https://orcid.org/0000-0001-7899-1674
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ABSTRACT
Background: Monoclonal antibody (mAb) drugs are increasingly important for the pharmaceutical industry across the globe. In China, mAb drug developments face many challenges. Multiple policies have been implemented recently to reinforce support in various areas. This study aims to investigate the latest landscape of mAb drugs in China from policy perspectives encompassing R&D, clinical trials, marketing approval, and talent pools.
Methods: Information about mAb drugs approved in the United States, the European Union, Japan, and China by 2017 and mAb-related policies in China were retrieved from government websites and third-party statistical databases for descriptive, statistical, and comparative analysis.
Results and discussion: In China, 21 mAb drugs (10 locally-developed and 11 imported) have so far been approved. For the 11 imported mAb drugs in China, the median drug lag in the marketing approval was estimated at 87.1 months, compared with the U.S. (0 months), the EU (8.9 months), and Japan (43.4 months). However, as far as the dramatically changing innovation supporting system in China is concerned, emergence of new biopharmaceutical companies, transformation of the current drug companies and their shift to antibody therapy, and the pooling of high-level talent contribute to mAb development in China. The number of clinical trials and marketing applications and approvals involving mAb drugs is also growing. Favorable policies will continue to play a role in the sustainable development of mAb drugs in China.
Conclusion: The research showed that the reform of multiple policies and incentives for attracting/retaining high-level talent has evidently been effective in addressing the drug lag of mAb drugs in China. In future development, China should actively monitor the global R&D outcomes and industrial development trends of mAb drugs and make the policy environment more attractive to enable more mAb drugs to be marketed in China as soon as possible.
Abbreviations
| mAb | = | monoclonal antibody |
| R&D | = | research and development |
| Ig | = | immunoglobulin |
| FM Burnet | = | Frank Macfarlane Burnet |
| FDA | = | Food and Drug Administration |
| EMA | = | European Medicines Agency |
| EPAR | = | European Public Assessment Report |
| CHMP | = | Committee for Medicinal Products for Human Use |
| PMDA | = | Pharmaceuticals and Medical Devices Agency |
| NMPA | = | National Medical Products Administration |
| CAGR | = | compound annual growth rate |
| CFDA | = | China food and drug administration |
| CDE | = | Center for Drug Evaluation |
| ICH | = | International Council for Harmonization |
Acknowledgments
We thank the National Office for Philosophy and Social Sciences for financial support for this research by the project 15ZDB167; and the University of Macau for financial support for this research by the project MYRG2016-00144-ICMS-QRCM. The authors have no conflicts of interest to disclose and no financial conflicts with the subject matter or materials discussed in the manuscript.
Disclosure of potential conflicts of interest
No potential conflicts of interest were disclosed.