On April 7, the CDE official website issued two notices in succession: "Notice on Public Solicitation of Opinions on <Guidelines for Clinical Trials of Trastuzumab Injection Biosimilars (Draft for Comment)>" and "Notice on Public Solicitation of Opinions on the Guiding Principles for Clinical Trials of Bevacizumab Injection Biosimilars (Draft for Comment)", plus the "On Public Solicitation of Adalimumab Injection Biosimilars" issued on April 1 Guidelines for Clinical Trials of Similar Drugs (Draft for Comment) > Notice of Opinions", the guidelines for clinical trials of biosimilars of three star drugs will be released soon.
Super "blockbuster" biosimilar race
Adalimumab, bevacizumab and trastuzumab, the three blockbuster drugs that have occupied the best-selling list all year round, all have huge sales volume. Among them, adalimumab garnered 19.169 billion in the global market in 2019. US dollars, bevacizumab sales were $7.933 billion, and trastuzumab sales also exceeded $6 billion. At present, domestic and foreign pharmaceutical companies have joined the research and development of these biosimilars, and some products have been approved for marketing.
Adalimumab (Humira) was launched in China in 2011, with indications for rheumatoid arthritis, ankylosing spondylitis and psoriasis. Despite the huge clinical demand, the domestic sales in the past five years have been less than 1% of the global total due to its high price and lack of access to medical insurance for a long time. In November 2019, the domestic "first copy" of adalimumab was approved for marketing, and was developed by Bio-Tech Biopharmaceutical Co., Ltd.; in December, Hisun's adalimumab was also approved for marketing. The domestic R&D competition for adalimumab is fierce, and more than 20 companies are currently developing it, including well-known pharmaceutical companies such as Chia Tai Tianqing, Qilu, and Innovent.
Bevacizumab (Avastin) was approved for marketing in China in 2010, and entered the National Medical Insurance Catalogue through negotiation in 2017. In the medical insurance negotiation catalogue announced on November 28, 2019, Avastin The renewal was successful, and the price was 1934.26 yuan. On December 9 last year, bevacizumab injection developed by Qilu Pharmaceuticals was approved for marketing, which is the first bevacizumab biosimilar in China. At present, Innovent Bio has submitted a marketing application for bevacizumab in China, and there are more than 20 biopharmaceutical companies in the clinical research stage; in the international market, the FDA has also approved two bevacizumab biosimilars. From Amgen/Allergan and Pfizer, respectively.
Trastuzumab (Herceptin) was approved for marketing in China in September 2002. So far, no trastuzumab biosimilar has been approved in China. In the first echelon are two drugs in the BLA application stage, namely CMAB-302 of Sunshine Guojian and HLX-02 of Shanghai Henlius. In addition, there are more than 20 drugs in clinical phase 3, clinical phase 1 and preclinical research.
The industry believes that for a long time, the price of many original research drugs is high, and the price reduction is not obvious after the patent protection period. Therefore, even if the annual sales of more than 10 billion US dollars are obtained abroad, only a few people in China can still use it. Once domestic biosimilars are approved, they will stir up the market structure of corresponding drugs in the domestic market with their price advantage, and are expected to increase the availability of medicines for patients at affordable prices. And with the gradual expansion of the national centralized procurement, the price reduction has become the general trend.
As we all know, there is no "super-national treatment" for the original research drug in the national centralized procurement. If the subsequent centralized procurement continues to expand the varieties, the original research drug wants to maintain its market share in mainland China, and it is destined to pass the consistency evaluation of generic drugs. Bid on the same stage. In addition, the more effective the drug is and the more widely used by patients, the more the original research manufacturer needs to prepare for centralized procurement, so as to be able to provide the best response when the competing biosimilar products "price down". Strategy.
Guangdong's heavy policy to create innovation highland
In the context of vigorously promoting the development of the biopharmaceutical industry and encouraging R&D innovation across the country, on April 8, the Guangdong Provincial Department of Science and Technology, the Guangdong Provincial Food and Drug Administration and other departments jointly issued the "Several Policies on Promoting the Development of Biopharmaceutical Innovation" Measures" (hereinafter referred to as "Measures"), is committed to enhancing the original innovation capability and international competitiveness of biomedicine, promoting the high-quality development of biomedical technology and industry, and improving the ability of biosafety governance.
It is worth noting that the "Measures" propose that for new anti-tumor drugs that are urgently needed for clinical use and that have not yet been approved for registration in my country and have been marketed abroad, strive for the state's permission to use them in nine mainland cities in the Guangdong-Hong Kong-Macao Greater Bay Area. Encourage medical institutions in Guangdong to increase the proportion of the procurement of innovative drugs and medical devices with definite curative effect, controllable quality and stable supply. Promote the inclusion of high-quality drugs produced in Guangdong Province into the National Basic Medical Insurance Drug List, and support inclusion in the National Essential Drug List. For drugs that have passed the consistency evaluation of the quality and efficacy of generic drugs, the price is negotiated at the same quality level as the original drug, and is not subject to restrictions such as drug cost control, drug proportion, variety, specification and quantity, second-line drugs, and adjuvant drugs.
In fact, the modern biopharmaceutical industry in Guangdong Province has developed rapidly in recent years. In 2016, Guangdong's biopharmaceutical industry achieved an output value of more than 300 billion yuan. In 2017, the added value of Guangdong's biopharmaceutical industry increased by 11.6%. In 2018, there were more than 1,200 biopharmaceutical enterprises in Guangdong Province, with an output value of more than 350 billion yuan. At present, the development speed and industrial scale of the biopharmaceutical industry in Guangdong are at the forefront of the country, and the industrial system is also becoming more and more perfect. In 2018, the number of patent applications in the biopharmaceutical industry in Guangdong Province was 49,479, accounting for about 11% of the national total.
Among them, Guangzhou, as the central city of the Guangdong-Hong Kong-Macao Greater Bay Area, has the superimposed advantages of a national bio-industry base and a national pharmaceutical export base. It is further optimizing and improving the spatial layout of the bio-pharmaceutical industry, vigorously developing the bio-pharmaceutical industry, promoting the innovation of life science and technology, and accelerating the global market share. The commanding heights of the development of the biopharmaceutical industry. As a key city in the Guangdong-Hong Kong-Macao Greater Bay Area, Shenzhen has continued to increase policy support since 2009, when it focused on building a biomedical industry cluster, promoting the agglomeration of industrial elements, and the scale of the biomedical industry has maintained rapid growth.
The development of the biopharmaceutical industry in Guangdong Province has created a large number of innovative enterprises. For example, Shenzhen Microchip has been engaged in pharmaceutical innovation and R&D for many years. Its innovative drug Chidamide is the world's first subtype-selective histone deacetylase. Inhibitors and the world's first oral drug approved for the treatment of peripheral T-cell lymphoma have also become the company's main products. From 2016 to 2018, the proportion of Chips Bio’s sales revenue from Chidamide increased year by year, accounting for 65.33%, 83.88%, and 92.57%, respectively. In order to enrich the company's products, Chipchip has established product pipelines at different stages in the three major therapeutic areas of oncology, metabolic diseases and immune diseases.
In the field of genetic testing, Guangdong is not only at the forefront of the country, but also at the forefront of the world. Among them, Shenzhen has many industry leaders such as the National Gene Bank, BGI, iCarbonX, Hanhai Gene, and Yuce Biology, and ranks first in the world in next-generation sequencing capabilities and ultra-large-scale bioinformatics computing and analysis capabilities. Especially during the COVID-19 epidemic, the first batch of BGI's two nucleic acid detection products passed the emergency approval of the State Food and Drug Administration, and the sequencer also entered major hospitals in Wuhan at the first time to help fight the epidemic. By mid-March, the daily production capacity of its test kits had increased to 600,000 copies, and it had assisted overseas to provide testing reagents and instruments to more than 60 countries and regions.
The "Measures" also pointed out that it will support Guangzhou to accelerate the layout and construction of industries such as life sciences, high-end medical care, health and safety, and marine drugs, introduce and cultivate a number of high-level biomedical R&D platforms and service institutions, and create life science cooperation in the Guangdong-Hong Kong-Macao Greater Bay Area. District and Biomedical R&D Center. Support Shenzhen in making high-performance medical devices, gene sequencing, bioinformatics analysis, cell therapy and other industries, cultivating world-leading biomedical companies and research institutions, and creating a global source of biomedical innovation and development.
Several policies and measures of Guangdong Province on promoting the innovation and development of biomedicine
In order to thoroughly implement Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era and the spirit of the 19th National Congress of the Communist Party of China, thoroughly implement the spirit of General Secretary Xi Jinping's important speech and important instructions to Guangdong, focus on improving the original innovation capability and international competitiveness of biomedicine, and promote the biological To develop high-quality medical science and technology and industries, improve biosecurity governance capabilities, and ensure the safety and health of the people, the following policies and measures are formulated.
1. Coordinate the layout of biomedical innovation and development
With Guangzhou and Shenzhen as the core, we will build a Guangzhou-Shenzhen-Hong Kong and Guangzhou-Zhuhai-Macao biomedical technology innovation cluster with reasonable layout, dislocation development, synergy and resource aggregation. Support Guangzhou to accelerate the layout and construction of life science, high-end medical care, health and safety, marine medicine and other industries, introduce and cultivate a number of high-level biomedical research and development platforms and service institutions, and build a life science cooperation zone and a biomedical research and development center in the Guangdong-Hong Kong-Macao Greater Bay Area. Support Shenzhen in making high-performance medical devices, gene sequencing, bioinformatics analysis, cell therapy and other industries, cultivating world-leading biomedical companies and research institutions, and creating a global source of biomedical innovation and development. Support Zhuhai, Foshan, and Zhongshan to build new biomedical resources allocation centers, biomedical science and technology achievement transformation bases, and biomedical science and technology international cooperation and innovation zones. Support Huizhou and Dongguan to build important nuclear medicine R&D centers and biomedical R&D and manufacturing bases in China. Support Jiangmen and Zhaoqing to build regenerative medicine large animal experimental bases and South Medicine health industry bases. Support the construction of chemical raw material drug production bases, authentic medicinal materials and Lingnan characteristic traditional Chinese medicinal materials raw materials industry bases in eastern Guangdong, western Guangdong and northern Guangdong. (The Provincial Development and Reform Commission takes the lead, and the Provincial Department of Science and Technology, the Department of Industry and Information Technology, the Department of Agriculture and Rural Affairs, the Health and Health Commission, the Bureau of Traditional Chinese Medicine, the Food and Drug Administration, and the people's governments at or above the local level are responsible)
2. Strengthening the supply of key core technologies in biomedicine
Give full play to the role of the National Natural Science Foundation of China Regional Innovation and Development Joint Fund (Guangdong), the Provincial Basic and Applied Basic Research Fund, and the Provincial, Municipal and Provincial-Enterprise Joint Fund, organize and implement major provincial basic and applied basic research projects in the field of biomedicine, and establish peer review and stability. Support mechanisms to promote innovation at the source and breakthroughs in underlying fundamental technologies. Facing the frontiers of international biotechnology, organize the implementation of provincial key special projects such as biotechnology safety, biomedical materials, synthetic biology and green biomanufacturing. Focusing on major diseases, population health and aging, key issues in drug research and development, inheritance and innovation of traditional Chinese medicine, medical device technology and industrial development needs, organize and implement provincial key points such as precision medicine and stem cells, new drug creation, key technical equipment of traditional Chinese medicine, and high-end medical devices special. Increase research and development efforts in detection and diagnosis, biological vaccines, and innovative antiviral drugs, support the research and development of traditional Chinese medicine prevention and control technologies and products, and make every effort to improve the ability to respond to major public health emergencies. Support the development of bioinformatics and promote the cross-integration of life sciences and information technology. Support the expansion and application of artificial intelligence, big data, 5G and other technologies in monitoring and early warning, virus traceability, new drug screening, prevention and treatment, etc., and promote the research and development, transformation and application of "Internet + medical health" and "smart medical care" related achievements. Support the research and development of marine biopharmaceuticals with characteristics of the South China Sea, and build a mid-to-high-end industrial chain of marine biopharmaceuticals. A provincial clinical medical research project was established to support the clinical application research of new technologies and methods for the prevention, diagnosis and treatment of frequently-occurring and rare diseases. (The Provincial Department of Science and Technology takes the lead, and the Provincial Department of Finance, Health Commission, Chinese Medicine Bureau, and Drug Administration are responsible)
3. Accelerate the construction of major scientific research and experimental platforms for biomedicine
Strengthen the construction of the provincial laboratory of regenerative medicine and health and the laboratory of the Ministry of life information and biomedicine, give them the autonomy of human, financial and material, and strive to become an important part of the national laboratory in the field of life and health. Focusing on key areas of biomedicine, a number of Guangdong-Hong Kong-Macao joint laboratories will be deployed. Promote the construction of a number of major scientific and technological infrastructures such as the national gene bank, human cell lineage devices, and large-scale precision medical imaging facilities, and create a cluster of major scientific and technological infrastructure for biomedicine. Give full play to the role of the National Supercomputing Center in Guangzhou, Shenzhen Center, Dongguan Spallation Neutron Source and other large scientific facilities, attracting top scientists and teams at home and abroad to cooperate in basic and applied basic research on biological information, drug screening, biological macromolecules and proteins. Accelerate the construction of provincial clinical medical research centers, strive for the establishment of national clinical medical research centers in key areas in Guangdong, grant the national clinical medical research center the right to independently initiate provincial scientific research projects, and build an influential national medical center and regional medical center. Strengthen the construction of new research and development institutions in the field of biomedicine, and promote the construction of the Guangdong-Hong Kong-Macao Greater Bay Area Biosafety Innovation Research Institute and the Nano Biosafety Center. Encourage high-level hospitals to cooperate with social forces to build clinical research institutions, build medical-engineering collaborative innovation bases with enterprises, and promote the construction of medical and health highlands. Start the construction of the South China biosafety laboratory system, rationally deploy and construct high-level biosafety laboratories, and speed up the construction of the provincial animal model research center to provide service guarantees for public health and safety in the Guangdong-Hong Kong-Macao Greater Bay Area. Strengthen the construction of statutory inspection institutions for biomedicine, promote the quality evaluation system of the whole industry chain of traditional Chinese medicine and the establishment of authoritative research institutions for international standards of traditional Chinese medicine in the Guangdong-Hong Kong-Macao Greater Bay Area, and accelerate the construction of drug safety evaluation centers with full-capacity GLP laboratories and high-level biosafety laboratories , to improve the inspection and testing capabilities of drugs and medical devices. Build a health and medical big data center to realize the sharing and exchange, cross-regional aggregation and scientific utilization of health and medical data. (The Provincial Department of Science and Technology takes the lead, and the Provincial Development and Reform Commission, the Department of Finance, the Health and Health Commission, and the Food and Drug Administration are responsible)
4. Cultivate and develop characteristic parks and key enterprises in the biopharmaceutical industry
Cultivate and construct about 10 biopharmaceutical industrial parks integrating R&D innovation, entrepreneurial incubation and high-end manufacturing, improve public services such as drug and medical device inspection, safety evaluation, clinical trials, venture capital, and environmental assessment, and develop and expand the biopharmaceutical industry Innovation cluster. Improve the innovation chain around the layout of the biopharmaceutical industry chain, strengthen the collaborative innovation of biopharmaceuticals and the health industry, and strengthen the production, storage and distribution capabilities of medical materials such as drugs, equipment, raw materials, and reagents in response to major public health emergencies. Promote the quality and efficiency of professional biomedical incubators, introduce the operation and management mechanism of internationally renowned biomedical incubators, and attract biomedical start-ups and innovation and entrepreneurship teams to settle in. Establish a biopharmaceutical leading enterprise cultivation library, and strive to cultivate 1 enterprise with R&D investment exceeding 5 billion yuan, 10 enterprises exceeding 1 billion yuan, 100 enterprises exceeding 100 million yuan, and 1,000 new national high-tech enterprises by 2022 . Encourage high-quality biopharmaceutical companies to list at home and abroad for financing, and to grow through mergers and acquisitions. Encourage banks to increase credit support for biomedical technology-based small and medium-sized enterprises, support angel funds and venture capital to invest in biomedical technology-based start-ups, and the provincial finance will give a certain amount of risk compensation according to the actual investment amount. Launched innovative financial products such as technology innovation coupon cloud loan and key scientific research plan project support loan on the Guangdong SME financing platform to provide online loan support for R&D enterprises such as drugs and medical devices. In the Guangdong Equity Exchange Center, a special section for biomedical property rights transactions has been opened to provide intellectual property financial services such as intellectual property pledge financing and intellectual property insurance, and develop intellectual property securitization financing products. For R&D service institutions such as drug non-clinical trial research institutions, drug clinical trial institutions, commissioned contract research institutions (CROs), commissioned contract manufacturing institutions (CMOs), and contract R&D and production service institutions (CDMOs), there is no investment in this R&D service institution. For related biopharmaceutical enterprises that provide technical services, qualified prefectures and cities are encouraged to give one-time rewards and subsidies based on a certain percentage of the technical contract turnover. (The Provincial Department of Science and Technology, the Department of Industry and Information Technology take the lead, and the Provincial Department of Finance, the Department of Ecology and Environment, the Health and Health Commission, the Market Supervision Bureau, the Local Financial Supervision Bureau, the Food and Drug Administration, and the listed people's governments at or above the local level are responsible)
5. Actively connect domestic and foreign high-end biomedical technology innovation resources
Promote the transformation of major national science and technology projects and achievements in the field of biomedicine in Guangdong by means of continuous support, linkage support, supplementary support, and supplementary support. Strive for the country to deploy major scientific and technological special projects and industrialization projects in Guangdong, and explore new models to promote the implementation of the 2035 national major scientific and technological projects in the fields of traditional Chinese medicine and major diseases, as well as the national key research and development plans in the fields of green bio-manufacturing. Support state-level colleges and universities, colleges and universities, enterprise groups, etc. to systematically deploy R&D and innovation systems in Guangdong. Well-known domestic and foreign biomedical institutions and Fortune 500 pharmaceutical companies are encouraged to set up R&D headquarters or regional R&D centers in Guangdong. Those who have been identified as provincial new R&D institutions with excellent evaluation will be awarded a maximum of 10 million yuan in rewards. Support Hong Kong and Macao universities and scientific research institutions to lead or independently apply for provincial science and technology projects in the field of biomedicine. Continue to implement the Guangdong-Hong Kong, Guangdong-Macao joint funding plan, focusing on supporting basic biomedical research and key core technology research. Support Zhuhai Hengqin Guangdong-Macao Cooperation Traditional Chinese Medicine Science and Technology Industrial Park and surrounding suitable development areas to carry out innovative pilot projects, and explore the construction of a public service platform for overseas registration of traditional Chinese medicine products in terms of standardization, internationalization and modernization of traditional Chinese medicine. Support the holding of internationally influential biomedical industry summits, high-end forums, academic exchange activities, etc., such as the Guanzhou International Biological Forum. Encourage universities and scientific research institutions in our province to take the lead in initiating or participating in international major scientific projects such as brain science and brain-inspired, synthetic biology, traditional Chinese medicine, etc. Priority funding will be given in the provincial international scientific and technological cooperation plan. Build a cross-organizational enterprise intellectual property construction and protection cooperation organization to jointly promote high-quality enterprises to participate in international competition. Strengthen exchanges and cooperation with innovative countries, key small countries and countries along the "Belt and Road" in the field of biomedical science and technology. (The Provincial Department of Science and Technology takes the lead, and the Provincial Development and Reform Commission, the Department of Education, the Department of Commerce, the Health and Health Commission, the Market Supervision Bureau, and the Bureau of Traditional Chinese Medicine are responsible)
6. Promote efficient cross-border flow of biomedical innovation elements
Improve the customs clearance mechanism for biological products, biological materials, and experimental animals in Guangdong, Hong Kong and Macao, and biomedicine-related units that need to carry out scientific research, clinical research or production supplies (reagents, instruments and equipment, biological samples, antibody original research reference drugs, etc.) import and export all year round. The science and technology department establishes a directory of units and regularly informs the customs department; the customs department conducts credit cultivation for the units that have entered the directory, and provides the units that have been certified by the customs to facilitate customs clearance. Strive for the state to allow the medical data and blood and other biological samples required by Guangdong-Hong Kong-Macao scientific research cooperation projects to be used across borders in limited universities, scientific research institutions and laboratories in the Guangdong-Hong Kong-Macao Greater Bay Area, and explore pilot implementation in the Guangdong-Hong Kong-Macao joint laboratory. Designated medical institutions operating in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area (the main body of medical and health service providers in Hong Kong and Macao are set up in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area in the form of sole proprietorship, joint venture or cooperation) are allowed to use clinically urgently needed medicines that have been listed in Hong Kong and Macao. For medicines, use medical devices that are urgently needed in clinical practice, have been purchased and used by public hospitals in Hong Kong and Macao, and have advanced clinical application. Hong Kong and Macao universities, scientific research institutions and hospitals registered with the Ministry of Science and Technology in Guangdong, enjoy the same policies as mainland institutions, and can directly apply for the export of human genetic resources samples to Hong Kong and Macao according to law. Promote the mutual recognition of registration and inspection standards for proprietary Chinese medicines in the Guangdong-Hong Kong-Macao Greater Bay Area, and build an integrated Chinese medicine evaluation mechanism. (Guangdong Branch of the General Administration of Customs takes the lead, and the Provincial Department of Science and Technology, the Department of Education, the Health and Health Commission, the Bureau of Traditional Chinese Medicine, and the Food and Drug Administration are responsible)
7. Improve the incentive mechanism for biopharmaceutical product research and development and clinical trials
Encourage qualified cities to implement preclinical research, clinical trials, and generic drug consistency evaluation awards and subsidies. After the medical device obtains the clinical trial license or filing, a one-time reward and subsidy will be given to the applicant for product registration. After the test, the applicant for product registration will be given a one-time reward and compensation in stages; for the medical device approved in accordance with the special approval procedure for innovative medical devices, after the clinical trial is completed, the applicant for product registration will be given a one-time reward and compensation; For drugs, a one-time reward and subsidy will be given according to a certain percentage of the actual R&D expenses. Encourage qualified prefectures and cities to give one-time awards to new drugs and high-end medical devices that have obtained registration certification from the U.S. Food and Drug Administration (FDA), the European Commission for Drug Quality Steering (EDQM), or the Japanese Ministry of Health, Labor and Welfare, etc. repair. Support medical institutions to carry out clinical trials, and include clinical trial conditions and capability evaluations in the level assessment of medical institutions. Support the construction of clinical research hospitals, and set up clinical research beds according to a certain proportion of the total beds in the top three hospitals that have obtained the qualification of clinical trial institutions, or set up clinical research areas independently; the beds only used for clinical trials are not included in the total hospital beds of medical institutions The number of hospital bed efficiency, turnover rate, utilization rate and other indicators are not specified. Improve the performance distribution incentive mechanism, treat clinical trials initiated by researchers as scientific research projects and include them in the scientific research performance evaluation, and enjoy the same treatment as clinicians in terms of job title and professional title promotion. (The Provincial Department of Science and Technology will take the lead, and the Provincial Department of Finance, Human Resources and Social Security, the Health Commission, the Food and Drug Administration, and the people's governments at or above the local level will be responsible)
8. Optimizing the system of drug device registration and marketing and promotion and application
Establish and improve the "one-stop" mechanism for the review and approval of drugs and medical devices, gradually implement the notification and commitment system for the administrative review and approval items with provincial authority in terms of drugs and medical devices, and give priority to the review and approval of the registration of innovative and clinically needed drugs and medical devices. For new anti-tumor drugs that are urgently needed for clinical use and have not yet been approved for registration in my country and have been marketed abroad, strive for permission from the state to be used in nine mainland cities in the Guangdong-Hong Kong-Macao Greater Bay Area. For medical devices that are undergoing clinical trials and are used to treat life-threatening diseases and have not yet been approved for registration in my country, strive for the state to allow expanded use in nine cities in the Guangdong-Hong Kong-Macao Greater Bay Area. Strive for the state to allow the provision of cutting-edge medical treatment services that have been approved by the competent authorities of developed countries or regions in designated medical institutions in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area. Strive for the state to establish a drug and medical device review and inspection agency in Guangdong. Encourage medical institutions in Guangdong to increase the proportion of the procurement of innovative drugs and medical devices with definite curative effect, controllable quality and stable supply. Promote the inclusion of high-quality medicines produced in our province into the National Basic Medical Insurance Drug List, and support inclusion in the National Essential Drugs List. For the medical special equipment included in the "Guidelines for the Promotion and Application of the First (set) Major Technical Equipment in Guangdong Province", the first purchase, ordering, etc. shall be used to purchase the special medical equipment, so as to promote the research and development and demonstration application of innovative products. For drugs that have passed the consistency evaluation of the quality and efficacy of generic drugs, the price is negotiated at the same quality level as the original drug, and is not subject to restrictions such as drug cost control, drug proportion, variety, specification and quantity, second-line drugs, and adjuvant drugs. Establish a docking mechanism between biopharmaceutical enterprises and medical institutions to promote the promotion and application of new pharmaceutical products. (The Provincial Food and Drug Administration takes the lead, and the Provincial Department of Science and Technology, the Department of Industry and Information Technology, the Department of Finance, the Health and Health Commission, and the Medical Insurance Bureau are responsible)
9. Strengthen the protection of high-level talents in biomedicine
Increase the support of major talent projects such as the "Pearl River Talent Program" and "Guangdong Special Support Program" for innovative and entrepreneurial teams and high-level talents in the biomedical field, and introduce and train a group of world-class strategic scientists, innovative and entrepreneurial talents, and compound talents. , young top-notch talents and interdisciplinary talents. Strengthen the construction of biomedical disciplines in colleges and universities, and accelerate the establishment of world-class disciplines such as clinical medicine, pharmacy, and traditional Chinese medicine. Deploy and build high-end think tanks in the field of biomedicine, and carry out strategic research focusing on major issues in the innovation and development of biomedicine. Special support for "one case, one discussion" will be given to the projects where top talents with international influence bring technology and teams to Guangdong for industrialization. Encourage medical personnel from Hong Kong and Macao to come to Guangdong for academic exchanges, and explore and promote qualified medical personnel from Hong Kong, Macao and foreign countries to practice directly in nine mainland cities in the Guangdong-Hong Kong-Macao Greater Bay Area. Implement the "through train" system for the evaluation of professional titles of technology entrepreneurs, and encourage qualified biomedical technology entrepreneurs to actively apply. Support the establishment of an inheritance studio for old Chinese medicine experts, and strengthen the cultivation of Chinese medicine talents and the inheritance of experience. Establish an apprenticeship system for senior Chinese medicine physicians, which is linked to professional title evaluation and evaluation of excellence. (The Organization Department of the Provincial Party Committee takes the lead, and the Provincial Development and Reform Commission, the Department of Education, the Department of Science and Technology, the Department of Human Resources and Social Security, the Health and Health Commission, the Bureau of Traditional Chinese Medicine, and the Food and Drug Administration are responsible)
10. Strengthen scientific and technological ethics and biosafety management
Establish and improve ethics committees at all levels and types, and build a biomedical science and technology ethics governance system with comprehensive coverage, clear orientation, standardization, order, and coordination. For scientific research activities in the fields of life sciences and medicine, the technology ethics commitment system shall be implemented before the project is established. Medical and health institutions involving human biomedical scientific research shall set up ethics committees in accordance with relevant national regulations, and conduct ethics review before the establishment of scientific research projects. Carry forward the spirit of scientists, strengthen the construction of work style and study style, establish a correct scientific research value orientation, and change the unreasonable scientific and technological evaluation system. Strengthen the integrity of scientific research activities, establish and improve a scientific research integrity management system with clear responsibilities and efficient coordination, strictly investigate and deal with data fraud, and implement joint credit punishment. Strengthen the construction of biosafety risk prevention and control and governance systems in our province, establish and improve a long-term mechanism for inter-departmental cooperation in response to major public health emergencies, and promote effective collaboration in scientific research, disease control, and clinical treatment. Develop biosafety monitoring and identification, active prevention and control and emergency response technologies, strengthen research on the composition and evolution of pathogens carried by wild animals, and the mechanism of cross-species transmission of important pathogens, and establish an early warning and traceability technology system. Strengthen the safety management of biotechnology R&D activities at different levels of risk, strengthen the safety management and control of biological information data, and ensure the safety and healthy development of biotechnology. (The Provincial Department of Science and Technology takes the lead, and the Provincial Department of Agriculture and Rural Affairs, the Health Commission, and the Traditional Chinese Medicine Bureau are responsible)