Anti-Alzheimer's Drug Market Heats Up as Numerous Companies Accelerate Pipeline Development

　　【Pharmaceutical Network | Industry News】Recent reports indicate that the U.S. FDA has granted accelerated approval to Aducanumab (Aduhelm), a novel drug co-developed by Biogen and Eisai, for the treatment of Alzheimer’s disease (AD) and cognitive impairment. Aducanumab is a fully human IgG1 monoclonal antibody with high affinity that targets the conformational epitopes of amyloid-beta (Aβ). It selectively binds to amyloid deposits in the brains of AD patients and facilitates their clearance by activating the immune system.
 

Industry analysis indicates that currently marketed anti-Alzheimer's disease (AD) drugs can only alleviate symptoms and cannot halt the disease's progressive course. Aducanumab, however, is the first therapy capable of controlling disease progression and may represent a new milestone in this field. Furthermore, Alzheimer's disease has historically been a notoriously high-risk domain for drug development, with numerous investigational therapies failing in late-stage clinical trials. As the first approved amyloid-beta (Aβ)-targeting therapy, Aducanumab is poised to restore confidence among pharmaceutical R&D companies in this sector.
 

It is reported that Alzheimer's disease (AD), also known as senile dementia, is a progressive neurodegenerative disease of the elderly with an insidious onset. The prevalence among individuals aged 65 and above is 4%–7%, rising to 20%–30% among those aged 85 and older. According to data from Alzheimer's Disease International, over 50 million people worldwide were living with dementia in 2019. Without intervention, this figure is projected to increase to 152 million by 2050.
 

Driven by the continuously growing population of patients with Alzheimer's disease and expanding market demand, numerous pharmaceutical companies have recently accelerated their strategic deployment into new therapeutic areas such as Alzheimer's. For example, in the field of Aβ-targeted drug development, publicly available data indicates that over 40 companies worldwide are currently advancing related R&D pipelines.
 

In China, Alzheimer's disease (AD) drugs have also become a key focus area for pharmaceutical R&D. Currently, several domestic pharmaceutical companies, including Green Valley Pharmaceuticals, HEC Pharm, Zhejiang Hisun Pharmaceutical, and Tonghua Jinma Pharmaceutical, are accelerating the research and development of both novel drugs and generics for Alzheimer's disease.
 

Among these, it is worth mentioning that in November 2019, GV-971 (sodium oligomannate capsules, trade name "Jiuqi Yi"), developed by Ocean University of China, the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, and Shanghai Green Valley Pharmaceutical, was granted conditional marketing approval, becoming China's first original novel drug targeting the brain-gut axis for the treatment of Alzheimer's disease, also known as senile dementia.
 

In addition to achieving breakthroughs in innovative drugs, domestic pharmaceutical companies are also vigorously developing in the generic drug sector. For example, in 2020, the National Medical Products Administration (NMPA) newly approved ten domestic pharmaceutical companies to manufacture Alzheimer’s disease treatments, specifically generic memantine hydrochloride, donepezil hydrochloride, and rivastigmine hydrogen tartrate, all of which are deemed to have passed the consistency evaluation. From January to May 2021, the NMPA further approved generic memantine hydrochloride from five domestic pharmaceutical companies, which are likewise deemed to have passed the consistency evaluation.
 

Currently, in addition to the aforementioned drugs, Qilu Pharmaceutical's Class 3 generic for idebenone and Sinopharm Guorui Pharmaceutical's Class 4 generic for rivastigmine hydrogen tartrate capsules are also under review and approval. Furthermore, Guangdong HEC Pharmaceutical's galantamine hydrobromide orally disintegrating tablets are currently progressing through bioequivalence trials. Based on current development trends, industry insiders believe that driven by the favorable market outlook for Alzheimer's disease medications, competition in both the innovative and generic drug sectors is expected to be exceptionally fierce.