China’s NMPA has accepted the BLA for Eisai and Biogen’s subcutaneous LEQEMBI for early Alzheimer’s. If approved, patients could begin once-weekly at-home injections from treatment initiation, potentially reducing reliance on IV infusions while expanding access.
Written By: Pharmacally Medical News Desk
China accepts subcutaneous LEQEMBI BLA
China’s National Medical Products Administration (NMPA) has accepted the BLA for a subcutaneous autoinjector formulation of LEQEMBI (lecanemab) for patients with early Alzheimer’s disease, including mild cognitive impairment and mild dementia due to Alzheimer’s pathology. If approved, it may become the first and only anti-amyloid therapy in China that can be initiated and maintained entirely at home, from the start of treatment.
The subcutaneous autoinjector delivers a total weekly dose of 500 mg as two 250 mg injections, with each injection taking about 15 seconds to administer. Patients could begin therapy with once-weekly at-home injections rather than traveling to infusion centers for intravenous (IV) dosing, potentially reducing treatment delays linked to capacity constraints.
Clinical evidence supporting lecanemab
LEQEMBI is a humanized monoclonal antibody that selectively targets amyloid beta protofibrils, which are considered among the most neurotoxic amyloid species linked to neuronal injury, synaptic dysfunction, and cognitive decline in Alzheimer’s disease. By reducing protofibril levels, lecanemab is designed to slow disease progression rather than simply treating symptoms, aiming to preserve cognition and function for longer.
The global development program for lecanemab includes the pivotal Phase 3 CLARITY AD trial (NCT03887455) and its open-label extension, which demonstrated a modest but statistically significant slowing of cognitive and functional decline in patients with early Alzheimer’s disease. The AHEAD 3-45 program (NCT04468659) is evaluating lecanemab even earlier in the disease continuum, in preclinical Alzheimer’s disease with elevated or intermediate amyloid, potentially informing future preventative or very early intervention strategies.
As with other anti-amyloid monoclonal antibodies, treatment with lecanemab is associated with risks such as amyloid-related imaging abnormalities (ARIA), so MRI monitoring and careful patient selection are expected to remain important even with a subcutaneous formulation. The subcutaneous route does not eliminate safety monitoring needs, but it can streamline routine dosing logistics once appropriate baseline and follow-up imaging protocols are in place.
Implications for Alzheimer’s care in China
Eisai estimates that around 17 million people in China were living with mild cognitive impairment or mild dementia due to Alzheimer’s disease in 2024, a figure expected to grow as the population ages. In this context, a home-administered subcutaneous anti-amyloid therapy could help address urban–rural access gaps and reduce dependence on large infusion centers concentrated in major cities.
LEQEMBI’s expanding global footprint
The acceptance of the BLA in China follows other recent milestones in the LEQEMBI franchise, including regulatory progress on subcutaneous maintenance options such as the LEQEMBI IQLIK formulation and submissions to agencies including Japan’s PMDA. Together with the IV formulation, these developments reflect a broader strategy to make disease-modifying Alzheimer’s therapy more accessible and practical for real-world healthcare systems.
On Pharmacally, prior coverage has highlighted reductions in amyloid beta protofibrils in cerebrospinal fluid, clinical outcomes from CLARITY AD, and regulatory decisions that are shaping how and where patients can receive lecanemab. China’s NMPA acceptance of the BLA for subcutaneous LEQEMBI adds a major market to this evolving global landscape and underscores the growing emphasis on at-home biologic administration in neurology.
Reference
Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Accepted in China, 05 January 2026, Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Accepted in China | Biogen
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment with Lecanemab in Participants with Preclinical Alzheimer’s Disease and Elevated Amyloid and Also in Participants with Early Preclinical Alzheimer’s Disease and Intermediate Amyloid, ClinicalTrials.gov ID NCT04468659, https://clinicaltrials.gov/study/NCT04468659
A Study to Confirm Safety and Efficacy of Lecanemab in Participants with Early Alzheimer’s Disease (Clarity AD), ClinicalTrials.gov ID NCT03887455, https://clinicaltrials.gov/study/NCT03887455
Van Dyck CH et al, Lecanemab in Early Alzheimer’s Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. Doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29. PMID: 36449413.