National Development and Reform Commission: Encourage the development of cell industry!
Release Date:2024-12-04

In December 2023, the National Development and Reform Commission issued the "Guidance Catalogue for Industrial Structure Adjustment (2024 Edition)", which will come into effect on February 1, 2024. In the "Catalog (2024 Edition)", there are 5 items in the encouragement category, 6 items in the restriction category, and 8 items in the elimination category. Among the encouraged categories, a large number of new technologies, new drugs and intelligent equipment technologies are included, and children's medicines, medicines in short supply, cell culture, cell therapy drugs, and high-end intelligent pharmaceutical equipment are included in the encouraged industry catalog.

Under the encouraged pharmaceutical sector, many areas involve the development of the cell gene industry, including encouraging large-scale and efficient cell culture and purification, gene therapy and cell therapy drugs, chemically limited cell culture media, high-end, intelligent pharmaceutical equipment, etc.!

In the medicine section of Article 13, it is pointed out that it is necessary to promote the breakthrough and application of core pharmaceutical technologies, the development and industrialization of new drugs (including gene therapy and cell therapy drugs, etc.), and biomedical supporting industries, which are expected to further promote the development of the industry.

The medical part of Article 13 of the original text is as follows:

1. Breakthroughs and applications of core pharmaceutical technologies: advanced manufacturing and green and low-carbon technologies of raw materials such as membrane separation, new crystallization, chiral synthesis, enzymatic synthesis, and continuous reactions, new pharmaceutical preparation technology, new biological drug delivery methods and delivery technology, large-scale and efficient Cell culture and purification, medicinal polypeptide and nucleic acid synthesis technology, antibody coupling, vector virus preparation and other technologies, are transformed and upgraded using modern biotechnology.

2. New drug development and industrialization: innovative drugs and improved new drugs with independent intellectual property rights, children's drugs, shortage drugs, rare disease drugs, major disease prevention and control vaccines, new antibody drugs, recombinant protein drugs, nucleic acid drugs, biological enzyme preparations, gene therapy and cell therapy drugs.

3. Biomedical supporting industry: Chemically limited cell culture media, new purified fillers and filter membrane materials, high-end pharmaceutical excipients, development and production of new vaccine adjuvants, new pharmaceutical packaging materials and technologies such as special functional materials, i.e., ready-to-use, intelligent packaging and other new packaging systems Development and production of drug delivery devices; high-end and intelligent pharmaceutical equipment, new preparation production equipment, large-scale bioreactors and accessory systems, efficient protein separation and purification equipment, and continuous drug production equipment; Standardized breeding of experimental animals and animal experimental services.

4. Innovative development of high-end medical devices: new gene, protein and cell diagnostic equipment, new medical diagnostic equipment and reagents, high-performance medical imaging equipment, high-end radiotherapy equipment, acute and critical life support equipment, artificial intelligence assisted medical equipment, mobile and remote diagnosis and treatment equipment, high-end rehabilitation assistive devices, high-end implant intervention products, surgical robots and other high-end surgical equipment and consumables, development and application of biomedical materials and additive manufacturing technology.

5. Inheritance and innovation of traditional Chinese medicine: inheritance and innovation of traditional Chinese medicine identification technology, inheritance and innovation of processing technology of traditional Chinese medicine pieces, development and production of innovative and improved new medicines of traditional Chinese medicine, compound preparations of ancient classic and famous prescriptions, and ethnic medicines.

Relevant policy support (partial)

The State Council's "Thirteenth Five-Year Plan" National Science and Technology Innovation Plan

National Development and Reform Commission's "Thirteenth Five-Year Plan" Bioindustry Development Plan

State Food and Drug Administration "Technical Guidelines for Clinical Trials of Immune Cell Therapy Products (Trial)"

National Health Commission's "Suggestions on Vigorously Developing the Health Care Industry to Help Healthy China Strategy"

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