Guotai Haitong: Alzheimer's Disease Opens a New Era of Disease-Modifying Treatments, Domestic Companies' Pipeline Layout Shows Strong Competitiveness

Guotai Haitong released a research report stating that the burden of Alzheimer's Disease (AD) is substantial and continues to expand. Traditional symptomatic medications have entered a plateau phase, while anti-A monoclonal antibodies have ushered in a new era of disease-modifying therapy (DMT). Multi-mechanism small molecules and next-generation brain-penetrating technologies are expected to further break through the delivery bottleneck across the blood-brain barrier, showcasing the strong competitiveness of domestic innovative pharmaceutical companies. Guotai Haitong's main viewpoints are as follows: Substantial disease burden; disease-modifying therapies open up market expansion opportunities The number of Alzheimer's Disease patients in China is projected to rise from 12.5 million in 2020 to 15.1 million by 2025, with estimates reaching 18.0 million and 21.5 million by 2030 and 2035, respectively, exceeding global growth rates. China's neurology drug market for degenerative diseases is expected to reach approximately $2.6 billion by 2025, with forecasts suggesting growth to $5.5 billion by 2030 (CAGR of approximately 16.0%), significantly faster than the global growth rate of 8.1%. Slow growth of traditional symptomatic medications, acceleration of A monoclonal DMT penetration Traditional drugs like Donepezil can only alleviate symptoms and have entered a plateau phase; monoclonal antibodies such as Lecanemab and Donanemab have been gradually approved since 2023, achieving breakthroughs in A clearance from the source. The AD treatment market is rapidly shifting from symptomatic treatment to disease-modifying therapies. Limitations remain for A monoclonal antibodies, multi-mechanism oral small molecules are expected to be an important supplement Intravenous infusion has poor patient compliance, and risks such as ARIA and high costs restrict their market growth; the oral A aggregation inhibitor ALZ-801 has shown significant efficacy and neuroprotective effects in early subgroups of MCI, highlighting the advantages of ease of administration. Next-generation brain-penetrating technologies improve delivery efficiency and reduce safety risks Technological breakthroughs such as receptor-mediated transport (TfR/ATV platform) and focused ultrasound have overcome the bottleneck of the blood-brain barrier. Animal models show that drug concentrations in the brain increase by 5-8 times, and ARIA-like lesions are almost eliminated. Domestic companies demonstrate competitive pipeline layouts Kangnuo's CM383 (with a half-life superior to approved anti-A antibodies), Heptares NEU2005 bispecific antibody and NEU3001 AOC, AKESO's AK152 (the first domestic A/BBB bispecific antibody, which is in Phase I), and Shandong Xinhua Pharmaceutical's OAB-14 (a novel oral RXR agonist with a unique mechanism of action, which has completed enrollment in Phase 2a). Risk warnings Risks of failure in innovative drug development, risks of clinical progress not meeting expectations, risks of drug sales growth not meeting expectations, risks of domestic drug overseas authorization not meeting expectations.