Chapter I General Provisions
Article 1 In order to promote the development of biomedicine and health industry in our region and to create a national innovative industrial cluster, according to the "Opinions of the People's Government of Guangdong Province on Cultivating and Developing Strategic Pillar Clusters and Strategic Emerging Industrial Clusters" (Guangdong Provincial Government Letter [2020] No. 82), "A Number of Policies and Measures on Promoting the Innovative Development of Biomedicine" ( Guangdong Science and Social Character [2020] No. 86), "Guangdong Province Development of Biomedicine and Health Strategic Emerging Pillar Industry Clusters Action Plan (2021-2025)" (Guangdong Science and Social Character [2020] No. 218) and other relevant documents, and based on the spirit of "Zhongshan Torch Development Zone Industry Support Special Funds Management Measures (Zhongkai Management [2023] No. 15), the formulation of this approach.
Article 2 The biomedicine and health industry referred to in these measures refers to the biomedicine and health industry and service industry in line with the guidance of industrial development in our region. Biomedicine and health industry, including chemical drugs, traditional Chinese medicine, biological raw materials and preparations, synthetic biology products, medical devices (including diagnostic reagents), animal drugs, cosmetics, as well as health food and special medical use formulations production and manufacturing industry; biomedicine and health services, including pharmaceuticals, medical devices (including diagnostic reagents), cosmetics, health food and special medical use formulas R & D The biopharmaceutical and health services industry includes pharmaceuticals (including diagnostic reagents), medical devices, cosmetics, health food and special medical formulas R&D and production services, sales and logistics distribution services, third-party medical testing services, life resource sample storage services, medical services, public technology and testing services, registration and reporting services, and business incubation services.
Article 3 of the special funds referred to in this approach refers to the annual budgetary arrangements by the district finance to support the introduction of the project, project research and development and industrialization, the construction of public service platforms, qualification certification and medical-industrial integration of the development of special funds.
Chapter II key industrial projects landing support
Article 4 for the new introduction of biomedical and health industry projects, to give the project settlement, start-up capital, equipment investment subsidies, rental subsidies and other support, the specific standards are as follows:
(a) for the world's top 500, China's top 500 and China's top 100 pharmaceutical industry, domestic and foreign listed companies, the pharmaceutical industry, the top 100 enterprises. (a) For the world's top 500, China's top 500 and China's top 100 pharmaceutical industry, domestic and foreign listed companies to settle in our region's domestic headquarters, were given a maximum of not more than 50 million yuan, 30 million yuan, 20 million yuan subsidies; above the provincial level, the regional headquarters to settle in our region, were given a maximum of not more than 20 million yuan, 10 million yuan, 5 million yuan subsidies.
(B) for the new introduction of doctoral and above high-level talents and teams of biomedicine and health industry projects, settled 1 year before the settlement to the settlement of 2 years to get the China Securities Investment Fund Industry Association filed market-oriented venture capital institutions 10 million yuan and above investment (not counting the part of the Zhongshan City, the District Financial Equity Investment Fund contribution), and paid-up registered capital amounted to 10 million yuan and above the project The maximum amount of reward will not exceed 50% of the actual amount of risk investment, with a maximum of 5 million yuan for each project.
(C) for the new introduction of our region with independent legal personality of the pharmaceutical business, distribution enterprises, paid registered capital of not less than 10 million yuan, since the date of settlement within two years of the cumulative realization of not less than 5 million U.S. dollars in the pharmaceutical import business, to give the project registration and settlement of 10% of the paid registered capital of the settlement of the two years of support (foreign currency funds in accordance with the People's Bank of China on the date of the input of the benchmark exchange rate converted), up to a maximum of The maximum amount is not more than 5 million yuan.
(D) merit support for new settlement of total investment of 100 million yuan and above and has its own core intellectual property rights of the biomedical and health industry projects, the project has been completed within three years of the settlement of total investment in fixed assets in the 30 million yuan and above, according to the amount of investment in fixed assets has been completed (excluding the cost of land acquisition) of 10% of the subsidies, the maximum of not more than 50 million yuan.
For the above (b) (c) (d) items in the biomedical and health industry leasing projects, as well as access to the city's biomedical and health industry special transitional housing subsidies for the establishment of the project and in line with the scope of support of these measures, to give a maximum of not more than 50% of the actual rent paid rent subsidies. The maximum amount of rental subsidy for a single project in our region within a 12-month period shall not exceed RMB 2 million, and the subsidy shall be granted for a maximum period of 36 months. If a project also receives a special rental subsidy for the city's biomedical and health industry, the rental subsidy at the city and district levels shall not exceed the amount of the project's actual rental expenditure.
The settlement time of newly-introduced projects is based on the time when the business license is first registered in the district. The same project can not be declared at the same time the above (a) (b) (c) support content, in accordance with the "higher not lower" principle, choose one of the declaration.
Article V for the settlement of our region to carry out a class of new drugs, three types of medical devices industrialization of biomedicine and health industry enterprises for the first time to apply for the purchase of land to implement the production of products, capital expansion, from the date of the enterprise to obtain a class of new drugs certificate, certificate of registration of the three types of medical devices within 36 months of the cumulative total of more than 100 million yuan in the main business income, the maximum award of five million yuan; 36 months within the main business income of more than 500 million yuan, the maximum award of five million yuan; 36 months within the main business income of more than 500 million yuan. If the cumulative revenue exceeds 500 million yuan within 36 months, the maximum reward will be 8 million yuan; if the cumulative revenue from the main business exceeds 800 million yuan within 36 months, the maximum reward will be 10 million yuan.
The above enterprises must be drug marketing license holders or medical device registrants, and sales settlement in our region.
Chapter III Public Service Platform Support
Article 6 For the biomedicine and health industry public service platform to carry out technological research and development, testing and inspection, precision medicine research, biomedicine and medical device business incubation, registration and declaration services and other businesses, the district economic and science and technology departments corresponding to the higher level of the business department identified or recognized as key development by the If the public service platform of biomedicine and health industry is recognized as the key development by the evaluation of our district organization, it will be supported by subsidies for rent, construction fee and operation fee on the basis of merit. Specific support standards are as follows:
(a) to give the platform to rent operating space to pay the actual rent subsidy, such as the platform has been obtained in Zhongshan City, biomedicine and health industry special rental support, then deducted the amount of relevant support has been obtained, to give the difference in part of the subsidy. A single platform in the 12-month cycle of rent subsidies up to 3 million yuan, subsidies up to 36 months.
(ii) Subsidies will be provided at 30% of the actual construction cost (including indoor decoration and purchase of instruments and equipment) of the platform project, and the actual construction cost must be more than 10 million RMB and the proportion of instrument and equipment input must not be less than 60%, and the maximum subsidy for each platform shall not be more than 20 million RMB.
(3) For the key development service platform, the operation subsidy will be given for a maximum of three years, and the full amount of the actual annual operating costs of the platform will be subsidized, with the maximum annual subsidy for a single platform project not exceeding 2 million yuan.
Article 7 supports the construction of biopharmaceutical contract manufacturing and contract development and production service platform (CMO/CDMO), and gives the following subsidies for leasing fees and service fees:
(a) For leasing platforms, each platform is given a rental subsidy of 60% of the site and instrument and equipment leasing for a maximum of 36 months, and the subsidy is limited to a maximum of 3 million yuan in a 12-month cycle.
(ii) for the annual business income of 5 million yuan and above platform, according to its external acceptance of the business of the main body of the previous year for the region and outside the enterprise (there is an investment relationship between the business acceptance of the main body of the main body of the business and the business of the main body of the business of the business of the main body of the business of the service amount of 10% to be subsidized, the maximum amount of a single enterprise not to exceed 5 million yuan per year, each platform funding for a maximum of no more than 3 years.
Article VIII of the aforementioned rental subsidy calculation standards for site rental subsidies up to 60 yuan / square meter - month. If the actual amount of invoices provided is less than the maximum subsidy standard, according to the actual amount of subsidies; instrument and equipment leasing subsidy standard in the 12-month cycle up to 10% of the original value of the leased instruments and equipment.
Chapter IV R & D and industrialization support
Article IX to support the project R & D and industrialization, the specific standards are as follows:
(a) in accordance with China's drug registration classification of each 1 class of traditional Chinese medicines, chemical medicines, biological products (except for diagnostic reagents managed by the pharmaceutical industry), in accordance with the actual R & D investment of 50% to give Subsidies: up to 8 million RMB for obtaining clinical approvals; up to 10 million RMB, 20 million RMB, and 30 million RMB for completing Phase I, II, and III clinical trials, respectively.
According to China's drug registration classification, subsidies are given to each Class 2 Chinese medicine, chemical medicine, and biological product (except diagnostic reagents managed as pharmaceuticals) in accordance with 50% of the actual R&D investment: up to 4 million RMB for obtaining clinical approvals; and up to 5 million RMB, 10 million RMB, and 15 million RMB for completing Phase I, II, and III clinical trials, respectively.
Our region's enterprises through the purchase or transfer of 1, 2 types of new drugs to obtain clinical approvals (for the record) results and to carry out phase I, II or III clinical trials of the project, without the need to provide proof of the actual R & D investment, 1, 2 types of new drugs were given directly to the preclinical research of 8 million yuan, 4 million yuan subsidies.
(ii) the drug marketing license holder to obtain a new drug certificate and the implementation of the production and sales settlement in our region, the 1 type of new drugs to give 10 million yuan to support, 2 types of new drugs to give 5 million yuan to support; to obtain a new drug certificate and sales settlement in our region, the 1 type of new drugs to give 6 million yuan to support, the 2 types of new drugs to give 3 million yuan to support.
(C) in accordance with national regulations through the consistency evaluation of generic drugs in our region production and sales settlement of drugs (different specifications are considered as a variety), to give consistency evaluation of the research cost of 50% of the one-time funding, each variety of funding up to 2 million yuan; the country's top three through the consistency evaluation of generic drugs, each variety of funding up to 3 million yuan.
(D) in accordance with the Chinese medical device registration classification, the enterprise product for the first time to obtain three types of medical device registration certificate (excluding diagnostic reagents) and achieve sales, to give each variety of the highest not more than 3 million yuan of support; for the entry into the country's innovative medical device special review process or medical device priority approval process for the registration certificate of the three types of medical devices, each variety of an increase of 2 million yuan of support. For enterprises to obtain the registration certificate of Class III medical devices (excluding diagnostic reagents) through purchase or transfer and realize sales, a maximum of no more than 1.5 million yuan support for each variety. For the enterprise product for the first time to obtain the registration certificate of the three types of diagnostic reagents and realize sales, to give each variety of the highest not more than 1 million yuan of support. The amount of funding for each project does not exceed 50% of the actual R&D investment or actual purchase cost of a single project.
(E) for the first time to obtain the State Drug Administration issued a special medical use of formula food approvals, each variety of up to 800,000 yuan funding; the first time to obtain health food, special cosmetic registration approvals, each variety of up to 200,000 yuan funding. To obtain the certificate of registration of new veterinary drugs and the implementation of production and sales settlement in our region, one, two, three categories of new veterinary drugs each given 1 million yuan, 600,000 yuan, 400,000 yuan one-time funding. The amount of funding for each project does not exceed 50% of the actual R&D investment in a single project.
For special medical use formula food, health food, special cosmetics, new veterinary drug funding, a single enterprise funding up to 3 million yuan per year; for medical devices (including diagnostic reagents) funding, a single enterprise funding up to 50 million yuan per year; for pharmaceutical funding, a single enterprise funding up to 100 million yuan per year.
Article 10 Encourage enterprises to actively participate in the national and provincial centralized purchasing of medicines and equipment to expand the market, the winning varieties of the total bid price of 3% to be rewarded, the maximum award for a single variety of up to 3 million yuan, the maximum annual funding for a single enterprise not more than 5 million yuan.
Article 11 Enterprises applying for the support of the above Article IX and X, must commit to 10 years of registration and office address does not move away from our region, does not change the tax obligations in our region, does not reduce the registered capital, and at the same time, committed to the enterprises registered in our region as a pharmaceutical listed licensee and registrant for medical devices, and committed to the implementation of the sale of the enterprise registered in our region to settle.
The drug listing license holder and medical device registrant has the industrialization conditions in principle requires the implementation of production in the region. Failure to implement sales settlement (or production and sales settlement) in our region or implementation of sales settlement (or production and sales settlement) for less than 10 years, shall be fully refunded in accordance with this approach to obtain support funds and pay interest in accordance with the National Center for Interbank Lending authorized to publish the loan market quoted interest rate standards.
Chapter V Licensing and Certification Support
Article 12 For the drug marketing license holders and medical device registrants to support the specific criteria are as follows:
(a) the region's drug marketing license holders (including self-declaration, purchase or transfer) for each obtained and held a drug variety (the variety has passed the consistency evaluation or deemed to have passed the consistency evaluation, different specifications are regarded as the same variety; varieties of traditional Chinese medicine do not require consistency evaluation), and sales in our region amounted to 20 million yuan or more, will be given a reward of 2 million yuan. The maximum total amount of the enterprise's annual reward for this item shall not exceed 10 million yuan. The same variety can not simultaneously enjoy the above Article IX R & D and industrialization support.
(b) for the region's drug marketing license holders and medical device registrants, in our region sales and settlement of pharmaceutical and medical device varieties, a single variety of annual sales revenue of 20 million yuan to 50 million yuan, in accordance with the varieties of sales revenue of 0.3% to give incentives; annual sales revenue of 50 million yuan to 100 million yuan, in accordance with the varieties of sales revenue of 0.4% to give Reward; annual sales revenue of 100 million yuan and above, according to the variety of sales revenue of 0.5% of the award. Each variety of incentives not more than three years, the maximum cumulative incentives do not exceed 100 million yuan.
Article XIII For the first time to obtain a pharmaceutical production license and implementation of the production of enterprises a one-time award of 500,000 yuan; for the first time to obtain a medical device (including diagnostic reagents) production licenses, laboratory animal use permits, laboratory animal production licenses, a one-time award of 300,000 yuan; for the first time to obtain the International Laboratory Animal Assessment and Accreditation Council certification ( AAALAC accreditation) of the enterprise a one-time incentive of 1 million yuan.
The medical institutions in the region that have passed the qualification accreditation of drug clinical trial organizations for the first time will be given a subsidy of RMB 2 million yuan, and an additional subsidy of RMB 500,000 yuan will be given for each new professional qualification accreditation.
Chapter VI Medical-industrial integration support
Article 14 Support for secondary and above comprehensive medical institutions to lease the use of our region's biomedical enterprises independently developed and produced medical instruments and equipment products, to give a maximum of no more than 36 months of instrumentation and equipment leasing cost subsidies, in the 12-month cycle of the subsidies up to more than 2 million yuan and not more than the actual incurred. The maximum subsidy for a 12-month period shall not exceed 2 million yuan and shall not exceed the actual leasing costs incurred. The maximum annual subsidy for each unit is not more than 4 million yuan.
The products used for leasing must be the first (sets) of major technological equipment products or the first (sets) of major technological equipment products in Zhongshan City, which have been supported by national and provincial special funds.
Article 15 support for the second and higher comprehensive medical institutions and biomedical enterprises in our region, scientific research institutions to build biomedical new technologies, new products R & D centers and technology application centers, with reference to the above Article VI of the public service platform standards to give preferential support.
Chapter VII By-laws
Article 16 has been supported by the District's original policy but the period has not expired or the District's relevant meeting resolution to support the project, in accordance with the original support standards and time limit for the implementation of the original period expired.
Article 17 For particularly important biomedical and health industry projects, public service platform projects, the District Management Committee may agree on a separate funding method and amount.
Article 18 The "maximum", "not more than", "not less than", all include this number.
Article 19 of this approach by the District Management Committee is responsible for the interpretation of the specific interpretation of the work undertaken by the District Economic and Science Bureau.
Article 20 These measures shall come into force on January 1, 2023, and shall be valid for three years.
