Akeso Receives NMPA Approval to Begin Clinical Trials for AK152, a First-in-China Bispecific Alzheimer's Antibody

Akeso has reached a major scientific milestone. The company announced NMPA approval to begin clinical trials for AK152, a novel bispecific antibody targeting amyloid-beta (Aβ) and a blood-brain barrier (BBB) receptor.

This positions AK152 as the first bispecific antibody developed in China for disease-modifying treatment of Alzheimer’s disease.

A Breakthrough in China’s Alzheimer’s Drug Innovation

AK152 is not only a first-in-class candidate in China. It is also Akeso’s first drug targeting the central nervous system (CNS). This move marks a strategic expansion of the company’s pipeline into neurodegenerative disorders — an area with massive unmet global medical need.

Akeso now strengthens its ambition to evolve into a global, fully integrated biopharmaceutical company.

Why Alzheimer’s Needs New Solutions

The abnormal buildup of Aβ plaques remains a defining feature of Alzheimer’s.
While several Aβ-targeting monoclonal antibodies have gained approvals globally, their impact is limited.

The core challenges:

• Poor blood-brain barrier penetration
• Insufficient Aβ clearance in the brain
• Safety concerns related to high dosing requirements

Better delivery into the brain is the next frontier — and AK152 attempts to solve this.

Inside AK152: A Dual-Targeted Strategy

AK152 is engineered with a bispecific design that hits two targets at once:

1. The Aβ Arm

• Binds directly to Aβ plaques
• Shows high selectivity for neurotoxic soluble Aβ oligomers
• Focuses on the forms of Aβ most responsible for cognitive decline

2. The BBB Receptor Arm

• Targets a receptor highly expressed at the blood-brain barrier
• Utilizes receptor-mediated endocytosis and transcytosis
• Dramatically increases drug penetration into the brain

This dual-target approach is a major advancement over conventional monoclonal antibodies.

Promising Preclinical Results

Preclinical studies show that AK152 delivers:

• Superior brain penetration
• Faster Aβ plaque clearance
• Reversal of Alzheimer’s-related pathology
• A favorable safety and activity profile

In animal models, AK152 demonstrated stronger therapeutic efficacy than existing Aβ monoclonal antibodies.

These results suggest the potential for AK152 to become a next-generation, disease-modifying therapy.

Why This Matters for CNS Drug Development

CNS disorders remain one of the toughest drug development areas. Barriers like safety, drug delivery, and lack of efficacy have slowed global progress.

Akeso’s track record in bispecific antibody engineering gives it a unique advantage in solving these challenges. AK152 showcases how bispecific design may unlock new treatment opportunities in Alzheimer’s and other CNS diseases.

About Akeso

Akeso (HKEX: 9926.HK) is a global biopharmaceutical company focused on developing first-in-class and best-in-class biological medicines. Founded in 2012, Akeso has built a fully integrated innovation ecosystem featuring its:

• ACE Platform for end-to-end drug development
• Tetrabody bispecific antibody platform
• GMP-compliant manufacturing
• Advanced commercialization systems

Pipeline Snapshot

• 50+ innovative assets
• 24 candidates in clinical trials
• 15 bispecific/multispecific antibodies and bispecific ADCs
• 7 commercialized drugs

Akeso aims to deliver high-quality, affordable biologics to patients worldwide and strengthen its global leadership in antibody innovation.

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