Research on biopharmaceutical industry policy in Yangtze River Delta region

At present, China's biopharmaceutical industry is forming the Yangtze River Delta region, Bohai Rim region and Guangdong, Hong Kong and Macao Bay Area as the core, Chengyu economic circle and other coordinated development of the four major industrial clusters, and the Yangtze River Delta region biopharmaceutical industry development in the national leading position.
, policy support has played an important role in the convergence, integration and development of high-quality innovation in the Yangtze River Delta biopharmaceutical industry.
This paper analyzes the industrial promotion policies issued by seven representative pharmaceutical industry development cities, such as Shanghai, Suzhou, Wuxi, Xuzhou, Hangzhou, Ningbo and Hefei, through the research of cross-regional collaborative innovation policies in the Yangtze River Delta biopharmaceutical industry, and summarizes the experience, with a view to providing industrial development advice and decision-making reference for local governments and industrial investors.
I. Under the background of Yangtze River Delta integration, the policy support system of regional biopharmaceutical industry is gradually strengthened, and the Yangtze River Delta region has initially formed policy innovation in coordination in regulatory coordination, clinical resource cooperation, ethical mutual recognition and financial support.
regulatory synergy, in October 2019, three provinces and one city in the Yangtze River Delta jointly issued the Implementation Plan for the Pilot Work of the Yangtze River Delta Regional Medical Device Registrar System, which formed an innovative breakthrough in the MAH system of cross-regional regulatory coordination; On July 1, Shanghai, Jiangsu and Zhejiang provinces jointly formulated "Several Policy Measures to Support the High-Quality Development of the Yangtze River Delta Eco-Green Integrated Development Demonstration Zone" and jointly constructed a policy framework system to support the development of the Integrated Demonstration Zone with the Yangtze River Delta Eco-Green Integrated Development Demonstration Zone.
proposed to innovate the mode of supervision and service of the pharmaceutical industry in the Yangtze River Delta region, optimize the import process of controlled drugs for global collaborative research on biopharmaceuticals, explore the introduction of market-oriented insurance mechanism, and improve the regulatory effectiveness of the pharmaceutical industry and other fields.
allow medical device registration applicants in the demonstration area to entrust Yangtze River Delta medical device manufacturers to produce products.
in terms of clinical resource cooperation, the Suzhou Municipal People's Government's "Several Measures to Accelerate the High-Quality Development of the Biopharmaceutical Industry in Suzhou City" proposed to integrate and utilize the resources of medical and health care, scientific research institutions and innovative enterprises in the Yangtze River Delta region, establish the Yangtze River Delta (Suzhou) Translational Medical Research Center, coordinate clinical resources, and enhance research and transformation capabilities.
in terms of ethical mutual recognition, the Suzhou Municipal People's Government's "Several Measures to Accelerate the High-Quality Development of the Biopharmaceutical Industry in Suzhou City" proposes to increase cooperation with clinical resources in Beijing, Shanghai, Nanjing and other places, promote the establishment of an ethics committee review mechanism for mutual recognition in the Yangtze River Delta region, and improve the efficiency and quality of ethical review.
in terms of financial support, the Shanghai Municipal People's Government's Action Plan for promoting high-quality development of shanghai's biopharmaceutical industry (2018-2020) proposes to strengthen the overall planning of the Yangtze River Delta and the construction of a collaborative innovation system in accordance with the overall deployment requirements of the Yangtze River Delta, give full play to the guiding role of the Yangtze River Delta Integrated Industrial Fund, support the synergies among the yangtze River Delta industrial parks, and jointly promote the Yangtze River Delta to become the world's top biopharmaceutical industry cluster as soon as possible.
Ii, some key cities in the Yangtze River Delta region initially set up a more detailed policy system for the development of the pharmaceutical industry to promote the development of the yangtze River Delta region biopharmaceutical industry key cities mainly from encouraging research and development services, encouraging support for key platform construction, encouraging enterprises to carry out generic drug quality and efficacy consistent evaluation work, encouraging the introduction of major projects, encouraging the introduction and cultivation of talent, encouraging the support of the financial system and other aspects to support industrial development.
(1) Encourage research and development innovation 1. Support pharmaceutical enterprises research and development innovation One is to enter the phase I., II., III. phase of clinical trials of new drug projects, to give 1-2.5 million yuan of financial support, of which, Suzhou's strongest support, into the I., II., III. phase of clinical trials of new drug projects, respectively, to give 1 million yuan, 1.5 million yuan and 2.5 million yuan of one-time support.
is to complete the phase I., II., III. phase of clinical trials of new drug projects, to give 10-30 million yuan of research and development expenses subsidy support.
Among them, Ningbo has the highest support limit, and for those who have completed the clinical II. period, the post-subsidy (including clinical I., II. period research and development expenses) shall be granted at 20% of the actual investment in research and development expenses, and the maximum amount shall not exceed 10 million yuan; 20% of the post-subsidy, up to a maximum of 30 million yuan, and the third is to obtain the national new drug registration certificate and industrialization in the city, to give 10 million yuan of financial support, such as Shanghai, Hangzhou, Xuzhou and other places to obtain the new drug certificate of enterprises to give 10 million yuan of financial assistance.
1-1 Details of policies to encourage research and development innovation in some key cities in the Yangtze River Delta region - Drug research and development innovation Source: Firestone Creation Collated according to public information 2. Support medical device enterprises to research and development innovation to approve two or three types of medical devices according to 10%-20% of research and development investment subsidies, of which Hefei City, Anhui Province, the policy is the strongest, the third category of medical devices major projects, preclinical research according to 20% of the cost of research and development, clinical trials according to 10% of the cost of research and development subsidies, the total amount of individual project subsidies up to 10 million yuan.
Table 1-2 Of the Yangtze River Delta region, some key cities encourage research and development innovation policy details - device research and development innovation source: Firestone creation according to public information collation 3. Encourage enterprises to carry out generic drug quality and efficacy consistency evaluation work for enterprises through consistent evaluation generally give 20% of the actual investment in research and development costs, up to a maximum of 5 million yuan of financial support.
Among them, Ningbo support is greater, wide coverage, through the national consistent evaluation of drugs, according to the actual investment of a single variety of research and development costs of 20% of the grant, the highest not more than 3 million yuan, the first three in the country through the evaluation of generic drug consistency, according to the actual investment in research and development costs of 20% of the subsidy, up to a maximum of 5 million yuan.
Table 1-3 Details of policies to encourage research and development innovation in some key cities in the Yangtze River Delta region - Consistent evaluation Source: Firestone creation according to public information collation (ii) Encouraging support for key platform construction mainly for drug non-clinical safety evaluation institutions, drug (including medical devices) clinical trial institutions, with special professional requirements The construction of important public service platforms such as clinical research hospitals, pilot and production platforms in the biopharmaceutical industry, professional incubators, experimental animal service platforms, biomedical logistics platforms, waste treatment facilities in the pharmaceutical industry, etc., shall generally be supported by no more than 30% of the total investment through investment subsidies for platform construction and investment subsidies for key equipment.
, Wuxi, Ningbo and other places to support the largest, to give the project up to 20 million yuan of support.
city of Hefei, China, shall subsidize the projects identified by the evaluation according to 10% of the investment in key equipment, up to a maximum of 20 million yuan.
Table 2 Details of policies for encouraging the construction of service platforms in some key cities in the Yangtze River Delta region Source: Firestone Creation encourages the introduction of major projects in key industrial development areas, the introduction of industrial special major projects, the introduction of the world's top 500, China's pharmaceutical industry, listed companies and other key enterprises and major national special projects, to project investment subsidies, or one-on-one policy.
Shanghai focuses on encouraging biopharmaceutical industrialization projects with a total investment of 50 million yuan or more and an important driving effect on industrial development, and Ningbo City gives different subsidies to projects with a new investment scale of 100 million yuan (including) or more, major innovative drugs and innovative medical devices industrialization projects, and winning projects in the national innovation and entrepreneurship competition. Table
3 Some key cities in the Yangtze River Delta region encourage the introduction of major project policy details Source: Firestone Creation according to public information collation (4) to encourage the introduction and cultivation of talent is not only for the introduction of high-end talent not only to provide a hierarchical monetary subsidy, but also to the talent housing, children's education, hukou bid, health care and other life support to give preferential treatment.
Among them, Suzhou City talent introduction policy is more perfect, support is strong, the introduction of industry-leading talent to give 1-4 million yuan project support and 100-2.5 million home subsidies, qualified biopharmaceutical industry top talent to give up to 5 million yuan purchase subsidies.
Second, the implementation of talent priority development and targeted training strategy, Hangzhou City around the biopharmaceutical industry transformation and upgrading needs, the preparation of the industry in urgent need of talent directory, improve the new drug innovation and entrepreneurship team recruitment and cultivation of incentive mechanisms for innovative entrepreneurs to provide a good entrepreneurial environment; Table
4 Details of policies to encourage the introduction and cultivation of talents in some key cities in the Yangtze River Delta region Source: Firestone Creation according to public information collation (V) encourages the support of the financial system to mainly use financial assistance to innovate research and development-oriented enterprise development, to achieve financial and industrial cluster coordination, to build diversified industrial development funds, to market-oriented approach, to help innovative enterprises to start businesses and listing, service scientific and technological achievements transformation. Table
5 Details of policies to encourage financial system support in some key cities in the Yangtze River Delta region Source: Firestone Creation according to public information, in general, at the Level of the Yangtze River Delta Cluster Area, the development of the Yangtze River Delta biopharmaceutical industry has formed a policy innovation in cross-regional cooperation;
Facing the future, the author thinks that under the trend of Yangtze River Delta integration, in order to promote the high-quality and integrated development of biopharmaceutical industry in Yangtze River Delta region, all regions should not only take the development demand of local industry as the guide, but also further deepen the policy system of industrial development promotion, and break down administrative barriers. , collaborative cooperation, focusing on the Yangtze River Delta biopharmaceutical industry integration and development of the top-level design, cross-regional collaborative innovation mechanism, cross-regional flow of innovation elements of the biopharmaceutical industry, the construction of new industrial infrastructure, the Yangtze River Delta biopharmaceutical industry key parks division of labor cooperation and industrial linkage and other content key breakthrough and innovation policies.
Reference Policy: "Action Plan for the Promotion of High Quality Development of Shanghai Biopharmaceutical Industry (2018-2020)" (No. 39, Shanghai Government Office Issued (2018)) A number of measures for the high-quality development of the biopharmaceutical industry in Suzhou (Sufu Office (2019) No. 69) Office of the People's Government of Hangzhou City on the implementation of the promotion of innovation and development of the biopharmaceutical industry in Hangzhou City (Hangzhou Office letter (2018) No. 66) Opinions on Speeding Up the Development of the Biopharmaceutical Industry (No. 50 of 2020)