Shanghai Action Plan for Promoting Innovation and Industrial Development in Cell Therapy (2022–2024)

To further boost innovation and industrial development in cell therapy in Shanghai, accelerate the establishment of a globally recognized hub for biopharmaceutical innovation, and vigorously build a world-class biopharmaceutical industry cluster, this Action Plan has been formulated based on the "14th Five-Year Plan for Building Shanghai into a Globally Influential Science and Technology Innovation Center," the "14th Five-Year Plan for Developing Strategic Emerging Industries and Leading Industries in Shanghai," and the "Several Opinions on Promoting High-Quality Development of the City's Biopharmaceutical Industry."

I. Guiding Principles

Guided by the Thought on Socialism with Chinese Characteristics, we will ground ourselves in the new stage of development, fully, accurately, and comprehensively implement the new development philosophy, and actively support the establishment of the new development paradigm. Upholding the "Four Orientations," we will address the inherent patterns and characteristics of cell therapy—such as the deep integration of innovation and industrial chains, rapid technological iteration, high clinical dependency, and the need for highly personalized product customization—while fostering continuous progress in this dynamic field. Focusing on establishing a hub for cell therapy innovation and an industrial growth engine, we will prioritize strengthening capabilities in original innovation, clinical translation, and industrial competitiveness. , we will build a policy framework that aligns with Shanghai's distinctive industrial development characteristics and connects seamlessly with international standards. This will accelerate the emergence of a new paradigm for scientific innovation and a fresh model for industry growth in the field of cell therapy, thereby powerfully driving the high-quality development of Shanghai's cell therapy sector.

II. Basic Principles

——Staying committed to driving innovation. Targeting the global cutting edge of cell therapy technology, this initiative focuses on key areas and critical stages such as immune cells and stem cells, strengthening both fundamental research and application-oriented basic research. It aims to accelerate breakthroughs in core cell therapy technologies, ultimately enhancing Shanghai's ability to serve as a global hub for innovation and scientific advancement in the field of cell therapy.

——Persist in the integration of dual chains. Streamline the fast track connecting basic research, applied research, and industrialization in both directions, accelerate the convergence of critical elements such as technology, talent, and capital, foster deep collaboration across the upstream and downstream segments of the industry chain, strengthen the integration of industry and medicine, and drive the commercialization and application of research breakthroughs—ultimately creating a new, integrated model for the cell therapy innovation ecosystem and industry chain.

——Persist in empowering industries. Focusing on the development needs of the cell therapy industry, we will further integrate the city's leading scientific research capabilities, clinical expertise, and industrial resources, optimize the spatial layout of the sector, foster a vibrant innovation and entrepreneurship ecosystem, and strengthen policy support in areas such as product launch and commercialization, specialized cargo clearance, ethical review, and human genetic resource approvals. This effort will drive the establishment of robust quality standards, accelerating the industry's ability to elevate both its developmental capacity and overall competitiveness in the cell therapy field.

— Uphold open cooperation. Driven by a global perspective on development and guided by a win-win mindset to foster collaboration, we will establish diverse platforms for cooperation and exchange, facilitating the convergence and flow of domestic and international innovation resources. This initiative will help more high-quality Shanghai-based cell therapy companies and their products expand beyond China, actively integrating into the dual-circulation framework—both domestically and internationally—and positioning Shanghai as a pivotal innovation hub for cell therapy, serving not only the nation but also radiating globally.

III. Main Objectives

By 2024, Shanghai's capability to drive innovation in cell therapy technology has significantly strengthened, with clinical research and translational applications accelerating markedly. Innovative resources are being efficiently allocated, leading to a substantial提升 of the industry's overall competitiveness. The industry has reached a scale of 10 billion yuan. Innovative talent is converging, as various research institutions, clinical research centers, and service platforms emerge one after another. Leading technology companies are also gathering, helping to establish a cutting-edge hub for cell therapy innovation—characterized by its strong scientific and technological support, deep integration of the innovation and industrial chains, and positioning as a new high ground for the biotech industry.

— Innovation and clinical translation capabilities have been significantly enhanced. A number of novel mechanisms, targets, and approaches for cell therapy have been explored and discovered, while also achieving breakthroughs in key technologies, core equipment, and materials that have long constrained industry development. A closely integrated, smoothly transitioning, and highly collaborative clinical research system has been established. Establish 20 city-level or higher cell therapy innovation bases and platforms (including key laboratories and technology innovation centers), build a group of public service platforms for R&D and manufacturing, and secure more than 20 additional clinical trial approvals and innovative project filings. 。

——The industry's capabilities have been significantly upgraded. Shanghai’s cell therapy industry is accelerating its move into the high-end segments of the global value chain, More than 3 applications submitted for innovative product launches Leveraging Shanghai's advantages as a hub for innovation in the biopharmaceutical industry, Cultivate more than five municipally-level cell therapy industry clusters, each with its own unique characteristics. , enhancing the industry's capacity to support growth. Attract We will cultivate 50 leading and innovative enterprises, attracting 50 top-tier industry professionals and 100 industry talents. 。

IV. Key Tasks

(1) Strengthening the Capacity for Generating Scientific and Technological Innovation

1. Strengthen forward-looking strategic planning for basic research

We will proactively plan and advance research in cutting-edge, interdisciplinary fields such as the discovery of novel immune targets, stem cell fate regulation, and innovative engineered cell therapies. This initiative aims to foster seamless integration between basic research and application-oriented foundational studies, while also strengthening collaborative innovation with disciplines like traditional Chinese medicine. Additionally, we will accelerate the establishment of key cell therapy laboratories and technology innovation centers, and actively explore and develop major municipal-level science and technology projects.

2. Strengthen efforts to tackle critical technologies

Strengthen research and development on key technologies such as high-throughput target screening, in vitro gene-editing systems, next-generation vector delivery technologies, high-quality source cell preparation, and cell product traceability. Additionally, promote the application of cutting-edge technologies like artificial intelligence and single-cell analysis to accelerate innovation and industrialization of engineering technologies and manufacturing processes related to cell therapy products. (Municipal Science and Technology Commission, Municipal Economic Information and Informatization Commission, Municipal Development and Reform Commission, Municipal Drug Administration, Municipal Health Commission)

3. Accelerate the R&D of core equipment and materials

We will undertake research, development, and application of advanced instruments and equipment such as automated closed-cell processing systems and process analytical technology platforms, along with functional assay reagents, cell culture media, and viral purification chromatography resins—along with other essential reagents and consumables. This effort aims to achieve independent control over core equipment and materials critical for cell therapy production. (Municipal Science and Technology Commission, Municipal Economic Information and Informatization Commission, Municipal Development and Reform Commission, Municipal Drug Administration, Municipal Health Commission)

(II) Enhancing Clinical Research and Translation Capabilities

4. Strengthen the strategic planning of clinical research

Improve the guidance and incentive mechanisms for medical institutions, attracting diverse innovation resources. Leverage leading hospitals to establish several clinical research centers in the field of cell therapy, creating a networked system of clinical research bases for cell-based treatments. Explore and initiate first-in-human clinical trials of cell therapies, while actively encouraging investigator-initiated clinical studies (IITs). Prioritize the development and technological advancement of cell therapy products targeting cancers, immune system disorders, neurological conditions, and musculoskeletal diseases. Additionally, promote the standardized clinical application of cell therapy products, enhancing both the capacity for cell therapy research and the overall quality of patient care and treatment. (Municipal Health Commission, Municipal Science and Technology Commission, Municipal Economic and Information Technology Commission, Municipal Development and Reform Commission, Municipal Drug Administration, and Shenkang Hospital Development Center)

5. Establish a Clinical Research and Translation Platform

Enhance the cell preparation, storage, testing, and R&D service capabilities of national stem cell translational resource platforms, such as the Chinese Academy of Sciences Cell Resource Bank, while driving the establishment of complementary cell resource banks. These initiatives will provide stable, high-quality cell sources and technical services to all innovative players in the cell therapy industry. Aligned with international standards, we will optimize and upgrade the functions of cell product R&D and preparation service platforms, as well as third-party testing service platforms. Additionally, we will build a city-level public service platform for clinical research in cell therapy, offering on-demand preparation of research-grade and clinical-grade cell products tailored to the specific needs of companies and medical institutions, along with comprehensive services like product quality traceability.

6. Deepen the integrated development of industry and healthcare

Leveraging the Municipal Hospital-Industry Collaborative Research and Innovation Platform (HI-CLIP), we will facilitate effective alignment between companies' R&D needs and clinical resources at medical institutions. We will support collaborations between cell therapy firms and nationally accredited stem cell clinical research centers, as well as industry-medical integration demonstration bases, to jointly conduct clinical research on cutting-edge cell therapy technologies and treatments. Additionally, we will establish robust mechanisms for sharing research benefits, encouraging enterprises to adopt and commercialize scientific and technological achievements from healthcare organizations. Furthermore, innovative cell therapy products and services will be recognized as high-tech achievement transformation projects. Finally, we will promote the exploration of new industry development models, such as the "front hospital, back factory" approach, to foster deeper integration between industry and medicine.

(III) Enhancing the Development Level of Industries

7. Optimize Industrial Space Allocation

Establish a distinctive, multi-faceted cell therapy industry cluster centered around "one core and multiple hubs." Leveraging the Zhangjiang Cell & Gene Therapy Industrial Park in Pudong, we will build a core hub for innovation in cell therapy technology and industrial development. Meanwhile, the Waigaoqiao Free Trade Zone No.1 Life Science Industrial Park in Pudong will serve as a demonstration site for the life and health industries powered by cell therapy. The Lingang New Area's Life Blue Bay will emerge as a globally competitive R&D and manufacturing base for cell therapies, while the Jinshan Bay Biomedical Port will become a first-class domestic platform for commercializing cell therapy products. Additionally, we will promote coordinated development among key cell therapy industry bases in Jiading Nanxiang, Baoshan North Shanghai, Xuhui Guanport, Minhang Pujiang, and Fengxian Meigu—ultimately fostering a world-class cell therapy industry cluster. (Shanghai Municipal Commission of Economy and Informatization, Shanghai Municipal Science and Technology Commission, Shanghai Science and Technology Innovation Office, and relevant district governments)

8. Enhancing the Level of Corporate Innovation

Optimize the allocation of cellular therapy resource elements and accelerate the establishment of innovation hubs such as technology innovation centers, manufacturing innovation centers, and industry innovation centers. Vigorously cultivate and support high-tech enterprises in the cellular therapy sector, while actively attracting leading companies, premium firms, and cutting-edge R&D institutions from both domestic and international cellular therapy value chains to establish operations in Shanghai. Encourage local cellular therapy companies to collaborate with globally renowned institutions and enterprises, fostering innovation in cellular therapies and promoting the industry’s globalization. Additionally, support cellular therapy firms in securing and integrating international patents, and motivate innovative companies to strengthen and expand their flagship products. (Shanghai Municipal Commission of Economy and Informatization, Shanghai Municipal Science and Technology Commission, Shanghai Municipal Development and Reform Commission, Shanghai Science & Technology Innovation Office, and relevant district governments)

9. Promote the development of the industry's entire value chain

Promote the collaborative development of the upstream and downstream sectors in the cell therapy industry chain by implementing the "Strengthen, Enhance, Supplement, and Extend" initiative. Accelerate the localization of critical equipment and materials such as high-end bio-reagents, biological raw materials, viral vectors, culture systems, testing instruments, and production devices. Enhance R&D service capabilities in areas like CRO, CDMO, and cell-based diagnostics within the cell therapy field, while speeding up the commercialization of innovative products such as immune cells and stem cells. Additionally, establish robust product supply chains and related distribution & trade platforms to ensure reliable drug availability and safeguard public medication safety. (Shanghai Municipal Commission of Economy and Informatization, Shanghai Municipal Science and Technology Commission, Shanghai Science and Technology Innovation Office)

10. Strengthening Industry Service Capacity Building

Establish industry organizations such as the Shanghai Cell Therapy Industry Alliance to foster collaboration and knowledge exchange, providing expert guidance to businesses and entrepreneurs. Additionally, build a robust brand for cell therapy forums and summits, helping to cultivate a vibrant ecosystem of innovation and entrepreneurship. Meanwhile, set up specialized committees focused on standardization related to cell therapy, driving the development of industry standards covering critical areas like sample collection, production preparation, and product quality testing—and actively promoting their widespread adoption. (Shanghai Municipal Commission of Economy and Informatization, Shanghai Municipal Science and Technology Commission, Shanghai Municipal Health Commission, Shanghai Municipal Market Supervision Administration, Shanghai Municipal Drug Administration, Shanghai Municipal Intellectual Property Office)

(IV) Strengthen Policy Support

11. Strengthen support and services for product launch approvals

To strengthen support for innovative products launched by local companies, enterprises registered in the city that obtain market authorization and subsequently commercialize cell therapy products within the city will receive financial assistance of up to 30 million yuan. The cumulative annual support for each entity will not exceed 100 million yuan. Additionally, companies involved in cell therapy are encouraged to purchase biomedical product liability insurance, with eligible entities receiving a 50% government subsidy on their premiums—capped at 500,000 yuan per policy. Following the principles of "early engagement and proactive service," efforts will be made to position key, pipeline cell therapy innovations developed locally as priority focus areas for early communication and collaboration at the Yangtze River Delta Branch Center of the National Medical Products Administration’s Drug Review and Inspection Agency. This initiative aims to provide tailored guidance and support throughout the review and approval process, accelerating the time-to-market for cell therapy products. Furthermore, a comprehensive policy compendium will be prepared to help stakeholders swiftly and accurately navigate the regulatory, administrative, and service-related processes—and access relevant preferential policies—specifically tailored to cell therapy products. (City Drug Administration Bureau, City Commission of Economy and Informatization, City Finance Bureau, City Science and Technology Commission, City Health Commission, City Local Financial Regulatory Bureau, Shanghai Banking and Insurance Regulatory Bureau)

12. Promote streamlined customs clearance for R&D materials and special items

Promote pilot programs for importing R&D-related materials, establish a joint regulatory mechanism for the import and export of special cellular therapy products, and streamline management procedures for high-risk therapeutic special items entering and leaving the country. Additionally, address potential risks—such as X-ray examinations potentially compromising the viability of blood cells—and explore optimized inspection measures. (Municipal Commission of Economy and Informatization, Municipal Commission of Commerce, Shanghai Customs, Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Ecology and Environment Bureau, Municipal Transportation Commission, Municipal Health Commission, Municipal Drug Administration, Shanghai Science and Technology Innovation Office, East China Regional Administration of Civil Aviation)

13. Optimize Ethical Review and Human Genetic Resources Approval Services

Explore initiatives to promote mutual recognition of ethical standards among hospitals, enhancing the efficiency and quality of ethical reviews while safeguarding the safety, health, and rights of participants. Regularly conduct professional training programs to strengthen the capabilities of human genetic resource specialists working in cell therapy-related companies, and reinforce advisory services for applications involving human genetic resources, ultimately improving the overall quality of service delivery. (Municipal Health Commission, Municipal Science and Technology Commission, Municipal Commission of Economy and Information Technology, Pudong New Area, Shinkang Hospital Development Center)

V. Assurance Measures

(1) Accelerate product promotion and application

Actively promote the inclusion of innovative, commercially available cell therapy products into the National Medical Insurance Drug List and people-benefiting commercial health insurance programs such as "Hu Huibao." Leverage the role of multi-tiered commercial health insurance systems to encourage collaboration among local enterprises, commercial insurers, and medical institutions in exploring innovative payment models, including installment payments and outcome-based reimbursement. Additionally, encourage research institutions, medical facilities, and companies involved in cell therapy to secure liability insurance coverage specifically designed for clinical trials involving human subjects. Under equal conditions, hospitals are encouraged to prioritize the use of cell therapy products developed and manufactured within the city. For cell therapy drugs currently undergoing clinical trials—particularly those targeting life-threatening diseases with no effective treatment options—patients who demonstrate potential medical benefits through careful observation and meet ethical guidelines may, following review and informed consent, be eligible for compassionate use at the same clinical trial site, provided they have similar disease profiles. (Shanghai Municipal Commission of Economy and Informatization, Shanghai Municipal Healthcare Security Bureau, Shanghai Municipal Local Financial Regulatory Bureau, Shanghai Branch of the China Banking and Insurance Regulatory Commission, Shanghai Municipal Drug Administration, Shanghai Municipal Science and Technology Commission, Shanghai Municipal Health Commission)

(II) Strengthen the Attraction and Development of Innovative Talent

Leveraging the brand influence of "Haiju Yingcai," we will implement a high-end technical talent evaluation program specifically for the cell therapy industry, actively attracting top-tier professionals to join our ranks. We will proactively recommend key institutions in the cell therapy sector to be included in the city’s priority list for talent recruitment, while also supporting eligible overseas talents with relevant cell therapy experience to apply for household registration under the policies designed for returning overseas students. Talents who have overseas work experience in cell therapy-related fields can similarly benefit from these favorable settlement policies. Additionally, we will provide policy support and assistance to ensure smooth access to education and residency visas for the children of high-level talents. Furthermore, we will strengthen existing talent programs like "Qimingxing" and "Discipline Leaders" to better support cell therapy-related professionals. To foster innovation and entrepreneurship, we’ll launch specialized initiatives such as the "Cell Therapy Industry Elite" program, focusing on cultivating pioneering leaders and nurturing young talent in this dynamic field. Finally, we’ll innovate talent development approaches by establishing cutting-edge education and training facilities dedicated to cell therapy, creating world-class clinical training centers, and deepening collaboration between academia, industry, and medical institutions—ultimately producing versatile, highly skilled professionals ready to drive advancements in the sector.

(III) Strengthen Financial Support

Leverage the guiding role of government investment funds such as the Shanghai Biopharmaceutical Industry Equity Investment Fund to significantly boost support for early-stage and growth-stage cell therapy companies. Increase credit allocations to cell therapy firms, encouraging banks in Shanghai to launch more tailored financial service products specifically designed for this sector, including initiatives like the "New Drug Loan" program adapted for cell therapy applications. Further deepen the "Pujiang Light" initiative, actively facilitating the listing of cell therapy-related companies on domestic and international capital markets, such as the STAR Market, while providing targeted support and incentives. Strengthen collaboration between securities firms and other financial institutions to enhance their underwriting and advisory services for high-quality cell therapy companies seeking public market access. Additionally, encourage and guide private capital to flow into the cell therapy sector, fostering strategic mergers and acquisitions to accelerate industrial upgrading, expand the scale of innovative enterprises, and help them achieve sustained growth and global competitiveness.