The Guojin Securities Research Report pointed out that there are many pharmaceutical companies participating in AD research and development in China, and there are pharmaceutical companies worthy of attention in terms of biopharmaceuticals and chemicals.
The Zhitong Finance App learned that on January 9, the domestic AD market ushered in new developments. According to the official website of the National Drug Administration, lecanemab-irmb (lecanemab-irmb), a new drug for Alzheimer's disease jointly developed by Bojian/Japan Eisai, has been approved for marketing to improve the treatment of mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) diseases caused by Alzheimer's disease. China is the third country to approve the marketing of luncanizumab after the US and Japan, showing that approval for the marketing of new drugs has been accelerated.
Luncanizumab is a humanized anti-soluble Abeta monoclonal antibody. Earlier, it was reported that the annual cost of luncanizumab treatment in the US is US$26,500. Currently, Eisai has not officially disclosed the price of the drug in China. However, the drug landed in the Hainan Boao Lecheng International Medical Tourism Pilot Zone in October 2023. The price disclosed at the time was 3328.2 yuan/bottle.
Alzheimer's disease, commonly known as “Alzheimer's disease,” is a brain disease that gradually worsens and is caused by damage to neurons in the brain. The first part of the brain that is damaged by this disease is the part responsible for memory, language, and thinking. As nerve cell damage spreads to parts of the brain that support basic functions such as walking and swallowing, patients can be bedridden and require round-the-clock care. Research shows that people aged 65 and over live an average of 4-8 years after being diagnosed with Alzheimer's disease, but some patients can survive for 20 years.
As the most common neurodegenerative disease among the elderly, Alzheimer's disease has always been regarded as the “jewel in the crown” by the drug development community due to its huge market demand. Well-known domestic and foreign pharmaceutical companies have invested heavily. Since 2002, pharmaceutical companies have successively invested more than 200 billion US dollars in research and development of new drugs for Alzheimer's disease. However, in more than 200 clinical studies, few products have been successfully marketed. High investment, high risk, and high failure rate have become characteristics of the development of new drugs for Alzheimer's disease.
According to the “China Alzheimer's Disease 2021 Report”, in 2019, the number of Alzheimer's patients in China reached 9.83 million. The prevalence and death rates of Alzheimer's disease and other dementias are slightly higher than the global average, making it the country with the highest number of Alzheimer's patients in the world. It is estimated that by 2025, the number of people with Alzheimer's disease will reach 15.5 million, and by 2030 it will further increase to 19.5 million, showing an accelerated growth trend.
According to the Galaxy Securities Research Report, there are 34 new clinical AD drugs in China. The Guojin Securities Research Report pointed out that there are many pharmaceutical companies participating in AD research and development in China, and there are pharmaceutical companies worthy of attention in terms of biopharmaceuticals and chemicals.
Tonexide Jinma is a novel acetylcholinesterase inhibitor. This drug is used to treat mild to moderate AD. In September 2023, Tonghua Jinma announced that significant research progress has been made in the amber octahydroaminoacridine tablet project independently developed by its wholly-owned subsidiary Changchun Huayang Hi-Tech Co., Ltd. The project underwent a double-blind, dual-simulation, randomized, placebo/positive parallel controlled phase III clinical trial, and recently completed phase III blindness detection and statistical analysis of the main data. Boosted by the above news of progress, Tonghua Jinma's stock price skyrocketed and became the “monster stock” of the time.
Currently, many domestic pharmaceutical companies are also developing drugs around the Abeta mechanism, but most of them are in the early stages of research.
In February 2022, Xiansheng Pharmaceutical announced that its clinical trial application for the development of the oral small molecule drug SIM0408 was approved by the Drug Administration to treat mild cognitive impairment or mild dementia caused by AD. This oral medication was obtained by Xiansheng Pharmaceutical from Vivoryon in June 2021. This collaboration of more than 500 million US dollars enabled Xiansheng Pharmaceutical to obtain the right to develop and commercialize 2 neurotoxic amyloid N3PE (pglu-abeta) AD treatments in Greater China, including SiM0408.
In March 2023, Hengrui Pharmaceutical announced that the Phase IB clinical trial of the anti-Abeta monoclonal antibody SHR-1707 injection independently developed by its subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd. to treat early AD completed the first patient enrollment and administration at the First Affiliated Hospital of the University of Science and Technology of China. In July 2023, the latest research progress on the drug was also presented at the Alzheimer's Association International Conference.
In addition to companies that develop and produce drugs, the upstream diagnostic industry of AD drugs also deserves attention.
According to the Guojin Securities Research Report, the severity of difficult diseases, advanced disease understanding, and breakthroughs in new drugs will accelerate the growth of related diagnostic circuits. Currently, there are few manufacturers participating in the AD diagnosis circuit in China, mainly focusing on emerging technology research. Diagnosis is expected to usher in sales opportunities along with drug release.
According to the Galaxy Securities Research Report, the main methods of AD diagnosis include cognitive assessment: an important early identification method, but relatively highly subjective; neuroimaging: the main technical methods include CT, MRL, etc., which can be used to distinguish the types of dementia and assist in evaluating the course of AD; in vitro diagnosis: main samples in vitro blood and cerebrospinal fluid (mainly Aβ/p-TAU/NFL/GFAP), but they each face the problems of difficult sampling and low abundance. Mass spectrometry/single-molecule immunoassay may be an optimal solution. Currently, the high-end diagnostic test market pattern is good.
Fangzheng Securities believes that there are few domestic pharmaceutical companies that have set up an AD circuit. It is a blue ocean track with relatively high demand and low competition. It is optimistic that the drug development and diagnosis industry chain will usher in broad opportunities. The agency expects China's AD diagnosis market to grow to 26.02 billion yuan in 2025, with a compound annual growth rate of 3.7%. In the context of aging, early diagnosis and prevention of AD will become the main theme in the future. If accurate diagnosis and prevention can be carried out at a lower price, combined with health examinations, so that the elderly can be screened regularly every year, then the size of the AD diagnosis market in China is expected to break 100 billion.
Related concept stocks:
China Antibody-B (03681): The company announced that on November 14, 2023, the company's new drug research application for suciraslimab (Suciraslimab, SM03) for mild cognitive impairment or mild dementia due to Alzheimer's disease has been submitted to the Drug Evaluation Center of the China National Drug Administration and has been accepted. If the application is successfully approved, the company will launch clinical research and development projects in China to treat early-symptomatic Alzheimer's disease, including mild cognitive impairment or mild dementia due to Alzheimer's disease.
Luye Pharmaceutical (02186): The company announced that it has developed an exclusive new drug in the field of central nervous system treatment, Lysimin transdermal patch, which has been approved by the National Drug Administration to treat symptoms of mild and moderate Alzheimer's disease.
Xiansheng Pharmaceutical (02096): The company is developing the oral small molecule drug SIM0408 (PQ912, varoglutamstat) and has obtained a drug clinical trial approval notice issued by the State Drug Administration. It is intended to be used to treat mild cognitive impairment (MCI) or mild dementia caused by Alzheimer's disease (AD). Additionally, the company's medicines for Alzheimer's disease include mecobirin hydrochloride.
Shandong Xinhua Pharmaceutical Co., Ltd. (00719): In January 2023, Xinhua Pharmaceutical announced that its OAB-14 dry suspension was approved to conduct clinical research on the treatment of Alzheimer's disease.
MineGene (06667): China's leading genetic testing platform. Since its establishment in 2016, it has been deeply involved in preventive medicine fields such as genetic testing and early tumor screening. It has launched nearly 100 testing services, covering a wide range of fields such as nutrition and metabolism, cancer risk assessment, chronic disease susceptibility, and cancer screening to meet the growing preventive medical needs of consumers. For Alzheimer's disease testing, Maingene helps diagnose and treat Alzheimer's disease early through advanced genetic testing technology and inclusive genetic testing services.