The biopharmaceutical industry in China: history and future perspectives

Abstract

Biopharmaceuticals reflect the rapid progress achieved in modern biomedical research. This area has also become one of the main criteria for assessing the development level of biotechnology for a particular country. Although it has been only three decades since the first biopharmaceutical, recombinant human insulin, was licensed by the US Food and Drug Administration, the biopharmaceutical industry has become the fastest growing, most dynamic and technology-intensive sector in the biomedical field. Since the licensing of recombinant human interferon α1b in 1989, the biopharmaceutical industry in China has gone through initial developments and gradually entered a period of rapid growth. This paper provides an overview of the status and development trends of biopharmaceuticals in China, and compares them with those observed in developed countries.

Keywords

biopharmaceuticals / antibodies / market trends / diseases / China / national regulatory agency

References

[1] European Directorate for Quality Medicines & Healthcare (EDQM). Recombinant DNA technology products of. In: EDQM. General Monograph, European Pharmacopoeia 7.0. Strasbourg, France:EDQM,2011: 692-693

[2] Wang JZ. Development and quality control of biopharmaceuticals.2nd Ed. Beijing: Science Press, 2007:76-77 (in Chinese)

[3] Li XY, Wang HG. Advance the biotechnology, leading the bio-economy. Beijing: China Medical Science Press, 2005: 8-20 (in Chinese)

[4] http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM164641.pdf(Access on January 18, 2012)

[5] http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080402.htm (Access on January 18, 2012)

[6] http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071118.pdf(Access on January 18, 2012)

[7] http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts (Access on January 18, 2012)

[8] http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts (Access on January 18, 2012)

[9] Hu XW, Ma QJ. The present and the future of bioindustry: biopharmaceuticals. In: Annual Report on Bioindustry in China (2006). Beijing: Chemical Industry Press, 2007: 45-74 (in Chinese)

[10] http://knol.google.com/k/krishan-maggon/top-ten-twenty-best-selling-drugs-2010/3fy5eowy8suq3/141# (Access on January 18, 2012)

[11] http://www.sfda.gov.cn/WS01/CL0001(Access on January 18, 2012)

[12] Li XY, Wang HG. Advance the biotechnology, leading the bio-economy. Beijing: China Medical Science Press, 2005: 69 (in Chinese)

[13] Wurm FM. Production of recombinant protein therapeutics in cultivated mammalian cells. Nat Biotechnol 2004; 22(11): 1393-1398

[14] Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet 2010; 376(9744): 895-902

[15] Barros FF, Powe DG, Ellis IO, Green AR. Understanding the HER family in breast cancer: interaction with ligands, dimerization and treatments. Histopathology 2010; 56(5): 560-572

[16] Scardino A, Alimandi M, Correale P, Smith SG, Bei R, Firat H, Cusi MG, Faure O, Graf-Dubois S, Cencioni G, Marrocco J, Chouaib S, Lemonnier FA, Jackson AM, Kosmatopoulos K. A polyepitope DNA vaccine targeted to Her-2/ErbB-2 elicits a broad range of human and murine CTL effectors to protect against tumor challenge. Cancer Res 2007; 67(14): 7028-7036

[17] Brockhoff G, Heiss P, Schlegel J, Hofstaedter F, Knuechel R. Epidermal growth factor receptor, c-erbB2 and c-erbB3 receptor interaction, and related cell cycle kinetics of SK-BR-3 and BT474 breast carcinoma cells. Cytometry 2001; 44(4): 338-348

[18] Choi DH, Woo JK, Choi Y, Seo HS, Kim CW. A novel chimeric DNA vaccine: enhancement of preventive and therapeutic efficacy of DNA vaccine by fusion of Mucin 1 to a heat shock protein 70 gene. Mol Med Report 2011; 4(5): 885-890

[19] Wang XJ, Wang ZB, Wei HF, Wu XL, Wang L, Yu YL, Wang LY. Enhancement of HSP-MUC1 antitumor activity by type C CpG-ODN BW005. J Cell Mol Immunol (Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi) 2007; 23(4): 338-340 (in Chinese)

[20] Li D, Li H, Zhang P, Wu X, Wei H, Wang L, Wan M, Deng P, Zhang Y, Wang J, Liu Y, Yu Y, Wang L. Heat shock fusion protein induces both specific and nonspecific anti-tumor immunity. Eur J Immunol 2006; 36(5): 1324-1336

[21] Wang XY, Zhang XX, Yao X, Jiang JH, Xie YH, Yuan ZH, Wen YM. Serum HBeAg sero-conversion correlated with decrease of HBsAg and HBV DNA in chronic hepatitis B patients treated with a therapeutic vaccine. Vaccine 2010; 28(51): 8169-8174

[22] Xu DZ, Zhao K, Guo LM, Li LJ, Xie Q, Ren H, Zhang JM, Xu M, Wang HF, Huang WX, Bai XF, Niu JQ, Liu P, Chen XY, Shen XL, Yuan ZH, Wang XY, Wen YM. A randomized controlled phase IIb trial of antigen-antibody immunogenic complex therapeutic vaccine in chronic hepatitis B patients. PLoS ONE 2008; 3(7): e2565

[23] Jia S, Liu Z, Zhang S, Liu P, Zhang L, Lee SH, Zhang J, Signoretti S, Loda M, Roberts TM, Zhao JJ. Essential roles of PI(3)K-p110β in cell growth, metabolism and tumorigenesis. Nature 2008; 454(7205): 776-779

[24] He B, Santamaria R, Xu W, Cols M, Chen K, Puga I, Shan M, Xiong H, Bussel JB, Chiu A, Puel A, Reichenbach J, Marodi L, Döffinger R, Vasconcelos J, Issekutz A, Krause J, Davies G, Li X, Grimbacher B, Plebani A, Meffre E, Picard C, Cunningham-Rundles C, Casanova JL, Cerutti A. The transmembrane activator TACI triggers immunoglobulin class switching by activating B cells through the adaptor MyD88. Nat Immunol 2010; 11(9): 836-845

[25] Giamas G, Filipović A, Jacob J, Messier W, Zhang H, Yang D, Zhang W, Shifa BA, Photiou A, Tralau-Stewart C, Castellano L, Green AR, Coombes RC, Ellis IO, Ali S, Lenz HJ, Stebbing J. Kinome screening for regulators of the estrogen receptor identifies LMTK3 as a new therapeutic target in breast cancer. Nat Med 2011; 17(6): 715-719

[26] Pan X, Zhou T, Tai YH, Wang C, Zhao J, Cao Y, Chen Y, Zhang PJ, Yu M, Zhen C, Mu R, Bai ZF, Li HY, Li AL, Liang B, Jian Z, Zhang WN, Man JH, Gao YF, Gong WL, Wei LX, Zhang XM. Elevated expression of CUEDC2 protein confers endocrine resistance in breast cancer. Nat Med 2011; 17(6): 708-714

[27] Zhou L, Li F, Xu HB, Luo CX, Wu HY, Zhu MM, Lu W, Ji X, Zhou QG, Zhu DY. Treatment of cerebral ischemia by disrupting ischemia-induced interaction of nNOS with PSD-95. Nat Med 2010; 16(12): 1439-1443

[28] Zhao WJ, Gao ZY, Wei H, Nie HZ, Zhao Q, Zhou XJ, Wang YX. Spinal D-amino acid oxidase contributes to neuropathic pain in rats. J Pharmacol Exp Ther 2010; 332(1): 248-254

Acknowledgements

This work was supported by the National “Key Technologies for New Drug Innovation and Development” Program (2009ZX09307-001), and the National High-tech Research and Development Program (“863 Program”) (2007AA021601 and 2007AA021204).

RIGHTS & PERMISSIONS

2014 Higher Education Press and Springer-Verlag Berlin Heidelberg