In recent years, cell technology has become an important "new track" for global science and technology and industrial competition, and is known as the representative of new quality productivity and the new engine of the future economy, which has attracted more and more attention from governments and market players. China Science and Technology Investment interviewed Kang Chunxin, chairman of the Stem Cell and Biomedical Industry Development Committee of the China Association of Development Zones, on issues related to the development of the cell industry in mainland China.
China's Science and Technology Investment: The Development Status and Trend of the Cell Industry in China?
Kang Chunxin:
(1) The level of cell science and technology in mainland China is in the forefront of the world
At present, the R&D level of cell technology in mainland China is generally the second in the world, but the gap between original achievements and the United States is still obvious.
From the perspective of basic research, the mainland has made outstanding achievements in many fields such as hematopoietic stem cells, embryonic stem cells, mesenchymal stem cells and induced pluripotent stem cells (iPS), but the basic research is still leading in Europe, the United States, Japan and Western developed countries, and from 2000 to 2019, the mainland has published a total of 56,913 papers in the field of stem cells, ranking second in the world.
From the perspective of clinical research, as of August 2023, a total of 9,915 stem cell clinical research projects have been registered worldwide, including 4,606 in the United States and 985 in the mainland, ranking second in the world for a long time.
(2) The development potential of the mainland cell industry is huge
The market demand for the cell industry in mainland China is huge. Cell medicine is another medical revolution after drug treatment and surgical treatment, and represents the direction of future medical development. With the gradual prominence of the aging society in mainland China and the large population base, the number of people suffering from various diseases, especially chronic diseases and tumors, is increasing. According to the Special Report of the Sixth National Health Service Statistical Survey, in 2018, the prevalence of chronic diseases among people aged 55 to 64 in mainland China reached 48.4%, and the incidence rate of the elderly aged 65 and above reached 62.3%. In 2020, there were 19.29 million new cancer cases worldwide, accounting for 23.7% of the world's total, and 9.96 million cancer deaths, accounting for 30% of the world's total. The cell industry will play an important role in the treatment of these diseases.
Great progress has been made in the important areas and key links of the mainland cell industry. In terms of clinical trials, as of March 2023, a total of 62 stem cell drug clinical trial applications (IND) from 42 companies in mainland China have been accepted, 47 clinical trial approvals have been granted by 30 companies, and the number of IND applications for induced pluripotent stem cell (iPS) drugs has gradually increased. In terms of product approvals, as of the beginning of 2022, there were 33 approved cell therapy products worldwide, including 12 immune cell products and 21 stem cell products, and the 2 approved cell therapy products in mainland China are immune cell products, and the overall level is in the second echelon. In terms of industrial chain, the mainland cell industry is currently mainly concentrated in the upstream collection and storage stage, and at the national level, 7 umbilical cord blood hematopoietic stem cell banks, 2 stem cell resource banks, most provincial and municipal levels have also established adult stem cell banks, and there are many market-oriented storage enterprises.
(3) The bioeconomy pilot zone will drive the rapid development of the cell industry
The national "14th Five-Year Plan" for the development of the bioeconomy clearly states that cities will build bioeconomy pilot zones in Beijing-Tianjin-Hebei, Yangtze River Delta, Guangdong-Hong Kong-Macao Greater Bay Area, Chengdu-Chongqing Shuangcheng Economic Circle and other cities, which is expected to promote the innovation of the institutional framework and policy system of the cell industry, is expected to promote the exploration of the development model and path of the cell industry, and is expected to promote the centralized construction of a number of cell technology and industrial innovation platforms, so as to guide and drive the rapid and healthy development of the cell industry.
At present, the development of the cell industry in the planned pilot area has a certain foundation. As of March 2022, a total of 137 stem cell clinical research institutions and 112 projects have been filed across the country, of which the three regions of Beijing-Tianjin-Hebei, Yangtze River Delta and Greater Bay Area account for 53.28% of the country's filings and 58.93% of the country's filings.
China's science and technology investment: what are the outstanding problems and bottlenecks facing the development of the cell industry in the mainland?
Kang Chunxin:
(1) There are blockages in the path of cell industrialization
At present, the United States and Japan, which have developed rapidly in the cell industry, have relatively clear industrial development paths. Among them, the United States has formed a path of drug management, but according to the "Jordan Act", patients are given the right to choose the application of cell technology therapy, and Japan has formed a "dual-track system" that allows the application of cell technology and can also apply for registered drugs.
In contrast, the mainland cell industrialization path has a single form, which is highlighted in the fact that cell research and technology are not allowed to enter clinical application, and the industrial path and development model only have one way to apply for drug registration, which limits the clinical application of cell technology therapy, greatly increases the cost of drug application and registration and investment risk, is not conducive to finished drugs, and has become the biggest blockage of the mainland cell industrialization path.
(2) There are difficulties in the supervision of cell industrialization
At present, the competent authority in the clinical research stage of the cell project is the National Health Commission, and the competent authority in the clinical trial stage is the Food and Drug Administration. The standards are different, they are not recognized when applying for drug clinical trials, and the clinical trial data cannot be fed back to the research stage, resulting in the transformation of technological achievements into drug registration, which not only greatly wastes the opportunity for scientific research funds and transformation of scientific and technological achievements, but also reduces the efficiency of cell drug registration and marketing, and at the same time, the lack of feedback of clinical trial data, technology research and development and clinical research can not get the data support required for iteration and correction, which greatly slows down the industrialization process.
(3) There are outstanding pain points in the middle and lower reaches of the cell industry chain
There are fewer funding channels for clinical research, insufficient state support funds, fewer institutions to carry out substantive clinical research, fewer research projects carried out by institutions, and slower progress in technology transfer and drug application and registration. As of March 2022, 70 filing institutions have completed project filing, but the other 67 filing institutions have not yet filed for projects. As of September 2022, 36 new stem cell drug projects in mainland China have obtained national clinical implicit approval (IND), but there has not yet been a single case of stem cell drug approval.
China's Science and Technology Investment: How to Promote the High-quality Development of the Mainland Cell Industry?
Kang Chunxin:
(1) Vigorously promote the construction of bioeconomy pilot zones
To speed up the implementation of the "14th Five-Year Plan" for the development of the bioeconomy pilot zone, it is recommended to give priority to the construction of the bioeconomy pilot zone in cities with relatively complete basic conditions in the pilot area, take the lead in trying out key measures such as scientific and technological innovation, access and supervision, and financial innovation, seek effective solutions to solve the difficulties and blockages in the development of the cell industry, and explore the industrialization development path suitable for the national conditions of the mainland.
Establish a management committee for the bioeconomy pilot zone. The Management Committee is responsible for the guidance, overall planning and coordination of important work and major matters in the planning and construction of the pilot area, and does a good job in the coordination and daily management of the construction of the pilot area.
Set up a panel of cell therapy technical experts in the pilot area. The committee is composed of experts in related specialties, and is mainly responsible for reviewing the selection, standard system, and ethical norms of clinical application technology, determining the types of diseases and patients to be tested, and carrying out medical arbitration.
Promote the clinical application of cell technology in the pilot area. It is recommended to set up research hospitals, research wards or translational medicine research centers in qualified medical institutions in the pilot area as soon as possible, give them more flexible pilot policies, and use research hospitals, research wards or translational medicine research centers as a bridge and link between basic cell scientific research, clinical research and application of cell technology and clinical trials, and drug registration and marketing. Research wards or translational medicine research centers carry out clinical research and application of cell technology, systematically collect and record process data, and enter the drug application process when conditions are ripe, so as to promote the linkage between cell therapy technology research and application and drug declaration.
(2) Focus on building a data collaboration platform and innovation consortium for the cell industry
At present, the data and platforms of each link of the cell industry chain exist discretely, and there is basically no application value, so it is suggested to establish a unified big data service platform to realize the transmission, sharing and mutual recognition of data such as technology research and development, clinical research, and clinical trials on the same data platform, so as to solve the problem of slow industrialization caused by the inability to collaborate and mutual segmentation caused by different data standards in the industrial chain.
The large-scale industrial big data is a valuable asset of the cell industry based on the national conditions of the mainland, and is the result of huge capital investment by the state and enterprises, and the synergistic effect of industrial big data should be given full play to promote the progress of the cell industry. Because big data collaboration technology can break the dilemma of information islands, revitalize the potential value of data, and promote the formation of a unified, efficient, and interconnected data and resource sharing layout between various links and departments, big data and collaborative platforms can provide strong support for basic research, clinical research and clinical trials, give new momentum to the rapid iteration and upgrading of the industry, give new momentum to technological innovation and product development and production, and promote the collaborative innovation of industry, university, research and application in the cell field and the transformation of scientific research achievements.
Encourage qualified research hospitals, scientific research institutions, and enterprises to form collaborative innovation consortiums, build industry-university-research exchange platforms with multi-level resource linkage, focus on breakthroughs in key core technologies in the cell industry, improve the efficiency of clinical resource utilization, and realize the organic unity and synergy of production, learning, research, use, and finance through the mutual promotion and integration of big data and collaborative platforms and innovation consortiums, and accelerate the rapid and healthy development of cell industrialization.
(3) Accelerate the establishment and improvement of financial guarantees for the development of the cell industry
Give full play to the role of special government funds in supporting and guiding the cell industry, set up special government funds for clinical research, and attract and leverage all kinds of social capital to actively participate in the development of the cell industry. Set up special funds for clinical trial stage projects, encourage and support the registration and listing of drugs as soon as possible in the form of investment subsidies from the central budget, set up an information database for cell industry financing projects, give full play to the role of pilot area funds, science and technology innovation funds, and industrial funds, and encourage financial institutions, investment and financing institutions, and insurance institutions to improve financial support for the cell industry and promote the diversified supply of funds.
(4) Summarize and promote successful experiences in a timely manner
Encourage the pilot area to boldly explore and innovate, encounter new obstacles and problems in a timely manner to the relevant departments for instructions, and put forward a pilot plan for decision-making reference. Support the Stem Cell and Biomedical Industry Development Professional Committee of the China Association of Development Zones to refine, summarize and publicize the successful experience of various places in a timely manner, promote the rapid and healthy development of the cell industry in the mainland, and strive to form an internationally competitive cell industry cluster, so as to provide strong support for the common construction of a healthy China and even the destiny of mankind.
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