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Biotherapy is a new technology and means of disease treatment based on biological macromolecules such as antibodies and cells. Compared with traditional methods, biotherapy is more targeted and accurate, safe and has no toxic side effects. It is the fourth largest tumor treatment technology after surgery, radiotherapy and chemotherapy. From the perspective of operation mode, it is divided into non-cell therapy and cell therapy. The cutting-edge technologies of biotherapy include biological cell immunotherapy, gene therapy, cancer stem cell targeted therapy, etc.

The global stem cell therapy market size is $9.87 billion in 2021 and is expected to reach around $31.41 billion by 2030, and is expected to grow at a compound annual growth rate (CAGR) of 13.73% during the forecast period from 2022 to 2030. Combined with the global stem cell medical market size, the Chinese stem cell medical market size was approximately $2.057 billion in 2020, equivalent to approximately RMB 14 billion. In terms of the clinical application of stem cells, as of February 17, 2022, a total of 28 new stem cell drug projects in China have obtained national clinical implicit approval.

In recent years, the State Council, the National Development and Reform Commission, the State Food and Drug Administration, the State Administration for Market Regulation and other departments have successively issued policies to support and regulate the development of the biopharmaceutical industry, covering biopharmaceutical development trends, biopharmaceutical R&D and production standards, and new biopharmaceutical technologies. On May 26, 2022, in order to standardize and guide the pharmaceutical research and development, production and registration of immune cell therapy products, under the deployment of the National Medical Products Administration, the Drug Evaluation Center organized the formulation of the "Guidelines for Pharmaceutical Research and Evaluation of Immune Cell Therapy Products (Trial)". The strategic emerging industries such as biomedicine, biomedical engineering, bio-agriculture, bio-manufacturing, bio-energy, bio-environmental protection, and biotechnology services have significantly improved their strategic position in the development of the national economy and society.