Some measures to promote the agglomeration development of biomedical industry in Shenzhen

       For implementation Guidance of the general office of the State Council on promoting the healthy development of the pharmaceutical industry  Issued by the State Council Office 2016 11 number ,Focus force,Make up the short plate,Enhance the independent innovation ability of biomedical industry in our city,Cultivate and expand new business forms and new models,Promote the industry to move towards medium and high-end,Promote high-quality economic development,This measure is specially formulated.

Chapter I  General

Article 1 In order to speed up the high-quality development of biomedical industry in Shenzhen,Focus on industry pain points and difficulties,Strive to improve the original innovation ability of the industry,Vigorously promote the transformation of innovative achievements,Actively lay out basic industrial application platforms,Realize the coordinated and dislocation development of industrial parks,Cluster major industrial projects,Build a source of industrial innovation and development with global influence.

Article 2 This measure is applicable to registration in Shenzhen Engaged in pharmaceutical industry with independent legal personality medical apparatus and instruments Research and development in cell and gene fields Production and service enterprises government-affiliated institutions Social organizations or private non enterprise institutions.Focus on supporting chemical drugs in the pharmaceutical field Biological products Traditional Chinese medicine and natural medicine, etc.In the field of medical devices, focus on supporting medical imaging devices Radiotherapy apparatus Medical diagnostic and monitoring instruments Clinical testing instruments Implant interventional instrument Medical rehabilitation apparatus In vitro diagnostic reagents, etc.The cell field focuses on supporting stem cell therapy Cellular immunotherapy, etc.The gene field focuses on supporting gene detection Gene therapy, etc.

Chapter II  Strive to improve the ability of independent innovation

Article 3 For new drugs that have carried out clinical trials in China and transformed in our city,It will be funded in stages according to its R & D progress.

   On the first1Class chemicals 1Biological products 1Traditional Chinese medicine and natural medicine,According to the actual R & D expenses40%Grant funding Obtaining clinical approval,Give up to800 10000 yuan subsidy completeI II III Of phase I clinical trials,Respectively up to1000 ten thousand 2000 ten thousand 3000 Ten thousand yuan,The maximum annual subsidy of a single enterprise shall not exceed1 RMB100mn.

   On the first2Class chemicals 2 5 Biological products 2 6 Traditional Chinese medicine and natural medicine,According to the actual R & D expenses40%Grant funding Obtaining clinical approval,Give up to200 10000 yuan subsidy completeI II III Of phase I clinical trials,Respectively up to300 ten thousand 800 ten thousand 1500 Ten thousand yuan,The maximum annual subsidy of a single enterprise shall not exceed3000 Ten thousand yuan.

   For the third party that has obtained the drug approval number3 4Class chemicals,According to the actual R & D expenses20%Grant funding,Up to500 Ten thousand yuan The maximum annual subsidy of a single enterprise shall not exceed1000 Ten thousand yuan.

Article 4 For the first three drugs that have passed the conformity evaluation of generic drugs in China,Cost evaluation based on actual input consistency20%Grant funding,Up to500 Ten thousand yuan For other drugs that have passed the conformity evaluation of generic drugs,According to the actual R & D expenses20%Grant funding,Up to300 Ten thousand yuan The maximum annual subsidy of a single enterprise shall not exceed1000 Ten thousand yuan.

Article 5 Second party to obtain medical device registration certificate Class III medical device products It does not contain class II diagnostic reagents and equipment parts ,According to the actual R & D expenses40%Grant funding,second The maximum of three types of medical device products shall not exceed300 500Ten thousand yuan,The maximum annual subsidy of a single enterprise shall not exceed1000 Ten thousand yuan.

Chapter III  Vigorously promote the development of high-end industries

Article 6 For biomedical enterprises in our city, according to the drug listing license holder system The medical device registrant system undertakes the production,Based on actual input cost20%Grant funding,Each variety shall not exceed1500 Ten thousand yuan,The maximum annual subsidy of a single enterprise shall not exceed3000 Ten thousand yuan.

Article 7 Through the U.S. Food and Drug Administration FDA  European unification CE  world health organization WHO And other internationally authoritative certified drugs and medical devices,It shall be subsidized according to the actual expenses after audit,The annual maximum of a single enterprise shall not exceed1000Ten thousand yuan.Drugs listed overseas through international joint clinical research,Based on actual input cost40%Grant funding,Up to1000 Ten thousand yuan.

Article 8 It meets the national drug clinical trial quality management specification GCP Clinical medical institutions,According to the total investment of the project40%Grant funding,Up to500Ten thousand yuan Every new1 individualGCP Professional discipline,Give extra50 10000 yuan reward The maximum cumulative reward for each unit shall not exceed1000 Ten thousand yuan.For the first time by the Asia Pacific ethics review committee FERCAP/SIDCER And other internationally renowned certification bodies,Expenditure according to the actual cost of the project unit20%Grant funding,Up to200 Ten thousand yuan.

Chapter IV  Building an industrial support service system

Article 9 Aiming at the weak and other pain points of basic research,Relying on Colleges and universities in our city Scientific research institutions gather the world's top scientific teams in synthetic biology Brain science Accelerate the construction of major scientific and technological infrastructure in biomedical big data and other fields,Leading the original technological innovation breakthrough.The project construction and operation funds are disbursed from the investment of the municipal government,The pre research funds are disbursed from the municipal special fund for the development of strategic emerging industries.

Article 10 Support new drugs that are expected to meet major clinical and market needs Core technology breakthrough of high-end medical devices,Give full funding to its preliminary research,Project implementation objective responsibility system management,Up to3000 Ten thousand yuan Focus on breakthrough high-end medical imaging New in vitro diagnostic products New target chemicals Antibody drug gene drugs Cell products Development and application of key components such as polypeptide drugs and enzyme engineering Stuck neck Technical breakthrough,Enhance industrial competitiveness,By total project investment40%Phased funding,Milestone management of project implementation,Up to3 RMB100mn.

Article 11 Accelerate the cultivation and introduction of industry leading contract R & D institutions CRO  Contract outsourcing production organization CMO  Contract customized R & D and production organization CDMO And other biomedical industry application basic platforms,By total project investment40%Grant funding,Up to5000 Ten thousand yuan Encourage enterprises and Universities Scientific research institutions strengthen cooperation,Support institutions to establish innovative medical devices drug discovery  Pharmacological and toxicological studies Industrial service platforms such as process development,By total project investment40%Grant funding,Up to1000Ten thousand yuan.

Article 12 Accelerate the construction of a research platform for the evaluation technology and standards of the consistency of quality and efficacy of generic drugs Biomedical Safety Evaluation Center Third party testing service platform for drugs and medical devices,Accelerate the cultivation and introduction of basic R & D innovation platforms Public platforms for major biomedical industries such as scientific and technological achievement transformation platform and full chain professional service platform,According to the actual total investment of the project40%Support by year,Up to3000 Ten thousand yuan.

Article 13 Medical institutions are encouraged to cooperate with universities in Guangdong, Hong Kong and Macao Scientific research institutions set up Shenzhen Hong Kong National Clinical Medicine Research Center in Shenzhen Hong Kong scientific and technological innovation cooperation zone,Carry out new technology development and application research, etc,Strengthening the transformation of medical scientific and technological achievements,Accelerate the innovation of pharmaceutical products,Improve the level of medical research and transformation in Dawan District, Guangdong, Hong Kong and Macao.

Article 14 Actively strive for the establishment of drug Medical device evaluation center CDE Guangdong Hong Kong Macao sub center,Promote the innovation and development of biomedical industry.Support the establishment of biomedical industry promotion center,Carry out the planning and construction of major industrial innovation platforms Transformation of scientific and technological achievements Incubation and Cultivation.

Chapter V  Create a good industrial innovation environment

Article 15 Accelerate the promotion of Pingshan national biological industry base Shenzhen Hong Kong biomedical innovation policy exploration zone Guangming Biomedical Engineering Innovation Demonstration Zone Baolong biopharmaceutical innovation and development pilot area Construction of key development areas of biomedical industry such as baguang International Biological Valley.Encourage all districts to expand the supply of land and housing for innovative industries,Support social capital to build characteristic Parks,Actively introduce innovative enterprises Professional service enterprises and Gazelle enterprise ,Park construction is based on the proportion of total investment20%Grant funding,Up to5000 Ten thousand yuan.Support the park to dispose of hazardous wastes The centralized treatment of solid waste shall be included in the supporting projects,Professional organization for hazardous waste treatment of biomedical enterprises in the park,Disposal fee per ton1000 element,Maximum annual1000 10000 yuan subsidy.Support the construction of drug screening in the park or enterprises in the park Drug evaluation GLP laboratory Laboratory animal service platform Inspection and detection platform GMP Common factory Public service platforms such as new drug approval,By total investment40%Grant funding,Up to1000 Ten thousand yuan Support enterprises in the park to carry out core key technology research or small-scale test Pilot production,Based on total investment40%Grant funding,Up to500 Ten thousand yuan.

Article 16 Investment in10 More than 100 million yuan 20 New biomedical industry projects with less than 100 million yuan,According to the actual investment of the project10%Water and electricity subsidies R & D funding Comprehensive supporting support such as loan interest discount.Investment in excess of20 Billion yuan may fill the gap in the industrial chain Major biomedical industry projects with outstanding economic and social benefits,Key support will be given after examination and approval by the municipal government.

Article 17 Actively encourage relevant insurance institutions to provide liability insurance for biomedical human clinical trials Customized comprehensive insurance products such as liability insurance for biomedical products,For qualified biomedical institutions and enterprises,According to the actual premium paid50%Grant funding,The maximum of a single policy is not more than50 Ten thousand yuan,The maximum annual subsidy of a single enterprise shall not exceed500 Ten thousand yuan.

Chapter VI  supplementary articles

Article 18 This measure shall come into force as of the date of promulgation,Valid for5 year.In case of any national province Adjustment of relevant municipal policies and regulations,This measure can be adjusted accordingly.

Article 19 This measure is similar to other similar preferential measures in our city,The enterprise shall independently choose to declare according to the principle of "high is not low",No duplicate funding.

Public mode Active disclosure

CC General Office of municipal Party committee,General Office of the Standing Committee of the Municipal People's Congress,Municipal Office,General Office of Municipal Commission for Discipline Inspection,Municipal Intermediate Court,Municipal procuratorate.

General Office of Shenzhen Municipal People's Government                    2020 year1 month23 Issued on