To accelerate the development of global biomedical research and development economy and industrialization highland, Shanghai issued policy measures Source: Shanghai Industrial Policy Service Center

Shanghai Government Office Regulation No. 13 [2022]

In order to support the development of biomedical R&D economy in Shanghai, the following policies and measures are proposed to accelerate the development of global biomedical R&D economy and industrialization:

  First, clarify the overall requirements

  (1) Guiding ideology

  Guided by Xi Jin Ping Thought on Socialism with Chinese Characteristics for a New Era, adhering to the orientation to the world's scientific and technological frontier, the main economic battlefield, the major national needs, and the people's life and health, giving full play to the agglomeration advantages of Shanghai's leading enterprises, scientific and technological facilities, professional talents, clinical resources, and financial capital, emphasizing the orientation of economic contribution, combining the length and length of policies, and being able to be implemented. To promote the commercialization of research and development results and the launch of products as the key focus, strengthen cross-departmental collaboration and the whole industry chain, encourage the substantive operation of biomedical research and development centers, introduce and foster innovative headquarters, improve the incubation and cultivation mechanism of scientific and technological enterprises, optimize R&D and production support policies, strengthen the guidance of public funds to social capital, To further increase the total economic contribution of biomedical research and development in Shanghai, and build a global economic and industrial plateau of biomedical research and development.

  (2) Main objectives

  By 2025, the development pattern of global biomedical research and development economy and industrialization will take shape in Shanghai. The overall scale of the research and development economy will reach more than 100 billion yuan. More than 100 innovative drugs and medical devices will be cultivated or introduced, and more than 50 innovative headquarters with multiple functions of biomedical research and development, sales and settlement will be cultivated. It has cultivated more than 20 high-level incubators and accelerators for biomedicine, promoted more than 1,000 biomedicine patents to be listed and traded in Shanghai, laid out more than 5 municipal biomedical engineering research centers, and provided innovative services such as engineering verification and transformation of early quality results of more than 100 universities and research institutes.

  By 2030, Shanghai's position in the global biomedical R&D economy and industrialization will be further highlighted, and the overall scale of its R&D economy will be further enhanced. A number of innovative drugs and medical devices that are developed and listed in Shanghai will emerge, and a number of innovative biomedical headquarters and innovation platforms with domestic and international influence will be gathered. Research and development economy has become an important supporting force for the development of bio-pharmaceutical industry in this city.

  Second, we will enhance our capacity for R&D and innovation

  (3) Strengthening the distribution of original innovation capacity.We will give full play to the role of Shanghai's major national science and technology infrastructure, such as light source and protein, and strategic science and technology forces, such as harbor laboratories, to further enhance our capacity for biomedical research and development services. Aiming at key fields such as synthetic biology, gene editing, stem cell and regenerative medicine, cell therapy and gene therapy, and AI-assisted drug design, it has laid out a number of municipal major science and technology projects and major projects in strategic emerging industries. We will support leading enterprises to collaborate with universities and research institutes to build a number of municipal engineering research centers, and further strengthen industry-university-research cooperation. (Responsible unit: Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Economy and Informatization Commission, Shanghai Science Foundation)

  (4) Better play the advantages of clinical resource concentration.Relying on the municipal hospital and medical enterprise cooperation research and innovation platform, promote the clinical resources of medical institutions to more efficiently connect and serve the R&D needs of enterprises, and support the development of R&D economy in Shanghai. We will support cooperation between medical and health institutions and enterprises to establish various forms of innovation consortia and platforms for proof of concept, and establish mechanisms for social joint investment and benefit sharing. To set up the scientific and technological achievements database of municipal medical and health industry, strengthen the development and utilization of scientific and technological achievements resources and their implementation tracking. (Responsible unit: Municipal Economic and Informatization Commission, Municipal Health Commission, Municipal Science and Technology Commission, Shenkang Hospital Development Center)

  3. Support new models of R&D and production of innovative drugs and medical devices)

  (5)Optimizing policies supporting the system of marketing authorization holders for innovative drugs.Relax the restriction of supporting conditions that the product registration and production must be in the city at the same time. For the Class 1 innovative drugs that the city registration applicant obtains the drug registration certificate and entrustments enterprises from other provinces and cities (including affiliated companies) to produce and realize the output, no more than 30% of the R&D investment and no more than 20 million yuan will be given to the qualified ones according to the procedures; The annual accumulative support quota of each unit shall not exceed 75 million yuan. (Responsible unit: Municipal Economic and Informatization Commission, Municipal Science and Technology Commission, Municipal Drug Regulatory Bureau, Municipal Finance Bureau)

  (6)We will improve policies supporting the marketing authorization system for improved new drugs.Relax the restriction of supporting conditions that the product registration and production must be in the city at the same time, which has obvious advantages of higher technical content, safety and effectiveness. The registration applicant in the city shall obtain the drug registration certificate, and entrust enterprises in other provinces and cities (including affiliated companies) to produce improved new drugs to achieve output. According to the procedures, the qualified enterprises shall be provided with no more than 15% of the R&D investment and no more than 7.5 million yuan of financial support; Each unit's annual accumulative support quota shall not exceed 15 million yuan. (Responsible unit: Municipal Economic and Informatization Commission, Municipal Science and Technology Commission, Municipal Drug Regulatory Bureau, Municipal Finance Bureau)

  (7)Optimize the supporting policies for the medical device registrant system.Relax the restriction of supporting conditions that the product registration and production must be in the city at the same time. For entering the national and municipal special examination procedures for innovative medical devices, the municipal registration applicant shall obtain the medical device registration certificate for the first time, and entrust enterprises from other provinces and cities (including affiliated companies) to produce the medical device products. According to the procedures, the qualified enterprises shall be provided with no more than 30% of the R&D investment and no more than 5 million yuan of financial support; Each unit supports no more than 12 million yuan annually. (Responsible unit: Municipal Economic and Informatization Commission, Municipal Science and Technology Commission, Municipal Drug Regulatory Bureau, Municipal Finance Bureau)

  4、Introducing and fostering innovative headquarters

  (8)Give graded awards to innovative headquarters.The innovative enterprises registered in this municipality with independent legal person status, cross-regional operation, innovation ability such as R&D investment and number of R&D personnel, assets and business income are all in a certain scale, shall be identified as innovative headquarters according to regulations; For those innovative headquarters whose paid-in capital and subsequent annual sales income reach a certain amount for the first time at the time of registration, the municipal and district governments will give them a one-time graded reward, and the host districts will provide rental subsidies. (Responsible units: Municipal Development and Reform Commission, Municipal Economy and Informatization Commission, Municipal Science and Technology Commission, Municipal Commerce Commission, Shanghai Science Foundation, Municipal Finance Bureau, relevant district government)

  (9)Support the upgrade of R&D center to multi-function R&D headquarters.Support the R&D centers set up by domestic biomedical enterprises in Shanghai to be upgraded to compound R&D headquarters integrating R&D, sales, settlement and other functions. If the level of additional sales and settlement reaches a certain scale, the municipal and district governments will give one-time graded awards according to the innovative headquarters support policy. Support innovative products researched and developed in Shanghai to apply for registration in Shanghai with the listing licensor system, entrust internal and external resources of the group to carry out contract production, and give corresponding R&D investment support to those who meet relevant conditions. (Responsible units: Municipal Economic and Informatization Commission, Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Drug Regulatory Bureau, Shanghai Science Foundation, Municipal Finance Bureau, relevant district governments)

  (10)We will support relevant facilitation policies.We will support the inclusion of innovation-oriented headquarters into the list of key employers and institutions for talent introduction of non-Shanghai college graduates for employment, and provide support for talents to settle down in Shanghai. For qualified talents imported from home and abroad, we will provide relevant policy support such as applying for permanent residence permit and facilitating entry and exit. Support their application to be included in the list of key enterprises for customs clearance facilitation of R&D goods and special goods, and simplify pre-review procedures. Further study and optimize the application conditions of drug trade license to facilitate the centralized sales function. (Responsible units: Municipal Human Resources and Social Security Bureau, Municipal Education Commission, Municipal Economy and Information Technology Commission, Municipal Commerce Commission, Shanghai Customs, Municipal Drug Administration, Shanghai Science Foundation)

  5、We will support the construction of high-level incubation and transformation platforms

  (11)To support the transformation of biomedical research achievements in universities.Select some colleges and universities in this Municipality to expand the pilot reform of horizontal surplus funds and allow horizontal surplus funds to be invested in start-up projects in biomedicine and other fields. Medical and health institutions affiliated to colleges and universities should be supported to determine the trading price of scientific and technological achievements and independently decide the transformation mode of scientific and technological achievements by means of pricing by agreement, trading by listing, auction, etc., with the proceeds mainly used to reward scientific and technological achievements. Key universities are encouraged to cooperate with well-known investment funds at home and abroad to set up special seed funds for the incubation of early results. (Responsible unit: Municipal Education Commission, Municipal Science and Technology Commission, Municipal Finance Bureau, Shenkang Hospital Development Center)

  (12)To support the construction of platforms for pilot test verification and transformation of technological achievements.We will support the construction of municipal functional platforms for biomedical research and development and transformation, and build phase II facilities for gene therapy, digital drugs and bioengineered enzymes on the basis of pilot test verification of innovative preparations and antibodies. Support the construction of a pilot trial validation and transformation platform for innovative drug achievements of research institutions, and provide research institutions in Shanghai with results screening, research and development services, approval application, investment and financing services based on the market-oriented and specialized pre-clinical contract research organization (CRO) technology platform. (Responsible unit: Municipal Science and Technology Commission, Municipal Development and Reform Commission, Municipal Economic Informatization Commission)

  (13)We will improve the incubation and cultivation mechanism of biomedical enterprises.Encourage science and technology business incubators, maker Spaces, university science and technology parks, industrial (science and technology) parks, high-tech zones and other areas to strengthen cooperation, take the docking of incubators with local industrial departments and the local implementation and transformation of graduate enterprises as important content of performance assessment, and provide support in terms of policies and funds to achieve positive results. We will encourage the development of new models such as industrial incubation and corporate venture capital investment. Further strengthen the "investment incubation" linkage function, explore the state-owned carrier with investment function as angel investment enterprises, referring to the management mode of state-owned investment companies, simplify the input and exit procedures; The pilot assessment of state-owned capital investment in incubators will be based on the performance of "total package", rather than on the success of "single investment". (Responsible units: Municipal Science and Technology Commission, Municipal Development and Reform Commission, Municipal Economy and Informatization Commission, Municipal State-owned Assets Supervision and Administration Commission, Shanghai Science Foundation)

  

       6. Increase the activity of biomedical intellectual property trading

       (14) Set up the "Biomedicine Board" in Shanghai Technology Exchange.In Shanghai Technology Exchange, a special trading section of biomedicine has been established to develop the trading service product of Milestone Payment for biomedicine. Enterprises, universities, scientific research institutes and medical and health institutions are encouraged to enter into transactions, and certain support is given to technology undertaking bodies that realize local transformation incubation by means of technology licensing, transfer, price-fixing investment or entrepreneurship, as well as technology transfer institutions that facilitate technology transactions. (Responsible unit: Municipal Science and Technology Commission, Municipal Finance Bureau)

  (15)We will explore a patent licensing system for universities, research institutes and medical and health institutions on a pilot basis.Taking the field of biomedicine as the pilot, for the patents obtained by universities, research institutes and medical and health institutions using the research projects funded by the municipal government, which have not been transformed or have no substantial intention of transformation for more than three years since the date of acquisition, the patent open licensing transfer system shall be gradually explored to improve the efficiency of transformation of scientific and technological achievements; We will gradually explore ways to include patent application rights and proprietary technologies in the pilot program. (Responsible units: Municipal Science and Technology Commission, Municipal Education Commission, Municipal Health Commission, Municipal Development and Reform Commission, Municipal Intellectual Property Bureau, Shenkang Hospital Development Center)

  7、Support the launch and use of R&D and innovative products

  (16)We will further speed up the review and approval of innovative products.For Class II medical devices with significant clinical value and strong innovation, it is recommended to enter the priority examination and approval procedure of Class II medical devices in this Municipality after meeting the basic requirements examined by relevant departments. On the basis of the safety of the medical devices of the same variety, the registration applicant can prove the safety and effectiveness of the products by analyzing and evaluating the clinical trials or clinical data of the second class medical devices of the same variety. To speed up the construction of drug and medical device technical evaluation and inspection Chief Triangle branch center of the State Drug Administration, take innovative products in key fields of the city as the key varieties of the branch center's priority communication, provide pre-event guidance and services for product evaluation and approval, and speed up the process of product marketing. (Responsible unit: Municipal Drug Administration, Municipal Commission of Economy and Information Technology, Drug Evaluation and Inspection Triangle Branch Center of State Drug Administration, Medical Device Technical Evaluation and Inspection Triangle Branch Center of State Drug Administration)

  (17)Speed up the use of innovative products in hospitals. Actively recommend innovative drugs to enter the national medical insurance drug list.To promote the use of innovative drugs in the national medical insurance drug list in municipal hospitals, municipal hospitals should, within 3 months after the release of the national medical insurance drug List and according to clinical needs and hospital characteristics, incorporate corresponding innovative drugs into the hospital drug supply list as soon as possible under the principle of "full allocation". The above-mentioned innovative drugs shall be listed separately in the budget and not included in the total budget of the hospital medical insurance in the current year. The innovation responsibility system has been gradually implemented on a pilot basis in municipal hospitals, and performance evaluation and incentive mechanisms such as innovative drug allocation, achievement transformation and clinical resource support for research and development needs of municipal hospitals have been established and improved. (Responsible unit: Municipal Medical Insurance Bureau, Municipal Health Commission, Municipal Economy and Informatization Commission, Shenkang Hospital Development Center)

  (18)We will improve the recommendation mechanism for innovative medical devices to be included in commercial medical insurance.For new class 1 innovative drugs that have not been included in the national medical insurance drug list, but whose marketing authorization holder is a municipal enterprise, as well as innovative medical devices that have high clinical use value but have not been included in the coverage of medical insurance, they are encouraged to apply for inclusion in the guarantee scope of "Shanghai Benefit Insurance" specific high-value drugs. We will establish a communication and information sharing mechanism between biomedical enterprises and commercial medical insurance companies, and promote the inclusion of more innovative medical devices in the reimbursement list of commercial medical insurance. (Responsible unit: Municipal Medical Insurance Bureau, Municipal Economic and Information Technology Commission, Shanghai Banking and Insurance Regulatory Bureau, Municipal Health Commission, Municipal Drug Regulatory Bureau, Shenkang Hospital Development Center)

  

       The policy measures will come into effect on October 31, 2022 and remain valid until October 30, 2027. If these policies and measures overlap with other similar policies of this Municipality, they shall be implemented in accordance with the principle of "being superior, being higher and not repeating".

Source: Shanghai Municipal Government

Shanghai Industrial Policy Service Center

Project Declaration Office: Director Fang

Tel: wechat: 15618903837

* The policy content published in this article is sorted out and interpreted by Shanghai Industrial Policy Service Center. If there is any mistake, please contact us.

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