Pharmaceutical company Eisai has announced that the Biologics License Application (BLA) for the treatment of early Alzheimer's disease with Leqembi (lecanemab), using a subcutaneous autoinjector (SC-AI), has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.
The BLA for the subcutaneous formulation was accepted for review by the NMPA in January 2026.
The Priority Review and Approval Procedure was implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value.
Under the procedure, the assessment period is expected to be shortened.
Why this matters
If approved, the SC-AI of 500 mg (two 250 mg injections) could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks in a hospital setting.
The potential approval of SC-AI would expand the option for patients and care partners to receive Leqembi treatment at home.
The injection time for each autoinjector (250 mg injection) is approximately 15 seconds.
The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall Alzheimer's disease treatment care pathway.
Eisai estimates that in 2024, there were 17 million patients with Mild Cognitive Impairment (MCI) or mild dementia due to Alzheimer's disease in China.
This number is expected to rise as the population ages.
Leqembi
Leqembi was launched in China in June 2024 and is available to the private market.
Furthermore, Leqembi has been included in the newly introduced "Commercial Insurance Innovative Drug List", which took effect in January 2026, under new Chinese government policies that support the development of and access to innovative medicines.
Based on the Commercial Insurance Innovative Drug List, commercial insurance companies will develop insurance products covering Leqembi.