Multinational Pharma Giants Accelerate in the Alzheimer's Drug Race with Major Breakthroughs in Early 2025

　　【Pharmaceutical Network Industry Dynamics】Alzheimer's disease (AD) is a fatal condition that leads to the gradual decline of memory and other cognitive functions. The disease is characterized by memory loss and cognitive decline, progressively interfering with daily life activities. Alzheimer's disease also involves impairments in other cognitive domains, such as language ability, thinking skills, decision-making, and executive function. According to relevant statistics, 32 million people worldwide are living with Alzheimer’s dementia, including nearly 9.83 million patients in China. Currently, there remains a significant unmet treatment need for AD patients, and the vast market potential is attracting multinational pharmaceutical companies to accelerate their competition in the AD new drug sector.
 

Just a few days into 2025, on January 8 local time, Johnson & Johnson announced that its investigational Tau monoclonal antibody, Posdinemab, had received Fast Track designation from the U.S. FDA for the treatment of patients with early Alzheimer's disease (AD).
 

Data show that Posdinemab is a monoclonal antibody (mAb) targeting phosphorylated tau protein, mainly used for treating patients with early-stage AD.
 

Currently, Johnson & Johnson is conducting a Phase 2b study in early AD patients to investigate Posdinemab, an internally discovered tau-targeted monoclonal antibody. The drug has shown potential in targeting disease-related phosphorylated tau proteins in the cerebrospinal fluid of AD patients and has halted the development and spread of tau aggregation in non-clinical models of memory-impairing diseases.
 

Posdinemab targets phosphorylated tau protein to reduce its accumulation in cerebrospinal fluid, thereby slowing or halting the progression of AD. This mechanism helps improve cognitive function and decelerate disease progression.
 

According to reports, the amyloid hypothesis was proposed by scholars long ago regarding Alzheimer's disease, suggesting that the accumulation of beta-amyloid (Aβ) in the brain may cause Alzheimer's disease. In recent years, all newly approved AD drugs globally have also been Aβ monoclonal antibodies.
 

For example, in January 2024, the website of the National Medical Products Administration showed that lecanemab-irmb, a new Alzheimer's disease drug jointly developed by Japan's Eisai and America's Biogen, was approved for marketing. It is used to improve the treatment of mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) caused by Alzheimer's disease (AD). This is the first anti-Aβ antibody drug approved for marketing in China so far.
 

On December 18, 2024, Eli Lilly announced that Donanemab Injection has been approved by the National Medical Products Administration (NMPA) for marketing in China. It is indicated for treating mild cognitive impairment and mild dementia in adults caused by Alzheimer's disease (AD). Donanemab, developed by Eli Lilly, is an antibody drug targeting a modified form of β-amyloid (Aβ) known as N3pG. It has been granted Breakthrough Therapy Designation and Priority Review by the U.S. FDA for the treatment of Alzheimer’s disease (AD). In January 2023, the CDE website indicated that Donanemab Injection had been included as a breakthrough therapy.
 

As early as 2012, Eli Lilly's Amyvid (Florbetapir F18) was approved for marketing by the U.S. FDA. In 2018, China launched clinical research on the generic version of Amyvid, with related companies including Anke Biotechnology and Beijing Xinhe.
 

In addition, the FDA has approved PET diagnostic drugs for amyloid, including flutemetamol F18 (Vizamyl) by GE Healthcare in 2013 and florbetaben F18 (NeuraCeq) by Piramal Imaging in 2014.
 

In addition to β-amyloid, microtubule-associated protein (Tau protein) is also considered a major cause of Alzheimer's disease progression. Many pharmaceutical companies are currently developing drugs targeting this protein. Among them, Biogen has three Tau-targeting drugs in development: BIIB092, an antibody drug targeting the N-terminal fragment of Tau (eTau) co-developed with Bristol-Myers Squibb (BMS); BIIB080, developed in collaboration with Ionis Pharmaceuticals; and BIIB076, an antibody drug targeting Tau. These studies are all in Phase I or Phase II clinical trials.
 

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