Source: Science and Technology Board Daily

By 2025, the global market size of the cell industry may reach 200 billion US dollars, and the Chinese market may reach 100 billion yuan. By 2024, the market size of China's stem cell therapy industry is expected to exceed 130 billion yuan. At present, there are three Chinese companies, Fosun Kat, Yao Ming Junuo and Legend Biology, successfully listed immune cell therapy drugs; Ji Min Medical is expected to submit IND application for clinical trial of new stem cell drug next year.

"According to my team, the cell industry could be worth $200 billion by 2025, and 100 billion renminbi in China." Recently, at the "Jimin Medical Cell Industry Development Seminar" sponsored by Jimin Health Management Co., LTD., the reporter of the "Science and Technology Board Daily" heard this set of data from Academician CAI Zhiming, director of the National Tumor Genome Application Engineering Laboratory. According to relevant information, the cell industry refers to the cell-based, research and application industry, including cell therapy, cell engineering, cell culture, cell storage and other fields. CAI Zhiming said that the cell industry has huge development potential and market prospects, and is an important direction for the future biomedical industry.

▌Cell therapy is promising but needs regulatory science

Further subdivided, the cell industry includes six 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 program that isolates and purifies cells in vitro and reimplants them into the human body. Its industry specifically points to cell therapy technology and cell therapy products, which are in the middle and lower reaches of the whole chain of cell industry.

In November last year, the Shanghai Municipal Science and Technology Commission, the Municipal Economic and Information Commission, and the Municipal Health Commission jointly issued the "Shanghai Municipal Action Plan to Promote Cell therapy technology Innovation and Industrial Development (2022-2024)", aiming at the forefront of global cell therapy science and technology, focusing on key areas such as immune cells and stem cells. Its goals include an industrial scale of 10 billion yuan by 2024, and the introduction and cultivation of 50 leading enterprises and innovative enterprises. According to incomplete statistics, in the whole year of 2022, there were more than 15 financing events in the field of cell therapy in China, and there were nearly 40 companies related to the field of cell and gene therapy that were financed in the first half of this year.

CAI Zhiming pointed out in the report that at present, more than 40 cell therapy products have been listed in the world (including products that have been withdrawn from the market), of which only 5 immune cell therapy products have been approved for listing (of which 3 are CAR T cells, 1 is DC cells, 1 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 diseases, cardiovascular diseases, metabolic system diseases, digestive system diseases, etc. Immune cell therapy products are mainly used for the treatment of blood tumors, and other cell therapy products are mostly used for tissue damage repair. From the perspective of the first listed countries and regions, cell therapy products are mainly distributed in the United States, South Korea, Japan and the European Union, and only two companies have been approved to list cell therapy products in China. "We only produce about 5 percent of the world's new drugs, compared to 55 percent in the United States."  He pointed out that pharmaceutical powers such as the United States, Europe and Japan have promoted scientific research and innovation in drug regulation as a national strategy, and formed a series of management mechanisms, systems and methods.

▌Companies accelerate the placement of cell therapies

At present, the global cell market is still dominated by European and American companies, the main players include Novartis, Roche, Sanofi, Pfizer and so on. In contrast, the domestic 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 therapy and surgical treatment, which should have unlimited potential to be explored. At the aforementioned meeting, Ren Jinon, director of the Drug Safety Evaluation Research Center of the Shanghai Institute of Materatology, Chinese Academy of Sciences, pointed out that the market potential of China's stem cell industry is huge in the future with the clarity of regulatory policies and the approval of related drugs.

By 2024, the market size of China's stem cell medical industry will exceed 130 billion yuan. Currently, the preclinical evaluation of autologous fat stem cells conducted by Ji Min Medical (603222.SH) has selected three indications of retinitis pigmentosa diseases, type 3 diabetes mellitus, and chronic obstructive pulmonary disease (similar symptoms of COVID-19 sequelae). Efficacy, safety and pharmacokinetics studies were conducted in authoritative drug safety evaluation institutions such as the Center for Drug Safety Evaluation, Shanghai Institute of Pharmaceutical Sciences, Chinese Academy of Sciences. Ren Jin said that in the future, Ji Min medical plans to carry out IIT non-registered clinical research projects, and is expected to apply for a new drug clinical trial IND to the Drug Review Center CDE of the State Food and Drug Administration next year. In the field of immune cell drugs, only three Chinese companies, Fosun Kat, Yao Ming Juno (0226.HK) and Legend Biology, have successfully listed immune cell therapy drugs. Among them, Fosun Pharmaceutical (600196.SH, 02196.HK) joint venture Fosun Kat's Akilense injection (trade name: Yikaida) is the first CAR T cell therapy product approved for market in China; Rechiolenxel injection (trade name: Benoda) is modified based on Juno Therapeutics' technology; Legendary Bio's Sidagiorunze injection (trade name: Carvykti) is available in the United States and European Union. It is worth mentioning that in June this year, Yikaida was newly approved for second-line indications for adults with large B-cell lymphoma (r/r LBCL) who have failed first-line immunochemotherapy or relapsed within 12 months after first-line immunochemotherapy.

Signs such as these suggest that the cell therapy industry is currently in an accelerated phase of layout. According to the Cancer Research Institute, as of June 1, 2022, there are 2,756 cell therapy pipelines in development worldwide, an increase of 39.8% from 2,031 pipelines in 2021.  Of the 135 applications, 70 were for CAR-T, 25 were for other types of immune cell therapy, 31 were for MSC, and 9 were for other types of precursor cells.

In terms of the primary market, recently, Chinese companies focusing on cell therapy such as Hanteng Biology and Sashuo Biology announced financing progress. Among them, Hanteng Bio completed more than 300 million yuan of C round financing, led by SDIC Venture Capital, will be used to promote the company's new technology research and development, commercial capacity construction; Gravel Bio has completed a RMB400 million Series B funding round led by CICC Capital's funds, which will be used to support the development of the company's tumor infiltrating lymphocyte (TIL) therapy pipeline.