Cell and gene therapy is one of the most potential field to develop in biomedical industry, and also the important direction for life and health industry. As a disruptive innovative technology, cell therapy is expected to overcome cancers, premature senility and other key diseases. The global cell market is expected to reach a trillion dollars by 2030. At the same time, China has given strong support to the health industry, especially the clinical research of cell technology and products, and national competent authorities and local governments have issued a number of favorable policies. In 2019, China has issued a series of policies to standardize and promote the clinical research and transformation application of stem cell therapy, providing a guarantee for the rapid development of stem cell technology. Local governments and industrial parks have also responded positively by issuing supporting policies to support the biomedical industry, especially the new technology of cell therapy represented by immune cell therapy and stem cell therapy.
The Ministry of Science and Technology has issued a Notice on the Release of Guidelines for the Application of Key Projects in 2019, including the National Key Research and Development Plan “Stem Cell and Transformation Research”,which pointed that we should give priority to support 12 research directions and allocate 400 billion yuan to encourage stem cell research and clinical transformation applications.
The National Municipal Health Committee has issued the Control Ordinance of Clinical Application of New Biomedical Technologies (draft for comments). It aims to standardize clinical research and transformation applications of new biomedical technology, promote medical progress, insure medical quality and safety, protect people’s dignity and life health.
The National Municipal Health Committee has issued the Clinical Research and Transformation Application Management of Somatic Cell Therapy (Trial) (Draft for Comments), to regulate and promote semantic cell therapy clinical research and transformation applications. The draft further clarifies that medical institutions, as the subject of responsibility, can conduct clinical research on new technologies such as somatic cell therapy, and can apply for clinical applications and charge fees after obtaining safety and effectiveness data.
The Ministry of Science and Technology and the Ministry of Finance has issued the Notice on the List of Optimization and Adjustment of the National Science and Technology Resource Sharing Service Platform, Which give permission to establish two state-level stem cell banks: National Stem Cell Bank and National Stem Cell Transformation Resource Bank.
The National Development and Reform Commission：Letter of Reply to Proposal No. 3324 (Medical and Sports No. 403) of the Second Session of the 13th National Committee of the Chinese People’s Political Consultative Conference.
1.Cell is an important resource for human life and health industry development. At present, with the deepening of cell research, cell technology has been widely used in biopharmaceutics, health immunity, antibody preparation, organ reconstruction, clinical treatment of major diseases and other fields, and is expected to become one of the best means to extend human life and improve the quality of life. Your suggestions to promote the development of cell therapy technology and related industries are very meaningful.
2.Our commission attaches great importance and actively carries out relevant work to promote the development of cell technology and industry. In the 13th Five-year Plan for the Development of Strategic Emerging Industries and the 13th Five-year Plan for the Development of Biological Industry, it has made clear arrangements to promote the development of immune cells and stem cell technologies, and proposed to accelerate the construction of a new medical model based on stem cell and regeneration technologies, continue to deepen the clinical application of stem cell and regeneration technologies, and support the construction of a number of innovative development platforms for the biological industry, such as the stem cell bank. Actively connect with major national strategy regions such as Guangdong-Hong Kong-Macao Greater Bay Area, Integration of Yangtze River Delta, Beijing-Tianjin-Hebei Area. Orient to good industrial development foundation and strong competitive advantage regions, such as the Pearl River Delta region, Yangtze River Delta region and Beijing-Tianjin-Hebei region, to strengthen the construction of biological industry innovation platform layout, and promote key biomedical fields such as cell industry cluster development.
3.Next, integrating your advice of developing and make plans and together with the Health Committee, SPDA and other department, we are going to actively accelerate innovative demonstration of cell technology such as immune cell therapy with emphasizing on breaking though a batch of core technology, promote the construction of a number of large-scale, standardized and normalized technology research and development, production and preparation, quality testing, demonstration applications and other supporting platforms, effectively promote the transformation of cell-related technological achievements and the market application of products, and comprehensively improve t people’s health security level.
The State Council issued the General Plan for Pilot Free Trade Zones in China (Shandong), (Jiangsu), (Guangxi), (Hebei), (Yunnan) and (Heilongjiang) (hereinafter referred to as the General Plan). All plans of the Five new pilot free trade zones include policies on stem cells and immunotherapy.
The National Development and Reform Commission, the Ministry of Education, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the Ministry of Civil Affairs, the Ministry of Finance,the Human Resources and Social Security, the Housing Department of Natural Resources, the Ecological Environment, the Urban and Rural Construction Ministry, the Ministry of Commerce,the Culture and Tourism, the National Health Committee, the People’s Bank of China, the Administration of Taxation, the Administration of Market Supervision, the General Administration of Sports, the Medical Insurance Bureau, Bureau of Traditional Chinese Medicine and the Drug Administration formulated the “Action Program for Promoting High-quality Development of the Health Industry(2019-2022). By 2022, there would basically form a health industry system with rich connotation and reasonable structure, the coverage of quality medical and health care resources would be further expanded, health industry alignment and collaboration would be further enhanced, competitiveness of science and technology of health industry would be further improved , talented person quantity and quality would increased to a higher level, a number of strong influence health industry cluster would form, and would lay a solid foundation for the health industry to become the important pillar industry of national economy. The government document clearly stated: support cutting-edge technology and product development applications. By playing department together, strengthen the continuity and cooperation of some policies such as scientific research project, clinical trials, access, regulatory, speed up the new generation of gene sequencing, tumor immunotherapy, stem cells and regenerative medicine, the key techniques research and transformation such as biomedical big data analysis, promote accurate application solutions and decision support system application for serious diseases such as early screening, individualized treatment.
The Ministry of Science and Technology has published a list of key projects to be approved in 2019 under the Stem Cell and Transformation Research initiative, with 22 projects receiving a total of more than 367 million yuan from the central government budget.
06/11/2019 The National Development and Reform Commission (NDRC) officially released the Guide Catalogue for Industrial Restructuring (the 2019 version), which will take effect from January 1, 2020. The new edition of industrial structure adjustment guide catalogue consists of three categories: Encouraged, Restricted and Eliminated Category. Among them, new technologies, new drugs and medical devices are largely included in the category of incentives for the pharmaceutical industry. The new catalog has a number of adjustments compared to the 2011 and 2016 editions. For the first time, medicines for children and shortages, as well as gene therapy and cell therapy drugs, were added to the list of Encouraged category.
The National Health and Fitness Commission has issued the Notice on the Implementation Plan for the Reform of “Certification Separation” in the Pilot Free Trade Zone (hereinafter referred to as the “notice”), announcing the implementation plan for 12 medical reforms. File requirements since December 1, 2019, in Shanghai, Guangdong, Tianjin, Fujian, Liaoning, Zhejiang, Henan, Hubei, Chongqing, Sichuan, Shanxi, Hainan, Shandong, Jiangsu, Guangxi, Hebei, Yunnan, Heilongjiang and other free trade area, implements full coverage list management for all the enterprises matters related to business license. Carry out the reform in four ways, namely, canceling the examination and approval directly, putting the examination and approval on record instead, implementing the notification commitment, and optimizing the examination and approval service, so as to achieve the full coverage of the reform of “separation of certificates and licenses” throughout the country, and achieve the system innovation results that can be copied and promoted.
The People’s Government of Guangdong Province issued the Notice on the Division of Labor Plan of Several Measures to Support the Deepening of Reform and Innovation in the Pilot Free Trade Zone : medical institutions in the pilot free trade zone may, according to their own technical capabilities, carry out research projects on cutting-edge clinical medical technology of stem cells in accordance with relevant regulations.
The Shanghai Municipal People’s Government promulgated the Implementation Plan of Shanghai City to Carry Out “ Measures to support Reform and Innovation in Pilot Free Trade Zones“, The Shanghai Free Trade Zone has launched a policy to support the stem cell industry and establish a rapid review channel for stem cell products, so that clinical studies can be carried out first after rapid review and approval of stem cell products listed in foreign countries.
10/05/2019 The official website of Chongqing Municipal People’s Government issued the Notice of Chongqing Municipal People’s Government on the Special Action Plan of Promoting High-quality Development of Manufacturing Industry (2019-2022), which clearly stated that the biomedical industry should be listed as the key development direction of the pillar industry.
Chongqing will emphatically introduce biological products and new vaccines cultivated based on immune antibody technology, protein recombinant and other genetic engineering technologies, and actively explore layout based on CAR – T (chimeric antigen receptors T cell immune therapy),TCR – T(genetically modified T cell immune therapy) and other genetic recombination T cell therapy drugs and biological products such as mesenchymal stem cells, neural stem cells, hematopoietic stem cells.
Zhejiang Provincial Department of Science and Technology has issued the Implementation Opinions on Accelerating the Innovation and Development of Life and Health Science and Technology (Draft for Comments) to strengthen policy support. Wenzhou Institute of Fudan University will be established to build a high-end industrial R&D platform focusing on innovative macromolecular drugs, stem cells and immune cells, and innovative medical devices.
By 2022, we would research and develop a number of innovative, high value-added products at some advantage areas such as small-molecule cancer drugs, antibody drugs, protein drugs, new vaccines, cell therapy products, high-end embedded or intervention products, high-end medical imaging equipment, and achieve the innovation in 20 or more drugs and more than 20 class III medical devices approved clinical studies or put on the market. In addition, regional cell preparation center, stem cell clinical research base and other R&D and service platforms would be built.
Chengdu released: vigorously develop stem cell and regenerative medicine, gene therapy and other cutting-edge technologies, focusing on the development of new antibodies, immunotherapy, stem cell therapy, anti-aging drugs, cancer vaccines and other innovative drugs.
Chongqing will build three demonstration centers for the application of cell therapy technology, and actively explore the distribution of mesenchymal stem cells, neural stem cells, hematopoietic stem cells, CAR-T, TCR-T and other cell products.
Hainan province issued the Reply from the Health Committee of Hainan Province to the 0391th Proposition of the 2nd meeting of the 7th Hainan Provincial Committee of the CPPCC (Reply classification: B). The reply mentioned that in terms pf cutting-edge medical technology research, to promote the area and regulate the biomedical cutting-edge technology into clinical research and application, Provincial Health Committee drew up the Management Measures on Access, Clinical Research and Transformation Application of Stem Cell Medical Technology in Pilot Zone (trial), which will be printed in the near future.
Hainan province has formulated the Measures for the Management of Stem Cell Medical Technology Access and Clinical Research and Transformation Application in Boao Lecheng Pilot Zone and the Application form for the Construction Project of New Drug Achievement Transfer and Transformation Base in Hainan Province, to explore the first trial of stem cell and new drug transformation in Boao Lecheng Pilot Zone of International Medical Tourism.
Shenzhen issued the Work Plan on Measures to Support the Deepening of Reform and Innovation in the Pilot Free Trade Zone, proposing 39 specific measures, one of them is that medical institutions in the free trade zone may conduct stem cell clinical cutting-edge medical technology research projects according to their own technical capability in accordance to relevant regulations.
The Information Office of the Beijing Municipal Government and the Beijing Municipal Bureau of Commerce held a press conference on the three-year action plan on opening up and reform in key areas of the comprehensive pilot program for expanding the opening up of the service industry: the reform measures clearly put forward that medical institutions in Beijing should be encouraged to carry out research projects on cutting-edge clinical medical technology of stem cells in accordance with their own technical capabilities and relevant regulations of the state. (Time limit: before the end of December 2019, Responsible Units: the Municipal Health Commission, the Municipal Science and Technology Commission)
Tianjin Binhai New Area has adopted the Action Plan for Technological Innovation of Cell Industry. The overall self-determined positioning of Binhai New Area is to gather high-end innovation resources of the global cell industry, build a “Cell Valley” with characteristics of Beijing, Tianjin and Hebei, and build Binhai New Area into a cell technology R&D and transformation base and industrial innovation center with international influence. According to the development goals, by 2022, Binhai New Area’s policy system to support innovative development of cell industry technology would be further promoted, cells and genes industry scale would reach 5 billion yuan; more than five leading enterprise in the field of national cells and gene would be introduced and cultivated ; five national innovation platform in cell and gene field would be established; five model clinical trials and clinical application institutions would be gathered. By 2025, a cell therapy innovation chain and industrial chain integrating storage, research and development, production, preparation, circulation and application would be established, with the cell and gene industry scale exceeding 10 billion yuan. By 2030, it would become an internationally influential technological innovation center for the cell industry, with a scale of 20 billion yuan for the cell and gene industries.
Hebei Provincial People’s Government officially released the Administrative Measures of China (Hebei) Pilot Free Trade Zone on its website. The measures were clear: in terms of industrial opening, the Pilot Free Trade Zone would strengthen innovation in biomedical research and development. We would support eligible medical and health institutions in the pilot free trade zone in carrying out research projects on cutting-edge clinical medical technologies related to stem cells, and establish a green channel for project registration. We would promote innovation in life science and biotechnology in the Xiongan Area. We would encourage enterprises to carry out research on new technologies such as immune cell therapy, monoclonal antibodies, gene therapy and tissue engineering, and allow them to develop new biologic therapies in accordance with the law and regulations and establish the human genetic resources clinical trial filing system. We would support the construction of a genetic data center in the Xiongan Area.
The People’s Government of Yunnan Province has officially released Several Opinions on Accelerating the High-quality Development of Biomedical Industry on its official website. The advice is clear: actively develop cell therapy products with a focus on stem cells. Strengthen basic research and translational research on the application of cell products, and promote the filing of clinical research projects on cell products. Relying on the scientific research institutions or related enterprises in Yunnan, promote the construction of cell product preparation center.
Promote the construction of cell product testing center, actively conduct regional third party testing and estimate services. Make unify, standard,formal technology quality system, promote the application of clinical research achievements commercialization. Encourage enterprises fight with malignant tumor treatment and defection on immunity function and speed up development of immune cell therapy products. (Lead by Provincial Health Committee; the Provincial Department of Science and Technology and Provincial Drug Administration shall be responsible according to their duty division)