Research and development of class 1 new drug for treatment of ischemic stroke

01 What is a stroke?

Stroke, also known as cerebrovascular accident "stroke", is an acute vascular disease that damages the brain tissue due to insufficient blood supply to the brain tissue due to cerebral vascular obstruction or rupture of the cerebral blood vessels.

It has the characteristics of high morbidity, high mortality, high disability rate, high recurrence rate and high economic burden.

According to the World Health Organization, 1 in 6 people in the world may suffer from stroke, 1 person dies from stroke every 6 seconds, and 1 person is permanently disabled due to stroke every 6 seconds, the first death in the world reason.

In my country, stroke has become the number one cause of death and disability among residents and the number one killer of people's life and health.

Moreover, with the acceleration of social aging and urbanization, the unhealthy lifestyles of residents are popular, the risk factors of stroke are generally exposed, and the incidence rate has risen sharply, showing an explosive growth trend and a younger trend.

At present, there are more than 12.42 million people suffering from the disease in my country. The first-time incidence rate of people aged 40-74 increases by 8.3% every year on average. The standardized prevalence rate of stroke among people over 40 years old is 2.19%, and the recurrence rate is 20.9%. The society and many families create a heavy economic burden.

02 What is ischemic stroke?

Stroke includes ischemic stroke and hemorrhagic stroke.

Among them, there are more patients with ischemic stroke (ICS), accounting for 70%-80% of the total incidence of stroke.

Ischemic stroke (commonly known as cerebral infarction) refers to the stenosis or occlusion of the arteries supplying blood to the brain, and the insufficiency of cerebral blood supply leads to clinical events of neurological dysfunction, including transient ischemic attack (TIA), reversible neurological dysfunction (RIND) , Progressive Stroke (SIP) and Complete Stroke (CS).

At present, the treatment of ischemic stroke at home and abroad mainly focuses on the improvement of blood perfusion therapy (thrombolytic therapy, antiplatelet aggregation, fibrosis therapy, anticoagulation therapy) and neuroprotection in specific therapy, as well as symptomatic therapy. nonspecific treatment. Due to the limited understanding of stroke diseases, drugs are mainly focused on symptomatic treatment. There is an urgent need for innovative drugs for pathological changes, which can improve survival, reduce morbidity, recurrence and disability rates, and reduce the economic burden on society, families and individuals.

03 Research and development of class 1 new drugs for ischemic stroke

Dr. Li Ming, Chief Scientist of Carebestcare, graduated from Harbin Medical University under the tutelage of Academician Yu Weihan, Ph.D. of Hokkaido University School of Medicine, Japan, Ph.D. , Director of Research and Doctoral Supervisor of the Department of Cardiology, Faculty of Medicine, The Chinese University of Hong Kong.

For more than 20 years, Dr. Li Ming has been engaged in the research of cardiovascular and cerebrovascular diseases, focusing on the research and development of stroke drugs.

In 1999, he proposed a new hypothesis for the treatment of ischemic disease.

In 2001, he discovered the effective parts of plants that satisfy the new hypothesis.

In 2004, a theoretical system for basic research on the treatment of ischemic diseases was established.

With the continuous deepening of the research content of major human diseases, the scientific research work of a single professional is no longer suitable for development. In order to meet the new scientific research requirements, he set out to form a multidisciplinary research team, involving clinical medicine, basic medicine, cell biology, molecular biology, natural medicinal chemistry and separation of active ingredients, pharmacodynamics, pharmacokinetics, The intersection and penetration of toxicology, histopathology and other disciplines have made all kinds of scientific research resources relatively concentrated, and various scientific and technological personnel can carry out coordinated research under a scientific research framework.

In 2009, with the support of the Hong Kong Science and Technology Commission, the Hong Kong University Research Grants Committee and other institutions, Dr. Li Ming formally established the Hong Kong Regenerative Medicine Laboratory, and led the laboratory to preside over nearly 20 research projects, and the research has overcome the pathological changes. Disease treatment, including: chronic coronary heart disease and myocardial infarction, and advanced heart failure; stroke, rehabilitation of stroke sequelae; cerebral ischemia and brain atrophy; senile dementia and vascular dementia; liver fibrosis, portal hypertension; tissue trauma and surgical wound healing. In 2010, a new research method for the mechanism of action of the treatment of cerebral ischemia was discovered.

Over the years, Dr. Li Ming's drug research and development team has successively obtained 12 international PCT patents (covering China, the United States, the European Union, Canada, Japan, Australia, Singapore and other countries), and published 16 related papers in international authoritative academic journals. He proposed and implemented curative treatment theories and treatment methods for pathological changes in cerebrovascular diseases; the research results were registered with the US FDA as a new type of drug, and were included in Japan's latest national recommended drugs in 2019. He has also been invited many times to give academic lectures in famous universities and research institutions in the United States, and was invited by Professor Craig Mello, the 2006 Nobel Laureate, and Olson, academician of the National Academy of Sciences, to cooperate on many long-term and substantial joint researches. subject.

The Class 1 New Drug Project for Ischemic Stroke Treatment uses the method of regenerative medicine to apply effective parts extracted from natural plants to induce and promote the regeneration of new blood vessels in the ischemic area of the brain, form new collateral circulation, and substantially increase the Cerebral blood flow and blood supply and oxygen supply in the ischemic area of the brain can fundamentally improve cerebral ischemia and achieve curative treatment of pathological changes in ischemic stroke.

By regenerating new blood vessels in the cerebral ischemia area, the living environment of brain tissue can be substantially improved. At the same time, the application of effective parts extracted from traditional Chinese medicine plants can promote the efficiency of local and circulating stem cells to differentiate into brain neuron cells, thereby regenerating Neuronal cells replace the lost neuronal cells and partially or fully restore the function of brain nerve tissue.

In a variety of cerebral ischemia-related animal models, the effective site can significantly promote angiogenesis in the ischemic area of the brain, increase cerebral blood flow, and can significantly improve the loss of neurons in the frontal cortex and hippocampus of the ischemic brain. Neurons become smaller, brain tissue shrinks and other pathological changes, and the behavioral performance of brain-injured animals is significantly improved, and it has a significant curative effect on brain-injured animals.

The application and registration of a national class 1 new drug for the treatment of ischemic stroke has been officially launched. At present, the pharmaceutical research has been completed, and the pharmacological and toxicological research is being carried out.

04 The advantages and social value of innovative stroke drugs

Class 1 new drugs for ischemic stroke have the characteristics and advantages of innovation, effectiveness, safety, controllability, and wide application, and can be used in the acute phase, recovery phase, sequelae phase and primary phase of ischemic stroke. Prevention and secondary prevention.

Innovative:

Curative treatment for the pathological changes of cerebral ischemia caused by cerebral insufficiency and nerve damage. At the same time, it can generate new blood vessels in the ischemic area and promote neuronal cell differentiation. It can improve cerebral ischemia, protect and restore neuronal function. It has revolutionary research results at the international forefront, and provides fundamental curative treatment for ischemic stroke and cerebral ischemic diseases, which is of great clinical significance and innovation.

Validity:

In a variety of cerebral ischemia-related animal models, the drug can significantly promote angiogenesis in the ischemic area of the brain, increase cerebral blood flow, and significantly improve the loss of neurons in the frontal cortex and hippocampus of the ischemic brain. Pathological changes such as brain tissue atrophy and brain tissue atrophy, and significantly improve the behavioral performance of brain-injured animals, and have obvious curative effect on animal functional damage caused by cerebral ischemia. The patients with severe cerebral ischemia have significant curative effect, and the recovery progress of the relief of functional impairment symptoms is very rapid, which greatly accelerates the recovery of patients (quick and comprehensive).

safety:

The drug is an extract of traditional local edible plants, which has passed all experiments as a new resource food, including acute toxicity test, genotoxicity test (AMES test, mouse bone marrow cell micronucleus test, mouse sperm acute test), 90 No toxic reactions have occurred in animal model tests or sympathetic treatment for several years, so it is very safe in application.

Controllability:

The drug has now completed all the pharmaceutical research work, has perfect quality control and quality standards, and has a clear and definite fingerprint. More importantly, a small molecule monomer compound (angioehancin) that promotes angiogenesis and a small molecule monomer compound (crdiogenin) that promotes cell differentiation efficiency have been isolated from this effective site, and have been registered in the US FDA for a period of time. Class new drug (registration number: HBI-3802).

Extensive application:

According to the existing research results and mechanism of action, the drug has a significant curative effect on ischemic stroke. Through further research, it also has a significant curative effect on other brain diseases caused by insufficient cerebral blood supply, and has a wide application prospect.

With the development of society and changes in lifestyle, the incidence and risk factors of cardiovascular and cerebrovascular diseases are increasing. The safe and effective treatment of patients with ischemic stroke Class 1 new drugs will greatly reduce the incidence of stroke. It has far-reaching social significance and value by improving the quality of life of patients, prolonging human lifespan, and reducing the burden on the country, society and family.

Thousands of trials and hardships, Yuru Yucheng. The company will adhere to the values of "life, technology, green", adhere to the concept of "create products, build platforms, and win-win future", continuously optimize processes, innovate development, and make every effort to promote the R&D application and industrialization layout of innovative stroke drugs. Further develop more new drugs with indications and make due contributions to the cause of human health.