期刊论文详细信息
Health Research Policy and Systems
Seizing the strategic opportunities of emerging technologies by building up innovation system: monoclonal antibody development in China
Yi-Tao Wang1  Hao Hu1  Jian Li2  Mao-Yu Zhang1 
[1] State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Room 2057, Building N22, Avenida da Universidade, Taipa, Macao, China;Faculty of Arts and Humanity, University of Macau, Macao, China
关键词: Monoclonal antibody;    Innovation system;    Emerging technology;    China;   
Others  :  1232623
DOI  :  10.1186/s12961-015-0056-1
 received in 2015-02-02, accepted in 2015-10-20,  发布年份 2015
PDF
【 摘 要 】

Background

Monoclonal antibodies (mAbs), as an emerging technology, have become increasingly important in the development of human therapeutic agents. How developing countries such as China could seize this emerging technological opportunity remains a poorly studied issue in prior literature. Thus, this paper aims to investigate the research and development of mAbs in China based on an innovation system functions approach and probes into the question of how China has been taking advantage of emerging technologies to overcome its challenges of building up a complete innovation system in developing mAbs.

Methods

Mixed research methods were applied by combining archival data and field interviews. Archival data from the China Food and Drug Administration, Web of Science, the United States Patent and Trademark Office, the Chinese Clinical Trial Registry, and the National Science and Technology Report Service were used to examine the status quo of the technology and research and development (R&D) activities in China, while the opinions of researchers and managers in this field were synthesized from the interviews.

Results

From the perspective of innovation system functions, technological development of mAb in China is being driven by incentives such as the subsidies from the State and corporate R&D funding. Knowledge diffusion has been well served over the last 10 years through exchanging information on networks and technology transfer with developed countries. The State has provided clear guidance on search of emerging mAb technologies. Legitimacy of mAb in China has gained momentum owing to the implementation of government policies stipulated in the “The Eleventh Five-year Plan” in 2007, as well as national projects such as the “973 Program” and “863 Program”, among others. The potential of market formation stays high because of the rising local demand and government support. Entrepreneurial activities for mAb continue to prosper. In addition, the situation of resource supply has been improved with the support of the State.

Conclusions

This study finds that a complete innovation system for mAb has begun to take shape in China. MAb innovators in China are capitalizing on this emerging technological opportunity to participate in the global drive of developing the value chain for the innovative drug. In the long run, the build-up of the research system for mAb in China could bring about more driving forces to the mAb innovation system.

【 授权许可】

   
2015 Zhang et al.

【 预 览 】
附件列表
Files Size Format View
20151115092517886.pdf 498KB PDF download
Figure 1. 17KB Image download
【 图 表 】

Figure 1.

【 参考文献 】
  • [1]Buss N, Henderson S. Monoclonal antibody therapeutics: history and future. Curr Opin Pharmacol. 2012; 12:615-22.
  • [2]Chon JH, Zarbis-Papastoitsis G. Advances in the production and downstream processing of antibodies. N Biotechnol. 2011; 28:458-63.
  • [3]Köhler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined. Nature. 1975; 256:495-7.
  • [4]Ober RJ, Radu CG, Ghetie V, Ward ES. Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies. Int Immunol. 2001; 13:1551-9.
  • [5]Hwang WYK, Foote J. Immunogenicity of engineered antibodies. Methods. 2005; 36:3-10.
  • [6]Morrison SL, Johnson MJ, Herzenberg LA, Oi VT. Chimeric human antibody molecules: mouse antigen-binding domains with human constant region domains. Proc Natl Acad Sci U S A. 1984; 81:6851-5.
  • [7]Reichert JM. Monoclonal antibodies as innovative therapeutics. Curr Pharm Biotechnol. 2008; 9:423-30.
  • [8]Nelson AL, Dhimolea E, Reichert JM. Development trends for human monoclonal antibody therapeutics. Nat Rev Drug Discov. 2010; 9:767-74.
  • [9]Wessner C. Government programs to encourage innovation by start-ups and SMEs: The role of US innovation awards. In: Handbook of research on entrepreneurship policy. Edward Elgar, Cheltenham; 2007: p.172-85.
  • [10]Arora SK, Youtie J, Shapira P, Gao L, Ma TT. Entry strategies in an emerging technology: a pilot web-based study of graphene firms. Scientometrics. 2013; 95:1189-207.
  • [11]Subramanian V, Woodson TS, Cozzens S. Nanotechnology in India: Inferring Links Between Emerging Technologies and Development. New York, NY, Springer New York; 2012.
  • [12]Khanagha S, Volberda H, Sidhu J, Oshri I. Management innovation and adoption of emerging technologies: the case of cloud computing. Eur Manag Rev. 2013; 10:51-67.
  • [13]Youtie J, Hicks D. Pathways from discovery to commercialisation: using web sources to track small and medium-sized enterprise strategies in emerging nanotechnologies. Technol Anal Strateg Manag. 2012; 24:981-95.
  • [14]Thukral IS, Von Ehr J, Walsh S, Groen AJ, van der S, Adham KA. Entrepreneurship, emerging technologies, emerging markets. Int Small Bus J. 2008; 26:101-16.
  • [15]Hsieh C-R, Löfgren H. Biopharmaceutical innovation and industrial developments in South Korea, Singapore and Taiwan. Aust Health Rev. 2009; 33:245-57.
  • [16]Guo Y, Huang L, Porter A. A hybrid innovation management model for emerging technology: Bibliometrics, qualitative methodology, and empirical study. Proc PICMET’12 Technol Manag Emerg Technol. 2012. p. 105–13.
  • [17]Hopkins MM, Martin PA, Nightingale P, Kraft A, Mahdi S. The myth of the biotech revolution: An assessment of technological, clinical and organisational change. Res Policy. 2007; 36:566-89.
  • [18]Castorena DG, Rivera GR, González AV. Technological foresight model for the identification of business opportunities (TEFMIBO). Foresight. 2013; 15:492-516.
  • [19]Hekkert MP, Suurs RAA, Negro SO, Kuhlmann S, Smits REHM. Functions of innovation systems: A new approach for analysing technological change. Technol Forecast Soc Change. 2007; 74:413-32.
  • [20]Hekkert MP, Negro SO. Functions of innovation systems as a framework to understand sustainable technological change: Empirical evidence for earlier claims. Technol Forecast Soc Change. 2009; 76:584-94.
  • [21]Negro SO, Hekkert MP, Smits REHM. Explaining the failure of the Dutch innovation system for biomass digestion—a functional analysis. Energy Policy. 2007; 35:925-38.
  • [22]Negro SO, Suurs RAA, Hekkert MP. The bumpy road of biomass gasification in the Netherlands: Explaining the rise and fall of an emerging innovation system. Technol Forecast Soc Change. 2008; 75:57-77.
  • [23]Leydesdorff L, Strand Ø. The Swedish system of innovation: regional synergies in a knowledge-based economy. J Am Soc Inf Sci Technol. 2013; 64:1890-902.
  • [24]Carlsson B, Stankiewicz R. On the nature, function and composition of technological system. J Evol Econ. 1991; 1:93-118.
  • [25]Suurs RAA, Hekkert MP. Cumulative causation in the formation of a technological innovation system: The case of biofuels in the Netherlands. Technol Forecast Soc Change. 2009; 76:1003-20.
  • [26]Sagar AD, Holdren JP. Assessing the global energy innovation system: some key issues. Energy Policy. 2002; 30:465-9.
  • [27]Cockburn IM, Stern S. Finding the endless frontier: lessons from the life sciences innovation system for technology policy. Capital Soc. 2010; 5(1):1.
  • [28]Walz R, Delgado JN. Different routes to technology acquisition and innovation system building? China’s and India's wind turbine industries. Innov Dev. 2012; 2:87-109.
  • [29]van Rijnsoever FJ, Hekkert MP, van den Berg J, Koch J. Technological variety in innovation systems: the role of actors, networks, resources and institutions. Proceedings of the 2013 EU-SPRI Forum Conference, Madrid 10–12 April 2013. European Forum for Studies of Policies for Research and Innovation. http://www. euspri-madrid2013.org/pdf/1074.pdf webcite
  • [30]Negro SO, Hekkert MP. Explaining the success of emerging technologies by innovation system functioning: the case of biomass digestion in Germany. Technol Anal Strateg Manag. 2008; 20:465-82.
  • [31]Johnson A. Functions in innovation system approaches. Aalborg; 2001. http://www. druid.dk/uploads/tx_picturedb/ds2001-205.pdf webcite
  • [32]Bergek A, Hekkert M, Jacobsson S. Functions in innovation systems: a framework for analysing energy system dynamics and identifying goals for system-building activities by entrepreneurs and policymakers. Foxon TJ, Kohler J, Oughton C (Eds.). Innovation for a Low Carbon Economy: Economic, Institutional and Management. Cheltenham: Edward Elgar; 2008. p. 79–111.
  • [33]Geels FW. From sectoral systems of innovation to socio-technical systems. Res Policy. 2004; 33:897-920.
  • [34]Scandura TA, Williams EA. Research methodology in management: current practices, trends, and implications for future research. Acad Manag J. 2014; 43:1248-64.
  • [35]Jick TD. Mixing qualitative and quantitative methods: triangulation in action. Adm Sci Q. 2014; 24:602-11.
  • [36]Yin RK. Case study research: design and methods (applied social research methods). Sage Publications, Inc., Thousand Oaks; 2008.
  • [37]Tang J. Opportunities and challenges brought by monoclonal antibodies rapid development to biopharmaceutical in China. Sci Technol Inf. 2010; 19:247-8.
  • [38]Reichert JM. Monoclonal antibodies as innovative anti-infective agents. Discov Med. 2005; 5:544-7.
  • [39]Besley JC, Kramer VL, Priest SH. Expert opinion on nanotechnology: risks, benefits, and regulation. J Nanoparticle Res. 2007; 10:549-58.
  • [40]Clayton MJ. Delphi: a technique to harness expert opinion for critical decision‐making tasks in education. Educ Psychol. 1997; 17:373-86.
  • [41]Reichert JM. Which are the antibodies to watch in 2013? MAbs. 2013; 5:1-4.
  • [42]Chai Y. Biotech: antibody production of the world’s leading enterprises. Innovation. 2010; 4:62-3.
  • [43]Xu X. Diversity at domestic enterprises in China: a case study of Chengdu Huasun group. Master thesis. Southwestern University of Finance and Economics, Chengdu; 2004.
  • [44]Zhang J, Sun Y, Wang K. Development and illumination: biopharmaceutical industry in the United States. Jiangsu Sci Inf. 2011; 1:11-4.
  • [45]Lian GY, Jin QY, Huang TK. Comparative research on the development of biopharmaceutical industry between foreign countries and China. China Pharm. 2007; 16:20-1.
  • [46]Sun F. Comparative research on the pharmaceutical industry policies in USA, India and China--From patent law perspective. Master Thesis, Suzhou University; 2004.
  • [47]Ahn MJ, Hajela A, Akbar M. High technology in emerging markets: building biotechnology clusters, capabilities and competitiveness in India. Asia-Pacific J Bus Adm. 2012; 4:23-41.
  • [48]Ramani SV. Who is interested in biotech? R&D strategies, knowledge base and market sales of Indian biopharmaceutical firms. Res Policy. 2001; 1300:1-18.
  • [49]Dhawan J, Gokhale RS, Verma IM. Bioscience in India: times are changing. Cell. 2005; 123:743-5.
  • [50]Konde V. Biotechnology business models: an Indian perspective. J Commer Biotechnol. 2008; 15:215-26.
  • [51]Deng CC. The Patent Bill Amendment in India: its impacts on pharmaceuticals. South Asian Stud Q. 2005; 2:30-5.
  • [52]Palnitkar U. Growth of Indian biotech companies, in the context of the international biotechnology industry. J Commer Biotechnol. 2005; 11:146-54.
  • [53]Bhattacharya S, Patra SK. Assessing competency of a developing country in high technology?: A case study based on Indian patenting activity in the biotechnology sector. Collnet J Sci Inf Manag. 2010; 4:21-34.
  • [54]Liu Y, Zhao Y, Wang Z. Strategy analysis of antibody industrialization in China. China Biotechnol. 2006; 26:93-7.
  • [55]Hao H, Zhang LM. Catch-up of Chinese pharmaceutical firms facing technological complexity. Int J Innovation Technol Management. 2015; 12:1550017.
  • [56]Qiu L, Chen ZY, Lu DY, Hu H, Wang YT. Public funding and private investment for R&D: a survey in China’s pharmaceutical industry. Health Res Policy Syst. 2014; 12:27. BioMed Central Full Text
  文献评价指标  
  下载次数:49次 浏览次数:47次