By Fineline Cube 
Akeso Inc. (HKG: 9926) announced that its self‑developed bispecific antibody AK152 has received regulatory approval from the National Medical Products Administration (NMPA) to launch clinical trials in patients with Alzheimer’s disease (AD).
Product & Mechanism
| Feature | Detail |
|---|---|
| Type | Bispecific antibody |
| Targets | Amyloid‑β (Aβ) and high‑expression receptors on the blood‑brain barrier (BBB) |
| Novelty | First bispecific AD drug approved in China for disease‑modifying therapy |
| Preclinical Efficacy | Rapid Aβ plaque clearance; ~3‑fold higher brain penetration vs. traditional monoclonal antibodies |
| Safety Profile | Favorable; no off‑target toxicities observed in vitro |
AK152’s dual‑binding design couples a classic anti‑Aβ arm with an affinity module for BBB‑relevant receptors, thereby facilitating transport across the BBB. Compared with conventional monoclonal antibodies, the bispecific format increases cerebral delivery, hastens plaque removal, and shows “significantly superior therapeutic efficacy” in animal models.
Preclinical Highlights
- Robust Biological Activity – Shown to reduce soluble and fibrillar Aβ species in relevant brain slices.
- Safety in Animal Studies – No dose‑limiting adverse events up to the highest tested concentrations.
- Clinical Potential – The enhanced brain entry could translate into a disease‑modifying effect rather than symptomatic relief, a critical unmet need in the AD landscape.
Regulatory Context
The NMPA approval is part of China’s expanding neuro‑degenerative disease regulatory architecture. The agency’s clinical‑trial authorization allows Akeso to initiate Phase I/II studies under an Investigational New Drug (IND) framework.
Market Impact & Outlook
- Strategic Positioning – Akeso becomes the sole Chinese company with a bispecific, brain‑penetrating AD candidate, differentiating it from competitors that rely on monoclonal antibodies or vaccines.
- Commercial Potential – Successful trials could pave the way for a first‑in‑class disease‑modifying therapy in a market of >15 million projected Chinese AD patients.
- Investor Signal – The approval underscores the growing confidence of Chinese regulators in complex biologics targeted at difficult‑to‑reach tissues such as the brain.
Forward‑Looking Statements
This briefing includes forward‑looking statements regarding Akeso’s drug program, regulatory developments and potential commercial success. Actual results may differ materially.-Fineline Info & Tech