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Cell therapy was first written in 2019 China's industrial structure adjustment guidance catalog
Medical Network May 9th Recently, the National Development and Reform Commission publicly solicited opinions on the "Industrial Structure Adjustment Guidance Catalogue (2019, Consultation Draft)". The new edition of the "Industrial Structure Adjustment Guidance Catalogue" consists of three categories: encouraged, restricted, and eliminated. Among them, there are 8 categories of incentives, 6 categories of restrictions, and 13 categories of elimination in the pharmaceutical industry. In the encouraged category, new technologies, new drugs, and medical devices are heavily incorporated.
Compared to the 2011 and 2016 editions, the new catalog has many adjustments. Children's medicines, shortage medicines, gene therapy drugs, and cell therapy drugs were first added to the encouraged category.
According to the catalogue, the encouraged categories are mainly important to promote economic and social development, and are conducive to meeting the needs of the people's better life and promoting high-quality development of technology, equipment, products and industries.
The catalogue of industrial structure adjustment has always been regarded as the “wind vane†for the development of the industry, from which it can be seen that the country is currently supporting the direction of industrial development. Relevant industries listed in the encouraged category will usher in new development opportunities. For example, companies that distribute innovative drugs, gene and cell therapy drugs, and children's drugs.
China has released six important documents
Support the development of cell therapy industry
The State Council clearly supports the construction of stem cells and stem cell banks in the "13th Five-Year National Strategic Emerging Industry Development Plan"; in January 2017, the National Development and Reform Commission released the "13th Five-Year Plan for Biological Industry Development" to pay attention to the biotechnology industry; The “Guide Catalogue for Key Products and Services for Strategic Emerging Industries†was released to support the development of bio-industries in the fields of cell therapy products including stem cells.
"13th Five-Year" National Strategic Emerging Industry Development Plan
On December 19th, 2016, after repeatedly mentioning the word medicine in the “13th Five-Year National Science and Technology Innovation Planâ€, and clearly identifying the “name†gene editing, immunotherapy, stem cells and other popular fields, the State Council officially The "13th Five-Year Plan for the Development of Strategic Emerging Industries" (hereinafter referred to as "Planning") was issued, and comprehensive arrangements for the development goals, key tasks, and policy measures of China's strategic emerging industries during the 13th Five-Year Plan period were made.
The "Plan" clearly states that by 2020, the scale of the bio-industry will reach 8-10 trillion yuan.
The State Council's "13th Five-Year Plan for the Development of Strategic Emerging Industries" reflects the importance attached to the development of the bio-industry and explicitly mentions the construction of supporting gene banks and stem cell banks.
The six ministries jointly issued a document requesting the strengthening of key technologies such as stem cell and immune cell therapy, accelerating the clinical application of biotherapeutic technology, and improving the level of clinical treatment.
The Ministry of Science and Technology, the National Health and Family Planning Commission, the General Administration of Sports, the General Administration of Food and Drug Administration, the State Administration of Traditional Chinese Medicine , and the Logistics Support Department of the Central Military Commission jointly issued the "13th Five-Year Plan for Health and Health Science and Technology Innovation." The plan clearly requires the strengthening of key technologies such as stem cell and regenerative medicine, immunotherapy, gene therapy, and cell therapy, accelerate the clinical application of cutting-edge technologies in biotherapy, innovate therapeutic techniques, and improve the level of clinical treatment.
The relevant content is excerpted as follows:
The Health and Welfare Commission and other six ministries re-issued the text: speed up the clinical application of stem cell technology, and rank stem cells, tumor immunotherapy (CAR-T), gene sequencing, etc. as the "13th Five-Year" key tasks
Ministry of Science and Technology Development and Reform Commission Ministry of Industry and Information Technology National Health and Family Planning Commission General Administration of Sport and Drug Administration jointly issued the "13th Five-Year Plan for Health Industry Science and Technology Innovation", the plan clearly defines stem cells and regenerative medicine, tumor immune cell therapy New diagnostic services such as CAR-T cell therapy are listed as key tasks for development. The planning also explicitly requires the accelerated clinical application of stem cells and regenerative medicine.
Note: The plan is different from the “13th Five-Year Plan for Health and Wellness Technology Innovation†issued by the six ministries and commissions a week ago.
The relevant file content is selected as follows (click on the image to enlarge)
"The 13th Five-Year Plan for Biological Industry Development" was released
According to the website of the National Development and Reform Commission, in order to further consolidate the innovation base of the bio-industry, promote modern biotechnology to benefit the people's livelihood, and focus on building new kinetic energy for the bio-economy, the National Development and Reform Commission issued the "13th Five-Year Plan for Biological Industry Development".
According to the plan, by 2020, the scale of the bio-industry will reach 8-10 trillion yuan, and the added value of the bio-industry will account for more than 4% of GDP, becoming the leading industry of the national economy.
The plan proposes that the 13th Five-Year Plan will expand the new application for benefiting people's livelihood, implement the bio-industry benefit project for the construction of healthy China and beautiful China, promote the application of emerging technologies such as genetic testing and cell therapy, and promote the industrial development achievements to benefit the people's livelihood. . An individualized immune cell therapy technology application demonstration center and a gene technology service center will be established.
Catalogue of Key Products and Services for Strategic Emerging Industries
In order to implement the “13th Five-Year Plan for the Development of Strategic Emerging Industries in the Countryâ€, the National Development and Reform Commission and relevant departments organized and compiled the “Guidance Catalogue of Key Products and Services for Strategic Emerging Industries†(hereinafter referred to as “Guidance Catalogueâ€) 2016 Edition. And officially announced the relevant content on the official website on February 4.
This nearly one-page "Guidance Catalogue" covers eight industries in five major areas of strategic emerging industries (listed separately in related service industries), 174 sub-directions in 40 key directions, and nearly 4,000 sub-products and services. Among them, the bio-industry includes 1) biomedicine, 2) biomedical engineering, 3) bio-agriculture, 4) bio-manufacturing, and 5) biomass energy.
Among them, biotechnology drugs mention "cell therapy products and gene drugs for refractory diseases such as malignant tumors."
　　 "13th Five-Year Plan" "Guidelines for the Development of Pharmaceutical Industry"
The Ministry of Industry and Information Technology, the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Commerce, the National Health and Family Planning Commission, and the State Food and Drug Administration have jointly issued the "Guidelines for the Development of the Pharmaceutical Industry", which aims to implement the National Economic and Social The 13th Five-Year Plan for Social Development and "Made in China 2025" guide the pharmaceutical industry to accelerate the transformation from large to strong.
The excerpts on stem cell and immune cell therapy are as follows:
Second, the "13th Five-Year" development situation
(2) Technological progress continues to accelerate
Precision medicine and translational medicine have provided a new direction for the development of new drugs and disease diagnosis and treatment. New innovative drugs based on new targets, new mechanisms and breakthrough technologies have emerged, and the pace of new technologies such as tumor immunotherapy and cell therapy has accelerated. Medical devices are developing in the direction of intelligence, networking, and portability. New materials are widely used. The Internet, health big data, medical products, and medical services are closely integrated, and industrial upgrading and development have injected new impetus.
Box 6 International Competitiveness Improvement Project
Cultivate new health consumer needs. Promote the development and application of home, pension, and rehabilitation medical devices to meet the needs of an aging population. Develop large health products and support pharmaceutical companies to extend to areas such as functional foods, formulas for special medical uses, cosmetics, and health care, prevention, and treatment. Support the development of new medical technologies such as gene sequencing, tumor immunotherapy, stem cell therapy, drug concomitant diagnosis, improve industry access policy, strengthen clinical application management, promote various technologies to meet clinical needs, and keep pace with international development.
V. Promote the development of key areas
(1) Biological drugs
4. Nucleic acid drugs and cell therapy products. Focus on the development of RNA interference drugs, gene therapy drugs, and cell therapy products such as stem cells and immune cells, including cell therapy products such as CAR-T.
5. Industrialization technology. Focus on the development of large-scale, high-expression antibody production technology, antibody-conjugated drugs, bifunctional antibodies and other new antibody preparation technologies, recombinant protein long-acting preparation technology, cell-based large-scale influenza vaccine high-yield technology, cell therapy product preparation technology, reorganization Large-scale expression and purification technology of human albumin, analysis and detection technology of extremely small impurities. Focus on developing products and establish quality control technologies that are in line with international advanced standards. Improve the production level of important raw and auxiliary materials for production such as serum-free protein-free medium, protein separation and purification medium, stabilizer and protective agent.