Nanjing issues document: Establishing a Pilot Demonstration Zone for New Medicine and the Life Sciences Industry, and advancing pilot initiatives in stem-cell therapy.


来源:Nanjing Municipal People's Government Official Website

2020-09-09

Focusing on establishing a landmark for the emerging pharmaceuticals and life sciences industries, we will champion integrated development to foster deep cross-sectoral synergies spanning "pharmaceuticals, healthcare, medical devices, health IT, medical care & wellness, and sports & fitness," thereby creating a robust industry ecosystem centered around life sciences. We will also embrace distinctive growth strategies, prioritizing cutting-edge fields such as innovative drugs, medical equipment, cell engineering, and gene technologies, to build a premier industrial hub with a strong emphasis on the cell and gene sector. Moreover, we will drive innovation by developing comprehensive public platforms that cover the entire R&D value chain, ensuring an innovation system powered by breakthroughs in critical technologies. Finally, we will promote cluster-based development, strategically positioning complementary and differentiated industry clusters to cultivate a unified brand that highlights regional identity and excellence. Together, these initiatives will propel our city’s pharmaceuticals and life sciences industries toward high-end, clustered, and internationalized growth—ultimately solidifying its position as a world-class, domestically leading hub for the new pharmaceuticals and life sciences sectors.

The Action Plan explicitly states: "Strengthen the construction of the pilot demonstration zone. Leveraging the Nanjing Area of the Pilot Free Trade Zone, establish a pilot demonstration zone for the new pharmaceuticals and life sciences industries, and actively seek support from the National Health Commission to advance pioneering trials in stem-cell therapy."

Here's the excerpt related to cell therapy:

Transform Nanjing into a globally leading center for innovative new pharmaceuticals, a world-renowned hub for the cell and gene industry, a uniquely vibrant cluster for medical and healthcare services, and a first-class domestic destination for rehabilitation and elderly care.

Stick to distinctive development, focusing on key areas such as innovative drugs, medical devices, cell engineering, and gene technology, to build an industry summit centered around the cell and gene sector.

Focus on developing the cell and gene industry, with key areas including cell storage, cell technology R&D, immune cell therapy, stem cell treatment, gene sequencing, gene editing, gene-engineered drugs, gene therapy, gene chips, and gene-based big data applications.

Develop cell and gene therapies, along with liquid biopsy technologies, and advance the standardized and regulated application of innovative, personalized biotherapeutic products.

By integrating the upstream and downstream sectors of the cell therapy industry, we can create a self-sustaining industrial ecosystem, fostering two-way collaborations among companies, between companies and hospitals, and between companies and research institutions—ultimately accelerating the rapid commercialization of cell therapies.

Building a high-end platform for the industry. Focusing on the innovation needs of the cell industry, we will establish "One Database and Four Centers" (a comprehensive human immune cell/stem cell library, a cell quality testing center, a cell preparation center, a cell clinical technology network service center, and an enterprise incubation center).

The full text is as follows:

Notice from the General Office of the Municipal Government on Issuing the Action Plan for Building Nanjing into a Leading Hub for New Medicine and Life Science Industries

To the People's Governments of all districts, the Municipal Government Departments and Commissions, and all directly affiliated units of the city:

With the approval of the municipal government, we are now issuing the "Nanjing Action Plan for Building a Leading Hub in the New Medicine and Life Sciences Industries." Please ensure thorough implementation.

Nanjing Municipal People's Government General Office

(This document is released for public distribution.)

Nanjing City Launches Action Plan to Establish a Leading Hub for New Medicine and the Life Sciences Industry

To put the new development philosophy into practice and deeply implement General Secretary Xi Jinping’s important instruction to "place people’s health at the forefront of our development strategy," we will align with the Municipal Party Committee and Government’s “Four New Initiatives” plan. Leveraging the city’s “4+4+1” leading industrial system, we will attract global resources and key elements from the emerging pharmaceuticals and life sciences sectors, aiming to establish Nanjing as the province’s premier, one of the top three nationally, and a globally influential industry hub. Our vision is to transform Nanjing into a world-leading center for innovative pharmaceutical development, a globally renowned stronghold for the cell and gene industries, a uniquely distinctive cluster for medical and healthcare services, and a first-class domestic destination for rehabilitation and elderly care—thus outlining the following action plan.

I. Overall Requirements and Objectives

(1) General Requirements

Focusing on establishing a landmark for the new pharmaceuticals and life sciences industries, we will uphold integrated development to foster deep synergy across sectors including "pharmaceuticals, healthcare, medical devices, health IT, medical care & wellness, and sports & fitness," thereby creating a robust industry ecosystem centered around life sciences. We will also embrace distinctive growth strategies, concentrating on cutting-edge areas such as innovative drugs, medical equipment, cell engineering, and gene technologies, to build a premier industrial hub with a strong emphasis on the cell and gene sector. Furthermore, we will champion innovation by developing comprehensive public platforms that span the entire R&D value chain, ensuring an innovation system driven by breakthroughs in critical technologies. Finally, we will promote cluster-based development, strategically positioning complementary and differentiated industry clusters to cultivate a unified brand that highlights regional identity and excellence. Together, these efforts will propel our city’s new pharmaceuticals and life sciences industries toward高端化 (high-end), 集聚化 (clustered), and 国际化 (internationalized) growth, ultimately establishing it as a world-class, domestically leading hub for the new pharmaceuticals and life sciences sectors.

(II) Main Objectives

By 2022, the city’s new pharmaceuticals and life sciences industry had surpassed 320 billion yuan in scale. The city’s biopharmaceutical industry ranked among the top five nationwide in overall innovation strength. More than 50 innovative drug applications have been submitted for clinical trials, and five companies have achieved annual sales revenues exceeding 5 billion yuan. Meanwhile, the development of the cell and gene therapy sector has significantly advanced, while health-related industries—such as medical care, healthcare integration, and sports-medicine convergence—are rapidly expanding. As a result, the new pharmaceuticals and life sciences industry has become a key driving force behind the city’s sustained economic and social growth.

By 2025, the city's new pharmaceuticals and life sciences industry is expected to surpass 540 billion yuan in scale. The city’s biopharmaceutical sector has firmly established itself among the top three nationwide in terms of overall innovation capability. To date, more than 100 innovative drug applications have been submitted for clinical trials, while five companies have achieved annual sales exceeding 10 billion yuan, and 10 companies have surpassed 5 billion yuan in revenue. Meanwhile, the city leads the nation in the cell and gene therapy industry, fostering a cluster of renowned domestic and international enterprises, flagship products, premier industrial parks (districts), and esteemed experts and institutions. As a result, Nanjing City’s new pharmaceuticals and life sciences industry has risen to become one of the country’s leading players.

II. Primary Focus Areas

(1) Pharmaceuticals: Develop the cell and gene industries, with a focus on advancing cell storage, cell technology R&D, immune cell therapy, stem cell treatments, gene sequencing, gene editing, gene-engineered drugs, gene therapies, gene chips, and gene-based big data solutions. Additionally, strengthen biopharmaceuticals by breaking through key core technologies in the development of innovative biotherapeutic products and biotech-based drug creation. This includes pioneering the production of novel biological medicines such as nucleic acids, antibodies, and vaccines, with an emphasis on attracting and nurturing high-quality, long-acting recombinant protein and peptide drug projects. Accelerate their commercialization and rapidly scale up production. Furthermore, foster innovation in chemical pharmaceuticals by overcoming critical technological hurdles in areas like lead compound optimization, drug polymorph research, and advanced drug formulation techniques. Intensify efforts to develop original, first-in-class drugs based on new molecular structures, novel targets, and groundbreaking mechanisms, ultimately bringing a pipeline of innovative and improved new medications to market. Lastly, advance modern traditional Chinese medicine (TCM) by accelerating the development of cutting-edge TCM innovations that deliver exceptional therapeutic efficacy, as well as enhancing the research and clinical application of improved TCM formulations with distinct clinical advantages. (Responsible Units: Municipal Bureau of Industry and Information Technology, Municipal Bureau of Science and Technology, Municipal Health Commission, Municipal Healthcare Security Bureau, Municipal Bureau of Commerce, Jiangbei New Area, and all relevant districts)

(2) Medical Engineering. Promote the development of advanced medical devices, including medical imaging equipment, real-time surgical imaging systems, medical robots, home-based health monitoring and wellness tools, and wearable devices. Additionally, advance innovations in fully automated biochemical analyzers, protein immunoanalyzers, high-throughput gene sequencers, and five-part differential blood cell analyzers—key components for in vitro diagnostic equipment. Vigorously support the industrialization of IVD technologies such as POCT and molecular diagnostics. Meanwhile, focus on developing tissue engineering materials, cutting-edge implantable/interventional products, image-guided therapy systems, laser treatment devices, and next-generation medical dressings. These efforts aim to drive a comprehensive transformation of the medical device industry toward innovation-driven growth. (Responsible Units: Municipal Bureau of Industry and Information Technology, Municipal Bureau of Science and Technology, Municipal Health Commission, Municipal Healthcare Security Bureau, Jiangbei New Area, Gaochun District, and other relevant districts.)

——Cell Engineering Base. Leveraging Jiangning District, this base fully capitalizes on the innovative resources and talent advantages of universities such as China Pharmaceutical University and Nanjing Medical University. With a distinctive focus on integrated university-local development, it is accelerating the construction of a comprehensive, end-to-end industry chain—from cell storage and core reagent development to cell culture media product innovation, clinical research, and ultimately, practical applications. By seamlessly connecting the upstream and downstream segments of the cell therapy value chain, the base aims to create a self-sustaining industrial loop, fostering **two-way collaboration** among enterprises, hospitals, and research institutions, and driving the rapid commercialization of cell-based therapies. (Responsible Units: Jiangning District, Municipal Planning and Natural Resources Bureau, Municipal Industry and Information Technology Bureau, Municipal Science and Technology Bureau, Municipal Market Supervision Administration, Municipal Ecology and Environment Bureau, Municipal Health Commission, Municipal Healthcare Security Bureau)

— Public Health Supplies Production Base. Leveraging the strengths of Gaochun District and Lishui District, we will establish a public health emergency supplies production system to support the manufacturing of essential medical protective gear. By fully harnessing the technological advantages of big data, artificial intelligence, and flexible manufacturing, we’ll empower enterprises to develop and produce core medical products such as basic healthcare items for household use and emergency protective equipment. Additionally, we’ll encourage companies to innovate and scale up the production of medical防护 devices and rapid-testing solutions tailored for responding to public health emergencies. This initiative will also drive the upgrade of flexible manufacturing capabilities, enabling businesses to actively pivot toward and expand production of critical protective equipment. (Responsible Units: Gaochun District, Lishui District, Municipal Development and Reform Commission, Municipal Science and Technology Bureau, Municipal Industry and Information Technology Bureau, Municipal Health Commission, Municipal Market Supervision Administration, Municipal Medical Insurance Bureau, Municipal Commerce Bureau)

(5) Healthcare and Elderly Care. Accelerate the development of the elderly care industry by fostering a group of socialized, comprehensive elderly care service providers. Enhance the aging health support system, promote research and manufacturing of senior-oriented products, and develop innovative financial services—such as wealth management, credit solutions, and insurance—tailored to the unique needs of seniors and other special populations. Additionally, support the growth of new health insurance offerings and encourage the integrated development of health insurance with health services. Furthermore, drive advancements in the rehabilitation sector by supporting businesses in creating functional compensatory devices, rehabilitation training tools, and cutting-edge smart assistive technologies equipped with features like flexible control, multi-sensor data fusion, motion information decoding, and advanced environmental awareness capabilities. Lastly, expedite the growth of wellness and preventive healthcare initiatives. In response to market demands related to sub-health conditions, chronic illnesses, allergies, and metabolic disorders, focus on developing and producing high-quality health foods, functional foods, cosmetics designed for specific purposes, and next-generation health supplements.

(6) Medico-Physical Integration. Support social entities in establishing a large number of health management institutions that combine physical activity with medical expertise, focusing on science-based fitness programs. These institutions will promote integrated health services centered around chronic disease prevention, sports rehabilitation, and overall health promotion. Develop and implement a development plan prioritizing outdoor sports activities, while also encouraging the growth of consumer-driven fitness and leisure initiatives. Additionally, provide support for research, development, and industrialization of sports and fitness equipment, fostering collaboration between sports/fitness activities and manufacturing industries. (Responsible Units: Municipal Sports Bureau, Municipal Health Commission, Municipal Industry and Information Technology Bureau, Municipal Science and Technology Bureau, Municipal Market Supervision Administration, Jiangbei New Area, Lishui District, and other relevant districts.)

III. Main Tasks

(1) Optimize Industrial Planning and Layout

1. Building a World-Leading New Drug Innovation Hub

— Gene and Cell Engineering Hub. Leveraging the Jiangbei New Area and seizing the development opportunities presented by Nanjing’s section of the Jiangsu Free Trade Zone, this initiative focuses on establishing a comprehensive gene-based public service platform, building Nanjing’s integrated cell resource bank and cell preparation center, and creating a robust public service platform for new drug testing and a CDMO service platform tailored for biopharmaceuticals. The project will also strategically position itself in cutting-edge areas such as genetic testing, gene editing, antibody-based therapeutics, immune cell therapies, and targeted drug technologies. Centered around Gulou Hospital’s Jiangbei International Hospital, the hub aims to become a nationally recognized clinical research center, accelerating the concentration of influential domestic and international companies specializing in gene, cell, and innovative drug R&D and manufacturing. Ultimately, it seeks to establish itself as the country’s premier gene and cell engineering base. (Responsible Units: Jiangbei New Area, Municipal Bureau of Planning and Natural Resources, Municipal Bureau of Industry and Information Technology, Municipal Bureau of Science and Technology, Municipal Administration for Market Regulation, Municipal Bureau of Ecology and Environment, Municipal Health Commission, Municipal Healthcare Security Bureau)

——Cell Engineering Base. Leveraging Jiangning District, this base fully capitalizes on the innovative resources and talent advantages of universities such as China Pharmaceutical University and Nanjing Medical University. With a distinctive focus on integrated university-local development, it is accelerating the construction of a comprehensive, end-to-end industry chain—from cell storage and core reagent development to cell culture media product innovation, clinical research, and ultimately, practical applications. By seamlessly connecting the upstream and downstream segments of the cell therapy value chain, the base aims to create a self-sustaining industrial loop, fostering双向 collaboration among enterprises, hospitals, and research institutions, and driving the rapid commercialization of cell-based therapies. (Responsible Units: Jiangning District, Municipal Planning and Natural Resources Bureau, Municipal Industry and Information Technology Bureau, Municipal Science and Technology Bureau, Municipal Market Supervision Administration, Municipal Ecology and Environment Bureau, Municipal Health Commission, Municipal Healthcare Security Bureau)

— New Drug Development Hub. Leveraging the strengths of Qixia District and Nanjing Economic & Technological Development Zone, this initiative fully capitalizes on the innovative resources and talent advantages of Nanjing University and Nanjing University of Traditional Chinese Medicine. It promotes collaborative innovation among industry, academia, and research institutions, establishes a shared public technology platform, and drives synergistic industrial development between Qixia District and the Economic Development Zone, ultimately positioning the region as a premier hub for innovative drug research and development. (Responsible Units: Qixia District, Nanjing Economic & Technological Development Zone, Municipal Bureau of Planning and Natural Resources, Municipal Bureau of Industry and Information Technology, Municipal Bureau of Science and Technology, Municipal Bureau of Market Supervision, Municipal Bureau of Ecology and Environment, Municipal Health Commission, Municipal Healthcare Security Bureau)

— Medical Engineering Hub. Leveraging Gaochun District, the hub will establish seven key platforms, including the Gaochun Branch of the Provincial Medical Device Testing Institute, a Medical Device Innovation Service Center, and the Big Data Monitoring Center of the Southern Pharmaceutical Economic Research Institute under the National Medical Products Administration. These platforms will focus on advancing cutting-edge, high-value-added medical devices such as in vitro diagnostic products, high-value consumables, and rehabilitation equipment, as well as public health emergency protection supplies, ultimately positioning the area as an innovative medical engineering base for the entire city. (Responsible Units: Gaochun District, Municipal Bureau of Planning and Natural Resources, Municipal Bureau of Industry and Information Technology, Municipal Bureau of Science and Technology, Municipal Market Supervision Administration, Municipal Bureau of Ecology and Environment, Municipal Health Commission, Municipal Healthcare Security Bureau)

——A Core Raw Materials Hub. Leveraging the Jiangbei New Area New Materials Science and Technology Park, we will advance the research, development, and production of active pharmaceutical ingredients (APIs), biomedical materials, and high-end reagents. This initiative aims to establish an industrial ecosystem centered on specialized API manufacturing, complemented by large-scale API production, while also serving as a platform for R&D incubation tailored to the biopharmaceutical and biomaterials industries. The hub will meet the API needs of our city’s key pharmaceutical companies, particularly for innovative drugs and first-to-market generics. Additionally, it will focus on developing the Taizhong Bio-Reagent Industry Cluster under the New Industry Group, positioning it as a leading base for upstream critical raw materials—including enzymes, monoclonal antibodies, cytokines, and other essential components—essential for the production of antibody drugs, recombinant protein therapies, and diagnostic reagents. (Responsible Entities: Jiangbei New Area, New Industry Group, Municipal Bureau of Planning and Natural Resources, Municipal Bureau of Industry and Information Technology, Municipal Bureau of Science and Technology, Municipal Administration for Market Regulation, Municipal Bureau of Ecology and Environment, Municipal Health Commission, Municipal Healthcare Security Bureau)

— Public Health Supplies Production Base. Leveraging the strengths of Gaochun District and Lishui District, we will establish a public health emergency supplies production system to support the manufacturing of essential medical protective gear. By fully harnessing the technological advantages of big data, artificial intelligence, and flexible manufacturing, we’ll empower enterprises to develop and produce core medical products such as basic healthcare items for household use and emergency protective equipment. Additionally, we’ll encourage companies to innovate and scale up the production of medical防护 devices and rapid-testing solutions tailored for responding to public health emergencies. This initiative will also drive the upgrade of flexible manufacturing capabilities, enabling businesses to actively pivot toward and expand production of critical protective equipment. (Responsible Units: Gaochun District, Lishui District, Municipal Development and Reform Commission, Municipal Science and Technology Bureau, Municipal Industry and Information Technology Bureau, Municipal Health Commission, Municipal Market Supervision Administration, Municipal Medical Insurance Bureau, Municipal Commerce Bureau)

—Precision Medicine Center. Leveraging the Jiangbei New Area International Life Health City and anchored by the Jiangbei International Branch of Gulou Hospital, the center focuses on specialized fields such as women’s and children’s health, ophthalmology, geriatrics, and oncology. It aims to attract world-class international specialty hospitals like the Joslin Diabetes Center and the Sino-German Geriatric Hospital, establishing a new hub for comprehensive diagnostics and cutting-edge treatment of complex medical cases. The center will also introduce innovative healthcare models, including physician groups, shared medical services, and integrative medicine, to consolidate top-tier medical resources across the board and position itself as a provincial leader in healthcare delivery. Furthermore, it will promote integrated development across "medical care, education, research, rehabilitation, and wellness," while partnering with premier international elderly care operators to advance community-based and home-care initiatives, ultimately creating a distinctive, high-end养老 experience that sets a benchmark for excellence.Leveraging opportunities for international academic collaboration and co-building partnerships, the center will establish itself as a pioneering hub for advanced medical services, an international specialist care center, and a comprehensive health service provider—delivering a robust, full-lifecycle, high-quality health management system. Additionally, local state-owned enterprises will be encouraged to participate in capital-driven projects, supporting the development of medical consortia, integrated healthcare platforms, and third-party diagnostic centers. (Responsible Units: Jiangbei New Area, Municipal Health Commission, Municipal Medical Insurance Bureau, Municipal Industry and Information Technology Bureau, Municipal Science and Technology Bureau, Municipal Market Supervision Administration, Municipal Planning and Natural Resources Bureau, Municipal Ecology and Environment Bureau)

2. Building a uniquely-featured hub for medical and healthcare services

——Precision Medicine Center. Leveraging the Jiangbei New Area International Life Health City and anchored by the Jiangbei International Branch of Gulou Hospital, the center focuses on specialized fields such as women’s and children’s health, ophthalmology, geriatrics, and oncology. It aims to attract world-class international specialty hospitals like the Joslin Diabetes Center and the Sino-German Geriatric Hospital, establishing a new hub for comprehensive diagnostics and cutting-edge treatment of complex medical cases. The center will also introduce innovative healthcare models, including physician groups, shared medical services, and integrative medicine, to consolidate top-tier medical resources across the board and position itself as a provincial leader in healthcare delivery. Furthermore, it will promote integrated development across "medical care, education, research, rehabilitation, and wellness," while partnering with premier international elderly care operators to advance community-based and home-care initiatives, ultimately creating a distinctive, high-end养老 experience that sets a benchmark for excellence. Taking advantage of opportunities for international academic collaboration and co-building partnerships, the center will establish itself as a pioneering hub for advanced medical services, an international specialist care center, and a comprehensive health service provider—delivering a robust, full-lifecycle, high-quality health management system. Additionally, local state-owned enterprises will be encouraged to engage in capital-driven projects, supporting the development of medical consortia, integrated healthcare platforms, and third-party diagnostic centers. (Responsible Units: Jiangbei New Area, Municipal Health Commission, Municipal Medical Insurance Bureau, Municipal Industry and Information Technology Bureau, Municipal Science and Technology Bureau, Municipal Market Supervision Administration, Municipal Planning and Natural Resources Bureau, Municipal Ecology and Environment Bureau)

——A Leading Center for Traditional Chinese Medicine Diagnosis and Treatment. Built around the core facilities of Nanjing University of Traditional Chinese Medicine’s National Medicine Hall and the Provincial Hospital of Traditional Chinese Medicine, this center brings together renowned TCM experts and National Masters of Medicine from across China. It has established a specialized TCM service zone that primarily focuses on TCM diagnosis and treatment, as well as herbal medicine-based wellness practices, while also offering complementary specialties such as rehabilitation therapy, chronic disease management, reproductive health care, oncology treatments, infectious disease care, and mental health services. (Responsible Units: Qinhuai District, Gulou District, Municipal Health Commission, Municipal Medical Insurance Bureau, Municipal Industry and Information Technology Bureau, Municipal Science and Technology Bureau, Municipal Market Supervision Administration, Municipal Planning and Natural Resources Bureau, Municipal Ecology and Environment Bureau)

3. Building a first-class health and wellness destination in China

——A Demonstration Base for Healthy Aging. Leveraging the Li Shui and Jiang Ning districts, this initiative aims to pioneer a new integrated model of medical, elderly care, rehabilitation, and nursing services, positioning itself as world-class while remaining a national leader. Taking key projects such as Jiangsu Provincial Rehabilitation Hospital, Nanjing Elderly Care Center, the Jingqiao Health & Wellness Industry Core Zone, and the Suhao Tangshan Health & Wellness Town as opportunities, the project will accelerate the development of health and wellness services. It will also intensify efforts to attract businesses specializing in health foods, cosmetics for special purposes, and innovative health products, fostering the establishment of a cluster of leading rehabilitation, elderly care, and wellness enterprises. Ultimately, the goal is to rapidly build the world’s largest, most comprehensive, and technologically advanced health and wellness demonstration base. (Responsible Units: Li Shui District, Jiang Ning District, Municipal Civil Affairs Bureau, Municipal Health Commission, Municipal Science and Technology Bureau, Municipal Market Supervision Administration, Municipal Planning and Natural Resources Bureau, Municipal Ecology and Environment Bureau, Municipal Medical Insurance Bureau)

— The Health and Sports Industry Base. Leveraging the Li Shui District, this initiative will tap into Nanjing’s rich sports resources, providing strong support for the "Li Shui National Sports Industry Demonstration Base." It aims to foster collaboration across manufacturing sectors, establishing Li Shui as a hub for advanced sports manufacturing and serving as a flagship model for "Healthy China." The project will build five key R&D and manufacturing centers focused on badminton, soccer, basketball, rubber balls, and smart fitness equipment, while also striving to become a premier outdoor sports destination in the Yangtze River Delta region. (Responsible Units: Li Shui District, Municipal Sports Bureau, Municipal Health Commission, Municipal Science and Technology Bureau, Municipal Market Supervision Administration, Municipal Planning and Natural Resources Bureau, Municipal Ecology and Environment Bureau)

(II) Strengthen the Cultivation of Leading Enterprises

1. Attracting Leading Enterprises: Focusing on key areas of industrial development, we will concentrate resources and efforts to draw in a batch of major industrial projects that boast high visibility, strong growth potential, and excellent economic returns. We’ll actively encourage Fortune Global 500 companies, industry leaders ranked among the top 100, and unicorn firms to establish their headquarters or R&D centers, as well as set up production facilities in Nanjing. Additionally, we’ll proactively integrate into the Yangtze River Delta’s integrated development framework, strengthening resource alignment and industrial collaboration with cities like Shanghai and Beijing. By doing so, we aim to take on cutting-edge, advanced industrial projects and adopt a “case-by-case” approach for handling these significant initiatives. (Responsible Units: Jiangbei New Area, Jiangning District, Qixia District, Gaochun District, Lishui District, Municipal Investment Promotion Bureau, Municipal Industry and Information Technology Bureau, Municipal Science and Technology Bureau, Municipal Finance Bureau, Municipal Development and Reform Commission, Municipal Ecology and Environment Bureau)

2. Supporting Enterprise Innovation: We will provide support for enterprises engaged in the research, development, and commercialization of innovative drugs and cutting-edge medical devices. Specifically, financial incentives will be awarded at key stages—such as Phase I, II, and III clinical trials—for newly registered Class 1 and Class 2 drugs, as well as biosimilar products. Additionally, funding support will be provided to new drug projects that receive production approvals and are subsequently commercialized within the city, based on product type and investment scale. Incentives will also be granted to projects that successfully obtain registration certificates for Class II and Class III medical devices and proceed with local industrialization. Furthermore, rewards will be offered to initiatives developing innovative health products, dietary supplements, rehabilitation aids, and other items that achieve medical rehabilitation application qualifications and are subsequently manufactured locally. Moreover, enterprises whose generic drugs pass the National Four Categories of Drugs Quality and Efficacy Consistency Evaluation will receive corresponding rewards. Finally, financial assistance will be provided to pharmaceuticals and medical devices that secure clinical trial approvals or overseas market authorization from prestigious regulatory bodies such as the U.S. Food and Drug Administration, the European Medicines Agency, and Japan’s Pharmaceuticals and Medical Devices Agency. (Responsible Units: Municipal Bureau of Industry and Information Technology, Municipal Bureau of Science and Technology, Municipal Bureau of Finance, Municipal Administration for Market Regulation, Municipal Development and Reform Commission, Municipal Health Commission, Municipal Healthcare Security Bureau)

3. Promote mergers and acquisitions as well as corporate restructuring. Focus on key sectors, establish a list of leading enterprises to nurture, and annually select 30 companies as potential industry leaders for prioritized development. Selected enterprises will receive tailored financial and policy support through a "one-company, one-policy" approach. Encourage our city’s core enterprises to pursue mergers and restructurings—vertically by targeting critical links in the industrial chain and cutting-edge technologies, enabling high-end acquisitions and strategic partnerships among industry giants; and horizontally by accelerating the clustering of complementary business types, particularly by acquiring R&D-focused firms that hold pioneering technologies and innovative product portfolios, thereby creating growth engines for further expansion of these industry leaders. Additionally, enhance financial support for corporate M&A activities through measures such as merger loans and convertible bonds, while encouraging diverse investors—including private equity funds, venture capital funds, and industry investment funds—to actively participate in enterprise mergers and restructurings.

(III) Enhance the Industry Development Platform

1. Build a high-end industry platform. Focusing on the innovation needs of the cell industry, establish a "One Database and Four Centers" infrastructure (including a Comprehensive Cell Bank for Human Immune Cells and Stem Cells, a Cell Quality Testing Center, a Cell Preparation Center, a Clinical Technology Network Service Center, and an Enterprise Incubation Center). Additionally, to support innovative drug development, create platforms for new drug screening, clinical evaluation, raw material synthesis, pilot-scale production, and process scaling-up. These initiatives will help companies build high-standard, shared manufacturing facilities and provide CMO/CDMO services, fostering industrial clustering and delivering robust R&D and innovation support to businesses. (Responsible Units: Jiangning District, Jiangbei New Area, Municipal Science and Technology Bureau, Municipal Industry and Information Technology Bureau, Municipal Market Supervision Administration, and other relevant districts.)

2. Open up established technology platforms. Promote the public availability of resources from university, research institution, and large enterprise service platforms—including the National Health and Medical Big Data Center (Nanjing), the National Genetic Engineering Mouse Resource Bank, the Multifunctional Stem Cell Bank, the State Key Laboratory of Natural Drug Active Components and Pharmacological Efficacy at China Pharmaceutical University, the State Key Laboratory of Pharmaceutical Biotechnology at Nanjing University, the State Key Laboratory of Translational Medicine and Innovative Drugs at CSPC Pharmaceutical Group, the Science and Technology Industrial Base for Modernization of Traditional Chinese Medicine, and the Nanjing Jiangbei New Area Biomedical Public Service Platform—enabling city-wide sharing of platform resources. (Responsible Units: Municipal Science and Technology Bureau, Municipal Industry and Information Technology Bureau, Jiangbei New Area, and all relevant districts)

3. Establish a Clinical Drug Research Center. Focus on supporting institutions such as Gulou Hospital’s Jiangbei International Hospital, Hengrui Nanjing’s Innovative Drug Clinical Research and Medical Translation Center, and others in building clinical drug research centers that meet international standards. These centers will feature fully functional, state-of-the-art facilities compliant with GCP guidelines, ensuring they are internationally recognized, highly specialized, and智能化 (intelligent) research-oriented wards. Additionally, establish mechanisms to streamline clinical trial processes, accelerate the prioritized entry of innovative drugs and medical devices developed locally into clinical trials at city-based medical institutions, and provide financial support to companies conducting clinical trials in local healthcare facilities.

4. Establish a Clinical Bio-sample Repository. Aiming for international accreditation in sample bank quality assessment, we will build a regionally integrated, multi-center clinical bio-sample resource-sharing platform that leverages expertise in major disease-specific resources. This platform will support cutting-edge research in cell biology, molecular biology, molecular pathology, genomics, and proteomics, enabling the development of innovative diagnostic and therapeutic strategies for disease prediction, early diagnosis, molecular subtyping, personalized treatment, and prognosis evaluation. Additionally, we will conduct large-scale validation studies on drug sensitivity and specificity to enhance the efficiency of drug screening and accelerate the timeline for new drug development. Finally, leveraging genomic insights from bio-samples, we will create advanced molecular profiling tools to guide personalized treatment approaches for various diseases.

5. Establish an industry exchange platform. Annually host the "Nanjing New Medicine and Life Sciences Industry Summit," fully leveraging Nanjing's robust resources in industrial economic cooperation and exchanges. Relying on platforms such as Nanjing Innovation Week, the Golden Autumn Economic & Trade Fair, the World Intelligent Manufacturing Conference, and the China International Software Expo, provide support for introducing, planning, and organizing international, national, and specialized biopharmaceutical industry exhibitions, summits, forums, and academic exchange events—along with corresponding subsidies. Additionally, support the establishment of biopharmaceutical industry associations and encourage internationally renowned associations to set up branch offices in Nanjing. Provide assistance to these associations through service procurement and other means to foster their growth.

6. Develop an R&D outsourcing platform. Foster a variety of R&D and service institutions in the emerging pharmaceutical and life sciences industries, encouraging R&D outsourcing companies to align fully with international standards. Accelerate the establishment of a market-driven, enterprise-led R&D ecosystem for pharmaceuticals and life sciences, integrating industry, academia, and research institutions. Support leading pharmaceutical contract development and manufacturing organizations in pioneering new integrated R&D-and-production models. Additionally, provide high-quality, internationally competitive services in areas such as pharmaceutical research, preclinical safety evaluations, clinical trials for innovative drugs, development and industrialization of novel drug manufacturing processes, and large-scale contract manufacturing of existing marketed drugs. (Responsible Units: Municipal Science and Technology Bureau, Municipal Industry and Information Technology Bureau, Municipal Finance Bureau, Municipal Health Commission, Municipal Medical Insurance Bureau, Jiangbei New Area, and all relevant districts)

( 4) Strengthen support for scientific and technological innovation

1. Attract top-tier talent. Leveraging key talent initiatives such as the "Entrepreneurial Nanjing" Talent Program, the "345" Overseas High-Level Talent Recruitment Plan, and the "Enterprise Expert Studio Development" project, we will recruit and cultivate a group of elite professionals and innovative entrepreneurial teams in the fields of new medicine and life sciences. Newly recruited talents will benefit from the city’s comprehensive policies supporting housing, financial incentives, and career development. Additionally, we will support the growth of relevant disciplines and programs in new medicine and life health at universities located in Nanjing. This includes establishing the Nanjing Biomedical Industry College at prestigious institutions like China Pharmaceutical University, Nanjing Medical University, Nanjing University, and Southeast University—fostering a targeted training system and jointly building cutting-edge talent incubation centers. To address the urgent need for advanced and versatile skilled professionals in areas such as biopharmaceutical process development, bioinformatics, medical AI, and healthcare big data, we will proactively build a strategic talent pipeline to meet future industry demands.

2. Strengthen technological innovation efforts. Focusing on high-tech enterprises and new R&D institutions, we will organize and conduct research on critical core technologies across key industries—including emerging biotechnology drugs like nucleic acids, antibodies, vaccines, and cell therapies—as well as medications for prevalent diseases such as cancer, cardiovascular and cerebrovascular conditions, and diabetes, alongside treatments for rare and serious illnesses like AIDS. Additionally, we’ll target cutting-edge medical devices. This initiative aims to tackle common industry challenges and resolve "bottleneck" technological issues. Each year, five major, high-priority technology projects will be selected and supported financially. (Responsible entities: Municipal Science and Technology Bureau, Municipal Finance Bureau, Municipal Industry and Information Technology Bureau, Municipal Health Commission, Municipal Medical Insurance Bureau, Jiangbei New Area, and all relevant districts.)

3. Strengthen collaborative innovation. Focusing on cutting-edge and emerging fields at the intersection of medicine and engineering—such as new drug development, medical devices, biomedical materials, regenerative medicine, and smart healthcare—establish a robust collaboration mechanism involving government, industry, academia, research institutions, finance, and healthcare providers. Leverage market-driven evaluation to encourage investment and financing organizations, as well as specialized agencies, to actively participate in project assessment and selection. Once approved by the science and technology authorities, each participating party will outline in a formal agreement the scale of their respective investments and the allocation of intellectual property rights. Projects that successfully advance toward industrialization within the city will receive targeted support. Furthermore, promote comprehensive integration and development between universities and local governments, as well as between academic institutions and industry partners. Accelerate the rapid translation of scientific and technological achievements from research institutes and medical facilities into practical applications. Encourage multi-party collaborations to co-build R&D laboratories, jointly train specialized talent, and motivate researchers to join local biopharmaceutical companies or even establish their own ventures.

4. Facilitate the translation of research into practical applications. Establish the Nanjing City Innovation and Transformation Project Guidance Fund, focusing on supporting major initiatives involving drugs, medical devices, medical consumables, and diagnostic reagents that demonstrate high clinical usage, strong market potential, significant room for improvement or replacement, and clear pathways toward domestic production. Encourage collaborative innovation among industry, academia, research institutions, and healthcare providers, prioritizing and providing financial support to projects jointly developed by medical institutions, universities, and enterprises. Additionally, promote theoretical research on technology transfer and foster innovative management practices, guiding healthcare organizations to establish robust systems for commercializing scientific and medical breakthroughs. Under the law, these institutions will be empowered with the rights to utilize, dispose of, and benefit from medical innovations. Furthermore, explore long-term, sustainable collaboration models involving medical research, industry, and finance, leveraging an "incubation + venture capital" service approach to deepen integration with businesses and private capital. This will help create seamless investment and financing channels, along with well-defined mechanisms for managing returns and ensuring smooth exits, ultimately building a direct pathway for the efficient transfer and commercialization of cutting-edge medical and scientific advancements. (Responsible Units: Municipal Health Commission, Municipal Science and Technology Bureau, Municipal Finance Bureau, Municipal Financial Regulatory Bureau, Municipal Industry and Information Technology Bureau, Municipal Market Supervision Administration, Jiangbei New Area, and all relevant districts)

(5) Optimize the Industrial Development Environment

1. Strengthen policy and institutional innovation. Seize the opportunities presented by the construction of the free trade pilot zone, amplifying the collaborative innovation effects between the Nanjing Area of China (Jiangsu) Pilot Free Trade Zone and various sectors within the city. Leveraging the unique characteristics of the new pharmaceuticals and life sciences industries, we will effectively utilize and adapt preferential policies and supportive measures in areas such as talent management, land use, taxation, customs, finance, trade, and service guarantees. This will drive forward targeted policy and institutional innovations, enabling the industry to achieve leapfrog growth. Additionally, we will expedite customs clearance for innovative drug R&D reagents, establish smooth pathways for domestic clinical trials of cutting-edge global therapies, streamline the negotiation and pricing processes for groundbreaking products, and ensure efficient logistics for transporting living cells and tissues. (Responsible Units: Municipal Bureau of Commerce, Municipal Development and Reform Commission, Municipal Bureau of Industry and Information Technology, Municipal Science and Technology Bureau, Municipal Finance Bureau, Municipal Health Commission, Municipal Healthcare Security Bureau, Municipal Market Supervision Administration, Municipal Party Committee Organization Department, Municipal Planning and Natural Resources Bureau, Municipal Taxation Bureau, Municipal Financial Regulatory Bureau, Jinling Customs, Municipal Ecology and Environment Bureau, Jiangbei New Area, and all relevant districts.)

2. Strengthen the development of the pilot demonstration zone. Leveraging the Nanjing area of the Free Trade Pilot Zone, establish a pioneering demonstration zone for the new pharmaceutical and life sciences industries. Actively seek support from the National Health Commission to advance pilot initiatives in stem-cell therapy. Additionally, proactively collaborate with the National Medical Products Administration to encourage medical institutions to conduct international multi-center clinical trials, enabling simultaneous participation with overseas partners in clinical studies for breakthrough treatments targeting major diseases. Furthermore, facilitate pilot programs allowing medical facilities to test and use small quantities of urgently needed imported drugs and medical devices under controlled conditions—clinical data generated from these trials can later be submitted as part of registration applications for imported medicines and medical devices. Finally, actively promote pilot programs for over-the-counter (OTC) drugs, including unmanned pharmacy trials.

3. Strengthen the promotion and application of innovative products. The Municipal Bureau of Industry and Information Technology, Municipal Health Commission, Municipal Healthcare Security Administration, Municipal Finance Bureau, and Municipal Science and Technology Bureau have jointly established a City-Level Promotion and Application Task Force for Biomedical Innovation Products in Hospitals. This task force will compile the "Nanjing City Core List of Biomedical Innovation Products" and issue it collectively to all medical institutions across the city. The Municipal Health Commission and the Municipal Healthcare Security Administration will provide guidance to healthcare facilities on adopting these new biomedical products. Meanwhile, the Municipal Health Commission, in collaboration with the Municipal Healthcare Security Administration and Finance Bureau, will develop implementation guidelines for evaluating and promoting the use of these innovative products in medical institutions. Within their respective responsibilities, the Municipal Healthcare Security Administration will incorporate the innovative products listed in that year’s "List" into the city’s medical insurance and procurement catalogs. Additionally, the administration will leverage the city-level Sunshine Supervision Platform for Pharmaceuticals and Medical Consumables to monitor and track the procurement and usage of these products across all local healthcare facilities. Regular reports will be shared publicly, and these metrics will also be factored into annual settlement assessments. The Municipal Science and Technology Bureau will support medical institutions that demonstrate outstanding performance in utilizing the biomedical innovation products listed in the "List," offering preferential treatment when they apply for project funding or are considered for awards. For any biomedical innovation products included in the "List," medical institutions are required to complete the procurement process within one month from the date the product is added to the provincial pharmaceutical procurement platform—streamlining the associated procedures. A dedicated "green channel" will be established to expedite approvals for these products, ensuring that factors such as drug review meetings, drug cost ratios, or limitations on the number of items in hospital formularies do not hinder the integration and use of the listed products. Finally, where clinical needs are met, healthcare providers are encouraged to prioritize the use of these new biomedical products over similar alternatives already available in the market. Medical institutions are also supported in providing real-world application scenarios for the city’s innovative pharmaceuticals and medical devices, thereby expanding the scope of clinical applications for these cutting-edge products. (Responsible Units: Municipal Bureau of Industry and Information Technology, Municipal Health Commission, Municipal Healthcare Security Administration, Municipal Finance Bureau, Municipal Science and Technology Bureau, Jiangbei New Area, and all relevant districts)

4. Strengthen innovation in the financial system. Attract domestic and international investment and financing institutions to establish operations in Nanjing, thereby broadening financing channels for companies in the new medicine and life sciences industries. Develop a multi-tiered equity investment fund ecosystem that spans early-stage R&D, project implementation, equity investments, new drug acquisitions, corporate mergers and acquisitions, and overseas expansion initiatives. Encourage the concentration and growth of angel investments, venture capital funds, and private equity investments tailored to the new medicine and life sciences sectors, offering eligible funds incentives such as establishment grants, capital increase rewards, investment awards, and risk compensation. Leverage the city- and district-level guiding funds—through mechanisms like initiating or co-investing in funds—to mobilize and attract diverse sources of social capital, fostering active participation across the board. Employ market-oriented operational strategies to guide the creation of a cluster of new medicine and life sciences industry-focused investment funds, with a total target scale of 20 billion yuan. Additionally, encourage financial institutions based in Nanjing to enhance their lending support for the new medicine and life sciences sectors, enabling them to develop specialized credit products and innovative collateral-based loan services aligned with the city’s industrial development priorities. Meanwhile, motivate insurance firms operating in Nanjing to introduce customized, comprehensive insurance solutions—such as product liability coverage—for the new medicine and life sciences industries, while also pioneering streamlined, fast-track claims processes specifically designed for this sector. (Responsible Units: Municipal Financial Regulatory Bureau, Municipal Finance Bureau, Municipal Industry and Information Technology Bureau, Municipal Science and Technology Bureau, Jiangbei New Area, Jianye District, and other relevant districts)

IV. Assurance Measures

(1) Organizational Leadership

Under the Leading Group for Industrial Landmark Development, a dedicated New Medicine and Life Health Task Force has been established. Co-chaired by leaders from the Municipal Party Committee and Municipal Government, the task force includes members from the Municipal Party Committee Organization Department, Municipal Development and Reform Commission, Municipal Science and Technology Bureau, Municipal Industry and Information Technology Bureau, Municipal Civil Affairs Bureau, Municipal Finance Bureau, Municipal Planning and Natural Resources Bureau, Municipal Ecology and Environment Bureau, Municipal Commerce Bureau, Municipal Investment Promotion Bureau, Municipal Health Commission, Municipal Market Supervision Administration, Municipal Sports Bureau, Municipal Statistics Bureau, Municipal Medical Insurance Bureau, and Municipal Financial Regulatory Bureau. The day-to-day coordination, organization, and oversight of the city’s new medicine and life health industry development initiatives are spearheaded by the Municipal Industry and Information Technology Bureau. This bureau is responsible for unifying resource allocation across the city, convening regular joint meetings, refining responsibility assignments based on each department’s specific industry focus, and ensuring that all districts (including development zones) and functional sectors effectively fulfill their local-level responsibilities while maintaining robust operational frameworks. (Responsible Units: Municipal Industry and Information Technology Bureau, Municipal Party Committee Organization Department, Municipal Development and Reform Commission, Municipal Science and Technology Bureau, Municipal Civil Affairs Bureau, Municipal Finance Bureau, Municipal Planning and Natural Resources Bureau, Municipal Ecology and Environment Bureau, Municipal Commerce Bureau, Municipal Investment Promotion Bureau, Municipal Health Commission, Municipal Market Supervision Administration, Municipal Sports Bureau, Municipal Statistics Bureau, Municipal Medical Insurance Bureau, Municipal Financial Regulatory Bureau, Jiangbei New Area, and all relevant districts.)

(II) Assessment and Evaluation

Establish an industry landmark promotion and assessment system, integrating it into the city’s comprehensive high-quality development evaluation framework. Tailored to the specific responsibilities and task characteristics of different departments and sectors, this system will seamlessly combine outcome-based metrics with process-oriented assessments. It will clearly define performance indicators and tasks for municipalities assessing districts, as well as for municipal departments evaluating their respective areas of responsibility. The approach will emphasize a balanced integration of routine and year-end evaluations, alongside qualitative assessments and quantitative scoring methods, ensuring that the evaluation process is both thorough and systematic. (Responsible Units: Municipal Bureau of Industry and Information Technology, Municipal Party Committee Organization Department, Municipal Development and Reform Commission, Municipal Science and Technology Bureau, Municipal Civil Affairs Bureau, Municipal Finance Bureau, Municipal Planning and Natural Resources Bureau, Municipal Ecology and Environment Bureau, Municipal Commerce Bureau, Municipal Investment Promotion Bureau, Municipal Health Commission, Municipal Market Supervision Administration, Municipal Sports Bureau, Municipal Statistics Bureau, Municipal Healthcare Security Bureau, Municipal Financial Regulatory Bureau, Jiangbei New Area, and all relevant districts.)

(III) Space Assurance

Under the premise of conforming to planning guidelines, prioritize the implementation of major projects in the new pharmaceuticals and life sciences industries. Support enterprises in making rational upgrades to factory facilities and infrastructure to expand their development space. While ensuring that industrial clusters maintain their core functions and uphold environmental quality standards, conduct environmental capacity assessments tailored to the unique positioning of each park, providing preferential treatment in environmental access policies. This will help guide project clustering and foster efficient utilization of environmental resources, ultimately driving sustainable industrial growth. (Responsible Units: Municipal Planning and Natural Resources Bureau, Municipal Ecology and Environment Bureau, Municipal Industry and Information Technology Bureau, Municipal Science and Technology Bureau, Jiangbei New Area, and all relevant districts)

(IV) Financial Support

Deeply implement fiscal support policies and effectively guide financial backing for key projects. Strengthen city-wide strategic coordination and significantly enhance policy and funding support for various industrial parks. Explore establishing specialized sub-funds within the existing government-guided investment fund framework, leveraging state-owned capital to attract private-sector investments, thereby boosting the vitality of market players and drawing in industry-focused venture capital funds and entrepreneurial investment institutions to back innovative pharmaceutical and life science initiatives. This will create a comprehensive, end-to-end capital support system tailored to these sectors. Meanwhile, Jiangbei New Area and all relevant districts should formulate targeted policies aimed at positioning their regions as premier hubs for the new pharmaceuticals and life sciences industries. (Responsible entities: Municipal Finance Bureau, Municipal Financial Regulatory Bureau, Municipal Industry and Information Technology Bureau, Municipal Science and Technology Bureau, Jiangbei New Area, and all relevant districts)