Guotai Haitong: Alzheimers disease treatment is moving towards a new era of disease modification. Domestic innovative pharmaceutical companies show strong competitiveness in their pipeline layout.

Guotai Haitong published a research report stating that the market for neurodegenerative disease drugs in China is expected to reach approximately $2.6 billion by 2025, and is projected to increase to $5.5 billion by 2030 (with a CAGR of around 16.0%), significantly faster than the global growth rate of 8.1%. The burden of Alzheimers disease (AD) is immense and continues to expand, while traditional symptomatic medications have entered a plateau phase. Anti-A monoclonal antibodies are ushering in a new era of disease-modifying treatments (DMT), and multi-mechanism small molecules along with new brain-penetrating technologies are expected to break through the delivery bottleneck of the blood-brain barrier, displaying strong competitiveness in the pipeline layouts of domestic innovative drug companies. Guotai Haitongs main points are as follows: The burden of the disease is enormous, and disease-modifying therapies open up market expansion. The number of people with Alzheimers disease in China is expected to increase from 12.5 million in 2020 to 15.1 million in 2025, and projected to reach 18.0 million and 21.5 million by 2030 and 2035, respectively, with growth rates consistently exceeding global figures. The market for neurodegenerative disease drugs in China is expected to reach about $2.6 billion by 2025, with an expected rise to $5.5 billion by 2030 (CAGR of about 16.0%), significantly outpacing the global growth rate of 8.1%. Growth of traditional symptomatic medications is slowing, while DMT therapies with A monoclonal antibodies are accelerating penetration. Traditional drugs such as donepezil can only improve symptoms and have entered a plateau phase; monoclonal antibodies like Lecanemab and Donanemab have been successively approved since 2023, achieving breakthroughs in the clearance of A from its source, with the AD treatment market accelerating its shift from symptomatic treatment to disease-modifying therapies. There are still limitations with A monoclonal antibodies, and multi-mechanism oral small molecules are expected to become an important supplement. Intravenous infusion has poor adherence, along with risks of ARIA and high costs limiting their large-scale use; the oral A aggregation inhibitor ALZ-801 has shown significant efficacy and neuroprotective effects in early subgroups of MCI, highlighting the advantages of convenient 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, with animal models showing a 5-8 times increase in drug concentration in the brain and nearly complete elimination of ARIA-like lesions. Domestic companies' pipeline layouts demonstrate competitiveness. Yuanjiahua CM383 (with a longer half-life than currently marketed anti-A antibodies), Hepta Med (NEU2005 bispecific antibody, NEU3001 AOC), AKESO AK152 (the first domestic A/BBB bispecific antibody, now in Phase I), and Shandong Xinhua Pharmaceutical OAB-14 (a novel mechanism oral RXR agonist that has completed enrollment in Phase 2a). Risk Warning Risks of failure in innovative drug research and development, risks of clinical progress not meeting expectations, risks of drug sales not reaching expected levels, and risks of domestic drugs not achieving expected outcomes in overseas licensing.