ET 03:32

GSK Announces CDE Submission for Arexvy Influenza Vaccine Review

IMP4.0
SNT+1.0
CONF90%
Regulatory

The U.S.-based biopharmaceutical company GSK (NYSE: GSK) submitted a regulatory application to China's National Medical Products Administration (NMPA), formerly the China Drug Enforcement Center (CDE), for review of its Arexvy influenza vaccine. The submission is expected to expedite potential approval in China, a key market for the vaccine. The NMPA is expected to complete its review within 60 days of receipt, with a target date of March 18, 2026. If approved, Arexvy could add a third dose schedule to the company's portfolio, enhancing its preparedness for future flu seasons.

EditorWong Mei Ling