Original Title: Implementation Rules for Several Policies on Accelerating the High-Quality Clustering and Development of the Biopharmaceutical Industry in Songjiang District
Chapter I General Provisions
Article 1 (Purpose and Basis)
The biopharmaceutical industry is one of the three key leading industries prioritized for development in Shanghai and a key sector targeted for development in Songjiang District during the 14th Five-Year Plan period. To further enhance the independent innovation capacity of Songjiang District’s biopharmaceutical industry, expand the scale of the industry, foster new business models and formats, accelerate the formation of a 100-billion-yuan biopharmaceutical industrial cluster with international influence, and achieve high-quality, leapfrog development of the industry, these Implementation Rules are formulated in accordance with the spirit of the “Several Policy Provisions on Accelerating the High-Quality Aggregated Development of the Biopharmaceutical Industry in Songjiang District.”
Article 2 (Principles of Use)
The use of special support funds shall comply with the industrial development policy orientations of the state, Shanghai Municipality, and Songjiang District, as well as relevant regulations on fiscal budget management and industrial special funds. It shall focus on key projects, adhere to the principles of openness, fairness, and impartiality, and ensure the safe and efficient use of funds.
Article 3 (Management Responsibilities)
The Songjiang District Economic Commission (hereinafter referred to as the “District Economic Commission”) shall, in accordance with these Detailed Rules, prepare the budget for the Special Support Fund for the Biopharmaceutical Industry, issue annual project application notices and guidelines, organize project evaluations, formulate funding plans, and provide project tracking services.
The Songjiang District Finance Bureau (hereinafter referred to as the District Finance Bureau) is responsible for the disbursement of the special support funds.
Article 4 (Eligible Recipients)
The recipients of the Special Support Fund shall be enterprises legally registered in Songjiang District that pay taxes locally and possess independent legal person status, and must also meet the following basic conditions:
(1) Possess a standardized corporate governance structure;
(2) Sound financial management systems and promising prospects for development;
(3) Good credit standing, with no serious violations or illegal activities occurring within the past two years;
(4) Possess the necessary capacity to undertake project construction.
Chapter II: Categories of Supported Projects
Article 5 (Encouraging the Introduction of Major Projects)
(1) For newly introduced key biopharmaceutical enterprises that lease production and office space within the district, a subsidy of up to 5 million yuan will be provided for a specified period; for those that purchase production and office space for their own use, a subsidy of up to 10 million yuan will be provided.For specific implementation of this project, please refer to the “Implementation Rules for Special Support for the Development of Newly Introduced Key Advanced Manufacturing Enterprises in Songjiang District” (Hu Song Jing [2020] No. 90) and subsequent relevant policies. For disruptive innovation projects in the biopharmaceutical sector, sales revenue requirements may be waived.
(2) For newly introduced key biopharmaceutical enterprises with fixed-asset investments of 100 million yuan or more, upon evaluation and approval, support of up to 10% of the approved total fixed-asset investment, with a maximum of 50 million yuan, will be provided. For the specific implementation of this project, please refer to the "Implementation Rules for Special Funds Supporting Industrial Fixed-Asset Investments in Newly Introduced Projects in Songjiang District" (Hu Song Jing [2019] No. 74) and subsequent relevant policies.
Article 6 (Encouraging Industrial Optimization and Upgrading)
Support will be provided to biopharmaceutical enterprises that utilize technologies such as industrial internet, big data, and artificial intelligence to carry out automation, informatization, intelligentization, and green transformation and upgrading of existing facilities, process conditions, and production services. Upon review and approval, support of up to 10% of the total approved project investment, with a maximum of 30 million yuan, will be granted. For the specific implementation of this project, please refer to the “Implementation Rules for Special Support for Technological Transformation of Industrial Enterprises in Songjiang District” (Hu Song Jing Gui [2022] No. 2) and subsequent relevant policies.
Article 7 (Encouraging Contract Manufacturing Within the District)
(1) Eligibility Criteria and Standards
1. For cases where a marketing authorization holder for pharmaceuticals or a medical device registrant commissions an enterprise within the district (with no investment relationship with the commissioning party) to provide production services, and where the tax settlement for product sales is conducted within Songjiang District, support of up to 5 million yuan will be provided based on 3% of the actual incremental contract transaction amount for that product, taking into account the project’s overall contribution.
2. For enterprises authorized by a drug marketing authorization holder or medical device registrant to undertake contract manufacturing, support of up to 2 million yuan shall be provided based on 1% of the actual incremental contract transaction value for that product, taking into account the project’s overall contribution.
3. Within the same calendar year, the same enterprise may not apply for project support simultaneously as both the commissioning party and the commissioned party.
(II) Application Materials
1. Basic Application Materials (see Article 20)
2. Audited financial reports for the two years prior to the application;
3. Contract or agreement for commissioned manufacturing
4. Supporting documents such as payment or accounting vouchers evidencing the fulfillment of the contract or agreement;
5. Proof of approval documents for drug marketing authorization or medical device registration;
6. Proof and written commitment that there is no investment relationship between the commissioning party and the commissioned party.
Article 8 (Encouraging the Promotion and Application of First-of-a-Kind Equipment)
Support is provided for the promotion and application of first-of-a-kind high-end medical devices and their core components. Upon evaluation and approval, based on the signed procurement and usage agreement for the first-of-a-kind technical equipment, a subsidy of up to 30% of the market price, with a maximum of 5 million yuan, will be granted.For specific implementation of this project, please refer to the "Implementation Rules for Special Support for the Promotion and Application of Enterprises' First-of-a-Kind Major Technical Equipment in Songjiang District" (Hu Song Jing [2019] No. 62) and subsequent relevant policies; the project execution period may be appropriately extended.
Article 9 (Encouraging Participation in National Centralized Procurement)
(1) Support Conditions and Standards
Support is provided to biopharmaceutical enterprises participating in national centralized procurement. For drugs or medical devices selected for the first time, a reward of up to 3% of the actual transaction amount of the first centralized procurement contract, with a maximum of 1 million yuan, will be granted. The annual maximum reward for a single enterprise is 2 million yuan.
(2) Application Materials
1. Basic Application Materials (see Article 20)
2. Supporting documents related to winning the national drug centralized procurement bid;
3. Procurement contracts, proof of payment for procurement, accounting vouchers, and other relevant materials.
Article 10 (Encouraging Enterprise Scaling)
(1) Eligibility Criteria and Standards
Biopharmaceutical enterprises whose annual main business revenue exceeds 50 million yuan, 100 million yuan, or 500 million yuan for the first time shall be awarded up to 200,000 yuan, 500,000 yuan, or 1 million yuan, respectively. Upon advancing to a higher annual main business revenue tier, the difference in support funds shall be supplemented.
(2) Application Materials
1. Basic application materials (see Article 20);
2. Audited financial reports for the two years prior to the application.
Article 11 (Support for Drug R&D)
(1) Eligibility Criteria and Standards
1. For innovative drugs (including Class 1 traditional Chinese medicines, Class 1 chemical drugs, and Class 1 biological products) that have completed Phase I, II, or III clinical trials in China, support of up to 3 million yuan, 5 million yuan, or 10 million yuan, respectively, will be provided based on 30% of the verified R&D investment for clinical trials. The maximum annual support per enterprise is 20 million yuan.
2. For improved new drugs (including Class 2 traditional Chinese medicines, Class 2 chemical drugs, Class 2 biological products, and biosimilars) that have completed Phase I, II, or III clinical trials in China, support of up to 1 million yuan, 2 million yuan, or 3 million yuan, respectively, shall be provided based on 15% of the verified R&D investment for the clinical trials. The maximum annual support per enterprise is 8 million yuan.
(II) Application Materials
1. Basic Application Materials (see Article 20)
2. Supporting documents such as clinical trial approval documents or notifications;
3. Clinical trial research reports, drug clinical trial approval documents issued by the ethics committee, records of communications with the National Medical Products Administration (NMPA), and other materials related to clinical trials;
4. Contracts signed between the applicant enterprise and the clinical trial institution, along with payment vouchers;
5. Specialized audit report on R&D expenditures for the clinical trial;
6. Supporting documents evidencing the acquisition of investment and financing.
Article 12 (Support for Enhancing Drug Commercialization Capabilities)
(1) Eligibility Criteria and Standards
1. Enterprises that have newly obtained drug registration approvals and achieved industrialization shall receive support equivalent to 3% of the previous year’s sales revenue for that drug. Specifically, enterprises obtaining registration approvals for innovative drugs shall receive up to 3 million yuan in support; those obtaining registration approvals for modified new drugs, generic drugs, modified biological products, and biosimilars shall receive up to 1 million yuan in support.
2. Enterprises obtaining a pharmaceutical production license for the first time shall be granted a reward of up to 1 million yuan.
3. For enterprises that change the address listed on their drug registration certificate to Songjiang District, a reward of up to 500,000 yuan will be granted if the drug’s sales revenue in the district for the previous year was 20 million yuan or more; a reward of up to 300,000 yuan will be granted if the drug’s sales revenue in the district for the previous year was between 10 million yuan and 20 million yuan. For a single drug, only one change-of-address reward will be granted, regardless of whether the change involves the production or registration address. The maximum annual reward for a single enterprise is 5 million yuan.
(II) Application Materials
Sub-item 1: Obtaining a Drug Registration Certificate and Commercialization
1. Basic Application Materials (see Article 20)
2. Drug registration approval documents, supplementary registration approval documents, etc.;
3. Drug Manufacturing License;
4. Specialized audit report on sales revenue.
Sub-item 2: Obtaining a Drug Manufacturing License
1. Basic application materials (see Article 20)
2. Drug Manufacturing License;
Subitem 3: Change of Address for Drug Registration Approval
1. Basic Application Materials (see Article 20)
2. Supporting documents related to the change of address on the drug registration approval;
3. Specialized audit report on sales revenue.
Article 13 (Encouraging the Conduct of Bioequivalence Evaluations for Generic Drugs)
(1) Eligibility Criteria and Standards
For the first drug nationwide to pass the generic drug quality and efficacy equivalence evaluation, support of 30% of the actual R&D investment, up to a maximum of 2 million yuan, will be provided. For other drugs that pass the generic drug quality and efficacy equivalence evaluation, support of 30% of the actual R&D investment, up to a maximum of 1.5 million yuan, will be provided. The maximum annual support per enterprise is 4 million yuan.
(2) Application Materials
1. Basic Application Materials (see Article 20)
2. Approval documents issued by the National Medical Products Administration (NMPA) upon passing the bioequivalence evaluation;
3. Specialized audit report on R&D expenditures.
Article 14 (Encouraging the Enhancement of Medical Device R&D and Production Capabilities)
(1) Eligibility Criteria and Standards
1. For newly obtained Class II medical device registration certificates that have been commercialized, a subsidy of 3% of the device’s sales revenue from the previous year will be provided, up to a maximum of 500,000 yuan; for newly obtained Class III medical device registration certificates that have been commercialized, a subsidy of 5% of the device’s sales revenue from the previous year will be provided, up to a maximum of 1,500,000 yuan.For medical devices that have newly obtained a registration certificate through the national or municipal special approval procedure for innovative medical devices, a subsidy of 5% of the device’s sales revenue from the previous year, up to a maximum of 2 million yuan, shall be provided.
2. For entities obtaining a Class II or Class III medical device manufacturing license for the first time, support of 100,000 yuan and 300,000 yuan, respectively, will be provided. For entities upgrading from a Class II to a Class III medical device manufacturing license, if they have previously received support under this program, the corresponding difference in support will be provided.
3. Enterprises that transfer the address of their medical device registration certificate to Songjiang District and achieve industrialization will receive a reward equal to 3% of the previous year’s sales revenue for that medical device within the district. Specifically, enterprises transferring the address of a Class III medical device registration certificate to Songjiang District will receive a reward of up to 500,000 yuan; those transferring the address of a Class II medical device registration certificate to Songjiang District will receive a reward of up to 200,000 yuan.
4. The maximum annual support per enterprise is 5 million yuan.
(II) Application Materials
Sub-item 1: Obtaining a Medical Device Registration Certificate and Achieving Industrialization
1. Basic application materials (see Article 20);
2. Medical device registration certificate and medical device production product registration form;
3. Specialized audit report on sales revenue.
Sub-item 2: Obtaining a Medical Device Manufacturing License
1. Basic application materials (see Article 20);
2. Medical Device Manufacturing License and Medical Device Product Registration Form.
Subitem 3: Change of Address on the Medical Device Registration Certificate
1. Basic application materials (see Article 20);
2. Supporting documents related to the change of address on the Medical Device Registration Certificate;
3. Specialized audit report on sales revenue.
Article 15 (Encouraging Innovative Drugs and High-End Medical Devices to Obtain International Certification)
(1) Application Requirements and Standards
For innovative drugs and high-end medical devices independently developed by enterprises that have obtained registration from international organizations such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), CE (European Union), WHO (World Health Organization), or PMDA (Pharmaceuticals and Medical Devices Agency of Japan), support of up to 2 million yuan will be provided based on the actual certification costs incurred. The maximum annual support per enterprise is 5 million yuan.
(2) Application Materials
1. Basic Application Materials (see Article 20)
2. Registration or certification service commission agreements, proof of payment for service fees, etc.;
3. Domestic registration approval documents and relevant overseas registration or certification supporting materials.
Article 16 (Encouraging Post-Market Re-evaluation of Innovative Products)
(1) Support Conditions and Standards
1. Support will be provided to biomedical enterprises that lead collaborations with hospitals, universities, research institutes, and other institutions to conduct post-market clinical re-evaluation studies, clinical trials for new indications, or real-world studies on innovative drugs that have obtained registration approvals. Projects that secure registration approvals for new indications or submit clinical summary reports will receive support equivalent to 25% of the project’s R&D costs, up to a maximum of 1 million yuan;
2. Support will be provided to biomedical enterprises that lead local hospitals, universities, research institutes, and other institutions in conducting clinical demonstration application studies or post-market re-evaluation studies on innovative medical devices that have obtained production licenses. Projects that develop product optimization plans will receive support equivalent to 25% of the project’s R&D costs, up to a maximum of 500,000 yuan.
(II) Application Materials
Sub-item 1: Post-Marketing Re-evaluation of Innovative Drugs
1. Basic application materials (see Article 20);
2. Drug registration approval documents, production licenses, and registration approval documents following the addition of new indications;
3. Supporting documents such as post-marketing study summary reports and research findings;
4. Specialized audit report on R&D expenditures.
Subitem 2: Post-market Re-evaluation of Medical Devices
1. Basic application materials (see Article 20);
2. Medical device registration certificate, manufacturing license, and medical device product registration form;
3. Supporting documentation such as post-market study summary reports and research findings
4. Specialized Audit Report on R&D Expenditures.
Article 17 (Encouraging the Strengthening of Platform Development)
(1) Eligibility Criteria and Standards
1. Support will be provided for the construction of public service platforms such as third-party testing facilities, GLP laboratories, and GMP laboratories serving the pharmaceutical and medical device sectors. Upon approval, funding of up to 5 million yuan will be provided, not exceeding 30% of the project’s fixed-asset investment.
2. Support will be provided to Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), Contract Development and Manufacturing Organizations (CDMOs), Contract Registration Agencies (CRAOs), third-party testing agencies, and post-marketing research service providers that offer specialized services to biopharmaceutical enterprises. Support will be provided at 5% of the verified actual service amount, with a maximum annual support of 1 million yuan per enterprise.
(II) Application Materials
Sub-item 1: Platform Fixed Asset Investment
1. Basic application materials (see Article 20);
2. Project-related approval documents or certification materials;
3. Specialized audit report on fixed asset investment related to the project.
Sub-item 2: Platform Expansion Services
1. Basic application materials (see Article 20);
2. Specialized audit report on service revenue.
Article 18 (Encouragement for Applying to National or Municipal Major Special Programs)
(1) Support Conditions and Standards
Support is provided to biopharmaceutical enterprises in this district for applying to national and Shanghai municipal major projects related to industrialization in the biopharmaceutical sector of strategic emerging industries, as well as national and Shanghai municipal advanced manufacturing innovation center projects. For projects receiving national or municipal financial support, matching funds will be provided at a ratio of up to 1:1 based on the actual amount of support received, with a maximum of 5 million yuan for national projects and 2 million yuan for municipal projects.Funds will be disbursed in batches corresponding to the disbursement schedule of national and municipal financial support. In principle, 50% will be disbursed upon project approval, and the remaining 50% will be disbursed after project acceptance.
(2) Application Requirements
1. Basic Application Materials (see Article 20)
2. Contracts, approval documents, and other relevant materials regarding major industrialization projects approved by national or municipal competent authorities;
3. Disbursement vouchers from relevant national and municipal departments.
Chapter III Project Management
Article 19 (Project Application)
The District Economic Commission generally issues an application notice once a year, specifying detailed requirements such as application and acceptance procedures.
Article 20 (Basic Application Materials)
When applying for a project, the applicant enterprise must submit the following basic application materials:
1. Project Application Form (to be completed online; after passing the preliminary review, print the form from the website and have it stamped by the sub-district or township);
2. Sub-district/Town Recommendation Form (to be printed online after approval by the sub-district/town and stamped by the sub-district/town);
3. Project Application Report;
4. Business license of the applying enterprise;
5. Latest credit report issued by the Credit Information Center (issued within two months prior to the project application start date);
6. Financial audit report for the previous fiscal year;
7. Other supporting documents as required.
Applicant enterprises shall log in to the “Songjiang District Industrial Development Special Fund Supervision Platform” and submit application materials in accordance with the requirements of the application notice.
Article 21 (Project Evaluation)
The District Economic Commission shall conduct a centralized review of the submitted application materials. Depending on the category of the project application, it shall organize expert reviews in conjunction with relevant departments or entrust a third-party institution to organize expert reviews, and determine the proposed projects to be supported and the amount of support based on the review results.
Article 22 (Project Announcement)
The District Economic Commission shall publicly announce information regarding the proposed supported projects.
Article 23 (Fund Disbursement)
Upon the conclusion of the public notice period without any objections, the District Economic Commission shall disburse funds to the enterprises selected for support.
Article 24 (Fund Management)
Support funds shall be shared by the district-level government and the sub-district/town (development zone) governments in a 7:3 ratio.
Article 25 (Penalties for Violations)
If an applicant enterprise is found to have obtained support funds through fraudulent means or other improper methods, all eligibility for support shall be immediately revoked and the funds recovered upon verification. In cases of serious violations, legal liability shall be pursued in accordance with the law. Acts of dishonesty shall be recorded in the public credit information database in accordance with relevant regulations.
Chapter IV Supplementary Provisions
Article 26 (Miscellaneous)
(1) Except for Article 5 (Encouraging the Introduction of Major Projects), Article 6 (Encouraging Industrial Upgrading), and Article 8 (Encouraging the Promotion and Application of First-of-a-Kind Equipment), an enterprise may apply for only one support project in the same year.
(2) Biopharmaceutical enterprises that meet the criteria of this policy may enjoy the preferential policies of Songjiang District regarding science and technology, talent, headquarters economy, and industrial parks in addition to the aforementioned policies. However, if there are identical or overlapping provisions, support shall be provided in accordance with the principle of selecting the most favorable option.
(3) Key projects that play a significant role in driving the development of the biopharmaceutical industry in Songjiang District may be granted priority support and assistance on a case-by-case basis, depending on the circumstances.
Article 27 (Interpretation)
The Songjiang District Economic Commission shall be responsible for interpreting these Implementation Rules.
Article 28 (Effective Date)
These Rules shall take effect on September 4, 2022, and remain valid for three years. The original "Implementation Rules for Several Policies on Accelerating the High-Quality Aggregation and Development of the Biopharmaceutical Industry in Songjiang District" (Hu Song Jing Gui [2021] No. 2) is hereby repealed. Should new policies or regulations be issued by the central government, Shanghai Municipality, or Songjiang District during the implementation process, such new policies or regulations shall prevail.
