Chapter I General Provisions
Article 1 In order to vigorously promote the high-quality development of biomedical industry in Chongqing Hi-Tech Zone, and to build a nationally influential biomedical industry agglomeration area, the Measures are hereby formulated.
Article 2 These Measures shall apply to biomedical enterprises or organizations that are registered, taxed, and statistically related to Chongqing Hi-Tech Zone and have independent legal personality, no bad credit record, and are engaged in the research and development, production, circulation, and ancillary services in the fields of pharmaceuticals, medical devices, and medical and nursing services.
Chapter II Guiding the development of biopharmaceutical cluster
Article 3 Create distinctive industrial clusters. In accordance with the general idea of northern creation and incubation, middle transformation, and southern manufacturing, the spatial pattern of linked development of industry, academia, research, and medicine is constructed. The northern part of the university city area plays a leading role in basic research and cutting-edge technology innovation, forming an industrial innovation source and results incubation center where scientific research results are transformed and innovation teams gather. The Life Island and Jinfeng National Biomedical Base in the central part of the city, led by Jinfeng Laboratory, gather innovative biomedical science and technology enterprises, and lay out R&D centers and headquarters bases. Bafu Area and Shiban Area in the south, focusing on the industrialization of innovation results, to create a first-class domestic manufacturing cluster of biological drugs, high-end chemical agents and medical devices.
Article 4 Focus on key segments to build an industrial ecosystem. With medical devices and biological drugs as the two nuclei, focusing on key segments of the track to build industrial pillars. In the field of medical devices, focus on the development of high-value consumables, in vitro diagnostics, and medical equipment. In the field of biopharmaceuticals, focus on the layout of antibody drugs, cell therapy, gene therapy and new vaccines. In the field of chemical drugs, focus on the development of isotope drugs and high-end preparations of chemical drugs. Promote the layout of the new track of digital healthcare.
Chapter III Support for Innovation and Transformation of Achievements
Article V Support for pharmaceutical research and development and transformation.
(1) Support for clinical research. In the research and development of innovative drugs to complete the phase I clinical trial research and enter the phase II clinical trials, complete the phase II clinical trial research and enter the phase III clinical trials, complete the phase III clinical trial research and submit a marketing application accepted, respectively, according to the stage of the actual R & D investment costs of 10%, 20%, 30%, respectively, to give the applicant for registration of the product a one-time maximum of up to 2 million yuan, 3 million yuan, 7 million yuan subsidy; in the research and development of improved new drugs and listed biological products after completing Phase I clinical trial research and entering Phase II clinical trial, after completing Phase II clinical trial research and entering Phase III clinical trial, after completing Phase III clinical trial research and submitting the marketing application for acceptance, according to the actual R & D investment costs in the stage of 10%, 20%, 30%, respectively, to give the product registration applicant a one-time maximum of not more than Give the applicant for product registration a one-time maximum of 1 million yuan, 1.5 million yuan, 3.5 million yuan of subsidies. The same variety of applications for multiple indications of clinical trials do not repeat support.
(b) The application for drug innovation R & D subsidies should be deducted from the amount of other R & D subsidies already enjoyed in the current year, a single enterprise to obtain the annual drug innovation R & D subsidies not exceeding 10 million yuan.
(c) Encourage the industrialization of new drugs. Drug registrants applying to obtain a drug approval number, or enterprises to introduce the way to obtain a drug approval number, in the high-tech zone directly under the Park for industrial production, to give each variety of one-time incentives for innovative drugs each reward 10 million yuan, for improved new drugs and listed biological products each reward 2.5 million yuan.
Article VI supports the transformation of medical device innovation. The high-tech zone directly within the scope of the park for the first time to obtain a medical device registration certificate, or the introduction of the way to obtain a medical device registration certificate, and industrialization of the production of varieties to give financial support. For the first time to be approved or the introduction of class III medical device registration certificate and industrialized production, the assessment of a single species to give a one-time financial incentive of 2 million yuan, through the national innovative medical device special review process, the national medical device priority approval process, a single species of funding ceilings were increased by another 2 million yuan, 1 million yuan respectively. For the first approval or introduction of Class II medical device registration certificate and industrialized production, a one-time financial incentive of 500,000 yuan will be given to individual varieties after evaluation, and the funding ceiling for individual varieties will be further increased by 1 million yuan and 500,000 yuan through the municipal innovative medical device examination and approval procedure and the municipal medical device priority examination and approval procedure, respectively. Each medical device enterprise will be rewarded up to 5 million yuan per year.
Article 7 Support for the inheritance and innovation of traditional Chinese medicine. Enterprises through the registration application or the introduction of the way to obtain the classic Chinese medicine formula compound preparation drug registration license, and in the high-tech zone directly under the Park to achieve industrialization, each variety of reward 500,000 yuan, each enterprise not more than 2 million yuan per year.
Article VIII support isotope drug research and development and industrialization. Enterprises obtain isotope drug approval number through registration application or introduction, and industrialized production in Hi-tech Zone Direct Park, a one-time award of 1.5 million yuan, not exceeding 3 million yuan per enterprise per year.
Article IX Support for AI+ drug, AI+ medical device R&D and industrialization. Support AI-enabled drug accelerated research and development platform and artificial intelligence medical device product research and development, the core algorithms and models that have accelerated drug research and development, and drug research and development enterprises to form a cooperation agreement to carry out substantive new drug research and development services, as well as with independent intellectual property rights, has obtained the state-recognized third-party testing organization type inspection report, with significant clinical application value of artificial intelligence medical device products, after evaluation According to the actual R & D investment costs of 15% to support, each project up to 1 million yuan.
Chapter IV Promote product production and marketing
Article X supports the industrialization of MAH production. High-tech zone directly under the park of drugs or medical devices listed license holder, commissioned by the jurisdiction of the enterprise (commissioned by the two sides must not be related) the production of its holdings of pharmaceutical and equipment products, and sales tax settlement in the high-tech zone directly under the park of the commissioned enterprise according to its annual new commissioned the actual transaction amount of the contract to give a reward of 3%, a single enterprise each year, the maximum of not more than 5 million yuan. To undertake the commissioned production tasks outside the jurisdiction and the output value settlement in the high-tech zone directly under the Park's enterprises (commissioned by the two sides must not be related), according to its annual new commissioned the actual transaction contract amount of 3% to give incentives for a single enterprise each year up to a maximum of 5 million yuan.
Article XI support for the application and marketing of pharmaceuticals.
(a) To establish the first purchase of innovative products and the first use of high-tech zones directly under the Park procurement support mechanism for medical institutions. For medical institutions to purchase the first (sets) of medical equipment identified by the city, to give its procurement amount of 20% of the incentive, a single medical institution incentives up to a maximum of 3 million yuan per year; medical institutions to purchase and use the high-tech zone directly under the control of the park without the production of related enterprises of the new drugs, high-value medical supplies, testing reagents and medical equipment and other products, the actual annual purchase amount of more than 2 million yuan, according to the actual annual purchase amount of 5% to give subsidies, the actual annual purchase amount of 5 percent. The actual annual purchase amount exceeds 2 million yuan, according to the actual annual purchase amount of 5% of the subsidy, the maximum does not exceed 1 million yuan.
(2) Encourage enterprises to participate in centralized purchasing. For the production and settlement in the high-tech zone directly under the park, and the inclusion of national centralized procurement of varieties, according to the annual centralized procurement amount to give 3% of the award, the maximum single variety of up to 3 million yuan, not more than 5 million yuan per year per enterprise.
(C) support the application of digital medical scene. Support high-tech zone direct park range of hospitals joint artificial intelligence enterprises to declare AI + medical imaging, AI + assisted diagnosis and treatment, AI + medical robot, AI + health management, AI + medical testing, AI + digital human hospital-land cooperation digital healthcare application scene projects. For projects in which both parties to the project are registered in the high-tech zone directly under the management of the park, according to the completion of the implementation of each project in phases to support the amount of support does not exceed 20% of the actual investment in the project, and the amount of support does not exceed 1 million yuan.
Chapter V Strengthening the construction of professional services platform
Article XII Strengthening the construction of professional and technical services platform.
(a) Support the construction of professional and technical service platform. The pilot service platform, high-end preparation platform, contract research and development organization (CRO), contract custom research and development production organization (CDMO), contract outsourcing production organization (CMO) and other application-based platforms, as well as new drug evaluation, experimental animals, testing and inspection, pharmaceutical supply chain and other industrial service platform construction, and the investment in fixed assets of the project (excluding land, plant investment) more than 10 million yuan (inclusive), the part not exceeding 50 million yuan (inclusive). Not more than 50 million yuan (inclusive) part, according to the actual completion of the fixed asset investment amount of 10% to be supported; more than 50 million yuan part, according to the actual completion of the fixed asset investment amount of 20% to be supported. The maximum amount of support for each enterprise shall not exceed 10 million yuan. For the landing of special major platform projects, according to the "one case at a time" to give support.
(ii) Encourage professional and technical service platforms to provide service support. Has been built for the professional and technical service platform for the jurisdiction of the unaffiliated enterprises or institutions to provide relevant services, the annual amount of actual service contracts in more than 3 million yuan, and in accordance with the relevant provisions of the registration of technology contracts, according to the contract of the annual amount of the actual service revenue 7% of the incentives, the maximum reward amount does not exceed 1 million yuan.
Chapter VI support for the growth and development of enterprises
Article XIII of the support for the growth and development of enterprises.
(a) Fixed asset investment subsidies. For the new fixed asset investment amount of 30 million yuan (including) or more (excluding land, plant investment), and a single unit (set) of productive equipment 500,000 yuan (including) or more, according to the actual payment of productive equipment in the current year and included in the amount of fixed assets to be given a subsidy of 10% of the amount of the maximum of 10 million yuan per enterprise. Have enjoyed the professional and technical service platform fixed asset investment support no longer enjoy this policy.
(ii) Rental support. Biomedical enterprises renting buildings/plants in Chongqing Hi-Tech Zone, with an annual invoicing revenue of more than 5 million yuan and an annual invoicing revenue of 6,000 yuan/square meter and above, will be given subsidies based on 40-100% of the paid rent, with the total amount of subsidies for a single enterprise not exceeding 1 million yuan per annum and enjoying subsidies for at most three years. One of the rented buildings, according to the enterprise at the end of the year in the Chongqing Hi-tech Zone Direct Park area to pay the number of social security, annual rental support for the floor area of no more than 15 square meters / person.
(3) Decoration support. For newly established, newly relocated or newly leased area for self-decoration of the enterprise, the amount of investment in fixed assets (excluding land, plant investment) in 20 million yuan (including) or more, according to the renovation of the floor area and the actual renovation costs to give renovation support, and the amount of subsidy does not exceed the actual renovation costs, each enterprise renovation cost subsidy does not exceed 2 million yuan.
For enterprises to renovate their own factory buildings, according to the maximum standard of 300 yuan / ㎡, to give subsidies for renovation costs;
For enterprises to renovate their own GMP workshop, according to the maximum standard of 800 yuan / ㎡, to give subsidies for renovation costs;
For enterprises to renovate their own GMP workshop, according to the maximum standard of 800 yuan / ㎡, to give subsidies for renovation costs;<
For enterprises to renovate their own office buildings, according to the maximum standard of 600 yuan / ㎡, to give subsidies for renovation costs.
Chapter VII Nurturing Health Industry
Article XIV Support for Clinical Research Transformation. Encourage medical institutions in Chongqing Municipality as the leader of the unit to undertake high-tech zone directly under the management of the park enterprise clinical trial projects, complete the project record and effectively carry out, after the assessment, to give the medical institutions a maximum of not more than 500,000 yuan reward. For medical institutions in the Hi-tech Zone directly under the management of the park to complete GCP certification (for the record), a maximum of 1 million yuan one-time incentive, and for each new GCP professional discipline, a reward of 500,000 yuan. The maximum annual reward for each organization is not more than 2 million yuan.
Article 15 Support the organization of influential industry summits, forums and other activities. For the organization of international / national, municipal and high-tech zone key support for the biomedical industry summits, forums and other activities, approved and agreed to, according to the activities of the actual costs incurred (audited by a qualified third-party institution) 50% of the support, the maximum subsidy for a single event not more than 1 million yuan, 500,000 yuan, 200,000 yuan, a single enterprise annual subsidy of not more than 1 million yuan. Encourage the industry's influential institutions, enterprises led by the high-tech zone within the direct park set up "AI +" Pharmaceutical Industry Alliance, merit to give a single organization up to a maximum of 1 million yuan in funding.
Chapter VIII Supplementary Provisions
Article XVI of the scientific and technological innovation, talent attraction, attraction of investment, financial support, openness and cooperation and other areas of supportive policies in accordance with the relevant policies of Chongqing Hi-tech Zone. Chongqing Hi-tech Zone relevant policies. These measures and other policies of Chongqing Hi-Tech Zone are duplicated or similar, in accordance with the principle of non-duplication of the implementation of the higher, has enjoyed the "one enterprise, one policy" enterprises will not repeat the enjoyment of the same kind of terms of this policy.
Article XVII These measures shall be implemented 30 days after the date of publication, and from January 1, 2023 to the implementation of these measures with reference to the implementation of these measures. During the implementation period in the event of national and municipal policy adjustments, according to the new policy to make corresponding adjustments. This approach to the implementation of the reporting standards, reporting conditions, reporting process, etc., separately formulated reporting rules; this approach by the Reform and Development Bureau to take the lead in organizing the declaration of the functional departments to confirm the audit, reported to the Reform and Development Bureau to be honored.
Article XVIII of these measures by the Chongqing Hi-tech Zone Management Committee is responsible for the interpretation.
