Since the development of cell therapy, whether it is "tumor immune cell therapy" based on cancer prevention or "stem cell therapy" aiming at regeneration and repair, there are extremely broad treatment and application scenarios, with trillions of market space, which also makes various countries attach great importance to cell therapy, and also closely introduced relevant laws and regulations and corresponding policies.

With the continuous progress of cell therapy technology, China has also issued a series of new policies to put forward more targeted recommendations and guidance for stem cell and immune cell research to support the development of the cell therapy field.

National level

一、February 1, 2024 "Industrial Structure Adjustment Guidance Catalogue (2024 edition)"

In accordance with the Decision of The State Council on Issuing and Implementing the Interim Provisions on Promoting Industrial Structure Adjustment (GuOFA (2005) No. 40), the National Development and Reform Commission led the revision and formation of the Guidance Catalogue for Industrial Structure Adjustment (2024 Edition) together with relevant departments, which will come into force on February 1, 2024. Cell culture, cell therapy drugs, high-end intelligent pharmaceutical equipment are included in the encouraged industry catalog.

The catalogue consists of three categories of encouragement, restriction and elimination, with a total of 1005 items, of which 352 are encouraged, 231 are restricted and 422 are eliminated. The encouraged category mainly refers to technologies, equipment and products that have an important role in promoting economic and social development. The encouraged category catalog focuses on basic, strategic and forward-looking key areas, focusing on encouraging matters that are difficult for the market mechanism to play an effective role, require the government to play a guiding role, and have an important guiding role for the development of the industry. In the "Catalogue", there are 5 encouraged categories, 6 restricted categories and 8 eliminated categories for the pharmaceutical industry. In the category of encouragement, new technologies, new drugs and intelligent equipment technology are included in a large number of children's drugs, shortage drugs and cell culture, cell therapy drugs, high-end intelligent pharmaceutical equipment are included in the encouraged industry catalog.

二、Jan. 18, 2024 "Technical Guidelines for clinical trials of Mesenchymal Stem cells for Prevention and Treatment of graft-versus-host Disease"

The Center for Drug Evaluation (CDE) of the State Food and Drug Administration issued the Technical Guidelines for Clinical Trials of Mesenchymal stem Cells for Prevention and Treatment of graft-versus-host disease. The guidelines apply to mesenchymal stem cell products derived from various tissues such as bone marrow, umbilical cord, cord blood or fat, as well as mesenchymal cell products derived from embryonic stem cells or induced pluripotent stem cells. 

三、December 29, 2023 "Technical Guidelines for Clinical Communication of Cell and Gene Therapy Products"

The Center for Drug Evaluation (CDE) of the State Food and Drug Administration has issued the Technical Guidelines for Clinical Communication of Cell and gene Therapy Products. The guidelines are intended to guide and standardize the preparation of communication materials and consideration of clinical research and development factors during the clinical research and development of cell and gene therapy products, so as to improve the efficiency of communication and help the clinical research and development of cell and gene therapy products to proceed smoothly.

四、November 23, 2023 "Work Plan to support Beijing in Deepening the construction of a Comprehensive Demonstration Zone for Expanding the Opening-up of the National Service Industry"

The State Council issued the Work Plan to Support Beijing in Deepening the construction of a Comprehensive Demonstration Zone for the wider opening of the National Service Industry. The plan proposes to support qualified foreign and Hong Kong, Macao and Taiwan doctors to set up clinics in Beijing; Explore equity incentive methods for foreign and Hong Kong, Macao and Taiwan employees of pharmaceutical R&D enterprises in the field of stem cells and genes; Support qualified medical institutions to carry out stem cell and other clinical trials; Support international cooperation in stem cell and gene research and development. To facilitate human genetic resources management services for enterprises in Beijing, Hong Kong and Macao.

五、October 31, 2023 Framework Plan for China (Xinjiang) Pilot Free TradeZone

The State Council has released the Overall Plan for the China (Xinjiang) Pilot Free Trade Zone. The China (Xinjiang) Pilot Free Trade Zone was approved to be established, becoming the country's 22nd free trade zone. Centering on the strategic positioning and development goals of the Xinjiang pilot free trade zone, the plan proposes 25 specific measures from eight major aspects, including accelerating the transformation of government functions, deepening investment reform, and building an open and distinctive industrial system. It also proposes to explore research on cutting-edge clinical diagnosis and treatment technologies such as stem cells, immune cells, and gene therapy.

六、September 23, 2023 "Biobank Pluripotent stem cell Management Technical Specification"

The 4th China Stem Cell and Regenerative Medicine Collaborative Innovation Platform Conference announced China's first national standard for personal stem cells - "Biobab pluripotent stem cell Management Technical Specifications" (standard number: GB/T 42466-2023). The release of this standard marks that China has standard technical support in the management of stem cell sample banks, which is of great significance to promote the standardization and standardization of stem cell research and application in China, and also provides an early example for the development of follow-up relevant standards in the field of stem cells.

七、29 August 2023 "Hetao Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone Shenzhen Park Development Plan"

The State Council issued the "Hetao Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone Shenzhen Park Development Plan". The plan proposes to explore and establish a new management model suitable for the research and development of new biological drug devices such as cell therapy and gene therapy in the customs supervision area of Shenzhen Park in accordance with laws and regulations, and to relax the access restrictions for foreign biomedical enterprises on a pilot basis.

八、August 1, 2023 "Notice on the Implementation of Recent Measures to Promote the Development of the Private Economy"

Eight departments, including the National Development and Reform Commission and the Ministry of Industry and Information Technology, jointly issued the Notice on Implementing Several recent Measures to Promote the Development of the Private Economy. The circular proposed that private enterprises will be supported to participate in major scientific and technological research, and take the lead in undertaking research tasks in areas such as gene and cell medicine.

九、June 21, 2023 "Technical Guidelines for Clinical Trials of Human Stem Cells and their Derived cell Therapeutic Products (Trial)"

The Center for Drug Evaluation (CDE) of the State Food and Drug Administration issued the Technical Guidelines for Clinical Trials of human Derived Stem cells and their derived cell therapeutic Products (Trial). The publication of the guidelines provides technical guidance and recommendations for conducting clinical trials of human derived stem cells and their derived cell therapeutic products.

十、April 25, 2023 "Guidelines for Pharmaceutical Research and Evaluation of human stem Cell Products (Trial)"

The Center for Drug Evaluation (CDE) of the State Food and Drug Administration issued the Technical Guidelines for Pharmaceutical Research and Evaluation of human stem Cell Products (Trial). The guidelines provide technical guidance for pharmaceutical research of stem cell products that are developed and registered in accordance with drugs.

"Human-derived stem cell products" in the guiding principles refer to adult (dry) cells, human embryonic stem cells and induced pluripotent stem cells originating from human beings, derived stem cells and their derived cells obtained through a series of in vitro operations involving stem cells, generally including expansion, gene modification, induced differentiation, transfer (differentiation), etc., adding preparation adjuvants, and packaging into specific containers. And meet specific drug release standards, can be applied directly, or can be combined with tissue engineering materials used in clinical therapeutic products. Among them, because human cells are involved, the production of cells must comply with the relevant provisions of national ethics.

十一、March 23, 2023 "Opinions on Further Improving the Medical and Health Service System"

The General Offices of the CPC Central Committee and The State Council issued Opinions on Further Improving the Medical and health Service System. In the opinions, it is proposed to strengthen the research and development system and capacity building of clinical medicine, public health and medical devices, and develop cutting-edge medical technologies such as omics technology, stem cell and regenerative medicine, new vaccines, biotherapy, and precision medicine.

Local level

一、February 28, 2024 Guangdong Provincial Action Plan on Fostering Future Life and Health Industry Clusters

The Science and Technology Department of Guangdong Province issued the Action Plan for Fostering Future Life and Health Industry Clusters in Guangdong Province. The plan puts forward key engineering efforts in five areas: gene technology, cell therapy, AI+ biomedicine, synthetic biology, brain science and brain-like research; By 2030, we will build a future life and health industrial park with distinctive characteristics, industrial elements gathering, complete industrial support and sound innovation chain. By 2035, we will gather a group of innovative enterprises with international influence and discourse power, constantly open up new industrial fields and new tracks, and form a number of global leading future life and health industry highlands.

二、February 20, 2024, Key Points of Health Work in Shanghai Municipality

 

The Shanghai Municipal Health Commission issued the Key Points of Shanghai's Health Work in 2024, which focuses on stem cell development.

三、February 15, 2024, Chengdu, Sichuan Province, "Code for the Establishment and Management of Cell Preparation Centers"

Chengdu, Sichuan Province issued the "Code for the Establishment and Management of Cell Preparation Centers", which for the first time clarified the standardized system of cell preparation centers and management in Chengdu, its purpose is to promote the stable, healthy and sustainable development of cell-related industries, and fill the gap in the field of cell production in Sichuan and Chongqing region!

四、List of Key Tasks in the 2024 Government Work Report of Beijing on February 1, 2024

Article 124 of the list of key tasks lists: give full play to the advantages of clinical research quality and efficiency, strengthen the research and development of original new drugs and high-end medical devices, give full play to the role of drug and medical device innovation service stations, strive for the pilot of innovative drugs and medical devices accelerated review policies, and improve the process of innovative drugs into hospitals. We will strengthen frontier and emerging fields such as cellular gene therapy and synthetic biological manufacturing, and promote the formation of a cluster development trend.

五、On July 19, 2023, Shenzhen, Guangdong Province, "20+8" the second batch of industrial fund establishment plan

Shenzhen released the "20+8" second batch of industrial fund establishment plan at the 17th China Fund Partners Summit, Shenzhen intends to invest 8.5 billion yuan to set up the second batch of industrial fund plan, mainly around cells and genes, biology, aerospace technology, blockchain and other four future industries, these four industries have begun to take shape, is expected to usher in rapid expansion in 5 to 10 years.

Among them, the Cell and Gene Industry Fund plans to invest 1.5 billion yuan, mainly for research in frontier fields such as cell and gene therapy, gene technology, new vaccine research and development, and new virus vectors, which has a significant "first-mover advantage" and subversive impact on social development.

六、September 1, 2023 Tianjin "Tianjin Gene and Cell Industry Promotion Regulations"

The Fourth meeting of the Standing Committee of the 18th Tianjin National People's Congress deliberated and adopted the "Tianjin Gene and Cell Industry Promotion Regulations", which will come into force on September 1, 2023. The regulation has a far-reaching impact on promoting the high-quality development of Tianjin's cell and gene industry and better meeting the health needs of the masses, mainly regulating the following contents:

● Clearly put forward to promote the development of the cell and gene industry, and detailed the regulatory policies of gene and cell technology products in the development, production, service and other aspects.

● Support and promote international and domestic cooperation in the cell and gene industry to promote innovative development.

● Promote the construction of parks such as "Cell Valley" in Binhai New Area, and actively introduce talents and capital.

● Ensure the rights and interests of patients and establish a rights and interests protection mechanism to carry out risk control.

七、Regulations on Cell and Gene Industry Promotion of Shenzhen Special Economic Zone, Shenzhen, Guangdong, March 1, 2023

The website of the Standing Committee of the Shenzhen Municipal People's Congress announced an important piece of legislation - "Shenzhen Special Economic Zone Cell and Gene Industry Promotion Regulations", which will be officially implemented from March 1, 2023. This is the country's first special legislation for the cell and gene industry, in response to the problem of "listing difficulties" of innovative drugs, the regulations require relevant departments to establish a convenient and smooth consultation channel, and fully support and assist enterprises to apply for listing registration.

In addition to the above policies, many representatives of the two sessions in 2024 are speaking out for stem cells, which shows us the country's determination to vigorously develop stem cells, and the prospect of stem cell therapy is broad and promising.

Sum up

It is foreseeable that in the coming decades, cell therapy will be an important pillar of medical care and become a key medical technology. With the release of more policies, the cell therapy industry will also become more formal and transparent, and enter thousands of households, and become an essential means for people to prevent and fight against diseases.