AstraZeneca (AZ, NASDAQ: AZN) and Sanofi (NASDAQ: SNY), co-development partners in the pharmaceutical industry, have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their drug Beyfortus (nirsevimab). The antibody is now approved for use in preventing lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants who are about to enter or are born during the first RSV infection season.
Nirsevimab, a long-acting monoclonal antibody (mAb), is the first and currently only RSV preventative therapy in China that covers healthy full-term infants, premature infants, and infants susceptible to severe RSV infection due to special health conditions. AstraZeneca agreed with Sanofi in March 2017 to take over the development and preliminary regulatory filing rights for the drug, with Sanofi leading the commercialization efforts. Beyfortus has already been approved in the EU and US in October 2022 and July 2023, respectively, and is awaiting regulatory decisions in Japan and other markets.
RSV is a common and highly contagious seasonal virus, recognized as the most common cause of lower respiratory tract infections in infants, such as bronchiolitis and pneumonia. It is also one of the primary reasons for hospitalization of infants, with the majority of those hospitalized being healthy infants born at full term. China experiences a high prevalence of RSV and has lacked an effective treatment for the infection until now.- Flcube.com
