Akeso's Bispecific Antibody Targeting Aβ and BBB-Expressed Receptor Approved for Alzheimer's Disease Clinical Trials in China

HONG KONG, Nov. 16, 2025 /PRNewswire/ -- 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.

Forward-Looking Statement of Akeso, Inc.

This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

About Akeso

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.

SOURCE Akeso, Inc.