Original Title: Notice on the Issuance of the "Shanghai Action Plan for Promoting Innovation and Industrial Development in Gene Therapy (2023–2025)"
Shanghai Science and Technology Bureau Regulation [2023] No. 10
To All Relevant Units:
With the approval of the Municipal Government, we hereby issue the "Shanghai Action Plan for Promoting Innovation and Industrial Development in Gene Therapy (2023–2025)" to you. Please ensure its thorough implementation.
This notice is hereby issued.
Shanghai Municipal Science and Technology Commission
Shanghai Municipal Commission of Economy and Information Technology
Shanghai Municipal Health Commission
August 31, 2023
Shanghai Action Plan for Promoting Innovation and Industrial Development in Gene Therapy (2023–2025)
Cell and gene therapy represent a crucial “new frontier” in global scientific, technological, and industrial competition. To implement the “14th Five-Year Plan for Building Shanghai into a Globally Influential Center for Science and Technology Innovation” and to further carry out the “Shanghai Action Plan for Promoting Scientific and Technological Innovation and Industrial Development in Cell Therapy (2022–2024),” this Action Plan is hereby formulated to promote the coordinated development of gene therapy and cell therapy, and to accelerate the creation of a “breakthrough hub” for biomedical innovation and an “industrial cluster” for the sector.
I. Guiding Principles
Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, we will thoroughly implement the spirit of the 20th National Congress of the Communist Party of China. Grounded in the new stage of development, we will fully, accurately, and comprehensively implement the new development philosophy, build a new development paradigm, and promote high-quality development,we will consistently adhere to the “Four Orientations.” Given the characteristics of gene therapy—including its broad interdisciplinary scope, high barriers to technological development, numerous challenges in clinical application, and significant potential for industrial growth—we will prioritize both research and development as well as translation, and advance innovation and service in tandem. We will make every effort to achieve breakthroughs in key core technologies, enhance clinical research and translation capabilities, drive progress in production processes, and optimize the industrial development ecosystem, thereby comprehensively elevating Shanghai’s capacity to generate innovation in gene therapy and the level of its industrial development.
II. Basic Principles
— Uphold innovation as the driving force and strengthen strategic planning. Focusing on the global frontiers of science and technology, we will strengthen forward-looking planning for basic research, promote innovation in fundamental theories and methods, and enhance original innovation capabilities; focusing on the entire industrial chain, we will strengthen planning for the conquest of key core technologies, strive to achieve breakthroughs in a number of foundational technologies, and provide support for the creation of a batch of blockbuster innovative products.
— Adhere to full-chain development and strengthen the integration of the four chains. Establish a full-chain resource allocation mechanism to promote the deep integration of the innovation chain, industrial chain, capital chain, and talent chain; strengthen collaboration among industry, academia, research institutions, and medical institutions; facilitate a fast track for two-way links between basic research, applied research, and industrialization; promote the transformation and industrialization of innovation outcomes; and build a new framework for gene therapy innovation and industrial development.
— Adhere to an industry-oriented approach and strengthen policy support. Innovate institutional mechanisms to foster innovation sources and industrial development; improve the policy support system to promote the organic integration of an efficient market and an effective government; accelerate the aggregation of innovation factors such as talent, technology, and capital; and create a favorable industrial development ecosystem.
III. Main Objectives
By 2025, Shanghai’s capacity to generate gene therapy innovation will be further enhanced, clinical research and translation capabilities will be further improved, the innovation system will be further refined, and the industrial ecosystem will be further optimized. Shanghai will become a major hub for gene therapy innovation, providing new momentum for high-quality industrial development.
— Continuously enhance innovation capabilities. Establish and upgrade more than 20 gene therapy-related innovation bases and platforms (such as key laboratories and technology innovation centers), and basically form an independent and controllable gene therapy technology innovation system; generate a number of innovative achievements, and develop a set of key core technologies with independent intellectual property rights in fields such as gene editing and drug delivery.
— Clinical translation capabilities will continue to strengthen. We will establish more than five clinical medical research centers and model research wards in gene therapy and related fields; explore the establishment of specialized research hospitals focused on gene therapy; and secure more than five new clinical trial approvals.
— Industrial vitality continues to surge. Build and upgrade public service platforms for R&D, preparation, testing, pilot production, and manufacturing in gene therapy-related fields; attract and cultivate more than 15 leading and backbone enterprises in the gene therapy industry; and file for market approval of 1–2 innovative products.
IV. Major Tasks
(I) Enhancing Innovation Capabilities
1. Conduct forward-looking planning for basic research
Strengthen basic research in areas such as disease genetics and pathogenesis, gene editing, and drug delivery; identify new targets for gene therapy; explore new pathways for gene expression and regulation; study new strategies for targeted delivery; and develop new gene therapy methods for complex polygenic diseases such as cancer, neurological disorders, and cardiovascular diseases, thereby solidifying the scientific foundation for gene therapy drug innovation.
2. Tackling Key Core Technologies
Strengthen research in areas such as nucleic acid sequence design and synthesis, new gene manipulation tools (including gene editing), and novel drug delivery carriers. Promote the convergence of cutting-edge technologies—such as artificial intelligence and synthetic biology—with gene therapy-related technologies to achieve breakthroughs in core technologies. Establish an independent and controllable gene therapy technology innovation system to support high-quality industrial development.
3. Independently Develop Key Equipment and Materials
Strengthen research and development efforts on core equipment such as tangential flow filtration systems, high-pressure homogenizers for liposomes, and single-use bioreactors; key raw materials and supplies including viruses, nucleases, and small guide RNAs; as well as critical consumables such as serum-free culture media and filtration membranes. This will promote self-reliance and control over the gene therapy R&D and production supply chain.
(II) Enhancing Clinical Research and Translation Capabilities
4. Strengthen Clinical Research Capacity Building
Aligning with world-class standards, establish several clinical medical research centers in gene therapy and related fields to accelerate clinical research and translation; explore the establishment of specialized research hospitals and model research wards for gene therapy to facilitate clinical trials and product development of gene therapy drugs;Establish disease-specific cohorts for major diseases such as cancer, neurological disorders, and cardiovascular diseases; build an open-access cohort-sharing platform to advance gene therapy product development and technological breakthroughs; and encourage medical institutions to formulate relevant regulations to ensure the standardized conduct of clinical research.
5. Encouraging Medical Institutions to Conduct Clinical Research
Encourage local medical institutions to undertake projects in the field of gene therapy, including clinical trials for new drugs developed by local enterprises and investigator-initiated trials (IITs) conducted independently in accordance with relevant regulations. Upon completion of the relevant research, funding will be provided to medical institutions on a competitive basis at a rate of 50,000 yuan per enrolled participant, with a total funding cap of 500,000 yuan per project and a cumulative annual funding limit of 5 million yuan per institution.
6. Optimizing Ethical Review and Human Genetic Resource Approval Services
Leverage the role of the Municipal Hospital Ethics Committee Alliance to develop operational rules and standards for expedited ethics review and establish a mutual recognition mechanism for ethics review results among municipal hospitals. Fully utilize the Shanghai Medical Ethics Expert Committee and the Shanghai Clinical Research Ethics Committee to organize research, consultation, services, and training related to ethics in the field of gene therapy, thereby enhancing the ethics review capabilities of medical institutions.Leverage the role of the Shanghai Pudong Human Genetic Resources Management Service Station to strengthen the dissemination and implementation of the "Implementing Rules of the Regulations on the Management of Human Genetic Resources," promote the development of dedicated teams of human genetic resources specialists within gene therapy-related enterprises, and improve service quality.
(3) Enhancing Public Service Capabilities
7. Strengthen the Development of Science and Technology Innovation Bases
Establish the Shanghai Institute of Frontier Biotechnology to strengthen cutting-edge basic biological research and technological breakthroughs, and explore and implement new research paradigms such as AI-enabled approaches and Trial Ready Cohorts (TRC); build and upgrade innovation bases in the gene therapy sector, including key laboratories, technology innovation centers, and enterprise technology centers, to enhance innovation generation capabilities and the level of commercialization and application of research outcomes in the gene therapy sector and related fields.
8. Strengthen the Development of Specialized Incubators and Innovation Platforms
Develop and upgrade a batch of high-quality specialized incubators to foster new technologies and incubate new enterprises; establish functional platforms such as intelligent process R&D platforms, automated testing platforms, and modular pilot-scale scale-up platforms; build a service system for engineering functional platforms in gene therapy and related fields that complies with Good Manufacturing Practice (GMP) standards; accelerate proof-of-concept, product testing, and pilot-scale scale-up; shorten R&D, clinical, and production cycles; and further optimize the innovation and entrepreneurship ecosystem.
9. Strengthen the Development of Industrial Service Capabilities
Encourage market entities such as CROs and CDMOs to build and optimize third-party service platforms—including vector library screening, formulation filling, and product evaluation—based on the needs of gene therapy drug companies. Provide services such as viral vector library establishment and storage, formulation development and production, and gene therapy product quality evaluation to relevant entities, thereby enhancing industrial service capabilities.
(IV) Elevating the Level of Industrial Development
10. Strengthening the “1+1” Industrial Spatial Layout
Centered on the Pudong Zhangjiang Cell and Gene Industry Park and other key sites, build world-class gene industry landmarks and create a hub for gene therapy innovation and industrial development; leveraging parks such as the Minhang Pujiang Gene Future Valley, establish a demonstration zone for the gene therapy industrial chain that integrates R&D, testing, and manufacturing; and, in line with the needs of the gene therapy industry, strengthen the supporting public facilities and comprehensive service systems of industrial bases.
11. Optimizing the Business Development Ecosystem
Guide the clustering of upstream and downstream enterprises—including those in raw materials, reagents, delivery vectors, facilities and equipment, and R&D services—to foster a comprehensive and convenient industrial supply chain; establish industry-academia-research-investment alliances; accelerate the formulation and active promotion of standards in key areas such as raw materials, production and preparation, quality testing, and storage and transportation to enhance the standardization level of the industrial chain; and promote the construction of the Shanghai Innovation Biologics Quality Inspection and Testing Center to improve testing capabilities for relevant products.
12. Promoting the Internationalization of Enterprises
Under the premise of controllable risks, support qualified diversified investment entities in conducting human cell and gene technology R&D and advancing industrialization in accordance with relevant laws and regulations, promoting the coordinated development and deep integration of industrial and capital chains; support international exchanges and cooperation, deeply integrate with advanced international technologies and regulatory systems, and elevate the international development level of gene therapy enterprises.
V. Support Measures
(1) Establish the “Shanghai Major Special Project for Gene Therapy Science and Technology Innovation”
Targeting frontier biotechnology fields such as gene therapy, organize and implement innovation projects to advance basic research, clinical translation, and product development; innovate scientific theories and methods; and develop a portfolio of key core technologies and innovative products with independent intellectual property rights.
(2) Accelerating Product Review and Application
Fully leverage the role of the Yangtze River Delta Branch of the Drug Evaluation and Inspection Center under the National Medical Products Administration to provide pre- and during-process guidance and services for the registration applications of key gene therapy products under development in the city; explore the establishment of a scientific research base for gene therapy regulation to support the enhancement of product regulatory standards; encourage the conduct of real-world studies and explore the application of real-world data in the clinical evaluation of gene therapy drugs for rare diseases.
(3) Strengthen Intellectual Property Protection and Utilization
For international invention patents in the gene therapy field that have been applied for abroad via the PCT route, undergone substantive examination by relevant patent examination authorities, and been granted, subsidies will be provided covering 50% of official fees such as registration and examination fees, with a maximum of 20,000 yuan per patent and support for up to five countries or regions per PCT international application; support key enterprises in applying to become registered entities for the Shanghai Intellectual Property Protection Center’s fast-track preliminary examination service to improve the quality of patent applications and the speed of examination, thereby enhancing enterprises’ intellectual property protection and risk management capabilities.
(4) Strengthening Fiscal and Tax Policy Support
For gene therapy products that have already undergone clinical trials in China, obtained marketing authorization through a Shanghai-registered enterprise, and are manufactured in Shanghai, financial support of up to 30 million yuan will be provided, with a cumulative annual support limit of no more than 100 million yuan per entity; efforts will be made to include Shanghai’s gene therapy products in the “List of Anti-Cancer and Rare Disease Drugs Eligible for Value-Added Tax Policies” to effectively ensure patients’ access to medications.
(5) Improving Insurance Support Measures
Actively recommend eligible, marketed innovative gene therapy products for inclusion in the National Medical Insurance Drug Directory and explore diversified and composite payment methods; support the inclusion of gene therapy drugs for rare diseases and other fields in the coverage scope of public-benefit commercial health insurance programs such as “Shanghai Huibao”;Leverage the role of multi-tiered commercial health insurance to encourage local enterprises, commercial insurance companies, and medical institutions to explore innovative payment models such as installment payments and outcome-based payments; support medical institutions, enterprises, and other entities in purchasing liability insurance related to human clinical trials, providing a 50% fiscal subsidy on premiums for eligible entities, with a subsidy not exceeding 500,000 yuan per policy.
(6) Strengthen Financial Support
Effectively coordinate the use of government-guided funds, biopharmaceutical industry equity investment funds, and other resources to guide social capital in jointly increasing support for gene therapy enterprises in their start-up and growth phases; provide grants of up to 2% of the actual equity financing amount (calculated based on the actual amount received) to gene therapy enterprises that successfully secure equity financing of 50 million RMB or more, with an annual cap of 10 million RMB per enterprise;Encourage banks in Shanghai to launch more financial service products and support the application of initiatives such as the “New Drug Loan” program to the gene therapy sector; deepen the “Pujiang Light” initiative to support gene therapy-related enterprises in listing on domestic and international capital markets, including the STAR Market; strengthen listing services provided by securities firms and other financial institutions to high-quality gene therapy enterprises; and promote the return of outstanding gene therapy companies and other technology enterprises listed overseas to list on the STAR Market of the Shanghai Stock Exchange.
(7) Strengthening the Recruitment and Cultivation of Innovative Talent
Continue to leverage the influence of the “Hai Ju Yingcai” brand to vigorously attract high-end talent; implement an evaluation program for high-end technical talent in the gene therapy industry, and recommend key institutions in the gene therapy sector for inclusion on the list of priority talent recruitment organizations; increase support for gene therapy-related talent through specialized programs such as the “Qixingming” Program, Academic/Technical Leaders, and Industry Elites;Pilot engineering master’s and doctoral training programs in the gene therapy sector and explore new models for on-site corporate training of engineering master’s and doctoral candidates; encourage enterprises and institutions in the gene therapy sector to establish postdoctoral research stations or join postdoctoral innovation practice bases, support postdoctoral researchers in applying for Shanghai’s “Super Postdoctoral” program, and cultivate scientific research talent that meets industrial development needs; leverage relevant industrial platforms in the gene therapy sector to strengthen talent training and improve the development of enterprises’ professional technical talent teams.
(8) Facilitating Customs Clearance for R&D Materials and Special Items
Promote pilot programs for the import of R&D materials in the gene therapy sector and support the inclusion of relevant enterprises and R&D materials on the “whitelist”; advance pilot initiatives for a joint supervision mechanism for the import and export of special items in the gene therapy sector; support key enterprises in applying to become pilot units under the joint supervision mechanism; optimize approval processes for key raw materials and supplies used in gene therapy R&D and production; and expedite customs clearance procedures.
