Policy blessing, immune cell drug research and development on a new stageArial

In June, the State Food and Drug Administration improved relevant regulations and guidelines, and promulgated the "Technical Guidelines for Pharmaceutical Research and Evaluation of Immune Cell Therapy Products (Trial)" to promote the development of cell therapy. It is understood that the guiding principles have standardized requirements and guidance on multiple dimensions such as cell drug research and development rules, marketing requirements, risk assessment, adoption process, testing, quality standards and risk release of immune cell therapy products. The promulgation of this guiding principle has promoted the policy support of immune cell therapy to a certain extent, and the research and development of immune cell drugs has reached a new level.

 In June, the State Food and Drug Administration improved relevant regulations and guidelines, promulgated the "Pharmaceutical Research on Immune Cell Therapy Products" Guidelines for and Evaluation Technology (Trial)" to promote the development of cell therapy. It is understood that the guiding principles have standardized requirements and guidance on multiple dimensions such as cell drug research and development rules, marketing requirements, risk assessment, adoption process, testing, quality standards and risk release of immune cell therapy products. The promulgation of this guiding principle has promoted the development of the immune cell therapy market to a certain extent. On the one hand, the regulatory authorities fully understand the particularity of cell therapy products, and formulate corresponding policies and norms to meet the needs of the industry and promote the development of the industry; It can formulate a clear development plan and launch cell therapy research products in a targeted manner.  

The advancement of modern medicine has made immune cell therapy an alternative to cell-killing treatments such as surgery, radiotherapy, and chemotherapy. Novel therapy. The traditional non-discriminatory cell killing therapy has certain damage to the patient's body. And immune cell therapy, one is to control tumor development through cell regulation, improve the body's biological response ability, and cause less damage to patients. The other is to install a "navigation system" on immune cells to tell the characteristics of the tumor to the immune cells, so that they can accurately find and kill cancer cells, so as not to cause harm to other cells of the patient. Therefore, immune cell therapy is expected to become a new hope for cancer treatment in the future. According to the Frost & Sullivan Report, the market size of cellular immunotherapy products in China is expected to increase from RMB 1.3 billion to RMB 10.2 billion from 2021 to 2023, and is expected to reach RMB 58.4 billion in 2030.  

Cell Therapy Advances to Advance Immune Cell Storage Market 

The development of immune cell therapy technology has also promoted the development of the immune cell storage market. In recent years, families that carry out immune cell storage have Also more. The newly issued guidelines also specifically regulate and require the extraction process, production and culture of immune cells, as well as storage conditions and containers. The promulgation of the "Guiding Principles of Immune Cell Pharmacy" provides guidelines for the standardized and large-scale development of immune cell therapy, and also allows more and more cancer patients to have a deeper understanding of the new technology of immune cell therapy, and promotes the immune cell storage market. development of. It is hoped that under the guidance of policies and market supervision, immune cell therapy will continue to improve and mature, and immune cell storage, as part of healthy storage, can truly bring good news to more patients.