China to Review Merck's Market Application for Respiratory Drug
Liao Shumin
DATE:  Apr 03 2025
/ SOURCE:  Yicai
China to Review Merck's Market Application for Respiratory Drug China to Review Merck's Market Application for Respiratory Drug

(Yicai) April 3 -- China's Center for Drug Evaluation has accepted the market application of Merck for Clesrovimab, an extended half-life monoclonal antibody designed as a passive immunization to prevent respiratory syncytial virus infections in newborns and infants.

Clesrovimab's key feature is that it is designed to be administered with the same single dose regardless of infants' weight, the CDE, which is under the National Medical Products Administration, said recently. The drug can provide direct, fast, and durable protection for healthy preterm, full-term, and at-risk infants against mild, moderate, and severe infections through their first RSV season, it added.

Last December, the US Food and Drug Administration accepted Merck's market application for Clesrovimab to protect infants during their first RSV season from related illnesses. The FDA review is scheduled to be completed by June 10.

RSV is a highly contagious virus responsible for seasonal infections worldwide, especially among infants and the elderly. It remains the leading global cause of hospitalization among healthy infants under the age of one, often triggering severe respiratory conditions, including bronchiolitis and pneumonia.

Editor: Martin Kadiev

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Keywords:   Merck