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1. Characteristics of biomedical innovationSecond, the development trend of China's medical-industrial integration3. Problems in the integration of medicine and industry in China4. Strengthen the operation of intellectual property rights and promote the integrated development of medicine and industry5. Case sharing1. Characteristics of biomedical innovation
(1) Large investment in the early stage and long profit cycle
There is a seemingly difficult "industry law" in biomedical innovation:
1) Long cycle and high cost;
2) Low success rate;
3) Costs increase over time.
From drug discovery, preclinical research, clinical trials to marketing and drug sales, it takes a very long time, including target discovery, new indication discovery, preclinical research, clinical trials, registration declaration, large-scale production, promotion and other complicated and high-cost work.
(2) R&D risk is high and technical personnel intensive
First of all, the high risk of R&D is mainly due to the lack of understanding of the occurrence, development and life process of diseases by people inside and outside the industry, and the pathogenic mechanism is highly complex. 
Secondly, there are a large number of research objects, and the research process is complex and random. From the perspective of target discovery, the success rate of the traditional model is extremely low, and it takes 2 to 3 years to speculate on the accumulation of relevant scientific research literature and personal knowledge and experience. Compound selection requires screening in a large number of compounds. 
In addition, it is difficult to predict the results at an early stage in the traditional mode of drug development, and compounds that are well validated in animal models may also have problems in clinical trials, such as the thalidomide incident, which caused the problem of seal limb deformities. 
Finally, the individualized differences of patients affect the results and efficacy of clinical trials, including age, gender, body type, genes, disease course, organ function, and environment. 
(3) Positive external benefits and policy dependence
1. China is facing fierce competition in the field of global life and health
More than 90% of China's innovative drugs, high-end diagnosis and treatment equipment, and high value-added medical consumables rely on imports. Moreover, on June 8, 2021, the U.S. Senate passed the United States Innovation and Competition Act of 2021, which identified for the first time 10 key technologies, Article 7 of which is biotechnology, medical technology, genomics and synthetic biology.
2. The state has issued a series of policies to encourage the original innovation of new drugs and medical devices
In March 2021, the "Outline of the 14th Five-Year Plan for National Economic and Social Development of the People's Republic of China and the Long-Range Objectives Through the Year 2035" pointed out that the ...... innovative drugs should be improvedThe rapid review and approval mechanism accelerates the review and approval of drugs and medical devices that are urgently needed in clinical practice and rare diseases. In December 2021, the "14th Five-Year Plan for the Development of the Bioeconomy" recommended that the original innovation ability of drugs should be the key development areas, aiming at frontier fields such as new drug creation, and implementing major national scientific and technological projects and key R&D plans. Promote the ...... of innovative drugs and high-end medical devicesAccelerate integration into the international market.
3. The progress of biomedical technology has positive social benefits, but the whole chain of the industry is affected and supervised by policies
Innovation in the biomedical industry can not only drive the technological progress of the entire industry and promote the improvement of productivity, but also improve the overall health level of the people, with positive external benefits. From the institutional system, personnel system to the product system, the state has relevant policies and norms to restrict
1) Pharmaceutical and medical device production and business enterprises enter the licensing system;
2) Quality management standard certification for the production and operation process of pharmaceutical devices (GMP, GSP certification);(3) Registration management of pharmaceutical and medical device production;
4) Standardized management of drug and device circulation.
After 2015, the country accelerated medical reform, and a series of medical reform policies have also created new strategic opportunities for the development of innovative drugs, medical devices, CRO CDMO and other fields in China.
(4) Medical-engineering integration: a new outlet for medical innovation
First of all, many advanced development regions around the world have formed good demonstration samples in terms of medical innovation and transformation. Developed countries such as the United States, Japan and Western Europe lead the world in the integration of medicine and engineering and medical transformation. Global medical-engineering integration Medical transformation mostly adopts the BBB or "clinical-research-education" innovation incubation model. On the one hand, the world-leading BBB (BED-BENCH-BED, that is, clinical-laboratory-clinical) R&D innovation model has been well practiced in industrial clusters such as Boston-Cambridge area in the United States, North Carolina Triangle Park in the United States, Cambridge Science Park in Cambridgeshire, and Haifa Life Science Park in Israel, and has achieved remarkable resultsOn the other hand, the world's top medical centers such as Mayo Clinic, Johns Hopkins Hospital, University Hospital of Lausanne in Switzerland, and ** Hospital in Singapore have adopted the "clinical-research-education" incubation model to promote innovation and transformation in the medical field, realizing the cross-integration, wisdom and efficient marketization of medicine and engineering.
Secondly, although China started late in the integration of medicine and engineering, it has carried out successful exploration. From the past 10 years, especially after China's accession to ICH in 2017, the policy reform of the domestic pharmaceutical industry has accelerated, the frequency of policy adjustment is higher, and the pharmaceutical industry has also presented a new situation of "a hundred flowers blooming". The chain has also established a relative comparative advantage, and the dividends of domestic scientific and technological talents and engineers have gradually improved.
Second, the development trend of China's medical-industrial integration
(1) Trend 1: The transformation of medical innovation has gradually shifted from a policy call at the national level to a conscious action at the local and medical institution levels
1. At the national level: the policy system to support the transformation of medical innovation achievements has been gradually improved
The national policy system to support the transformation of medical innovation achievements has been gradually improved at the policy level.
The report of the 19th National Congress of the Communist Party of China pointed out that we should adhere to the world's scientific and technological frontiers, the main battlefield of the economy, the major needs of the country, and the lives and health of the people, and accelerate the realization of high-level scientific and technological self-reliance and self-reliance. Guided by the national strategic needs, we will gather strength to carry out original and leading scientific and technological research, and resolutely win the battle of key core technologies. We will speed up the implementation of a number of major national science and technology projects that are strategic and forward-looking, and enhance our ability to innovate independently. Strengthen basic research, highlight originality, and encourage free exploration. Improve the efficiency of science and technology investment, deepen the reform of the mechanism for the allocation and use of financial science and technology funds, and stimulate innovation vitality.
At the same time, the "Several Opinions of the Communist Party of China on Deepening the Reform of the System and Mechanism and Accelerating the Implementation of the Innovation-Driven Development Strategy" proposes to establish a convenient and efficient regulatory model for innovative products such as drugs and medical devices, deepen the reform of the review and approval system, increase review resources through multiple channels, optimize the process, shorten the cycle, and support the development of new organizational models such as commissioned production. "Improve the supervision of the Internet, finance, environmental protection, medical and health, culture, education and other fields, and support and encourage the development of new forms of business and new business models. In addition, in the "Opinions on Strengthening the Performance Appraisal of Public Hospitals" issued by the General Office of the People's Republic of China in 2019, the two important indicators of "scientific research project funding per 100 health technicians" and "amount of transformation of scientific research achievements per 100 health technicians" were included in the performance appraisal, and the results were transformed into the indicators of the "national examination" of public hospitals, and the transformation of achievements was officially promoted to the strategic level of hospital development.
2. At the level of the National Health Commission: the operability has been further enhanced, and the status of medical and health institutions as the main body of innovation has been clarified
In the "Guiding Opinions on Comprehensively Promoting Health and Health Science and Technology Innovation" (2016), it further clarifies the functional positioning of various innovation entities such as medical and health institutions, scientific research institutes, colleges and universities, food and drug inspection and testing institutions, and enterprises, and accelerates the construction of a coordinated and efficient health and health science and technology innovation system for various innovation subjects. "Relying on the National Clinical Medical Research Center and the collaborative research network, we will give full play to the core role of medical institutions in demand proposal, research organization, achievement transformation and application, and talent training." "Vigorously promote the collaborative innovation of "medical research enterprises". With the technology market, capital market and talent market as the link, and the open sharing of resources as the means, strengthen the cooperation of various innovative subjects such as medical and health institutions, scientific research institutes, colleges and universities, food and drug inspection and testing institutions and enterprises, build institutional mechanisms and models of collaborative innovation, promote the close integration of medical industry, university and research, and build a number of "medical research enterprises" collaborative scientific and technological innovation demonstration bases and teams with strong driving force, and play a leading and exemplary role. The "Guiding Opinions on Strengthening the Transfer and Transformation of Health and Health Science and Technology Achievements" (2016) proposes that the transfer and transformation of scientific and technological achievements is an important part of health and health science and technology innovation, and is a key link to strengthen the close integration of scientific and technological innovation and health and health development, which is of great significance to promoting the construction of "Healthy China". The transfer and transformation of health and health science and technology achievements should be closely related to the development needs of health and health undertakings, to meet the needs of people's health and solve the key problems that hinder the transfer and transformation of scientific and technological achievements, and to establish a system for the transfer and transformation of scientific and technological achievements that conforms to the characteristics of the health and health industry and the laws of the market economy. "Medical and health institutions and other relevant units should study and formulate methods for rewarding and distributing benefits for the transfer and transformation of scientific and technological achievements, improve the system of service inventions, and reward other personnel who have completed the transformation of scientific and technological achievements and made important contributions to the transformation of achievements."
3. Local level: Local governments are paying more and more attention to the integration of medical enterprises in the development of the biomedical industry
Shanghai and Beijing have explored the integration of medical enterprises from the policy level. The "Several Opinions of the General Office of the Shanghai Municipal People's Government on Promoting the High-quality Development of the Biomedical Industry in Shanghai" (2021) states: strengthen incentives for the transformation of clinical research results. Relying on the "Action Plan for Promoting Clinical Skills and Clinical Innovation in Municipal Hospitals", support relevant hospitals to carry out clinical research and transformation of achievements". "Enhance the ability of innovation in the integration of industry and medicine. Establish a demonstration base for the integration of industry and medicine and a working mechanism for the docking of medical enterprises, and improve the collaborative research and innovation platform for medical enterprises and the digital management platform for clinical trials in municipal hospitals. Support qualified institutions to build research-oriented hospitals, and jointly establish technology transformation platforms with enterprises". The "Beijing Action Plan for Accelerating Collaborative Innovation in Medicine and Health (2021-2023)" (2021) points out that it is necessary to accelerate the deep integration of clinical and industry, promote the close collaboration of industry, academia, research and medicine, and improve the level of capacity simultaneously"."To implement the provisions of the Beijing Municipal Regulations on Promoting the Transformation of Scientific and Technological Achievements, medical and health institutions and their innovation teams can realize the transformation and return appreciation of the research results held by them through ownership reform, patent transactions, licensing or investment in shares, so as to form a stable and diversified incentive mechanism." "Support the National Clinical Medical Research Center, Beijing Clinical Medical Research Center and other units to carry out high-level clinical research and medical-engineering collaborative innovation product research and development such as rewriting domestic and foreign guidelines".
4. At the level of medical institutions: continuously improve the system and mechanism for the transformation of achievements in the hospital, and the status of medical institutions in the innovation system has begun to appear
Many medical institutions have taken the initiative to build systems and mechanisms for innovation and transformation in hospitals, build management systems, and establish management and service platforms for innovation transformation systems. The number of achievements transferred and transformed by medical and health institutions has grown rapidly, and the role of medical and health institutions in pharmaceutical innovation and industrial promotion has begun to appear.
(2) Trend 2: The value of doctors and medical institutions in the process of medical innovation is gradually being verified and strengthened
The value of doctors and medical institutions in the process of medical innovation has been gradually verified and strengthened, which is manifested as follows: First, the role and value of doctors in the process of medical innovation run throughout. As the proposer of clinical needs, the inventor of medical innovation, the assistant of technological development, the executor of clinical experiments and the user of the product after it is launched, doctors are in the core position in the process of medical innovation. Second, the integration and development of medicine and engineering will be the only way for medical device innovation. Throughout the development history of medical devices, the emergence of each epoch-making medical device has experienced a long history of mutual confirmation of scientific research and clinical practice, the development process of the integration of medicine and engineering, and the development of each medical device has experienced the process of concept proposal, technological breakthrough, clinical trial, industry follow-up, high-level clinical research verification, guideline recommendation, and industrial explosion. Third, the enthusiasm of medical service personnel and clinical researchers to innovate is increasing. The institutional barriers to the transformation of scientific and technological achievements in medical and health institutions have been removed, the incentive arrangements for scientific and technological innovation of medical and health institution staff have been institutionalized, and the enthusiasm of medical service personnel and clinical researchers for innovation has been continuously improved.
(3) Trend 3: The paradigm of domestic medical innovation is gradually changing to clinical and medical-engineering integration
At present, the paradigm of domestic medical innovation based on imitation in China needs to be changed urgently. In the past, China's innovation paradigm was "the introduction of foreign products from large manufacturers, imitation of a certain generation of products from large manufacturers, localization exploration and production", the innovation paradigm is based on imitation, products can not be iterated and followed, and the road of industrial innovation and development is unsustainable. Therefore, the paradigm of medical innovation should shift to clinical needs and medical-engineering integration. In the future, the paradigm of medical innovation should gradually shift to "starting from clinical needs, combining medicine and engineering for product innovation and R&D, forming a knowledge system, and achieving steady iteration".
(4) Trend 4: A clear path has been explored for the transformation of the results of doctors and medical institutions
At present, a clear path has been gradually explored for the transformation of the achievements of doctors and medical institutions. From ideas to products, there are traces of medical innovation. For example, in the transformation of medical innovation achievements, doctors have gone through the path from innovative ideas, product production to industry formation, through patent protection and product realization to develop clinically good innovative ideas into products, through project evaluation and contract signing to industrialize products, doctors gradually realize personal value. Another example is that from systems to ecosystems, medical innovation has a promising future. Doctors can play a role in the development of disciplines and create ecology in the transformation of medical innovation achievements, by building innovation platforms and holding innovation activities, committed to discipline innovation, through the combination of **, capital, enterprises and other resources, providing innovative services to help project incubation, and gradually build a good ecology of specialty innovation, doctors gradually realize social value.
(5) Trend 5: Doctors and medical institutions have made great progress in innovation and transformation
According to statistics, the number of patent transfers by medical institutions has increased steadily. In the past ten years, the number of patent transfers in the country's tertiary hospitals has been growing steadily, especially after 2014, with the introduction of a series of national policies to promote the transformation of scientific and technological achievements, the number of patent transfers has grown rapidly, and the number of transfers in 2021 has doubled compared with 2020, reaching nearly 700, and it is expected to continue to accelerate.
In addition, relevant typical cases continue to emerge, and clinicians have a lot to do in the process of transforming results, and gradually explore a number of models and cases. Peking University Third Hospital, West China Hospital of Sichuan University, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Peking University First Hospital have completed a number of classic cases, and Beijing Jishuitan Hospital has explored a new model of "empowerment + shareholding" and adopted the first case in the industry.
(6) Trend 6: A collaborative innovation ecology of government, industry, academia, research and medical institutions is taking shape for the transformation of medical innovation
1. Industry authorities gradually support the transformation of projects of doctors and medical institutionsThe relevant competent departments have issued a series of support policies to support the transfer and transformation of medical institutions. Since 2017, the Beijing Municipal Health Commission hosted the first Capital Medical Innovation and Transformation Competition, more and more industry organizations have begun to pay attention to clinical medical innovation projects, the National Health Commission Medical and Health Science and Technology Development Research Center, the Chinese Academy of Medical Sciences, the China Medical Device Industry Association, and various local ** and industry associations held the innovation competition will be given financial and service support for the innovation and transformation of medical institutions as a separate track.
2. Industry and capital return to the origin of innovation, and pay more attention to early-stage projects starting from clinical developmentClinical demand is the starting point and foothold of medical innovation, and according to the investment data in the medical field in the last two years, projects with solid clinical needs are more favoredIndustry and capital pay more attention to early-stage projects starting from clinical practice, and clinical needs, clinical trends, and clinical values have become the core demands of industry and capital in judging early-stage projects.
3. The successful exploration and practice of departmental medical institutions have produced a wide range of demonstration effects
1) Taking West China Hospital as an example, the overall situation of the transformation of achievements in West China Hospital has increased year by year in recent years, including patent applications and authorizations and horizontal projects in the past five years. Among them, in 2020, 930 patent applications were filed, of which 57% were invention patents, and 56.3 billion yuan, 56 transfer licenses in 2020, and the conversion amount reached 6900 million RMB. (2) A professional transfer and transformation institution and team have been established, and West China Hospital has established an achievement transformation department and a western medical technology transfer center to promote the transfer and transformation of scientific and technological achievements through collaborative innovation and industry-university-research-application public innovation.
3. Problems in the integration of medicine and industry in China
(1) Problem 1: The grafting of resources inside and outside the hospital for medical innovation and transformation is not smooth
Due to the long chain of medical innovation and transformation, systematic support is more needed. In the research and development of medical innovative products, the three stages of "discovery of clinical pain points (project establishment), layout and protection of invention patents, and production and verification of prototypes" can be completed independently with the resources and advantages of hospitals, but other links need the support of a systematic service platform. In addition, medical innovation requires multidisciplinary cooperation, but it is difficult to support hospital resources. In medical device innovation, multidisciplinary cooperation is required, including biology, materials science, electronic information science, mechanical science, big data and AI.
At the same time, all aspects of medical innovation and transformation require professional services. The transformation of a scientific and technological innovation achievement is complex and professional, involving a wide range of fields and information, and requires the participation of professional service institutions and teams in technology transfer and transformation from project analysis, project evaluation, selection of transformation methods, and signing of partners and contracts.
(2) Problem 2: There are limitations in the medical innovation awareness and innovation achievements of medical institutions
First of all, there is a mismatch between doctors' knowledge systems and the needs of medical innovation transformation. The group of doctors has rich clinical experience and clinical foundation, but there is no systematic concept of the path of achievement transformation and the knowledge required. Whether it is the characteristics of universities, enterprises and capital and other partners and the market-oriented achievement transformation system in the later stage, there is a lack of understanding. Second, the vast majority of innovations are virtually untranslatable. Restricted by various factors such as scientific research orientation, doctors' understanding of innovation transformation and lack of platforms, most of the doctors' innovation projects are in the stage of innovative ideas, engineering realization and clinical value have not yet been verified, and commercial value (operational market means) needs to be considered, and most of them are difficult to transform at this stage. Finally, a very small number of scientific and technological achievements can or are suitable for independent capital operation. Because even the medical scientific and technological achievements that can be transformed, most of them belong to micro-innovations that grasp the clinical pain points, and the most reasonable transformation destination is to supplement the product line of the counterpart enterprise, and only a few achievements are suitable for the establishment of independent companies to carry out the operation of the capital market.
(3) Problem 3: There is an extreme shortage of professional service institutions and talents for the transformation of medical achievements and technology transfer
There is a lack of professional technical service system and personnel for the transformation of medical achievements. The vast majority of medical institutions in China do not have independent technology transfer service institutions, and usually only set up 1-2 administrative personnel to be responsible for the management of achievement transformation, which is extensive management and difficult to effectively form professional and systematic support for the transformation of achievements. Moreover, the professional requirements for talents for the transformation of scientific and technological achievements are high, and there is an extreme shortage of compound talents. In the process of achievement transformation, it involves multidisciplinary professional knowledge and skills such as intellectual property rights, transfer and transformation, engineering technology, clinical verification, registration and approval, business management, etc., which has high requirements for innovation and transformation talents, a long training cycle, and an extreme shortage of talents for achievement transformation.
(4) Problem 4: Lack of professional proof-of-concept incubation platform and industry docking cooperation platform
First, there was a lack of early project proof-of-concept support. Doctors do not have the relevant knowledge background, and with the lack of engineering and material resources, it is difficult to produce prototype samples for scientific verification, and most projects stay in the early concept and preliminary design stage. There is an urgent need to set up a professional proof-of-concept platform to assist in making prototype samples and promote the process of achievement transformation. Secondly, there is a lack of incubation acceleration system suitable for innovative projects in medical institutions. The advantages and characteristics of early-stage innovation projects in medical institutions are not suitable for the current industry set up for mature enterprise projects**. It is necessary to connect industrial resources such as parks, medical enterprises, and investment institutions, and gradually explore the establishment of an early financial support system and industrial innovation base that meet the characteristics of medical institution transformation projects, so as to provide systematic support for project development. Finally, there is a lack of professional clinical industry docking and cooperation platforms. The advantages and characteristics of early-stage innovation projects in medical institutions are not suitable for the current industry set up for mature enterprise projects**. It is necessary to connect industrial resources such as parks, medical enterprises, and investment institutions, and gradually explore the establishment of an early financial support system and industrial innovation base that meet the characteristics of medical institution transformation projects, so as to provide systematic support for project development.
4. Strengthen the operation of intellectual property rights and promote the integrated development of medicine and industry
(1) Countermeasure 1: Build an innovation ecology of medical-engineering integration
Open innovation is an innovation in a decentralized resource environment, and an innovation model with the best efficiency in the context of social division of labor. As the right carrier of innovation achievements, intellectual property is the basis for allocating innovation element resources with a market-oriented mechanism in the medical-industrial integration ecology. At the same time, intellectual property runs through the whole process of medical-engineering integration. It is necessary to build a collaborative innovation consortium for the integration of medicine and engineering, and build a normalized platform for the display and exchange of intellectual property rights and achievements. (2) Countermeasure 2: Comprehensively improve the awareness and ability of medical institutions to acquire intellectual property rights
In order to comprehensively improve the intellectual property awareness and ability of the medical structure, it is necessary to set up special departments and posts to systematically manage the scientific research achievements of the hospital, gradually establish the intellectual property management system of the whole process, and carry out training in the whole chain and a combination of various methods, so as to improve the intellectual property awareness and ability of all employees of the hospital. (3) Countermeasure 3: Formulate guidelines for the transformation of intellectual property rights and scientific and technological innovation achievements of medical institutions
In recent years, the number of medical innovation projects has increased, and the demand for transformation has increased, but the industry has not yet issued operational guidelines for the transformation of intellectual property rights and achievements of medical innovation projects. In order to help the transformation and implementation of scientific and technological innovation achievements in medical institutions, the Guidelines for the Transformation of Intellectual Property Rights and Scientific and Technological Innovation Achievements of Medical Institutions should be formulated for the executors of innovation transformation and achievement transformation service personnel according to the characteristics of the transformation of medical innovation projects, analyze the practice path of project transformation cases, condense the point cases and services into systematic and systematic value output, and guide the specific practice of medical innovation transformation. Specifically, specific transformation work items need to be specified in clinical needs, project evaluation, intellectual property protection, medical-engineering integration, transformation path design and transformation landing. 
Fourth, case sharing.
(1) In cooperation with the Second Hospital of Sun Yat-sen University, Bio-Island Laboratory has successfully developed a portable artificial intelligence ultrasound bone densitometer
In view of the rapid increase in osteoporosis caused by the aging of the population, as well as the current problems of low osteoporosis examination rate, low inspection rate, and high examination cost, Bio Island Laboratory and the Second Hospital of Sun Yat-sen University have cooperated to develop a portable artificial intelligence ultrasound bone densitometer, build big data collection and network construction, and become the best prevention and control system for osteoporosis. 
The biosafety evaluation of the self-developed wrist band probe was completed in cooperation, and the SOS RF value of the band probe was stable, which met the national standard YY T 0774-2019 for ultrasonic bone densitometry.
The cost of bone densitometry is reduced by 6-50 times, and the detection performance is significantly better than that of the current ultrasound bone densitometer (technical readiness level 7).
Clinical studies are being conducted in multiple centers.
From the perspective of the expected results and benefits of the project, the market share mainly comes from patient purchases, medical institution purchases, etc. It is estimated that by 2050, the number of patients with osteoporosis or osteopenia in China will reach 53.3 billion. According to the purchase ratio of 1% of family doctors, about 5.33 million units were sold. It is estimated that 949983 primary medical and health institutions will purchase the products, plus about 1 million hospitals below the secondary hospital. Primary medical and health institutions sold about 500,000 units at a 50% purchase rate. From the perspective of cost and benefit, a large amount of money will be saved in fragility fractures**, and in the prevention of osteoporosis**, the cost of DXA bone densitometer examination will also be saved every year, and based on 2025, it is expected that the number of osteoporosis patients will reach 53.3 billion, there may be a demand for 1 million medical institutions, and the product revenue will increase significantly.
(2) In cooperation with the Second Hospital of Sun Yat-sen University, the Bio-Island Laboratory has successfully developed an intelligent wearable cardiopulmonary signal detector
In cooperation with the Second Hospital of Sun Yat-sen University, the Bio-Island Laboratory has developed an intelligent wearable cardiopulmonary signal detector. The detector has multiple advantages and overcomes the shortcomings of existing wearable devices.
The equipment has obtained 5 Chinese invention patents, 1 Japanese invention patent, and 4 Chinese utility model patents.
The largest multi-center clinical research cohort for sudden cardiac death and high-risk populations in China has been established, and according to statistics, as of December 2022, the number of cases in each group of clinical studies conducted is as follows.
*: Frontiers of Intellectual Property.
Editor: Yoyo