By Fineline Cube 
China’s Center for Drug Evaluation (CDE) website indicates that US giant Merck, Sharp & Dohme’s (MSD, NYSE: MRK) clesrovimab (MK-1654) is on course to obtain priority review status. The drug is intended for newborns and infants entering or born during their first respiratory syncytial virus (RSV) season to prevent lower respiratory tract infections caused by the virus.
Mechanism of Action
Clesrovimab is a prophylactic long-acting monoclonal antibody (mAb) that works by binding to the RSV fusion glycoprotein to induce passive immunity. This provides direct, rapid, and durable protection against RSV.
Clinical Trial Results
The CLEVER study, a randomized, double-blind, placebo-controlled Phase IIb/III trial, demonstrated that within 150 days after administration, clesrovimab reduced RSV-related lower respiratory tract infection medical visits by 60.5% and hospitalizations by 84.3%. Additionally, the SMART study, a head-to-head comparative trial, showed that clesrovimab had comparable efficacy and safety to the existing RSV antibody palivizumab in high-risk infants.
Regulatory Status
The drug was approved by the U.S. FDA in June of last year and is currently awaiting regulatory decisions in China. At present, only AstraZeneca/Sanofi’s nirsevimab is approved in China. Meanwhile, two other RSV mAbs, Trinomab’s TNM001 and Reyoung Pharma’s RB0026, have entered Phase III clinical trials.-Fineline Info & Tech