ET 03:30

Eisai and Biogen's Subcutaneous LEQEMBI Granted China NMPA Priority Review

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Regulatory

The National Medical Products Administration (NMPA) in China has granted priority review to the subcutaneous formulation of LEQEMBI (iqbifigimod), developed by Eisai and co-developed by Biogen, for the treatment of early-stage Alzheimer's disease. The decision, effective February 09, 2026, reflects expedited regulatory consideration for the therapy, potentially accelerating its approval timeline in mainland China. Key figures: The subcutaneous formulation is designed for once-weekly dosing, with a target approval date expected in the first quarter of 2026. The priority review underscores the NMPA's focus on therapies addressing neurodegenerative diseases, following a positive review by the European Medicines Agency in May 2025.

EditorLim