China Grants Priority Review to Leqembi's Subcutaneous Formulation

Event summary

  • BioArctic's partner Eisai received Priority Review designation from China's NMPA for the subcutaneous formulation of Leqembi (lecanemab) for early Alzheimer's disease.
  • The BLA for the subcutaneous formulation was accepted for review by the NMPA in January 2026.
  • If approved, the subcutaneous autoinjector (SC-AI) would allow once-weekly at-home administration, replacing the current IV treatment every two weeks in a hospital setting.
  • Leqembi was launched in China in June 2024 and included in the Commercial Insurance Innovative Drug List in January 2026.

The big picture

The Priority Review designation for Leqembi's subcutaneous formulation in China underscores the country's push to accelerate access to innovative medicines. This move aligns with broader trends in healthcare, where subcutaneous formulations are increasingly preferred for their convenience and potential to reduce healthcare resource utilization. With China's aging population and the growing burden of Alzheimer's disease, the approval of this formulation could significantly impact treatment paradigms and market dynamics in the region.

What we're watching

Regulatory Approval
The pace at which the NMPA completes its Priority Review and whether the subcutaneous formulation gains approval by mid-2026.
Market Expansion
How the subcutaneous formulation's approval could expand Leqembi's market reach in China, particularly among the 17 million patients with Mild Cognitive Impairment or mild dementia.
Commercialization Strategy
Whether the inclusion of Leqembi in the Commercial Insurance Innovative Drug List will drive significant uptake through commercial insurance products.