默沙东(MRK.US)长效RSV单抗在中国拟纳入优先审评

Group 1 - Merck's Clesrovimab (MK-1654) injection has been submitted for priority review for the prevention of RSV-related lower respiratory tract infections in newborns and infants [1] - Clesrovimab is a long-acting monoclonal antibody that provides passive immunity against RSV by binding to its fusion glycoprotein, offering direct and lasting protection for infants [1] - Clesrovimab is the first and only single-dose RSV monoclonal antibody approved for infants, regardless of their weight [1] Group 2 - The CLEVER study demonstrated that Clesrovimab reduced the incidence of RSV-related lower respiratory tract infections requiring medical attention by 60.5% and RSV-related hospitalization by 84.3% compared to placebo [2] - The SMART study showed that the efficacy and safety of Clesrovimab were comparable to that of Palivizumab in high-risk infants with severe RSV infections [2] - In China, only AstraZeneca/Sanofi's Nirsevimab has been approved, while Merck's Clesrovimab has been submitted for market approval, and two other RSV monoclonal antibodies are in Phase III trials [3]