed out that Nisetumab has filled the gap in the prevention of respiratory syncytial virus in newborns and infants in China, and is of great significance for protecting the health of Chinese infants. We hope that this drug can provide an "immune umbrella" for newborns and infants during their first RSV infection season. In the future, AstraZeneca will also accelerate research and development innovation, further enriching its product pipeline.