Portfolio News
HONG KONG, Nov. 16, 2025 -- Akeso, Inc. (HKEX: 9926. HK) announced that its AK152, a novel bispecific antibody targeting both amyloid-beta (Aβ) and blood-brain barrier (BBB) expressed receptor, has been granted approval by the National Medical Products Administration (NMPA) to initiate clinical trials for Alzheimer's Disease.
AK152 is the first bispecific antibody developed in China for disease-modifying therapy in Alzheimer's Disease, marking a significant breakthrough in the field. Furthermore, it is Akeso's first innovative therapeutic candidate designed to target the central nervous system (CNS). This achievement underscores a critical milestone in expanding Akeso's research and development pipeline into neurodegenerative diseases and positions the company to strengthen its presence as a globally comprehensive pharmaceutical company.
The abnormal aggregation and deposition of amyloid-beta (Aβ) is a key pathological driver of Alzheimer's Disease. Several monoclonal antibodies targeting Aβ have received approval, and clinical data show that these agents can slow cognitive decline by clearing cerebral Aβ plaques. However, the therapeutic efficacy of these antibodies is limited by poor blood-brain barrier (BBB) penetration, resulting in insufficient brain exposure and raises significant safety concerns.
AK152 is a bispecific antibody that simultaneously targets both Aβ and a receptor highly expressed on the blood-brain barrier. The Aβ-binding arm of AK152 binds to Aβ plaques and exhibits high selectivity for the neurotoxic soluble Aβ oligomers. The receptor-binding arm of AK152 leverages the receptor-mediated endocytosis-transcytosis mechanism to significantly enhance the brain penetration of AK152.
Preclinical studies have demonstrated that AK152 possesses robust bioactivity and a favorable profile. Compared to conventional monoclonal antibodies targeting Aβ, AK152 significantly improves brain penetration, accelerates the clearance of Aβ plaques, and reverses the progression of Alzheimer's-related neuropathology in pre-clinical models, offering a potentially promising new treatment options for Alzheimer's patients. CNS disorders have long posed significant therapeutic challenges on a global scale. Akeso, with its deep expertise in bispecific antibody development, is at the forefront of creating novel therapies to address critical unmet clinical needs in CNS diseases.
About AK152
AK152 is a bispecific antibody developed by Akeso designed to simultaneously target Aβ and a receptor highly expressed at the blood-brain barrier (BBB). On the Aβ side, it not only binds to Aβ plaques but also selectively targets the more neurotoxic soluble Aβ oligomers. On the BBB side, it leverages receptor-mediated endocytosis to significantly enhance brain penetration. Preclinical studies have shown that AK152 demonstrates strong bioactivity and a favorable safety profile, effectively increasing brain penetration, accelerating Aβ plaque clearance, and exhibiting superior therapeutic efficacy over monoclonal antibodies in AD mouse models. These initial promising results suggest that AK152 has the potential to become a next-generation disease-modifying therapy for Alzheimer's disease.
