Harbin Boken Biotechnology Co., Ltd.

On August 23, Eisai and Boken announced that the humanized anti-soluble aggregation amyloid-beta (Aβ) monoclonal antibody Roncanizumab was officially approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of Alzheimer's disease (AD) -derived mild cognitive impairment and mild AD patients. The drug is indicated for adult patients regardless of whether they are heterozygotes or non-carriers of apolipoprotein E ε4 (ApoE ε4).   Lencanizumab becomes the first treatment in Europe to target the underlying cause of early Alzheimer's disease, mild cognitive impairment or mild dementia caused by Alzheimer's disease. The drug selectively binds to Aβ aggregates, specifically targeting toxic fibril, while acting on Aβ fibers, the main component of Aβ plaques, effectively neutralizing and removing Aβ plaques from the brain.   The approval is based on data from Eisai's Phase 3 clinical study (CLARITY AD), a global, randomized, double-blind, parallel group, placebo-controlled study. The results showed that at 18 months, the change from baseline in the Clinical Dementia Rating Scale subitem total or sum (CDR-SB) reached the primary endpoint and all key secondary endpoints and was statistically significant.   In the UK population, the most common adverse events associated with lencanizumab included infusion-related reactions, amyloid-related imaging abnormalities with bleeding (microhemorrhagic spots) (ARIA-H), falls, headaches, and amyloid-related imaging abnormalities with cerebral edema (ARIA-E).   Eisai is actively working with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the National Health Service (NHS) to make this drug available to eligible patients with early Alzheimer's disease as soon as possible. The global development and registration application of lencanetzumab was led by Eisai, and the product was commercialized and promoted jointly by Eisai and Bojian. In terms of decision-making rights, the health company has the final decision-making rights. In the UK market, Eisai and Bojian will jointly be responsible for the commercial marketing of the product, and Eisai will distribute the product as the marketing authorization holder.