Several measures to promote the development of medical and health industry in Daxing District (revised in 2022)
For the implementation of the general office of the Beijing municipal people's government about the Beijing to speed up the medical health collaborative innovation action plan (2021-2023) notice (Beijing ZhengBan hair [2021] 12) job requirements, continue to promote the development of innovative medicine and accelerate the medical equipment industry technology innovation, promote the development of medical health industry integration, actively undertake Beijing and global scientific and technological innovation, seize daxing unique opportunities, attract domestic and international high quality resources, realize daxing district pharmaceutical health industry high quality cluster development, formulates this measure.
Chapter I: General Provisions
This measure applies to enterprises, institutions, social organizations, private non-enterprises and other institutions engaged in the field of medicine and health. Focus on supporting the research and development of new targets, new mechanisms, new structures and new technologies in the field of innovative drugs; supporting the research and application of frontier key technologies in the field of life science; supporting the rapid development of the field of medicine and health, artificial intelligence, big data and 5G emerging technologies; supporting the construction and development of third-party professional service platforms; supporting the establishment of innovative clinical research centers, and establishing the multi-party collaborative innovation model for medical research enterprises.
Chapter II Supporting the implementation of innovation resources
Article 1 To support the implementation of major achievements and innovative resources.
1. For a major breakthrough in the field of medical health industry, with international level leading talent team, have the introduction of international leading level technology and varieties, has a certain scale investment conditions of enterprise or project landing, according to the project fixed assets (except real estate, land and personnel) 30% of the total investment in stages, a single project does not exceed 300 million yuan.
2. For all kinds of functional rooms such as office, research and development, production and leasing with legal compliance procedures, the maximum financial support of 50% of the 50% of the previous year and the maximum shall not exceed 50% of the guiding rent price of the area.
Chapter III Supporting innovation, research and development experiments
Article 2 Support the innovation and development of new drugs and devices. New drugs undergoing clinical trials and transformation will be supported in stages according to their research and development progress.
3. For class I chemical drugs, Class I biological products and class I Traditional Chinese medicine, up to 10 million yuan, 20 million yuan and 40 million yuan will be given according to the completion of phase I, phase and phase clinical trials, and the maximum annual support for a single enterprise shall not exceed 100 million yuan.
4. For class II chemical drugs, Class II biological products (excluding in vitro diagnostic reagents) and Class II Traditional Chinese medicine, up to 3 million yuan, 8 million yuan and 18 million yuan shall be given according to the completion of phase I, phase and phase clinical trials respectively, and the maximum annual support for a single enterprise shall not exceed 30 million yuan.
5. For the completion of clinical trials of category III medical devices approved for inclusion in the national medical device innovation or priority approval channel, a financial support of up to RMB 3 million will be given. For other type III medical devices that complete clinical trials, a financial support of up to 1 million yuan shall be given.
Chapter IV Supporting the transformation of innovation achievements
Article 3 Support obtaining the registration certificate.
6. For three years of drug registration approval documents and has implemented the industrialization project, the national class of new drugs each approval documents for one-time 10 million yuan, national class new drugs each approval documents for 5 million yuan, other class each approval documents for one-time 3 million yuan, the same enterprise annual highest support does not exceed 20 million yuan.
7. For the first imitation drugs (chemical drugs and biological products) for the treatment of major diseases, for the projects that have obtained the drug registration approval within three years and have implemented industrialization, a one-time financial support of 3 million yuan will be given for each approval document.
8. For the third-class medical device products that have obtained the medical device registration certificate within three years and have implemented industrialization, a one-time financial support of RMB 2 million yuan shall be given for a single variety, and the maximum annual support for a single enterprise shall not exceed RMB 5 million yuan.
9. For the third class of medical device products that have passed the national special examination procedure for innovative medical devices, the medical device registration certificate obtained within three years and has been industrialized, each license shall be given a one-time financial support of RMB 3 million.
Article 4 Support the commissioned production and sales of the products.
10. For the drug marketing authorization holder or medical device registrant, who entrust a bio-pharmaceutical enterprise to produce the products held by it, a maximum of 5 million yuan shall be given according to 10% of the actual transaction amount of the product, and the maximum annual support for a single enterprise shall not exceed 20 million yuan.
11. For biomedical enterprises that undertake production in accordance with the drug marketing authorization holder system and the medical device registrant system, they shall support 10% of the actual input cost, and the maximum support for each variety shall not exceed 15 million yuan, and the maximum annual support for a single enterprise shall not exceed 30 million yuan.
12. Encourage biomedical sales platform enterprises to undertake the sales of innovative products, and provide an annual financial support of no more than 20 million yuan according to 2 ‰ of the sales revenue.
Article 5 Support the development of cross-integrated new forms of business.
13. Support the application projects of artificial intelligence in the whole industrial chain in the medical field. Support digital future trend projects of digital health, support digital application scenarios in the biomedical industry, including digital acceleration of innovation and development, intelligent management of clinical trials, digital transformation of production processes, etc. Support "Internet + medical treatment", covering online consulting, telemedicine, online pharmacy, Internet hospitals, digital application of clinical information collection and other projects. Support the cross-integration project of medical and industry, including AI-assisted image recognition and diagnosis, precision minimally invasive surgical robot, absorbable and dissolved biological materials, 3D printing and biomimetic, regeneration, and creative tissue repair, etc.
The above projects will be supported by 20% of the actual total investment of the project (except real estate, land and personnel), and each project will be supported by a maximum of 10 million yuan.
Chapter V Supporting the industry to become bigger and stronger
Article 6 Supporting the growth and development of enterprises.
14. For pharmaceutical enterprises whose main business income reaches more than 500 million yuan (including) in the previous year, the support fund shall be 2 ‰ of the main business income, with the maximum not more than 100 million yuan. For the pharmaceutical enterprises whose main business income reached more than 500 million yuan (inclusive) in the previous year and achieved positive growth, financial support will be given according to 3 ‰ of the increment of the main business income of the previous year.
15. For the enterprises that have been supported by the national and municipal special funds in the previous year, the supporting funds shall be provided according to 1:1 and 1:0.5 respectively. The annual matching quota of enterprises with national special support shall not exceed 10 million yuan, and the annual matching quota of enterprises with municipal special support shall not exceed 5 million yuan.
16. For pharmaceutical enterprises with annual output value of single variety products exceeding 500 million yuan, 10 billion yuan and 2 billion yuan for the first time, give one-time support of 2 million yuan, 5 million yuan, 5 million yuan and 10 million yuan respectively.
17. Support and encourage enterprises to carry out evaluation of consistent quality and efficacy of generic drugs and evaluation of biosimilar drugs, and give one-time financial support of RMB 1 million to the varieties that have passed the evaluation and are selected in the national centralized drug procurement.
Article 7 Support domestic and foreign qualification certification.
18. Through the US Food and Drug Administration (FDA), European Drug Administration (EMA), Japan pharmaceutical and medical device administration (PMDA), the World Health Organization (WHO), international drug certification cooperation organization (PIC / S) direct registration and other international authoritative certification of drugs and medical devices (only medical devices three categories), each product to give one-time 1 million yuan, a single enterprise shall not exceed 10 million yuan.
19. For the first time, the international Laboratory Animal Assessment and accreditation Committee (AAALAC), the World Health Organization (WHO), the Ethics Committee of the Asia-Pacific region (FERCAP / SIDCER), the American Association for human Research Protection Project Certification (AAHRPP), 20% of the actual certification fee, the maximum is not more than 2 million yuan. The maximum of a single enterprise shall not exceed 10 million yuan per year.
20. Support shall be given to enterprises or institutions that have obtained the Quality Management Practice for Drug Non-clinical Studies (GLP), the National Code for Quality Management of Drug Clinical Trial (GCP), the National Accreditation Service for Conformity Assessment (CNAS) and the Qualification of National Inspection and Testing Institutions (CMA). RMB 2 million will be supported for the GLP certification project; clinical medical institutions with GCP certification will be supported up to 40% of the total project investment; an additional RMB 500,000 million; the cumulative amount of each unit shall not exceed RMB 10 million. For those who have obtained CNAS certification for the first time, one-time support will be given according to 20% of the actual amount of equipment purchased by the project unit, and the maximum financial support shall not exceed 1 million yuan. For the enterprises or institutions that have obtained the qualification of national inspection and testing institutions (CMA) for the first time, one-time support shall be given at 20% of the actual amount of equipment purchased by the project unit, with the maximum not exceeding RMB 1 million.
Chapter VI Supporting the building of an innovation ecology
Article 8 Strengthen financial investment support.
21. Establish a special fund for the transformation of scientific and technological achievements, mainly invested in the medical and health industry. The special fund shall not hold any more than 30% of the investment project or the total share capital of the enterprise. The special fund mainly introduces and supports the research and development of biomedical innovation projects, biomedical start-ups and high-growth enterprises and key projects.
22. Encourage social capital to participate in investment, and provide guide funds exceeding 30% of the fund size for venture capital funds and private equity funds that invest in medical devices and biomedical projects.
23. For pharmaceutical enterprises with loans or financial lease projects of more than 3 million yuan (including) in the previous year, the discount interest rate of no more than three years and no more than 5 million yuan at the maximum more than RMB 5 million yuan per year.
Article 9 To support the development and construction of innovation platforms.
24. Support the contract research and development institutions (CRO), contract outsourcing production organization (CMO), contract custom research and development production institutions (CDMO) development, to provide drug screening, drug synthesis, pharmacological toxicology, research, effectiveness evaluation, experimental animal service, new drug clinical research registration application service, post-marketing clinical research services, pharmaceutical industrial waste treatment, pharmaceutical intellectual property transactions and other professional technology, public service platform, according to the review, 20% of the actual service amount support, maximum does not exceed 10 million yuan a year, not more than three years.
25. Support the construction of clinical medical research centers. We will support enterprises, universities and relevant institutions to cooperate in cooperation to build clinical medical research centers, carry out international multi-center clinical trials, build clinical sample resource database, health big data platform, and clinical evaluation platform for drugs and medical devices. Support will be given according to the proportion of 50% of the actual total investment of the project (except for real estate, land and personnel), and the amount of support shall not exceed 30 million yuan.
26. Support the construction of the national offshore innovation and entrepreneurship base for overseas talents, and encourage the offshore innovation center to introduce international projects and talent teams in the base.
Article 10 Support and encourage the application of innovative drugs and devices.
27. Actively assist pharmaceutical and health enterprises to produce innovative drugs, innovative medical devices and major generic drugs that meet the access conditions into the centralized drug procurement record catalogue.
28. Actively assist in promoting the entry of innovative drugs, innovative medical devices and major generic drugs with intellectual property rights into the medical insurance list.
29. Encourage medical institutions to purchase innovative products that have been included in the centralized drug procurement list.
30. Encourage medical institutions to purchase the first set (set) of medical devices recognized by the relevant urban departments.
Chapter VII Supplementary Provisions
31. The enterprises supported by this measure shall follow the principle of good faith and the spirit of contract. At the same time, in line with other policies and provisions of Daxing District, it shall be supported according to the principle of "selecting the best, not repeating", except as otherwise stipulated.
32. The measures are interpreted and implemented by the District Science and Technology Commission. This measure shall come into force as of the date of its promulgation. After the implementation, the original "Daxing District Measures to promote the Development of medical and Health Industry (Trial)" (Jingxing Kefa [2021] No.28) policy was abolished. During the implementation period, if the relevant policies of the state and Beijing change, adjustments will be made accordingly.