Simcere Pharma's RSV Antibody Injection Wins China Approval

Simcere Pharmaceutical Group (02096) said a domestically developed Class 1 biologic, clesrovimab injection, branded as Yingmule, was approved by China's National Medical Products Administration for sale in China, according to ETNet. The drug was developed under a strategic collaboration with Sanyou Biopharmaceutical and is intended for newborns and infants born at or after 35 weeks' gestation who are entering, or were born during, their first respiratory syncytial virus season. It is used to prevent lower respiratory tract infection caused by respiratory syncytial virus and excludes children with chronic lung disease, including bronchopulmonary dysplasia, or clinically significant congenital airway abnormalities.