內容目錄
At this meeting, Luo Yongzhang, member of the National Committee of the Chinese People’s Political Consultative Conference and member of the National Committee of the Chinese People’s Political Consultative Conference on Education, Science, Health and Sports, paid attention to the research and development of drug candidates for major diseases such as Alzheimer’s disease. He suggested that provide a green channel for the development of drug candidates for major diseases and help the development of innovative drugs in my country.
Luo Yongzhang said that Alzheimer’s disease and Parkinson’s disease are common and major age-related degenerative diseases that plague the global population. There are at least 13 million Alzheimer’s patients in my country. The world’s top ten pharmaceutical companies have all challenged Alzheimer’s disease, but since the 21st century, more than 320 clinical trials have ended in failure, and the failure rate of new drug development is as high as 99.6%.
According to relevant requirements, obtaining clear safety and efficacy verification through animal experiments is an important prerequisite for applying for clinical research. Luo Yongzhang said that the pathogenesis of diseases such as Alzheimer’s disease and Parkinson’s disease is still unclear, and animal models cannot truly simulate the pathogenesis of human patients, so it has been difficult to find suitable animal models for pharmacodynamic evaluation.
“Diseases that do not have a clear and effective clinical treatment plan and no suitable pharmacodynamic animal model are often major scientific problems that have plagued human beings for a long time.” Luo Yongzhang said that for Alzheimer’s disease and Parkinson’s disease drug candidates are limited by the lack of appropriate animal models, the inability to observe the efficacy of animal experiments and the inability to conduct clinical trials, which not only delays or even misses promising drug candidates to a large extent, but also seriously hinders the development of innovative drugs in my country. process.
Luo Yongzhang suggested that policy support at the national level should be provided, regulatory requirements should be improved, and the list of such indications should be clarified. Experts in the review center recognize that the environment for efficacy verification in animal trials is skipped, and drug candidates for such indications are approved to verify efficacy in human clinical trials.
“The national regulatory authority can formulate a special regulatory mechanism for this type of clinical research.” Luo Yongzhang said, in this way, on the premise of ensuring the rights and interests of subjects, drug candidates for major diseases can be made research and development to open up a green channel.
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