Xiamen City Accelerates High-Quality Development of the Biopharmaceutical Industry


来源:Xiamen Municipal Government

2020-06-17

Biopharmaceutical companies are encouraged to adopt cutting-edge technologies, advanced equipment, innovative processes, and state-of-the-art materials to upgrade and modernize their existing production facilities, optimize process conditions, and enhance manufacturing environments. Additionally, biopharmaceutical firms are supported in launching信息化 (IT-driven) transformation initiatives. Eligible companies will receive subsidies for investments in technological upgrading equipment, as well as financial assistance through dedicated technology transformation funds. Specifically, the subsidy for equipment purchases—covering both the machinery itself (including related technology and software, but excluding taxes)—will amount to 10% of the total equipment expenditure, with a cap of up to RMB 10 million per project. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Bureau of Finance) To accelerate the high-quality development of Xiamen’s biopharmaceutical industry, the Xiamen Municipal Government has unveiled the "Several Measures to Accelerate the High-Quality Development of Xiamen’s Biopharmaceutical Industry," aimed at strengthening the biopharmaceutical industry chain—including its industrial, innovation, financial, talent, and service networks—while optimizing the broader ecosystem to foster a distinctive, nationally recognized biopharmaceutical industry cluster.

To the People's Governments of all districts, Municipal Commissions, Offices, and Bureaus, Management Committees of all Development Zones, and Relevant Organizations:

To accelerate the high-quality development of Xiamen's biopharmaceutical industry, we propose the following measures aimed at strengthening the biopharmaceutical industry chain—including enhancing its industrial, innovation, financial, talent, and service networks—while optimizing the overall ecosystem to foster a nationally recognized, distinctive biopharmaceutical industry cluster.

1. Enhance R&D and Innovation Capabilities

Increase investment in clinical research, accelerate the industrialization and certification of new products, optimize the allocation of innovation resources, support the development of innovative platforms and cutting-edge R&D institutions, and vigorously foster both independent innovation capabilities and enterprises' ability to establish sustainable roots—ultimately enhancing the industry's competitive edge in innovation.

(1) Support businesses in conducting research and development innovation. For innovative drugs, improved new drugs, and generic drugs that undergo clinical trials and are subsequently commercialized within the city, rewards will be provided in stages according to their R&D progress.

1. A one-time reward of 4 million yuan will be granted for completing preclinical studies of innovative drugs (Class 1 biologics, chemical drugs, and traditional Chinese medicines). For advancing to Phase I, II, and III clinical trials, one-time rewards of 5 million yuan, 10 million yuan, and 15 million yuan will be provided, respectively. Additionally, a one-time reward of 3 million yuan will be awarded for successfully completing clinical studies conducted overseas.

2. A one-time reward of 1 million yuan will be granted to those who complete preclinical studies for improved new drugs (including improved biologics, improved chemical drugs, and improved traditional Chinese medicines). Additionally, one-time rewards of 2 million yuan, 4 million yuan, and 8 million yuan will be provided upon completion of Phase I, Phase II, and Phase III clinical trials, respectively. An additional one-time reward of 2 million yuan will be given to projects that successfully complete clinical studies conducted overseas.

3. A one-time reward of 3 million yuan will be granted for each of the first three generic drugs nationwide that have passed the evaluation of quality and therapeutic equivalence. (Responsible units: Municipal Science and Technology Bureau, Municipal Finance Bureau)

(II) Supporting the Industrialization of Innovative Varieties

1. For drugs—including innovative medicines, improved new drugs, and generic drugs (covering biologics, chemical drugs, and traditional Chinese medicines)—that have obtained registration certificates and are commercialized for the first time in this city, a reward of RMB 10 million, RMB 5 million, or RMB 3 million will be granted per product category, respectively.

2. For Class II and Class III medical devices that have obtained registration certificates and are being industrialized for the first time in this city, a reward of RMB 400,000 will be granted per product category for Class II devices and RMB 1 million per product category for Class III devices. The maximum annual reward for a single enterprise will not exceed RMB 5 million. (Responsible units: Municipal Science and Technology Bureau, Municipal Finance Bureau)

(III) Supporting International Product Certification

1. For innovative drugs and improved new drugs that have obtained registration approvals from overseas ICH member countries or have passed the World Health Organization Prequalification (WHO PQ), a one-time reward of RMB 3 million will be granted for each category of product, and RMB 1.5 million for each category.

2. Medical device products that obtain domestic Class II or Class III medical device market access certifications in the EU, U.S., UK, Japan, Australia, Brazil, Russia, and other countries will receive a one-time reward of RMB 300,000 for Class II products and RMB 500,000 for Class III products, respectively. (Responsible units: Municipal Science and Technology Bureau, Municipal Finance Bureau)

(4) Support enterprises in pursuing major technological innovations. For enterprises undertaking national key science and technology projects in the biopharmaceutical sector, including major R&D programs and significant scientific and technological achievement transformation projects, matching funds will be provided at a 1:1 ratio based on the actual national funding received. However, the total amount of funding from national, provincial, and municipal sources shall not exceed the project’s overall investment. (Responsible units: Municipal Science and Technology Bureau, Finance Bureau, and relevant district governments as well as the Torch Management Committee.)

(5) Build a platform for scientific and technological innovation. Strongly support universities, research institutions, and enterprises in establishing major innovation platforms closely aligned with the development of the biopharmaceutical industry. Newly recognized National Key Laboratories, National Engineering Research Centers, National Technology Innovation Centers, National Industry Innovation Centers, and National Manufacturing Innovation Centers will each receive a subsidy of 10 million yuan, while newly designated National Enterprise Technology Centers will be granted a subsidy of 5 million yuan. (Responsible Units: Municipal Science and Technology Bureau, Development and Reform Commission, Industry and Information Technology Bureau, and Finance Bureau)

(6) Vigorously introduce new types of R&D institutions. Leveraging universities, research institutions, and leading enterprises, the city will introduce high-level, independently-legal biomedical R&D institutions. Those institutions that meet the city’s criteria for recognizing new types of R&D organizations will receive subsidies of up to 65 million yuan. (Responsible units: Municipal Science and Technology Bureau, Municipal Finance Bureau)

2. Strengthen the Growth Momentum of Industrial Development

Adhere to the strategies of strengthening internally while attracting external expertise, optimize existing assets and expand new growth areas. Support biopharmaceutical companies in upgrading their technologies, boosting production and efficiency, and pursuing mergers and acquisitions. Vigorously promote the introduction, localization, and nurturing of innovative projects, headquarters enterprises, and cutting-edge business models and formats. Help companies demonstrate and scale up the commercial applications of their innovative products, fostering the development of a group of industry leaders—both domestically and internationally recognized—with strong competitiveness—as well as "hidden champions" in niche sectors, thereby expanding the overall size and advanced capabilities of the industry.

(7) Support enterprise technology upgrades. Biopharmaceutical companies are encouraged to adopt new technologies, equipment, processes, and materials to upgrade and modernize their existing production facilities, process conditions, and manufacturing environments. Additionally, biopharmaceutical firms are supported in implementing信息化 (IT-based) transformation projects. Eligible companies will receive subsidies for investment in technological upgrading equipment, as well as financial support through technology transformation funds. Specifically, the subsidy for equipment investments—covering both the equipment itself (including technology and software, but excluding taxes)—will amount to 10% of the total equipment expenditure, with a cap of up to RMB 10 million per project. (Responsible units: Municipal Bureau of Industry and Information Technology, Municipal Bureau of Finance)

(8) Encourage enterprises to increase production and improve efficiency. Leverage the leading role of top-tier biopharmaceutical companies within the industry chain, supporting them to grow stronger, expand their presence, and establish deep roots in the market. Cultivate "Gazelle enterprises" and "hidden champions" in the biopharmaceutical sector, fostering a group of industry leaders with global competitiveness. For biopharmaceutical companies whose annual sales first reach 100 million yuan, 500 million yuan, or 1 billion yuan, one-time rewards of 3 million yuan, 5 million yuan, and 10 million yuan will be provided, respectively. (Responsible units: Municipal Science and Technology Bureau, Municipal Finance Bureau)

(9) Encourage enterprises to pursue mergers and acquisitions. Enterprises are encouraged to engage in capital operations and mergers & acquisitions. To support such initiatives, the city will provide subsidies covering pre-transaction costs—including valuation, auditing, and legal advisory services—incurred during M&A projects involving companies with no existing investment ties, as well as interest on M&A-related loans. The maximum subsidy per project is capped at 3 million yuan. (Responsible Units: Municipal Bureau of Industry and Information Technology, Municipal Bureau of Finance)

(10) Supporting the implementation of innovative projects. Attracting new investments and supporting existing ones: For newly introduced projects and additional investment projects by local enterprises with a total investment exceeding 50 million yuan, a reward will be provided equivalent to 5% of the actual capital contributed, with a cap of 5 million yuan per project. (Responsible Units: Each District, Torch Management Committee)

(Eleven) Develop headquarters economy projects. For Fortune Global 500 companies, China's Top 500 enterprises, as well as renowned domestic and international biopharmaceutical companies and large biopharmaceutical corporations (groups) that establish regional headquarters or functional headquarters such as R&D centers and operational hubs in Xiamen, the city will provide support measures under its policies aimed at fostering the growth of the headquarters economy, including business contribution incentives and talent attraction programs. (Responsible Units: Municipal Development and Reform Commission, Bureau of Finance, and various districts, along with the Torch High-Tech Zone Administration.)

(12) Cultivating New Business Models and Trends

1. Support enterprises in conducting R&D innovation and facilitating the transfer and commercialization of research outcomes under the Drug Marketing Authorization Holder (MAH) system and the Medical Device Registration Holder (RMH) system. For biomedical companies in this city that undertake contract manufacturing under the MAH or RMH systems, and whose actual contract value first reaches 10 million yuan, a one-time reward of 2 million yuan will be granted to the contract manufacturer.

2. Foster the development of the biopharmaceutical services sector by providing subsidies—up to 20% of the total fixed asset investment—for establishing industry-specific platforms such as contract research organizations (CROs), contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs). The maximum subsidy per project is capped at RMB 20 million.

(Responsible Units: Municipal Science and Technology Bureau, Industry and Information Technology Bureau, Finance Bureau)

(13) Strengthen demonstration projects for the first-of-its-kind applications. Strengthen efforts to promote, publicize, and increase procurement and usage of the first-of-its-kind medical device equipment. For medical devices recognized as the nation’s first major technological or intelligent manufacturing equipment, a subsidy will be provided at up to 60% of the sales amount; for equipment designated as the province’s first-of-its-kind model, the subsidy will cover up to 30% of sales—with a maximum individual subsidy capped at 5 million yuan. (Responsible units: Municipal Bureau of Industry and Information Technology, Bureau of Science and Technology, and Bureau of Finance)

3. Optimize the Industry Ecosystem

Deepen key reforms and innovations, address critical bottlenecks, streamline vital pathways in the biopharmaceutical sector, strengthen efforts to expand markets for innovative products and connect them with clinical resources, enhance capabilities in registration, certification, and testing/inspection services, facilitate cross-border trade of specialized biomaterials and bio-based products, bolster industry support through robust investment, talent development, and dedicated infrastructure, and continuously refine the industry's ecosystem.

(Fourteen) Promote the market development of innovative products. Increase efforts to apply and promote cutting-edge innovations—such as screening and prevention/treatment tools for major diseases and infectious diseases—developed by enterprises. Support clinical research on innovative pharmaceuticals and medical devices at local healthcare institutions, and ensure that newly approved products are promptly listed on the province-wide joint price-limiting and transparent procurement platform for drugs and medical devices. Encourage the rational use of newly listed products, streamline procurement processes like hospital bidding for innovative medicines, medical devices, and consumables, and urge and guide local healthcare facilities to promptly integrate these listed products into their institutional purchasing catalogs. (Responsible Units: Municipal Medical Insurance Bureau, Health Commission)

(15) Strengthen the Supply of Clinical Resources

1. Integrate the city’s clinical institution resources to enhance the quality and efficiency of clinical trial capacity-building, thereby strengthening support for clinical trials conducted by biopharmaceutical companies. Medical institutions are encouraged to actively register as clinical trial centers. For those that provide clinical trial services to local biopharmaceutical companies and help accelerate the translation of research findings into commercial products, a reward will be granted equivalent to 5% of the institution’s revenue generated from these services, with a cap of up to RMB 2 million.

2. Encourage registered medical institutions to establish and refine their review mechanisms, streamline the processes for clinical trial initiation, ethical reviews, and protocol approvals, and expedite project launches to accelerate the clinical trial phase of product development. Additionally, promote collaboration between medical staff from healthcare institutions and companies or R&D organizations to jointly conduct clinical application research and share resulting findings. Furthermore, support healthcare facilities in developing robust incentive systems—such as career advancement opportunities and competitive compensation packages—for clinical trial researchers, thereby boosting healthcare professionals' enthusiasm for engaging in clinical trials. Finally, enhance the availability of high-quality clinical trial samples to foster faster translation of innovative research outcomes into commercialized products. (Responsible Units: Municipal Health Commission, Science and Technology Bureau, Finance Bureau)

(Sixteen) Support the establishment of clinical medicine research centers. For those accredited as Municipal Clinical Medical Research Centers or Provincial Clinical Medical Research Centers, a subsidy of 2 million yuan will be provided (with no duplication of benefits). Additionally, centers receiving an "Excellent" evaluation will receive rolling support of 1.5 million yuan. For those awarded the qualification of Xiamen Branch Center for National Clinical Medical Research Centers, a subsidy of 4 million yuan will be granted, with an additional 2 million yuan in rolling support for centers earning an "Excellent" evaluation. Finally, institutions recognized as National Clinical Medical Research Centers will receive supplementary funding to reach a total of 10 million yuan. (Responsible Units: Municipal Science and Technology Bureau, Municipal Finance Bureau)

(17) Enhancing Registration, Certification, and Inspection & Testing Capabilities

1. Strengthen coordination and communication with national and provincial drug regulatory authorities, and optimize the review and approval processes for pharmaceuticals and medical devices. Leveraging the Xiamen Biomedical Port Service Workstation under the Fujian Provincial Drug Administration, provide robust guidance services for early-stage product registration and technical reviews. Additionally, enhance industry oversight by attracting specialized talent and offering targeted professional training, thereby elevating the quality of regulatory services and fostering a favorable, streamlined environment for product application and registration.

2. Support the establishment of medical device testing and inspection institutions, creating facilities that reflect local strengths and address specific needs. Encourage leading, capable enterprises to participate in building third-party testing and inspection service providers, thereby enhancing the city's regional influence and driving role in biopharmaceutical testing and inspection. (Responsible Unit: Municipal Market Supervision Administration)

(18) Leverage the effectiveness of "Dual Self-Driven Initiatives." Enhance the functionality of Xiamen's Public Service Platform for Cross-Border Trade in Special Biological Materials, aligning it with world-class and domestic leading standards. Continuously optimize the facilitation of cross-border trade for products such as reagents, instruments and equipment, biological samples, and innovative antibody-based drugs, thereby supporting import and export activities of entities involved in the biopharmaceutical sector. (Responsible Units: China (Fujian) Pilot Free Trade Zone Commission, Xiamen Municipal Science and Technology Bureau, Xiamen Customs)

(19) Strengthen the development of the investment and financing system

1. Leverage the roles of Xiamen’s Industry Guidance Fund and the Science & Technology Achievement Transformation and Industrialization Fund, encouraging fund companies to establish dedicated funds primarily focused on the biopharmaceutical sector. Additionally, incentivize industry players to jointly initiate and set up specialized funds, with a particular emphasis on investing in early-to-mid-stage, innovative, and entrepreneurial biotech companies based in the city.

2. Encourage high-quality biopharmaceutical companies to fully leverage multi-tiered capital markets—both domestic and international—to raise funds through IPOs and listings. During the restructuring and listing process, for any approval procedures or issuance of relevant certifications required, coordinate with relevant departments to provide streamlined support. Additionally, biopharmaceutical companies will receive immediate financial assistance without the need for separate application: a one-time subsidy of 300,000 RMB upon completion of guidance and filing with the Xiamen Securities Regulatory Bureau; and another one-time grant of 700,000 RMB once their initial public offering application is formally accepted by the China Securities Regulatory Commission or a stock exchange. Furthermore, for companies registered in Xiamen that successfully list on domestic or overseas securities markets, a subsidy of up to 1.5 million RMB will be provided based on the total financing amount raised. If at least 40% (inclusive) of the raised funds are reinvested within the city, an additional reward equal to the original subsidy amount will be awarded.

3. Encourage all types of financial institutions in the city to prioritize supporting the biopharmaceutical industry through government-bank-enterprise matchmaking initiatives. Tailor innovative service models to meet enterprises' needs for credit, leasing, and insurance, while enhancing the investment and financing service system. Additionally, encourage government-backed guarantee institutions to provide financing credit enhancement support. (Responsible Units: Municipal Financial Regulatory Bureau, Finance Bureau, Science and Technology Bureau, Xiamen Securities Regulatory Bureau, and Banking and Insurance Regulatory Bureau)

(20) Enhance the Industry Talent Support System

1. Strengthen efforts to attract and cultivate high-level and core talent in the biopharmaceutical sector, offering eligible professionals convenient benefits such as housing assistance, healthcare support, education for their children, spouse placement, and entrepreneurship incentives.

2. Encourage local universities and research institutions to strengthen the cultivation of talent in relevant disciplines by aligning with industry needs, support order-based talent development programs, organize open training workshops, and nurture professionals at all levels, thereby building a well-structured talent pipeline for the biopharmaceutical industry.

3. Deeply advance the reform of professional title evaluations in the biopharmaceutical industry, adopting a demand-driven approach and expanding career advancement pathways for specialized talent. (Responsible Units: Municipal Party Committee Organization Department, Municipal Science and Technology Bureau, Human Resources and Social Security Bureau, Health Commission, Development and Reform Commission, Housing Authority, Industry and Information Technology Bureau, Education Bureau, as well as all districts and the Torch High-Tech Zone Management Committee)

(21) Rationally Plan the Spatial Layout of Industrial Development

1. Strengthen integrated planning and categorized guidance to establish a spatial layout characterized by "one core with multiple hubs, each with unique features and complementary development." Prioritize the construction of key platforms such as Xiamen Biomedical Harbor and Xiang'an Digital Economy Industrial Park. Encourage universities, research institutions, and leading enterprises to either independently build or jointly develop innovation and entrepreneurship incubation parks and bases, thereby enhancing the capacity to support industry-driven innovation projects and fostering clustered industrial growth.

2. Deeply advance the integrated park development model of "Industrial Park + New-Type Incubator + Industry Fund + Industry Alliance," enhancing the parks' capacity for sustainable growth. Each district will formulate relevant support policies—such as subsidies, grants, and loan interest subsidies—based on the specific conditions of parks within its jurisdiction. Financial incentives will be provided to parks that successfully attract investments and nurture large-scale enterprises through incubation programs. (Responsible Units: Municipal Development and Reform Commission, Bureau of Resources and Planning, all districts, and Torch Management Committee)

4. Strengthen Organizational Support Services

Strengthen top-level design, enhance city-level overall coordination, refine the communication and collaboration mechanisms for biopharmaceutical industry development, leverage industry organizations as bridges and platforms to deliver services, foster and expand industry alliances and associations, and elevate the quality of services supporting industrial growth.

(22) Strengthen city-level overall coordination and management. Establish a more effective communication and coordination mechanism by building upon the city-level industrial development leadership group, introducing a joint meeting system and an entrepreneur dialogue platform. These initiatives will focus on collaboratively addressing key challenges in industrial and enterprise development. Additionally, strengthen collaboration between the city and its districts—each district can formulate tailored measures to specifically boost the growth of the biopharmaceutical industry, based on its unique circumstances. (Responsible units: Municipal Party Committee Organization Department, Municipal Development and Reform Commission, Science and Technology Bureau, Finance Bureau, Industry and Information Technology Bureau, Health Commission, Medical Insurance Bureau, Market Supervision Administration, Financial Regulatory Bureau, Commerce Bureau, as well as all districts and the Torch High-Tech Zone Management Committee.)

(23) Support the development of industry organizations. Strengthen the organizational development of industry alliances, trade associations, and other relevant groups in the biopharmaceutical sector. Support their activities—such as industry planning and management, trend analysis, and statistical monitoring—through service procurement and other mechanisms as stipulated by regulations, enabling them to serve as vital bridges, conduits, and think-tank platforms. Encourage industry organizations to foster industry-academia-research collaborations, facilitate talent certification and evaluation processes, provide technical consulting services, and contribute to standard-setting initiatives. Additionally, promote the planning and organization of national or specialized industry forums, summits, exhibitions, and academic exchange events, helping to create a thriving ecosystem for growth and innovation. (Responsible Units: Municipal Science and Technology Bureau, National Development and Reform Commission, Municipal Bureau of Commerce)

V. Other

This measure applies to enterprises, institutions, organizations, and social groups—both public and private—that are registered for business and tax purposes in Xiamen City, possess independent legal status, and are engaged in research and development, manufacturing, or service activities within the biopharmaceutical sector. It also covers marketing authorization holders and medical device registration holders whose sales tax settlements are processed in this city.

This measure is interpreted by the Office of the Xiamen City Leading Group for Promoting the Development of Bio- and New Pharmaceutical Industries. In special cases, additional support may be considered on a case-by-case basis. During implementation, adjustments may be made in response to any relevant policy changes introduced by the national or provincial authorities.

This measure takes effect from the date of its issuance and will remain in force for three years. The "Notice from the General Office of the Xiamen Municipal People's Government on Issuing Several Measures to Accelerate the Development of the Biopharmaceutical and Health Industries" (Xiamen Government Office [2018] No. 45) is hereby repealed simultaneously.

 Xiamen Municipal People's Government

  June 4, 2020