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Akeso's Bispecific Antibody Targeting Aβ and BBB-Expressed Receptor Approved for Alzheimer's Disease Clinical Trials in China
Prnewswire· 2025-11-17 02:29
Core Insights - Akeso, Inc. has received approval from the National Medical Products Administration (NMPA) to initiate clinical trials for its bispecific antibody AK152, targeting Alzheimer's Disease [1][2]. Company Overview - Akeso is a leading biopharmaceutical company founded in 2012, focusing on innovative biological medicines and has developed a comprehensive end-to-end drug development platform [10]. - The company has a robust pipeline of over 50 innovative assets across various disease areas, with 24 candidates currently in clinical trials [10]. Product Development - AK152 is the first bispecific antibody developed in China aimed at disease-modifying therapy for Alzheimer's Disease, marking a significant breakthrough in the field [2]. - The antibody targets both amyloid-beta (A) and a receptor expressed on the blood-brain barrier (BBB), enhancing brain penetration and therapeutic efficacy [4][6]. Mechanism of Action - AK152 binds to amyloid-beta plaques and selectively targets neurotoxic soluble A oligomers, while also utilizing receptor-mediated endocytosis to improve brain penetration [4][6]. - Preclinical studies indicate that AK152 significantly improves brain penetration and accelerates the clearance of A plaques compared to conventional monoclonal antibodies [5][6]. Clinical Significance - The development of AK152 addresses critical unmet clinical needs in treating Alzheimer's Disease, which has long posed therapeutic challenges globally [5]. - The promising preclinical results suggest that AK152 could become a next-generation disease-modifying therapy for Alzheimer's patients [6].