To implement the decisions and plans of the central and provincial governments regarding the development of the biomedical industry, foster new drivers of growth, promote the high-quality development of Hefei’s biomedical industry, and strive to establish our city as a core hub and R&D hub for the biomedical industry, these policies have been formulated.
I. Supporting Industrial R&D and Innovation
1. Enhancing Innovation Capabilities. Relying on national-level research institutions such as the Institute of Health Sciences at the Hefei Comprehensive National Science Center, we will strengthen high-level basic research in cutting-edge fields centered on new targets, new sites, new mechanisms, and new molecular entities, and strive to attract several major national scientific and technological infrastructure projects and biosafety laboratories to the city.Focusing on cutting-edge global scientific fields such as life sciences and disease prevention and control, we will launch a series of major municipal-level science and technology projects and encourage leading enterprises in scientific and technological innovation to undertake relevant research and development tasks. We will support relevant units in integrating their leading research capabilities to establish several influential innovation research institutions. (Responsible Units: Municipal Development and Reform Commission, Municipal Science and Technology Bureau, Municipal Health Commission)
2. Support new drug R&D. For new drugs—including chemical drugs, biological products, traditional Chinese medicines, and natural medicines—that undergo clinical trials and are commercialized in our city, provide phased grants and subsidies based on their R&D progress:
For innovative drugs (including those approved for emergency use), those newly entering Phase I, II, or III clinical trials will receive subsidies of up to 5 million yuan, 10 million yuan, and 20 million yuan, respectively, based on 40% of the enterprise’s actual R&D investment, with a maximum of 50 million yuan per enterprise per year.
For improved new drugs, those newly entering Phase I, II, or III clinical trials will receive subsidies of up to 4 million yuan, 8 million yuan, and 15 million yuan, respectively, based on 40% of the enterprise’s actual R&D investment, with a maximum of 30 million yuan per enterprise per year. (Responsible Units: Municipal Bureau of Economy and Information Technology, Municipal Development and Reform Commission, Municipal Market Regulation Bureau)
II. Accelerating the Commercialization of Innovation Outcomes
3. Encourage local commercialization of pharmaceuticals and medical devices. For innovative drugs (including those approved for emergency use), improved new drugs, chemical generic drugs, biosimilars, and traditional Chinese medicine compound preparations based on ancient classic formulas that have newly obtained registration approvals and commenced production in our city, grants of up to 10 million yuan, 5 million yuan, 2 million yuan, 2 million yuan, and 1 million yuan, respectively, will be provided to the holders of marketing authorization certificates based on the category of the approval.For innovative drugs and improved new drugs already on the market that are produced in our city and undergo further development to add new indications, a single product will be eligible for a grant of up to 2 million yuan. The annual limit per enterprise is 30 million yuan.
For Class III medical devices and Class II medical devices (limited to non-component medical instruments and devices, domestically pioneered devices, and high-value consumables) that have newly obtained registration certificates and commenced production in the city, one-time grants of up to 1 million yuan and 300,000 yuan will be provided, respectively. The maximum annual grant per enterprise is 10 million yuan.
For solid dosage forms and injectables that pass the bioequivalence evaluation for generic drugs, grants of up to 5 million yuan and 1 million yuan per product will be provided, respectively. Additionally, products that are among the first three of their kind nationwide to pass the bioequivalence evaluation will receive an additional grant of up to 1 million yuan. The annual cap per enterprise is 12 million yuan.
For active pharmaceutical ingredients (APIs) and excipients (status code A) that obtain a registration number for the first time and commence production in our city, the registrant will receive a grant of up to 200,000 yuan; for associated finished dosage forms that obtain marketing approval for the first time, or for associated varieties of already marketed finished dosage forms that pass the association review and approval for the first time, the registrant will receive a grant of up to 300,000 yuan. The annual cap per enterprise is 5 million yuan.(Responsible Units: Municipal Bureau of Economy and Information Technology, Municipal Development and Reform Commission, Municipal Market Regulation Bureau)
4. Encourage Contract Manufacturing. Enterprises in Hefei are encouraged to upgrade their existing production facilities and process equipment toward high-end, intelligent, and green standards, continuously enhancing their quality management capabilities and standards for pharmaceuticals and medical devices. For enterprises in Hefei that undertake contract manufacturing of pharmaceuticals and medical devices from outside the city (where there is no investment relationship between the two parties) and settle and sell the products in Hefei, a subsidy of 5% of the contract value will be provided annually to both the contracting party and the contractor.The annual cap is 5 million yuan per product and 10 million yuan per enterprise (or institution). (Responsible Units: Municipal Bureau of Economy and Information Technology, Municipal Development and Reform Commission, Municipal Market Regulation Bureau)
III. Cultivating and Strengthening Market Entities
5. Support the Scaling Up of Enterprises. Actively cultivate enterprises with annual revenues of 10 billion yuan, implement plans to double the number of enterprises with annual revenues of 100 million yuan and National High-Tech Enterprises, and support enterprises in expanding through independent innovation, acquisitions, and mergers. Dynamically conduct the identification of key enterprises in the biopharmaceutical industry chain, establish a project repository for key biopharmaceutical industry projects, and adopt a mechanism of scheduling, reporting, and supervisory services to accelerate the advancement of key projects. (Responsible Units: Municipal Bureau of Economy and Information Technology, Municipal Development and Reform Commission, Municipal Science and Technology Bureau)
6. Support the promotion and application of innovative products. Compile a catalog of key cultivation varieties for Hefei’s biopharmaceutical industry and support the participation of listed pharmaceuticals and medical devices in public resource transactions. Encourage demonstration applications of the “Three Firsts” (first-of-a-kind equipment, first-batch materials, and first-version software). For high-end medical devices and key components recognized at the provincial level as first-of-a-kind, provide a reward of up to 3 million yuan to the R&D unit and the application enterprise, respectively, equivalent to 15% of the product’s unit price (value).For pharmaceuticals where annual sales revenue of a single product first exceeds 1 billion yuan, 500 million yuan, 300 million yuan, or 100 million yuan, and for medical devices where annual sales revenue first exceeds 500 million yuan, 300 million yuan, 100 million yuan, or 50 million yuan, enterprises will be granted tiered rewards of up to 1 million yuan, 800,000 yuan, 500,000 yuan, and 300,000 yuan, respectively. Encourage medical institutions in Hefei to engage in modern medical technology innovation and clinical application.(Responsible Units: Municipal Bureau of Economy and Information Technology, Municipal Development and Reform Commission, Municipal Public Administration Bureau, Municipal Health Commission)
7. Support enterprises in expanding into international markets.For new pharmaceuticals and medical devices developed in this city that have recently obtained registration or certification from the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) or the European Directorate for the Quality of Medicines (EDQM), the UK Medicines and Healthcare products Regulatory Agency (MHRA), or the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and have achieved sales in relevant overseas markets, holders will receive a subsidy of up to 1 million yuan per product based on actual investment.The maximum annual award per enterprise is 5 million yuan. (Responsible Unit: Municipal Bureau of Economy and Information Technology)
IV. Supporting Industrial Cluster Development
8. Encourage the development of specialized industrial parks. Prioritize the inclusion of premises, land, and energy resources for the biopharmaceutical industry in construction plans, energy consumption guarantees, and land allocation to ensure development space for high-quality enterprises.Priority will be given to the development of key clusters such as the Central China National Health and Medical Big Data Center, the Provincial Biopharmaceutical and High-End Medical Device Industrial Base, the Institute of Health at the Hefei Comprehensive National Science Center, the International Biopharmaceutical Port, the Yangtze River Delta G60 Science and Technology Innovation Corridor Industrial Cooperation Demonstration Zone (Biopharmaceuticals), and the Provincial Active Pharmaceutical Ingredients (API) Base, to create distinctive biopharmaceutical industrial parks.Encourage parks to construct standardized factory buildings that meet the needs of biopharmaceutical R&D and manufacturing enterprises. For new projects entering the park with fixed-asset investments of 10 million yuan or more, a subsidy of up to 20 million yuan will be provided, equivalent to 10% of the fixed-asset investment. For existing enterprises undertaking upgrades and renovations with investments of 5 million yuan or more, a subsidy of up to 20 million yuan will be provided, equivalent to 15% of the equipment investment.Leading enterprises and key supporting enterprises introduced into the biopharmaceutical industry chain that meet the relevant criteria in the "Hefei Guidelines for the Recognition of Major Investment Projects" may apply for support under Hefei’s major project initiative. (Responsible Units: Municipal Development and Reform Commission, Municipal Bureau of Economy and Information Technology, Municipal Investment Promotion Bureau, Municipal Bureau of Natural Resources and Planning, Municipal Ecology and Environment Bureau, Municipal Health Commission)
9. Support for the Construction of Supporting Platforms. Establish a citywide database of public service platforms. For industrial application-oriented platforms such as Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), and Contract Development and Manufacturing Organizations (CDMOs) built within industrial clusters and specialized industrial parks, as well as industrial public service platforms including medical big data clinical research application centers, testing and inspection centers, translational medicine centers, clinical medical research centers, and research centers for generic drug quality and efficacy equivalence evaluation technologies and standards,with fixed-asset investments of 5 million yuan or more, a grant of up to 5 million yuan will be provided, equivalent to 30% of the investment amount. For major projects such as R&D platforms for innovative drugs and high-end medical devices, as well as pilot production and manufacturing platforms in the biopharmaceutical industry, separate support will be provided on a case-by-case basis. Establish drug and medical device registration guidance service stations, and provide an annual subsidy of up to 600,000 yuan to the entities responsible for their construction and operation.For public platforms providing services to local enterprises (where there is no investment relationship between the two parties), as well as alliances, associations, and service organizations offering drug and medical device approval support, industry training, and entrepreneurship services, a grant of up to 10% of the total annual service contract value (capped at 1 million yuan) will be provided based on the scope and effectiveness of the services. (Responsible Units: Municipal Development and Reform Commission, Municipal Bureau of Economy and Information Technology, Municipal Health Commission, Municipal Investment Promotion Bureau)
Enterprises (or institutions) that obtain Good Laboratory Practice (GLP) certification for the first time, covering 3 major categories or 5 major categories, will be awarded up to 1 million yuan or 2 million yuan, respectively. For each additional test project added subsequently, a reward of up to 500,000 yuan will be provided.Enterprises (or institutions) obtaining Good Clinical Practice (GCP) certification for the first time will receive a reward of up to 2 million yuan. For each additional specialized discipline added subsequently, a reward of up to 500,000 yuan will be granted. The cumulative reward for a single enterprise (or institution) shall not exceed 5 million yuan. (Responsible Units: Municipal Bureau of Economy and Information Technology, Municipal Health Commission)
10. Optimize the Development Environment. In conjunction with the construction of national regional medical centers, promote collaborative innovation among medical care, education, and industry. Strengthen the translation of clinical research and medical-enterprise collaboration, and establish demonstration bases for industry-medical integration and mechanisms for medical-enterprise对接. Support local medical institutions in conducting clinical research and translating research outcomes into practical applications, and encourage the transformation of high-quality in-house preparations into new drugs. Support local universities in collaborating with pharmaceutical enterprises to cultivate specialized talent through targeted training programs.Encourage leading enterprises, universities, and research institutes to establish or jointly build industrial innovation and entrepreneurship incubators. Provide awards and subsidies of up to 1 million yuan to municipal-level or higher science and technology enterprise incubators, maker spaces, and various types of parks that provide comprehensive services such as production and sales to small and medium-sized enterprises and achieve excellent performance in evaluations. Increase efforts to attract domestic and international biopharmaceutical funds. Invest in biopharmaceutical industry funds established by private capital to support the introduction of pharmaceutical industry projects.We will invest in funds initiated by local pharmaceutical enterprises to support their growth and expansion, as well as the introduction of supporting enterprises. We encourage various insurance institutions in Hefei to provide customized comprehensive insurance products, such as liability insurance for biomedical human clinical trials and liability insurance for biomedical products. (Responsible Units: Municipal Health Commission, Municipal Bureau of Economy and Information Technology, Municipal Development and Reform Commission, Municipal Education Bureau, Municipal Science and Technology Bureau, Municipal State-owned Assets Supervision and Administration Commission, Municipal Finance Bureau, Municipal Financial Bureau, Municipal Human Resources and Social Security Bureau, etc.)
This policy applies to enterprises engaged in the research, development, production, and services of pharmaceuticals and medical devices, as well as relevant public institutions, social organizations, and private non-enterprise entities. The maximum annual award or subsidy for a single enterprise (or institution) is 200 million yuan. This policy implements total control based on the annual budget and is executed in accordance with the principle of selecting the highest amount without duplication when combined with other municipal policies. The funding for support policies is shared on a 1:1 basis between the municipal and county (city), district, and development zone finances.
This policy shall take effect from the date of issuance and remain valid for two years. The Municipal Bureau of Economy and Information Technology, in conjunction with relevant departments, shall be responsible for its interpretation. Should relevant policy provisions be adjusted during the implementation period, such adjustments shall prevail.
