The cell industry has entered a great era of development, and the stags are leading the way

the rapid evolution of global biotechnology breakthrough and industrialization, technology turnover and results transformation cycle is shortening day by day, the new technology represented by cell therapy has become an important driving force for the development of biopharmaceutical industry in recent years, and is expected to become the "third pillar of medicine". According to the principle of treatment, cell therapy is mainly divided into stem cell therapy (mainly used in rare diseases, major chronic diseases and severe trauma repair in the field of regenerative medicine) and immunocellular therapy (mainly in the field of tumor), and gradually become an indispensable and effective means to make up for traditional treatment. Taking this new crown pneumonia as an example, nearly 60 research projects on stem cell treatment of new crown pneumonia are in full swing around the world. Wuhan has completed more than 200 cases of stem cell therapy, the United States, South Korea, the United Arab Emirates, etc. have completed some of the new crown medium / severe patient stem cell therapy, clinical treatment is safe, for the new coronary pneumonia treatment provides a new method and model.There are currently 42 cell therapy products on the market worldwide, and there are approximately 7,900 registered clinical trials of cell therapy products. Although there are still many engineering and regulatory challenges in cell therapy, with the breakthrough of basic research and the rapid development of clinical applications, the cell industry has caused huge market space. The stem cell industry is expected to be worth about $400 billion worldwide by 2020, and immunocellular therapy will account for at least 10 percent of the total tumor treatment market.

development of the cell industry is no longer a choiceGrabbing the commanding heights of biotechnology and bio-industry has become a major strategy for countries to improve their international competitiveness and take the initiative to develop, and the cell industry, as an important area of a new round of biotechnology transformation in the world, has been regarded as the key direction to support development. For example, to encourage car-T cell therapy-based immunotherapy, the U.S. Congress has allocated $1.8 billion to the Cancer Moon Project, and Japan and the United Kingdom have introduced a national system of stem cell therapy to encourage and promote the development of a well-regulated cell industry.Although the development of the cell industry is facing many quality testing standards and regulatory norms, the Wei Izexi incident in 2016 caused China's cell industry to stagnate for some time, but the country has issued the "cell therapy product research and evaluation technical guidelines (trial)," biomedical new technology clinical application management regulations (draft for comments), somatic cell therapy clinical research and conversion application management methods (trial draft) (draft for comments), etc., for the domestic cell therapy industry to develop detailed general and universal guidelines, cell industry standardization.At the same time, China has also clearly formulated a series of guidelines and policies to accelerate the development of the cell industry, "13th Five-Year Plan" National Strategic Emerging Industry Development Plan, "Strategic Emerging Industry Key Products and Services Guidance Directory," "13th Five-Year Plan" bio-industry development plan, "13th Five-Year Plan" health and health science and technology innovation special plan, "Promoting high-quality health industry development platform (2019-2022)" and other key technical research to strengthen stem cells, immunocellular therapy and other key technologies. The 2019 edition of the Industrial Structure Adjustment Guidance Directory, which is regarded as the trend of industry development, for the first time adds cell therapy drugs to the encouragement catalogue, marking that cell therapy in China has entered the stage of industrialization. In 2019 alone, 11 local governments and industrial parks have introduced support policies to explicitly support the development of the cell industry.Therefore, the development of the cell industry not only responds positively to the national call, but also opens up the opportunity of regional industrial competitiveness oversized, which has a profound impact on the change of the biopharmaceutical industry pattern. In the post-epidemic era, all over the layout of biomedicine, the concept of the cell industry is hot, not talking about "whether to develop the cell industry", but "how to develop the cell industry."

the development of cell industry in local governments or parks requires professional and systematic layoutCompared with other sub-sectors of biomedicine, the development of cell industry in local governments or parks has certain particularities.First, the development of cell industry is still in its infancy, cell therapy has not yet formed a corresponding industrial cluster, domestic and foreign can learn from the development experience is very small.Second, cell therapy is a technology-intensive emerging technology, with a large number of speculative and profit-based clinical studies, high potential risks, the success rate of preclinical projects is generally very low, most products at least until the clinical II. period will be clear its potential value, in the short term it is difficult to achieve the economic benefits of the industry. The introduction of screening for related enterprises or projects requires a professional and accurate assessment.Third, China's access requirements for the cell industry are very high. For example, the Special Management Measures for Foreign Investment Access (Negative List) (2020 Edition) clearly stipulates that foreign investment in "the development and application of human stem cells, genetic diagnosis and therapeutic technologies" is prohibited. Policy barriers and investment mine zones in different industrial chains of the cell industry need to be carefully screened.Fourth, the industrial chain of the cell industry is very long, including cell extraction and storage, quality control testing, research and development and production, clinical applications, cold chain logistics, etc., but the development of different links is difficult. Local governments or parks need to compare the industrial base of different industrial links, such as research institutes, existing enterprises, clinical filing institutions for stem cells or immune cells, and make clear the priority of the layout of the cell industry development system for development prospects, market value, entry threshold and difficulty, competitiveness, major enterprises and projects.Fifth, cell therapy in recent years only rapid development, most of them are start-up or growth stage of small and medium-sized innovative enterprises, is in the important point of breeding to be developed, only on their own to achieve rapid development is very difficult, in addition to financial support, but also for the cell industry public service platform, GMP plant and other related supporting support. Local governments or parks need to professionally design targeted and truly service-oriented technical service platforms and support systems to attract outstanding enterprises and projects.Sixth, enterprises stationed in the local or park is most concerned about one is supporting, the other is talent, cell therapy as the cutting-edge biotechnology on the talent requirements are very high. The importance of introducing research and development talents is self-evident, but the particularity of the cell industry lies in the extreme scarcity of talents such as cell screening, cell plant construction optimization and quality control testing. Choose which talents and how to retain the pulse that needs to be systematically organized according to the layout of the cell industry.It can be seen that the cell industry "where the development path" is not a hot-headed on the hot development, but the need to combine national policy guidance, industrial development trends and regional competition patterns, in the analysis of the industrial base, tap potential, analysis of pain points on the basis of clear target positioning and development path. Professional system planning layout is very important to the development height and speed of the cell industry, the introduction of talent, the project landing. (Medical Geography)
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