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CGT Enterprises Accelerate Commercialization


Time:2024-07-24 10:36:25  Source:  Author:

 

Cell therapy mainly utilizes autologous (or allogeneic) adult cells (or stem cells) for disease treatment, which can provide a new treatment method for diseases such as cancer. Compared with traditional chemical drugs, it has the characteristics of fast technological iteration, great innovation potential, and high clinical dependence. At present, cellular gene therapy (CGT) has been regarded as one of the promising research and development directions in the field of biomedicine, and the market size is expected to continue to expand. Data shows that from 2020 to 2025, the compound annual growth rate of China's CGT market will reach 276%, and it is expected that the size of China's CGT market will reach 2.59 billion US dollars by 2025.

 
 
 
 
It is worth mentioning that as the number of entrants increases, the competition on the track will also become increasingly fierce. As of now, 8 CAR-T therapies have been approved for market worldwide, among which the CAR-T therapies that have been launched in China include Fosun Kite's Yikaida (Akilensai injection), Shanghai Pharma's Beinuoda (Ruiqiolonsai injection), and Heyuan Biotech's Hejilunsai. According to other data, as of December 15, 2022, the number of CAR-T clinical trials conducted globally reached 2035, of which 1096 were conducted in China, indicating that competition may become increasingly fierce in the future.
 
 
 
To enhance competitiveness, some pharmaceutical companies are accelerating the process of entering clinical trials, registration, and commercialization of their products by establishing new bases. For example, Hebei Senlang Biotechnology Co., Ltd. (Senlang Biotech), which is committed to promoting the clinical application of cell therapy, held the opening ceremony of its newly built commercial production base for cell therapy products in Shijiazhuang in early July this year.
 
 
 
It is reported that Senlang Biotechnology has established a one-stop platform for the research and industrialization of cell therapy drugs, as well as a platform for the development and screening of nanobodies. It has mastered core technologies such as large-scale plasmid preparation, lentiviral vector preparation, and primary immune cell preparation, and has successfully established a CAR-T full process industry chain in China. At present, the company has 6 cell therapy pipelines under development.
 
 
 
The total investment of the new base is 120 million yuan, with a total area of 14000 square meters. It integrates plasmid and lentiviral vector production, CAR-T cell production, quality control, warehousing, and research and development. After being put into use, it will accelerate the official clinical, registration, and commercialization process of Senlang Biotechnology's CAR-T cell therapy with independent intellectual property rights.
 
 
 
Behind the construction of the commercial production base for Senlong Biological Cell Therapy products, the support of the upstream pharmaceutical equipment industry is indispensable.
 
 
 
It is reported that Chutian Technology, as an important provider of related technology and equipment, has participated in the construction of the commercial production base for Senlang Biotechnology's cell therapy products. It has provided Senlang Biotechnology with a series of important core equipment, including raw material freeze-drying equipment, disposable products, cell preparation isolators (including cell sorting operation isolators, cell harvesting preparation operation isolators, cell transduction replenishment isolators), honeycomb culture systems, immune cell honeycomb culture systems, sterile cell filling and capping isolator production lines, mycoplasma culture isolators, etc., to help Senlang Biotechnology further layout in the field of cell therapy products.
 
 
 
The industry believes that cell and gene therapy have enormous potential and development momentum, especially in the treatment of refractory diseases, where more and more clinical trials of cell and gene therapy are being initiated. However, overall, many CGT companies in China are currently focusing their resources on research and development, and do not yet have commercialization capabilities. With more and more pharmaceutical companies entering this track, or more pharmaceutical companies focusing on commercialization capabilities, the domestic cell drug preparation system will have great potential in this context.

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