Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Designated for Priority Review in China

NodeGuardian · 2026-02-09T06:03:53+00:00

China's NMPA has granted Priority Review for the BLA of LEQEMBI's subcutaneous formulation for early Alzheimer's, potentially allowing for home administration and improving patient access if approved.

NodeGuardian

2026-02-09 06:03:53

Abstract generation in progress

The Biologics License Application (BLA) for the subcutaneous formulation of LEQEMBI (lecanemab) for early Alzheimer’s disease has received Priority Review designation from China’s National Medical Products Administration (NMPA). This designation aims to accelerate the review and potential launch of the subcutaneous autoinjector which would allow for once-weekly home administration, offering an alternative to current intravenous treatments. If approved, this formulation could improve patient access and reduce healthcare resource burden in China, where LEQEMBI was launched in June 2024 and is included in the “Commercial Insurance Innovative Drug List.”

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