Source: China (Shandong) Free Trade pilot Zone

In order to implement the task requirements of the "deepening Reform and Innovation Plan of China (Shandong) Free Trade Experimental Zone" issued by the Shandong provincial government, and to further give play to the role of innovation drive in Jinan, the free trade pilot area of China (Shandong), the work deployment of the "Project Breakthrough year" of the municipal party committee and municipal government for service guarantee has been accelerated to promote the scientific and technological innovation and industrial development of cell therapy in Jinan recently.

The Jinan District Management Committee, together with the Municipal Development and Reform Commission, the Municipal Science and Technology Bureau, the Municipal Industrial and Information Bureau, the Municipal Health Commission and the Municipal Market Regulatory Administration, jointly issued "some measures to promote the innovative Development of Cell Therapy Industry in Jinan, China (Shandong) Free Trade Experimental Zone". To seize the opportunity of scientific and technological frontier development in the field of global cell therapy driven by innovation.

We will speed up the construction of innovative sources of cell therapy and new industrial highlands with international influence.

With the characteristics of rapid technological iteration, great potential for innovation, high clinical dependence and personalized customization of products, cell therapy has become a "new track" for the layout of various countries. It is estimated that by 2025, the global market size of cell therapy industry will reach 30.54 billion US dollars. Jinan District is the most innovative and dynamic gathering area of cell therapy industry in the province, with nearly 100 cell therapy enterprises, forming upstream and downstream industrial chains such as cell collection and storage, cell technology and product development, cell transplantation and treatment, cell preparation and production, etc. Stem cells and immune cells have comparative advantages in the country.

In order to further seize the advantages of future industrial development through free trade system innovation, under the condition of fully investigating the market demand of enterprises, clinical demands of medical institutions and the development trend of industrial innovation, the Jinan District Management Committee, together with relevant departments, in accordance with the principle of "reform proposed, industry supplement, enterprise needs, and expectations of the masses", give full play to the role of the free trade experimental zone as a pilot and demonstration leader, based on the reality of cell therapy industry in Jinan.

Focus on the bottleneck of the development of cell therapy industry, formulate "some measures to promote the innovative development of cell therapy industry in Jinan, China (Shandong) Free Trade Experimental Zone", and formulate 14 innovative policies from four aspects. to promote the high-quality development of cell therapy industry in Jinan.

The first is to enhance the scientific and technological innovation capability of the cell therapy industry. Encourage enterprises, institutions of higher learning, scientific research institutions and medical and health institutions to carry out industry-university-research cooperation, accelerate the innovation of engineering technology and production process related to cell therapy products, accelerate the R & D and transformation of clinical technologies such as CAR-T, CAR-B, CAR-M, CAR-NK cell therapy, and promote the innovation of cell therapy research and development and the effective integration of public resources.

The second is to improve the transformation of clinical research in cell therapy industry.Qualified medical and health institutions are encouraged to carry out clinical research and clinical trials on cell therapy. To explore the application of real-world data of cell therapy and to build a multi-level clinical research service platform for cell therapy according to the international standard. Explore collaborative research and innovative cooperation between medical enterprises, and jointly carry out clinical research on new technologies and new therapies for cell therapy.

The third is to cultivate the development momentum of cell therapy industry.Vigorously cultivate and support high-tech enterprises in the field of cell therapy, speed up the commissioning of foreign-invested projects in the field of cell therapy on the premise of complying with relevant laws and regulations, and encourage foreign-invested enterprises to carry out clinical trials of overseas listed cells and gene therapy drugs in Jinan area in accordance with the law. Build a high standard CDMO platform, public laboratory, shared GMP laboratory, public sample repository, industrial acceleration base, and establish an innovation gathering area for cell therapy industry in Jinan.

The fourth is to strengthen the support of the cell therapy industry security system.Set up a cell and gene therapy industry promotion platform, cell and gene therapy industry associations and other organizations, and set up a cell and gene therapy strategy advisory steering committee. We will strengthen support for the listing of innovative products by enterprises in Jinan area, explore the establishment of a "green channel" for patent examination and approval in the cell industry, and speed up the transformation of cell therapy technology achievements. Encourage the establishment of various investment funds covering the "full-stage + whole-industry chain" of the cell therapy industry. To construct a safety prevention system with the convergence of cell therapy system, management and industry standards.

In the next step, Jinan District will actively implement the Promotion Strategy of Free Trade Experimental Zone, strengthen coordination, integrated innovation and open development, and vigorously implement the promotion plan of cell therapy industry. we will form a new paradigm for promoting scientific and technological innovation and a new model for industrial development in the field of cell therapy, and speed up the construction of a policy system that matches the characteristics of industrial development in Jinan and connects with international standards, so as to establish national trial systems and standards. Create welfare and vitality for patients, seek development and development space for the industry, and speed up the construction of an innovative highland of cell therapy industry with international influence.

At the same time, we should give full play to the advantages of free trade innovation, actively explore and strive for new targets, new pathways, and clinical transformation and application of new mechanisms of cell therapy, and build a new pattern of deep integration and development of cell therapy innovation chain and industry chain. to contribute to free trade to speed up the creation of the province's international medical and health industry innovation highland!