Original Title: Notice of the Fengxian District People’s Government on Issuing the “Several Policies of Fengxian District for Promoting the High-Quality Development of the Life and Health Industry”
To the People’s Governments of All Towns, Subdistrict Offices, Development Zone Administrative Committees, and All Departments of the District Government:
The "Several Policies of Fengxian District on Promoting the High-Quality Development of the Life and Health Industry" are hereby issued to you. Please ensure their thorough implementation.
People’s Government of Fengxian District, Shanghai
April 10, 2023
Several Policies of Fengxian District to Promote the High-Quality Development of the Life and Health Industry
To implement the spirit of the document “Several Opinions of the General Office of the Shanghai Municipal People’s Government on Promoting the High-Quality Development of the City’s Biomedical Industry” (Shanghai Municipal Government Office Regulation [2021] No. 5), accelerate the optimization of the innovation and development environment for the life and health industry in Fengxian District, and enhance the industry’s overall competitiveness, these policies are hereby formulated.
Article 1: Eligible Entities
Enterprises, public institutions, or private non-enterprise entities legally registered in the district that are engaged in the research and development, production, sales, and services of the life and health industry, including pharmaceuticals, medical devices, and foods for special medical purposes. Greater support will be provided to products, platforms, and projects that are technologically advanced, have promising application prospects, demonstrate strong exemplary and leading roles, and occupy key links in the industrial chain.
Article 2: Support for Project Construction
1. Support will be provided for the introduction of industrial projects, key links in the industrial chain, and projects addressing critical shortages that play a leading and driving role in the development of the life and health industry. Support will be granted at 20% of the total investment in production equipment for each project, with a maximum of 30 million yuan per project.
2. Domestic and foreign enterprises are encouraged to establish high-end R&D centers. Upon certification, support will be provided equivalent to 30% of the innovation and R&D expenses incurred in the two years following the center’s establishment, with a maximum of 5 million yuan per project.
3. Accelerate the introduction and cultivation of high-quality third-party service providers—such as Contract Research Organizations (CROs), Contract Development and Manufacturing Organizations (CDMOs), Contract Manufacturing Organizations (CMOs), and Contract Sales Organizations (CSOs)—as well as technology transfer centers. Support will be provided at 20% of the total project investment, with a maximum of 10 million yuan per project.
4. Support enterprises, universities, and specialized institutions in collaborating to establish clinical medical research centers, conduct international multicenter clinical trials, build clinical sample repositories, health big data platforms, and clinical evaluation platforms for drugs and medical devices. Upon approval, support will be provided at 30% of the total project investment, with a maximum of 10 million yuan per project.
5. Support will be provided for the construction of public service platforms, including third-party testing and certification services for drugs and medical devices, GMP shared laboratories, laboratory animal services, drug screening, pharmacology and toxicology research, efficacy evaluation, new drug approval applications, and pharmaceutical industrial waste treatment. Upon approval, support will be provided at 30% of the total project investment, with a maximum of 10 million yuan per project.
Article 3: Support for Technological Innovation
1. For Class I and II chemical drugs and biological products, as well as innovative traditional Chinese medicines (TCM) and improved TCM new drugs with clinical advantages, support of 30% of the product R&D costs will be provided upon approval: a reward of 1 million yuan will be granted upon entry into domestic clinical trials; upon completion of Phase I and Phase II domestic clinical trials, support of up to 2 million yuan and 3 million yuan, respectively, will be provided.
2. Enterprises are encouraged to collaborate with universities, hospitals, research institutes, and third-party service providers to undertake research and development of key technologies. For projects that are approved in advance and subsequently pass expert review, support will be provided at 30% of the project’s R&D costs, with a maximum of 2 million yuan.
3. For lead entities newly awarded national or municipal-level major science and technology projects under the Major New Drug Innovation Program, support will be provided at 10% of the project’s actual expenditures upon approval, with a maximum of 3 million yuan for national projects and 2 million yuan for municipal projects.
4. Third-party medical laboratories that have newly obtained national or municipal medical institution practice licenses will, upon approval, receive support of 500,000 yuan and 300,000 yuan, respectively.
5. For specific total nutritional formula foods for special medical purposes that have entered the clinical trial phase, upon approval, support of up to 1 million yuan will be provided, equivalent to 10% of the actual R&D costs for that product.
Article 4: Support for Regulatory Approval and Market Launch
1. For entities that have newly obtained drug registration certificates for Class I and II chemical drugs, biological products, innovative traditional Chinese medicines (TCM), improved TCM formulations, or TCM compound preparations based on ancient classic formulas, and have commenced production, or have become marketing authorization holders and commenced production within this district, upon review, a one-time subsidy of up to 2 million yuan will be provided for each certificate (authorization), equivalent to 20% of the project’s R&D costs.
2. For generic drugs that have newly passed bioequivalence evaluation and obtained approval documents from the National Medical Products Administration, upon review, a subsidy of up to 2 million yuan will be provided for each individual product, equivalent to 20% of the project’s R&D costs. The cumulative subsidy for a single enterprise in the same year shall not exceed 4 million yuan.
3. For products that have newly obtained Class II (excluding Class II diagnostic reagents and equipment components) or Class III medical device registration certificates and are manufactured within this district, upon approval, support of up to 500,000 yuan and 2 million yuan, respectively, will be provided based on 20% of the project’s R&D costs.
Article 5: Support for Contract Manufacturing
Enterprises are encouraged to outsource R&D and production activities through Contract Manufacturing Organizations (CMOs) or Contract Development and Manufacturing Organizations (CDMOs). Support will be provided to both contracting parties (which must have no investment-related ties) at a rate of 0.5–1% of the contract value for the first transaction per product, with a maximum of 2 million yuan for each party.
Article 6: Support for Market Development
1. Hospitals and pharmaceutical wholesale and retail entities are encouraged to make initial purchases of innovative drugs and medical devices that have been on the market for less than two years and with which they have no affiliate relationship. Upon approval, support of up to 1 million yuan will be provided, equivalent to 5% of the procurement amount. For enterprises selling products for the first time, support of up to 500,000 yuan will be provided, equivalent to 50% of the insurance premiums paid.
2. For innovative drugs that have newly obtained registration or certification from regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the European Union (CE), the World Health Organization (WHO), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), or Notified Bodies (NBs) recognized by the EU, and have achieved sales in relevant overseas markets, support of up to 2 million yuan will be provided, equivalent to 20% of the project’s R&D costs, subject to approval;For high-end medical devices that have newly obtained registration or certification from the aforementioned regulatory bodies and have achieved sales in relevant overseas markets, upon approval, support of up to 500,000 yuan will be provided, equivalent to 20% of the project’s R&D costs.
3. To encourage the hosting of high-end, specialized, and international forums, conferences, and other events with significant influence within the zone, upon approval, the organizing entity will receive support equivalent to 50% of the actual expenses incurred, with a maximum of 500,000 yuan per event.
4. For products that win bids in the national centralized bulk procurement of pharmaceuticals, support of up to 1 million yuan will be provided.
Article 7: Support for Third-Party Services
1. Support will be provided to third-party service agencies and public service platforms that provide services to life sciences and healthcare enterprises. Support will be granted at 5% of the annual actual service amount, with a cumulative maximum of 2 million yuan.
2. Support will be provided for the development of pharmaceutical and medical device incubators. Upon approval, support will be granted at 20% of the incubator’s annual operating expenses, up to a maximum of 1 million yuan. Policy benefits will be cumulative: incubators designated as municipal-level science and technology enterprise incubators will receive an additional 300,000 yuan in support, and those designated as national-level incubators will receive an additional 500,000 yuan in support.
Article 8: Support for Talent Recruitment and Cultivation
1. For projects involving the introduction of outstanding talent teams to the life sciences and health industry, upon approval, funding of up to 20 million yuan will be provided; for projects involving the introduction of leading innovation and entrepreneurship teams, upon approval, funding of up to 10 million yuan will be provided.
2. Entities that hire senior experts such as recipients (or nominees) of internationally renowned awards (e.g., the Nobel Prize), academicians from developed countries, members of the Chinese Academy of Sciences or the Chinese Academy of Engineering, national-level high-caliber overseas talents, recipients of major national science and technology awards, technical directors of major foreign scientific infrastructure projects, or chief technology officers of the world’s top 100 foreign companies shall, upon verification, receive a reward of up to 2 million yuan;Enterprises that hire National-level Outstanding Overseas Young Talents or National Top-tier Young Talents, upon verification, will be granted a reward of up to 300,000 yuan; enterprises that hire Shanghai Overseas High-level Talents, Shanghai Leading Talents, or Shanghai Top-tier Young Talents, upon verification, will be granted a reward of up to 200,000 yuan.
3. High-level talent introduced or cultivated by the life sciences and healthcare industry, as well as their immediate family members, shall be provided with benefits including residency registration, home purchase, housing rental, medical coverage, and children’s education.
4. In accordance with Fengxian District’s relevant talent policies, specialized talent support measures will be implemented for professionals in the life sciences and health sector engaged in basic research, industrial technology, regulatory filing, capital investment, marketing, and park operations.
5. Local units are encouraged to provide support to high-level talents and their teams.
Article 9: Guarantee of Production Factors
1. Ensure the availability of spatial resources. Guarantee land supply for high-quality projects (including large enterprises, platforms, research institutes, academies, and organizations led by high-level talent, or industrial projects with a relatively high concentration of technological innovation talent). Implement flexible-term land grants for industrial use, with a maximum term of 50 years. For high-quality projects involving the redevelopment of existing land, land prices may be set with reference to those for newly granted land. Support industrial parks in providing rent-free periods for high-quality industrialization projects.
2. Innovate financial support methods. Implement an integrated “grant-investment-loan” model. For innovative small and medium-sized enterprises (SMEs) in the biopharmaceutical sector that are in the start-up or growth stages and possess exemplary, leading, and driving roles, upon certification, provide “tailored support plans” for each enterprise by integrating multiple funding sources, including fiscal “grants,” equity “investments” from state-owned enterprises, and “loans” from financial institutions. The maximum amount of special fiscal funds provided to a single enterprise shall be 10 million yuan.
Article 10 Supplementary Provisions
1. For the same project or matter that meets the provisions of this policy and also complies with other support policies of Fengxian District (including policies where municipal departments require Fengxian District to provide matching or bear funding), support shall be provided in accordance with the principle of “choosing the higher amount without duplication.” Furthermore, the cumulative support amount for a single enterprise in a given year shall not exceed 15 million yuan. Support shall be provided through phased disbursements or a one-time ex-post subsidy.
2. Relevant support funds shall be shared proportionally among the district, towns (development zones), and state-owned enterprises. Expenses related to project identification, fund evaluation, expert consultation, and other activities necessary for implementing this policy may be allocated as special expenditures.
3. This document shall take effect on May 15, 2023, and remain valid until December 31, 2024. Should relevant national or municipal policies be adjusted during the implementation period, corresponding adjustments may be made.
