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The cell therapy industry has great potential for development
As usual, at 8 o'clock in the morning, Zhang Yingchi, a researcher at Tianjin Cell Ecology Haihe Laboratory, came to the laboratory, changed into clean clothes, turned on the UV light in the biosafety cabinet, and placed the culture medium in a water bath. Half an hour later, he began processing the cells. Under the microscope, the cells are evenly distributed and in good growth condition. After digestion and passage, the cells will be used to provide T cells with precise weapons to kill tumor cells, and then enter clinical practice, ultimately becoming third-generation drugs - cell therapy drugs.
As an emerging treatment method, cell therapy has shown good results in the treatment of many diseases, especially cancer, genetic diseases, and infectious diseases. In recent years, driven by technology, policies, and markets, China's cell therapy industry has shown a thriving development trend and is expected to become a highly promising new track in the field of biomedicine.
Immune cell therapy generally refers to the targeted treatment of certain types of immune cells such as T cells, NK cells, etc. in vitro before reintroducing them back into the human body to demonstrate functions such as killing tumor cells and clearing viruses. Zhang Yingchi said that stem cell therapy involves transplanting healthy stem cells into the patient's body to repair diseased cells or rebuild normal cellular tissue. The most commonly used types of stem cells in clinical practice are mesenchymal stem cells, hematopoietic stem cells, neural stem cells, etc.
Stem cells have become one of the core areas of cell therapy research due to their multi-directional differentiation, immune regulation, and cytokine secretion functions. In recent years, the development of genetic engineering technology has improved the targeting of cell therapy and promoted the combination of cell therapy and gene therapy, resulting in the emergence of in vitro gene therapy and vector gene therapy.
Zhang Yingchi gave an example: "Some diseases related to the hematopoietic system are usually mainly caused by abnormalities in hematopoietic stem cells, where some genes have mutated. At this time, we can take out the patient's hematopoietic stem cells, use gene editing technology to repair the mutated genes to a normal state, and then transplant them back. This is ex vivo gene therapy
The emergence of cell therapy has provided a new option for the treatment of some diseases that are ineffective and difficult to treat with traditional therapies. For example, due to individual differences, it is difficult to control the optimal dosage of traditional drugs for each patient. But in cell therapy, synthetic biology can be applied to design gene switches to control drug synthesis or release. At the same time, dynamic adjustments and prognostic monitoring can be made based on the patient's condition development status to achieve long-term therapeutic effects.
Compared with traditional chemical drugs, cell therapy products have the characteristics of fast technological iteration, great innovation potential, high clinical dependence, and personalized customization. Many countries are competing to layout them.
Currently, the global cell therapy industry is entering a fast lane of development. According to statistics, by early 2022, there will be a total of 33 approved cell therapy products worldwide, including 12 immune cell products and 21 stem cell products.
The development time of cell therapy in China is relatively short, but it is full of momentum. In recent years, Beijing, Shanghai, Tianjin, Shenzhen and other places have been vigorously developing the cell therapy industry. Shanghai has launched the "Action Plan for Promoting Technological Innovation and Industrial Development of Cell Therapy in Shanghai (2022-2024)", aiming to achieve a cell therapy industry scale of 10 billion yuan in Shanghai by 2024. Last year, Shenzhen successively released documents to support the development of the biopharmaceutical industry, with a focus on supporting high-quality development of industrial clusters including cell therapy drugs.
In Tianjin, the Binhai High tech Zone has taken the cell industry as a breakthrough point to promote the high-quality construction of the Beijing Tianjin Hebei characteristic cell valley. The "One Core, One Belt, One Circle" industrial development spatial layout system has been formed around the cell ecology Haihe Laboratory as an innovative driving force. Currently, more than 40 cell related enterprises have gathered.
We vigorously promote in-depth cooperation between large institutions and high growth enterprises, "said Zheng Chunlin, Deputy Director of the Biomedical Bureau of Tianjin Binhai High tech Zone
According to experts, in the main field of cell therapy technology - immune cell therapy, China has become the country with the largest number of clinical studies on CAR-T cell therapy in the world. According to relevant data statistics, the market space for cell therapy in China is expected to grow from 1.3 billion yuan in 2021 to 58.4 billion yuan in 2030, with an average annual growth rate of 53%. It is expected that the next 10 years will be a period of rapid growth for the domestic cell therapy industry.
Cell therapy is considered a niche track in the field of innovative drug development. The relevant regulatory authorities have issued multiple application guidelines related to cell therapy products in the past two years, promoting the review and approval of related products. Domestic cell therapy products have received clear guidance on all stages from application to production. Local governments have also continuously introduced policies to support and encourage the development and launch of cell therapy products.
At present, research in the field of cell therapy in China has become an important force in global research and development. At the same time, experts believe that as an emerging industry, the cell therapy industry still faces many challenges. Despite continuous technological breakthroughs, achieving widespread adoption of cell therapy products is not an easy task. On the one hand, the industrial chain for the transformation and application of cell therapy technology is not yet mature enough, and on the other hand, its cost is still relatively high.
Zheng Chunlin introduced, "If the relevant equipment and consumables can be localized, it will greatly reduce the cost of cell therapy products." It is understood that there are still many devices involved in the research and production of domestic cell therapy products, as well as supporting cell culture consumables, that need to be imported.
The scarcity of clinical resources also restricts the clinical translation and application of cell therapy technology. Yan Fengying, Vice President of Tianjin Institute of Materia Medica, said, "Compared with traditional chemical drugs, cell therapy products have the characteristics of multiple cell sources and types, and strict production and preparation process requirements. Therefore, it is necessary to establish a quality control and guarantee system that conforms to the characteristics of cell therapy products, including research and development, production, preclinical evaluation, and clinical research. At the same time, it is necessary to establish some professional clinical research-oriented medical institutions or wards to carry out systematic and standardized clinical trials. Based on in-depth research on the basic biological characteristics and mechanism of action of cell therapy products, clinical safety and effectiveness studies should be carried out
Hui Lijian, a researcher at the Center for Excellence and Innovation in Molecular Cell Science of the Chinese Academy of Sciences, suggested that in the process of innovation and transformation of cell therapy, new technologies for cell therapy should be established through original innovation, and the evaluation of cell quality and safety, clinical research norms and product standards should be improved, so as to promote the clinical transformation and application of cell therapy and promote the healthy and rapid development of the cell therapy industry.