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Edit Spinach's Starry Sky.
Typesetting Hot pot under the stars.
Decades of silence without significant progress have almost made patients and pharmaceutical companies discouragedAlzheimer's diseaseThe (AD) field finally ushered in the dawn this year, and the new drug lencanemab jointly developed by Biogen and Eisai based on the amyloid hypothesis showed outstanding clinical results, slowing the cognitive decline of early Alzheimer's patients by 27%. This performance also makes the drug the first AD drug to be fully approved by the U.S. Food and Drug Administration (FDA) in nearly 20 years.
In addition, the new drug donezumab developed by multinational giant Eli Lilly has also successfully reached the phase III clinical endpoint and is scheduled to be approved by the FDA in the near futurePeriod
In China, where the patient base is huge, breakthroughs in the field of AD are naturally enough to become a biomedical sectorFront-page headlines。At the end of August, Tonghua Jinma (000766) disclosed that a new AD drug under development - succinyloctahydroamacridine tablets held a preliminary meeting for the unblinding of phase III clinical trials, and the follow-up announcement further stated that the experimental results showed that the drug had obvious clinical significance for the improvement of ADAS-COG. This is the fastest progressing new AD drug in China since Green Valley Pharmaceutical's mannitna capsule was "born".
After that, the stock price of Tonghua Jinma directly started to soar mode, and it was recorded in just 13 trading daysup and down! Although the market has repeatedly questioned the actual performance and commercialization prospects of the drug, it has not affected Tonghua Jinma's soaring popularity, and the popularity has not diminished for several months. On December 13, after harvesting another price limit, the ** price has been as high as 2386 yuan, and in August it was still hovering around 7 yuan.
Huajinma stock price chart **Compiled by the author.
Alzheimer's disease**prospectsWhere is it? Can the current market really support such a "bursting" performance of relevant listed companies?
1. The burden of Alzheimer's disease is huge
Alzheimer's disease is the most commonNeurocognitive disorders, which has a serious impact on the quality of life of patients. The onset is insidious and progressively irreversible, with a high prevalence and inability to **. The main manifestations are memory loss and cognitive impairment, and the ability to take care of oneself is gradually reduced, and the late stage is often combined with malnutrition, lung and urinary tract infections and other diseases, and even generalizedExhaustion
Dementia classification and proportion.
*: 2018 Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment in China (1), China Galaxy ** Research Institute, China Dementia and Cognitive Impairment Guidelines Writing Group.
Alzheimer's disease is the most important thing that global pharmaceutical companies want to overcome in addition to malignant tumorsDifficultyOne. On the one hand, this is because the patient base is very large, and on the other hand, because AD patients are gradually "disabled", and there is a great need for long-term care and comorbidities, which will bring a burden to both families and society. According to a domestic article published in 2017, the average annual cost of each Alzheimer's disease patient in China isAbout 10,000 RMB.
In 2022, China has more than 2Of the 800 million people over the age of 60, the proportion of these elderly people with cognitive impairment is 604%。In this group of cognitive impairment, 60-80% are caused by Alzheimer's disease, corresponding to more than the patient group10,000 people As we all know, the pace of aging in China is still irreversibly accelerating. It is conceivable that the patient population will also expand rapidly, and the whole society will need to face this potentially huge burden. Based on the current patient stock base alone, the total socio-economic cost of AD patients per year is already there1 trillionRMB or more.
2. Breakthroughs have been made in drug research and development
The pathogenesis of Alzheimer's disease is complex, and we have not yet studied it, so we can only propose a few such as abnormal amyloid (A) deposition, tau phosphorylation, cholinergic damage, etcHypothesis。The author will not expand on the details of the hypothesis, in short, human beings are trying to develop corresponding drugs based on these hypotheses, such as lecanemab (lecanemab) and donanemab (donanemab), which have made progress this year, are both based on hypothesis A. Although no significant progress has been made in the field of AD** for decades, the research and development of new drugs is always in full swing. As of January this year, there are already in the world141 pcsAD investigational drugs enterClinical trialsStage.
Global R&D Pattern of Alzheimer's Disease Antibody Innovative Drugs Targeting A **Pharmaceutical Rubik's Cube, Everbright** Research Institute.
Alzheimer's disease drugs that have entered the clinical stage in China are also availableThat's a lot. Although phase III and later drugs are mainly imported products focusing on target A, the number of new domestic drugs is also quite large. Hengrui Pharmaceutical (600276) has a A monoclonal antibody in the 1B clinical stage, Simcere Pharmaceutical (02096)'s QPCT small molecule has entered the IIB stage overseas, and the products of Kangyuan Pharmaceutical (600557), Xinhua Pharmaceutical (000756) and other companies have also enteredClinical stage
Clinical progress of new AD drugs in China **Insight, China Galaxy **Research Institute.
3. Diagnosis or new air outlet
In addition to medications, diagnosis may be more critical for AD**.
Alzheimer's disease if it progresses toLate stageIt is difficult to reverse, so how to detect and intervene in the early stage (MCI stage and before) is a difficult problem that needs to be broken through in the field of AD**. At present, cognitive assessment is mainly used, including seven areas, including orientation, memory function, and speech function. Although clinical scales are used to achieve a certain degree of consistency and comparability, they still carry a strong forceSubjectivecolor, and it is difficult to fully reflect the progress of the disease, which leaves a huge space for diagnostic methods such as imaging, blood, and body fluids. According to research institutions, the scale of China's AD diagnostic market has reached 21.7 billion yuan in 2020 and is expected to grow to 26 billion yuan in 2025.
The scale of China's AD diagnostic market is expected to gradually expand **Toubao, Gaohe Investment Research Center, Guojin ** Research Institute.
With the resurgence of Alzheimer's disease this year, many companies such as Hotgen Biotechnology (688068) have also crashed into the field of AD detection and diagnosis.
Let's start with diagnostic imaging, which is a routine adjunct. Devices such as computed tomography (CT), magnetic resonance imaging (MRL), and positron emission tomography (PET-CT) can be used to assess and identify AD, or at least have some reference significance. In the field of these three types of medical equipment, the domestic manufacturer United Imaging Medical (688271) has been able to compete with imported manufacturersWrestle your wristsIn a category with a relatively low technical threshold such as CT, it has even firmly occupied the top spot in the number of sales. In addition to the device itself, the developer is also an essential presence in diagnosis. In this field, Dongcheng Pharmaceutical (002675) and China Tongsheng (01763) hold the production and sales approvals for key products such as 18F-deoxyglucose. In addition, Hokuriku Pharmaceutical (300016) also has a magnetic resonance imaging-assisted AI software - Yiwei Brain Doctor has been approved.
In vitro diagnostics, domestic manufacturers are concentratedPeripheral bloodmarker detection. Jinyu Medical (603882) has launched a peripheral blood AD early screening project in 2022, while manufacturers such as Dian Diagnostics (300244) and Hotgen Biotechnology have also launched related products, and they have all prepared a complete set of solutions.
Although the research and development of new drugs for Alzheimer's disease has seen the dawn, there is still a huge number of documents on the commercialization prospects of domestic manufacturers' products. Comparatively, the field of diagnostics may be moreCertaintyopportunities.
Note: This article does not constitute any investment advice. **There are risks, and you need to be cautious when entering the market. There is no harm in buying and selling.