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Cell industry is an important direction of biomedicine industry in the future
"According to my team, by 2025, the scale of the cell industry may reach 200billion dollars, and China will reach 100billion yuan."
A few days ago, at the "Jimin Medical Cell Industry Development Seminar" hosted by Jimin Health Management Co., Ltd., the reporter heard this group of data from caizhiming, the director of the national tumor genome application engineering laboratory.
According to relevant data, the cell industry refers to the cell-based research and application industry, including cell therapy, cell engineering, cell culture, cell storage and other fields.
Caizhiming said that the cell industry has great development potential and market prospects, and is an important direction of the future biomedical industry.
▌ cell therapy is favored by capital, but needs scientific supervision
Further breakdown, the cell industry includes six major industries, including cell therapy industry, stem cell industry, immune cell industry, cell culture industry, cell biopharmaceutical industry and gene editing industry.
Among them, cell therapy is a treatment scheme by re implanting cells into the human body after in vitro separation and purification. Its industry specifically points to cell therapy technology, cell therapy products, etc., and is in the middle and lower reaches of the whole chain of cell industry.
In November last year, the Shanghai Municipal Commission of science and technology, the Shanghai Municipal Commission of economy and information technology, and the Shanghai Municipal Commission of health care jointly issued the "Shanghai action plan for promoting technological innovation and industrial development of cell therapy (2022-2024)", aiming to target the scientific and technological frontier in the field of cell therapy worldwide and focus on key fields such as immune cells and stem cells. Its goals include reaching 10billion yuan in industrial scale by 2024, introducing and cultivating 50 leading enterprises and innovative enterprises.
According to incomplete statistics, in 2022, there were more than 15 financing events in the field of cell therapy in China, and nearly 40 related enterprises in the field of cell and gene therapy were financed in the first half of this year.
Caizhiming pointed out in the report that at present, more than 40 cell therapy products (including products that have been withdrawn from the market) have been listed in the world, of which only five immune cell therapy products have been approved for listing (three are car-t cells, one is DC cells, and one is T cells), and the rest are stem cell therapy products and other cell therapy products.
From the perspective of indications, the indications of stem cell products are very wide, including cancer, nervous system disease, cardiovascular disease, metabolic system disease, digestive system disease, etc; Immune cell therapy products are mainly used to treat blood tumors, while other cell therapy products are mostly used for tissue damage repair.
From the perspective of countries and regions that are first listed, cell therapy products are mainly distributed in the United States, South Korea, Japan and the European Union, and there are only two enterprises approved to list cell therapy products in China.
"Our new drugs account for only about 5% of the world, while the United States accounts for 55%. In response, Professor maozhenbin, former director of the Department of science, technology and international cooperation of the State Drug Administration, said at the aforementioned meeting:" the reason why the United States can approve so many new drugs is regulatory science. "He pointed out that the United States, Europe, Japan and other pharmaceutical powers have promoted scientific research and innovation in drug regulation as national strategies, And formed a series of management mechanisms, systems and methods.
▌ enterprises accelerate the layout of cell therapy
At present, the global cell market is still dominated by European and American enterprises, and the main players include Novartis, Roche, Sanofi, Pfizer, etc. In contrast, in China, the cell therapy market has formed a situation with many players, fierce competition and obvious advantages of leading enterprises.
In the field of stem cell drugs, as far as the commercialization process is concerned, there are currently no stem cell drugs on the domestic market. However, stem cell technology has always been regarded as "regenerative medicine technology", known as the third medical revolution after drug treatment and surgical treatment, in which the infinite potential remains to be explored.
At the aforementioned meeting, Ren Jin, director of the drug safety evaluation research center of Shanghai Institute of Materia Medica, Chinese Academy of Sciences, pointed out that in the future, with the clarification of regulatory policies and the approval of related drugs for listing, the market potential of China's stem cell industry is huge. By 2024, the market size of China's stem cell medical industry will exceed 130billion yuan.
At present, the preclinical evaluation of autologous adipose derived stem cells conducted by Jimin medical has selected three indications: retinitis pigmentosa, type 3 diabetes, and chronic obstructive pulmonary disease (similar symptoms of new crown sequelae), and has carried out effectiveness, safety, and pharmacokinetics studies in authoritative drug safety evaluation institutions such as the drug safety evaluation center of Shanghai Institute of Materia Medica, Chinese Academy of Sciences.
Ren Jin said that in the future, Jimin medical plan will first carry out IIT non registered clinical research projects, and it is expected to apply for new drug clinical trial ind to CDE of the drug evaluation center of the State Food and drug administration next year.
In the field of immune cell drugs, only Fosun Kate, Yao Ming Juno and legendary biology have successfully listed immune cell therapy drugs.
Among them, Fosun Pharmaceutical Joint Venture Fosun Kate's Agilent injection (trade name: ekida) is the first car-t cell therapy product approved for listing in China;; Regoraxel injection (trade name: benoda) was improved on the basis of Juno therapeutics technology; Legendary biologicals' sidakiolanza injection (trade name: carvykti) is listed in the United States and the European Union.
It is worth mentioning that in June this year, ejeda added an approved second-line indication for adult large B-cell lymphoma (r/r lbcl) that failed to respond to first-line immunochemotherapy or relapsed within 12 months after first-line immunochemotherapy.
Such signs indicate that the current cell therapy industry is in the accelerated layout stage. According to the Cancer Research Institute, as of June 1, 2022, there were 2756 cell therapy pipelines under research worldwide, an increase of 39.8% over 2031 pipelines in 2021.
In terms of product acceptance, maozhenbin pointed out in the report of the aforementioned meeting that as of March 2022, CDE had accepted a total of 135 applications for cell therapy products. Among the 135 applications, 70 were car-t, 25 were other types of immune cell therapy, 31 were MSC, and 9 were other types of precursor cells.
A few days ago, at the "Jimin Medical Cell Industry Development Seminar" hosted by Jimin Health Management Co., Ltd., the reporter heard this group of data from caizhiming, the director of the national tumor genome application engineering laboratory.
According to relevant data, the cell industry refers to the cell-based research and application industry, including cell therapy, cell engineering, cell culture, cell storage and other fields.
Caizhiming said that the cell industry has great development potential and market prospects, and is an important direction of the future biomedical industry.
▌ cell therapy is favored by capital, but needs scientific supervision
Further breakdown, the cell industry includes six major industries, including cell therapy industry, stem cell industry, immune cell industry, cell culture industry, cell biopharmaceutical industry and gene editing industry.
Among them, cell therapy is a treatment scheme by re implanting cells into the human body after in vitro separation and purification. Its industry specifically points to cell therapy technology, cell therapy products, etc., and is in the middle and lower reaches of the whole chain of cell industry.
In November last year, the Shanghai Municipal Commission of science and technology, the Shanghai Municipal Commission of economy and information technology, and the Shanghai Municipal Commission of health care jointly issued the "Shanghai action plan for promoting technological innovation and industrial development of cell therapy (2022-2024)", aiming to target the scientific and technological frontier in the field of cell therapy worldwide and focus on key fields such as immune cells and stem cells. Its goals include reaching 10billion yuan in industrial scale by 2024, introducing and cultivating 50 leading enterprises and innovative enterprises.
According to incomplete statistics, in 2022, there were more than 15 financing events in the field of cell therapy in China, and nearly 40 related enterprises in the field of cell and gene therapy were financed in the first half of this year.
Caizhiming pointed out in the report that at present, more than 40 cell therapy products (including products that have been withdrawn from the market) have been listed in the world, of which only five immune cell therapy products have been approved for listing (three are car-t cells, one is DC cells, and one is T cells), and the rest are stem cell therapy products and other cell therapy products.
From the perspective of indications, the indications of stem cell products are very wide, including cancer, nervous system disease, cardiovascular disease, metabolic system disease, digestive system disease, etc; Immune cell therapy products are mainly used to treat blood tumors, while other cell therapy products are mostly used for tissue damage repair.
From the perspective of countries and regions that are first listed, cell therapy products are mainly distributed in the United States, South Korea, Japan and the European Union, and there are only two enterprises approved to list cell therapy products in China.
"Our new drugs account for only about 5% of the world, while the United States accounts for 55%. In response, Professor maozhenbin, former director of the Department of science, technology and international cooperation of the State Drug Administration, said at the aforementioned meeting:" the reason why the United States can approve so many new drugs is regulatory science. "He pointed out that the United States, Europe, Japan and other pharmaceutical powers have promoted scientific research and innovation in drug regulation as national strategies, And formed a series of management mechanisms, systems and methods.
▌ enterprises accelerate the layout of cell therapy
At present, the global cell market is still dominated by European and American enterprises, and the main players include Novartis, Roche, Sanofi, Pfizer, etc. In contrast, in China, the cell therapy market has formed a situation with many players, fierce competition and obvious advantages of leading enterprises.
In the field of stem cell drugs, as far as the commercialization process is concerned, there are currently no stem cell drugs on the domestic market. However, stem cell technology has always been regarded as "regenerative medicine technology", known as the third medical revolution after drug treatment and surgical treatment, in which the infinite potential remains to be explored.
At the aforementioned meeting, Ren Jin, director of the drug safety evaluation research center of Shanghai Institute of Materia Medica, Chinese Academy of Sciences, pointed out that in the future, with the clarification of regulatory policies and the approval of related drugs for listing, the market potential of China's stem cell industry is huge. By 2024, the market size of China's stem cell medical industry will exceed 130billion yuan.
At present, the preclinical evaluation of autologous adipose derived stem cells conducted by Jimin medical has selected three indications: retinitis pigmentosa, type 3 diabetes, and chronic obstructive pulmonary disease (similar symptoms of new crown sequelae), and has carried out effectiveness, safety, and pharmacokinetics studies in authoritative drug safety evaluation institutions such as the drug safety evaluation center of Shanghai Institute of Materia Medica, Chinese Academy of Sciences.
Ren Jin said that in the future, Jimin medical plan will first carry out IIT non registered clinical research projects, and it is expected to apply for new drug clinical trial ind to CDE of the drug evaluation center of the State Food and drug administration next year.
In the field of immune cell drugs, only Fosun Kate, Yao Ming Juno and legendary biology have successfully listed immune cell therapy drugs.
Among them, Fosun Pharmaceutical Joint Venture Fosun Kate's Agilent injection (trade name: ekida) is the first car-t cell therapy product approved for listing in China;; Regoraxel injection (trade name: benoda) was improved on the basis of Juno therapeutics technology; Legendary biologicals' sidakiolanza injection (trade name: carvykti) is listed in the United States and the European Union.
It is worth mentioning that in June this year, ejeda added an approved second-line indication for adult large B-cell lymphoma (r/r lbcl) that failed to respond to first-line immunochemotherapy or relapsed within 12 months after first-line immunochemotherapy.
Such signs indicate that the current cell therapy industry is in the accelerated layout stage. According to the Cancer Research Institute, as of June 1, 2022, there were 2756 cell therapy pipelines under research worldwide, an increase of 39.8% over 2031 pipelines in 2021.
In terms of product acceptance, maozhenbin pointed out in the report of the aforementioned meeting that as of March 2022, CDE had accepted a total of 135 applications for cell therapy products. Among the 135 applications, 70 were car-t, 25 were other types of immune cell therapy, 31 were MSC, and 9 were other types of precursor cells.
In the primary market, Chinese companies focusing on cell therapy, such as hanteng biology and shashuo biology, recently announced financing progress. Among them, hanteng biology completed more than 300million yuan of round C financing, led by SDIC, which will be used to promote the company's new technology research and development, commercial capacity construction, etc; Shagravel biology completed a round B financing of 400million yuan, led by the fund under CICC capital, which will be used to support the development of the company's tumor infiltrating lymphocyte (TIL) therapy pipeline.
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