Stem cells are a kind of cells that have the potential of multi-differentiation, self-renewal and secreting various cytokines to participate in the repair of damaged tissues and organs. With the continuous improvement of scientific research, stem cells have been widely used in the treatment of diseases in China, and have achieved exciting results. It is worth noting that in recent years, at the national and local two sessions, stem cells have been mentioned many times by members of the National People's Congress and the CPPCC. Today, this article will give you an inventory of the voice of stem cells at the 2024 two sessions.

Ding Liming, member of the CPPCC National Committee: Vigorously promote the stem cell industry and gene therapy research and development

Ding Leiming, member of the CPPCC National Committee, Chairman and CEO of Beida Pharmaceutical Co., LTD

CGT products are different from traditional chemical drugs and biological products, and their highly personalized characteristics make them show great potential in the treatment of tumors and rare diseases. At present, China is almost in sync with the international community in CGT drug research and development. Among the CGT products that have been listed in the world, there are 5 CAR-T products from China. Member Ding Lieming believes that it is necessary to vigorously promote the development of the CGT industry, so that China can turn from a "runner" to a "leader". To achieve this, the Ding Leeming proposal recommends:

1 Strengthen the review and approval force, strengthen communication and guidance, and improve the efficiency of review and approval.It is recommended to encourage drug regulatory departments, scientific research departments, and R&D enterprises to participate in key technology discussions and standard formulation, form industry consensus, quickly update the guidelines in the field of cell and gene therapy, and adopt an open attitude to allow wide entry and strict exit; Establish a special review department for cell and gene therapy drugs, increase the number of reviewers, enhance their professional quality and review ability, and improve the frequency of communication meetings; We will try out a priority review voucher system and encourage review resources to strongly support high-quality projects.

2 From the level of supporting industrial development, we will strengthen layout planning and policy supply, and encourage open competition and high-quality development. It is suggested to strengthen the supply of industrial policies, guide domestic capital investment, deepen international cooperation, and accelerate the integration of industrial chain, supply chain, capital chain, and talent chain.

3 Focus on key areas and key links, and vigorously support translational research and clinical applications. It is suggested to give strong support to scientific research projects and research teams with original and core competitiveness, help solve the problem of "congestion" in the underlying technology, accelerate the establishment of China's self-developed clinical level human induced pluripotent stem cell bank, and get rid of the dependence on overseas technology as soon as possible. At the same time, it is suggested that the clinical transformation should be scientific and efficient, allowing the first trial of stem cell therapy programs that have been verified in clinical studies in research hospitals, and to be widely promoted after progress is made to promote the treatment of major diseases.

Liu Yun, member of the CPPCC National Committee: It is suggested to improve the stem cell industry system to better benefit the world

Committee member Liu Yun found in the previous research that the policies and regulations on stem cells are still relatively lagging behind; In addition, the relevant culture materials, reagents, including some instruments and equipment in the whole process of the preparation of stem cells are also starting in our country, but there is still a certain gap, so this time I want to focus on these dimensions, accelerate the development process of cell biotherapy in China, and better benefit the Chinese people and the world.

Therefore, Liu Yun's proposal mainly focuses on the industrial system of stem cells: first, on cell biotherapy, especially on the future industrial development of stem cells. The second is how to better promote the construction of national medical centers and regional medical centers and promote the balanced distribution of high-quality medical resources.

"How to build a perfect system, increase the quality control standards of stem cells, including the development of production lines, the construction of cell factories, and so on, to better benefit our people." Liu Yun introduced, "Last year, Jiangsu Provincial People's Hospital also carried out a series of thematic research around stem cells, and took it as one of the ten key tasks created by our national medical center, our brother enterprise hospitals are also in the linkage, the industry is paying attention to, and the relevant regulations have been updated in a timely manner."

Wang Guilin, member of the National Committee of the Chinese People's Political Consultative Conference: It is suggested to support the clinical application of stem cells in the Guangdong Free Trade Zone

Member Wang Guilin believes that the current national policy to encourage the development of the stem cell industry is not accurate enough. At present, the legal requirements and ethical guidelines related to systematic cell research and industrial application, especially the regulations, industrial policies and government supervision measures for the research and industrial application of allogeneic cells and allogeneic cell products, are not perfect. Therefore, Member Wang Guilin suggested:

1 It is suggested that more efforts should be made to improve policies and regulations and strike a balance between development and security. At the national level, a management system of "risk classification and access classification" has been established, and an industrial policy system and supervision model in line with international standards have been established.

2 It is recommended to introduce a pre-trial policy for clinical application of stem cells and regenerative medicine within the scope of China (Guangdong) Free Trade Zone, support stem cell drugs that have completed clinical safety evaluation (clinical trial phase I), carry out clinical effectiveness verification in the national stem cell clinical research record institution within the scope of the free Trade Zone, and obtain approval from the provincial health department. Clinical applications were carried out at designated points and quotas in the above clinical institutions, and supervised by the provincial Stem Cell Clinical Quality Control and Evaluation center.

Yuan Xiaofeng, CPPCC member of Shaanxi Province: Promote the development of stem cell and regenerative medicine industry in Shaanxi Province

Member Yuan Xiaofeng said: In recent years, with the rapid development of economy and society, the problem of elderly diseases has become increasingly prominent, and stem cell technology is an important medical means to achieve disease prevention. A number of relevant ministries and commissions in the country have successively issued a series of supportive policies in three directions: continuous support for industry research, introduction of social capital entry and support for application transformation, providing a good policy environment for the development of stem cell medical industry. Therefore, Member YUAN Xiaofeng suggested:

1 Relevant departments should introduce or improve the legal and regulatory framework for stem cell technology and stem cell drugs from laws and regulations to industry guidelines as soon as possible, and conduct classified management of stem cell technology and stem cell drugs.

2 Shaanxi Province shall set up a special zone for the development and application of stem cell therapy technology, support qualified and required franchised medical institutions to carry out research and application of cutting-edge medical technologies such as immune cells and stem cell clinical treatment, include stem cell research and industrial development in Shaanxi Province's major science and technology projects, and establish stem cell research sharing centers, demonstration bases, technology research institutes, etc. Build a coordinated innovation mechanism to improve the ability and level of clinical research and transformation of stem cells.

"Stem cells have been proven to be effective in many fields, such as diabetes, Parkinson's syndrome, Alzheimer's disease and anti-aging," said Yuan Xiaofeng, a member of the committee, in the conclusion and outlook of the proposal. "Stem cell research is expected to lead a new revolution in regenerative medicine."

Zhang Yi, Member of the Standing Committee of the Shanghai CPPCC: Accelerate the creation of global stem cell research and development economy and industrialization highland

Stem cells have become one of the hottest areas of biomedical research today. Data show that the global stem cell therapy market is expected to reach 226.1 billion yuan by 2030, with a compound annual growth rate of 13.73%. However, no stem cell products have been approved for sale in China. Zhang Yi said that in order to consolidate Shanghai's first-mover advantage in the stem cell industry, it is necessary to further strengthen top-level design, seize opportunities and optimize the ecology.

1 To strengthen the legislative promotion of local regulations for the stem cell industry. It is necessary to study and formulate relevant norms for the construction and management of the city's research and development and preparation service platform for stem cell preparations, clarify the standardized management requirements that need to be followed for the preparation of research and clinical stem cell products, covering the whole process of stem cell source, collection, storage, preparation and testing; To study and formulate relevant regulations on the management of medical enterprises' association of stem cell products and the promotion of the transformation of results, clarify the specific support mechanism for stem cell research and development enterprises to undertake the research results of national stem cell clinical research filing institutions, establish and improve the revenue sharing mechanism with medical institutions, and promote the deep integration of production and medicine; To study and formulate relevant regulations on the collection and notification of perinatal stem cells.

2 We will promote the formation of local standards for strong inspection. Shanghai should actively strive for the localization of stem cell inspection standards, led by the municipal government to negotiate with the Central Inspection Institute, the Central Inspection Institute and the Shanghai Food and Drug Inspection Institute to jointly establish the Yangtze River Delta stem cell inspection branch, firmly grasp the core advantages of product quality testing, form a leading domestic quality control standard, and further strengthen the safe base for the innovation and development of stem cell industry in Shanghai.

3 Create a convenient way to transform the results of stem cell industry. Give full play to the flexible advantages of private enterprises in industrial innovation, model innovation, and mechanism innovation, establish a long-term income distribution and sustainable development mechanism, and fully activate the enthusiasm of experts and talents within the system. Establish a practical and effective enterprise counseling system, when necessary, pull, push, take a step, the industry's blocking points as their own "blood clots", timely and thoroughly open.

The National Two sessions have become an important stage for stem cell technology to show its great potential and value, and 2024 will undoubtedly become the golden development period of the cell therapy industry, we look forward to seeing more proposals and proposals on stem cells, and call on the government and all sectors of society to pay attention to and support the development of this cutting-edge technology. We believe that with the deepening of scientific research and technological breakthroughs, the field of stem cells will usher in a brighter moment. In the near future, stem cell technology will benefit more patients and light the light of hope for human health!