On July 2, 2024, People's Daily-People's Daily released the latest financial observation article: The industry is accelerating the layout of "cell intelligence" and entering the "fast lane", which may indicate that stem cell therapy will accelerate to benefit the whole people and become a booming emerging medical care. Health industry!

Life begins and ends in cells. As an emerging industry,"cell intelligence" is becoming a new focus in the development of the medical and health industry.

"Intelligent cell manufacturing" mainly refers to the empowerment of the cell industry through biomaterials and automation technology in the cell therapy industry, and the transformation of cell preparation technology to "digital, automated, large-scale, closed, and activated (DAEA) Intelligent Manufacturing Factory" has greatly reduced the cost of cell preparation and improved the stability of cell preparation.

At present, my country has formed a relatively complete cell therapy industry chain covering the upper, middle and lower reaches, and the development of the industry is booming. Driven by factors such as technology, policies, and market in the future,"cellular intelligent manufacturing" is expected to be empowered through intelligent and automated technology to usher in more standardized and orderly high-quality development.

The industry accelerates the layout of "cell intelligent manufacturing"

"Cell therapy can show good results in the treatment of many diseases, especially cancer, genetic diseases, etc., and provide patients with new treatment strategies." According to Han Zhongchao, director of the National Stem Cell Engineering Technology Research Center, cell therapy may become a disruptive prevention and treatment technology to overcome refractory diseases.

In order to promote the development of the cell therapy industry, in 2023, Shenzhen announced and implemented the country's first special legislation on the cell and gene industry,"Shenzhen Special Economic Zone Cell and Gene Industry Promotion Regulations", from the perspectives of covering the entire industry chain, strengthening talent protection, and innovating industrial clusters. Support the development of related industries in all directions.

Cell therapy technology iterates rapidly and has great potential for industrial development. Beijing, Shanghai, Tianjin and other places are also stepping up their deployment. According to relevant statistics, my country's cell therapy market space will increase 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 in the next 10 years, my country will usher in a period of rapid growth in the cell therapy industry.

"Orderly supervision" promotes the standardized development of industries

In recent years, my country has issued a series of policies and regulations in the field of cell therapy, such as the "Guidelines for Quality Management of the Production of Cell Therapy Products (Trial)" and "Technical Guidelines for Clinical Trials of Human-derived Stem Cells and Their Derived Cell Therapy Products (Trial)", focusing on the production management, quality management, clinical trials, clinical applications, etc. of cell products have been continuously strengthened.

What cannot be ignored is that as an emerging industry,"cellular intelligence" still faces many challenges. From the overall perspective of the industry, cell therapy has large investment in research and development, high production costs, and high treatment costs. There is an urgent need to break through from different dimensions.

In this regard, Han Zhongchao, director of the National Stem Cell Engineering Technology Research Center, suggested further increasing investment in new cell drug creation companies; encouraging the establishment and expansion of research-oriented hospitals or new drug clinical trial medical centers, and cultivating clinical trial professional teams; and smoothing the green channel of stem cell clinical trials to standardize and accelerate the approval process for conditional listing.

Promoting the development of the cell therapy industry, improving quality control standards, and strictly enforcing regulatory requirements are also important keys. According to Yuan Baozhu, former director of the Cell Resource Preservation Research Center of the China National Academy for Food and Drug Control, this not only requires relevant departments to speed up the formulation of management standards, but also actively formulate technical standards and product standards. Supervision and innovation promote and unify each other. Only when supervision is in place can we participate in international competition and only when innovation-driven development can we continue.

Some experts also pointed out that cell therapy requires quality standards control in terms of the time, weight, and source of raw materials. Taking mesenchymal stem cells as an example, considering the importance of controlling the source of raw materials, establishing a unified standard is particularly critical.

Achieving the safety, effectiveness and repeatability of cell therapy is not only an external requirement of supervision, but also the key to the inherent innovative research and development of cell therapy. Therefore, the country's orderly supervision of cell therapy is of great significance to regulating the healthy development of the industry.