Seizing the strategic opportunities of emerging technologies by building up innovation system: monoclonal antibody development in China

Abstract

BackgroundMonoclonal 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.MethodsMixed 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.ResultsFrom 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.ConclusionsThis 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.

Managing the challenges of pharmaceutical patent expiry: a case study of Lipitor

“…Facing the advent of patent expiration, generic manufacturers should refer to the historical experience and prepare themselves for the global generic market. In addition, such an experience also should be referred by newly entering pharmaceutical firms from emerging economies that want to seize the emerging biopharmaceutical opportunities (Hu and Chung, 2015; Zhang et al , 2015). Drug quality should be the core development orientation.…”

The effects of government policies targeting ethics and governance processes on clinical trial activity and expenditure: a systematic review

“…The governance interventions were divided into: co-ordinating centre (Thompson et al, 2009;Care ACoSaQiH, 2020;Industry CDo, 2011;Committee UHoCSaT, 2013), (a new government office was implemented to shepherd trials through the approval pathway); scope guidelines (Madhani, 2010;Mani, 2006;Sarma, Manisha (2018)), (governance bodies were encouraged to process applications in a particular way); single application (Srinivasan et al, 2009;Hudson et al, 2016;Srinivasan, 2009;Haynes et al, 2010), (using a centralised governance body for all institutions); streamlined approval (Fudge et al, 2010;Ippoliti, Falavigna (2014); Choudhury, Saberwal (2019)), (whereby applications were given some form of special treatment or consideration for rapid approval), other regulatory changes (Kong, 2007;Mossialos et al, 2016;Zhang et al, 2015;Caulfield 2001;Thompson, 2014;van Oijen et al, 2017;Reith et al, 2013;Berge et al, 2015;McGee, 2006;Warlow, 2005;Care ACoSaQiH, 2020;Chen, 1998;Ikegami, Campbell (1999); Konishi et al, 2018;Hackshaw et al, 2008;Newman et al, 2016;Kwon, Jung (2018); ATIC Australian Trade and Investment Commission (2018); Chengodu, 2013;Webster, Temple-Smith (2013)), (a range of different changes to the regulatory process) or other (non-regulatory governance interventions, including programmes focused on knowledge sharing, safety, or specific programmes for orphan drugs). While some interventions included aspects of another, they were categorised according to the primary objective of the intervention strategy.…”

“…Effects of interventions targeting governance reform. Of the 28/ 32 interventions targeting governance reform for which outcome data were available, seventeen (ATIC Australian Trade and Investment Commission, 2018;Caulfield, 2001;Zhang et al, 2015;Kong, 2007;Mossialos et al, 2016;Choudhury, Saberwal (2019); Srinivasan et al, 2009;McGee, 2006;Srinivasan, 2009;Ippoliti, Falavigna (2014); Konishi et al, 2018;Chen, 1998;Haffner, 1994;Care ACoSaQiH 2020;Sarma and Manisha, 2018) were positive, three were null (Fudge et al, 2010;Industry CDo., 2011) and eight were adverse (Van Oijen et al, 2017;Reith et al, 2013;Berge et al, 2015;Newman et al, 2016;Ikegami and Campbell, 1999;Warlow, 2005;Haynes et al, 2010;Hackshaw et al, 2008;Kwon and Jung, 2018;Hudson et al, 2016) (Table 3). The positive effects were mostly derived from two intervention strategies that overlapped with those effective in ethics review reform ('scope guidelines' and 'defined timelines').…”

“…Ethics review and governance have been the target of multiple government interventions designed to increase clinical trial activity (Zhang et al, 2015;Kong, 2007;Madhani, 2010;Sarma and Manisha, 2018;Srinivasan, 2009). Ethics review describes the formal evaluation of the moral grounding of the proposed research project and governance the processes used by institutions to ensure that they are accountable for research conducted under their auspices.…”

Changes in Availability and Affordability of Therapeutic Monoclonal Antibodies After New Medical Reform in Hubei Province, China

“…As of March 2016, 13 mAb drugs (excluding fusion protein antibody drugs) were approved by the NMPA of China for marketing [15]. Table 1 lists the general information on the indications, targets, and supply sources of the 13 mAbs [16]. Each mAb drug was investigated for the availability and prices of the original brand-name drug and generic drug in the hospital.…”