Challenges and prospects for monoclonal antibodies in China


  • Honghao Shi
  • Meiwan Chen
  • Yunzhen Shi
  • Hao Hu University of Macau
  • Yitao Wang



Biotechnology, China, humanized product, monoclonal antibody


The technology of monoclonal antibodies has been developed since the 1990s and is attracting more and more attention in China during the 21st century. The first monoclonal antibody product was introduced by the Chinese local producer in 1999, and presently seven products are listed, of which three are humanized products. There are several technical constraints that are affecting the development of monoclonal antibodies in China: limitations to the number of drug targets, restricted biological diffusion, limitations to administration routes, and species-specific issues, as well as China’s own limitations in production and R&D capabilities. This article provides suggestions relevant for the Chinese development of monoclonal antibodies. In the long run China is expected to catch up with its own technology roadmap.


Dong, Z. W., Qiao, Y. L. and Li, L. D. (2002) Report of Chinese cancer control strategy. Bulletin of Chinese Cancer 11(5): 250-260.

Jin, F. Y. (2005) Market Analysis of antitumor drugs. Chinese Journal of Pharmaceuticals 36(006):7-14.

Ziegelbauer, K. and Light, D. R. (2007). Monoclonal antibody therapeutics: Leading companies to maximise sales and market share. Journal of Commercial Biotechnology 14(1):65-72.

Weiner, L. M., Murray, J.C. and Shuptrine, C. W. (2012) Antibody-based immunotherapy of cancer. Cell 148(6):1081-1084.

Schrama, D., Reisfeld, R. A. and Becker, J. C. (2006) Antibody targeted drugs as cancer therapeutics. Nature Reviews Drug Discovery 5(2):147-159.

Reichert, J. M. and Valge-Archer, V. E. (2007) Development trends for monoclonal antibody cancer therapeutics. Nature Reviews Drug Discovery 6(5):349-346.

van Dongen, G. A. M. S., Visser, G. W. M., Lub-de Hooge, M. N., de Vries, E. G. and Perk, L. R. (2007) Immuno-PET: A navigator in monoclonal antibody development and applications. The oncologist 12(12):1379-1389.

Oldham, R. K. and Dillman, R. O. (2008) Monoclonal antibodies in cancer therapy: 25 years of progress. Journal of Clinical Oncology 26(11):1774-1777.

Nimmerjahn, F. and Ravetch, J. V. (2012) Translating basic mechanisms of IgG effector activity into next generation cancer therapies. Cancer Immunity 12:13-19.

Reichert, J. M. and Dhimolea, E. (2012) The future of antibodies as cancer drugs. Drug Discovery Today 17(17-18): 954-963.

Tabrizi, M. A., Bornstein, G. G., Klakamp, S. L., Drake, A., Knight, R. and Roskos, L. (2009) Translational strategies for development of monoclonal antibodies from discovery to the clinic. Drug Discovery Today14(5-6):298-305.

Cai, Z. X. and Gan, R. F. (2004) Market analysis of antitumor drug. World Clinical Drugs 25(5):317-320.

Zhou, X. Y. and Peng, W. Q. (2007) Marketing stats analysis for antineoplastic angents. Medical Information 20(9):1555-1559.

Mach, J. P. (2012) Introduction to monoclonal antibodies. Cancer Immunity 12:11-20.

Buss, N. A. P. S., Henderson, S.J., McFarlane, M., Shenton, J. M. and de Haan, L. (2012) Monoclonal antibody therapeutics: History and future. Current Opinion in Pharmacology 12(5): 615-622.

Fuh, G. (2007) Synthetic antibodies as therapeutics. Nature Chemical Biology 7(1):73-77.

Melero, I., Hervas-Stubbs, S., Glennie, M., Pardoll, D. M. and Chen, L. (2007) Immunostimulatory monoclonal antibodies for cancer therapy. Nature Reviews Cancer. 2007;7(2):95-106.

Ritz, J. and Schlossman, S. F. (1982) Utilization of monoclonal antibodies in the treatment of leukemia and lymphoma. Blood 59(1):1-11.

Ricart, A.D. and Tolcher, A. W. (2007) Technology insight: cytotoxic drug immunoconjugates for cancer therapy. Nature Clinical Practice Oncology 4(4):245-255.

Levene, A.P., Singh, G. and Palmieri, C. (2005) Therapeutic monoclonal antibodies in oncology. Journal of the Royral Society of Medicine 98(4):146-152.

Catane, R. and Longo, D. (1988) Monoclonal antibodies for cancer therapy. Israel Journal of Medical Sciences 24(9-10):471-476.

Dillman, R. O. (1989) Monoclonal antibodies for treating cancer. Annals of Internal Medicine 111(7):592-603.

Oleksiewicz, M. B., Nagy, G., and Nagy, E. (2012). Anti-bacterial monoclonal antibodies: Back to the future?. Archives of Biochemistry and Biophysics 526(2): 124-131.

Gatto, B. (2004) Monoclonal antibodies in cancer therapy. Current Medicinal Chemistry-Anti-Cancer Agents 4(5):411-414.

Carter, P. J. and Senter, P. D. (2008) Antibody-drug conjugates for cancer therapy. The Cancer Journal 14(3):154-169.

Bornstein, G. G., Klakamp, S. L., Andrews, L., Boyle, W. J. and Tabrizi, M. (2009) Surrogate approaches in development of monoclonal antibodies. Drug Discovery Today 14(23-24):1159-1165.

Rosenberg, S. A., Terry, W. D. (1977) Passive immunotherapy of cancer in animals and man. Advances in Cancer Research 25:323-388.

Hong, C. W. and Zeng, Q. (2012) Awaiting a new era of cancer immunotherapy. Cancer Research 72(15):3715-3719.

Baker, M. (2005) Upping the ante on antibodies. Nature biotechnology 23(9):1065-1072.

Kozlowski, S. and Swann, P. (2006) Current and future issues in the manufacturing and development of monoclonal antibodies. Advanced Drug Delivery Reviews. 58(5):707-722.

Konde, V. (2008) Biotechnology business models: An Indian perspective. Journal of Commercial Biotechnology 15(3):215-226.