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Frontiers of Medicine

ISSN 2095-0217

ISSN 2095-0225(Online)

CN 11-5983/R

Postal Subscription Code 80-967

2018 Impact Factor: 1.847

Front Med    2012, Vol. 6 Issue (2) : 101-111     DOI: 10.1007/s11684-012-0191-9
Review |
The biopharmaceutical industry in China: history and future perspectives
Kai Gao, Junzhi Wang()
National Institutes for Food and Drug Control, Beijing 100050, China
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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     
Corresponding Authors: Wang Junzhi,   
Issue Date: 05 June 2012
URL:     OR
Fig.1  Growth of the global biopharmaceutical market 2000–2010. Data source:;
Fig.2  Growth of the biopharmaceutical market in China 2001–2010. Data source: Annual Report of the Chinese Pharmaceutical Industry (2001–2010).
CategoryNameExpression systemIndicationsMethod of administration
Recombinant cytokinesRecombinant human interferon α1bEscherichia coliViral diseases/malignanciesInjections, sprays, and eye drops
(n= 14)Recombinant human interferon α2aE. coli/yeastsViral diseases/malignanciesInjections and suppositories
Recombinant human interferon α2bE. coli/yeasts/Pseudomonas putidaViral diseases/malignanciesInjections, sprays, suppositories, Unguentum cream, eye drops, and effervescent tablets
Recombinant human interferon γE. coliRheumatoid arthritisInjections
Recombinant human interleukin-2 (including 125 Ala)E. coliViral diseases/malignanciesInjections
Recombinant human interleukin-11E. coli/yeastsThrombocytopeniaInjections
Recombinant human granulocyte colony-stimulating factorE. coliNeutropeniaInjections
Recombinant human granulocyte colony-stimulating factorE. coliLeukopenia after chemotherapy for tumorsInjections
*Recombinant bovine basic fibroblast growth factorE. coliChronic wound healingGel and solutions for external use
*Recombinant human basic fibroblast growth factorE. coliChronic wound healingSolutions for external use
*Recombinant human acidic fibroblast growth factorE. coliPromotes the healing of deep second-degree burns and chronic ulcer woundsSolutions for external use
Recombinant human epidermal growth factorE. coli/yeastsChronic wound healingGel, eye drops, and solutions for external use
Recombinant erythropoietinCHO cellsAnemia due to renal dysfunctionInjections
*Recombinant human thrombopoietinE. coliThrombocytopeniaInjections
Recombinant hormonesRecombinant human growth hormonesE. coliGrowth hormone deficiencyInjections
(n= 5)Recombinant human insulinE. coliDiabetesInjections
Recombinant human insulin glargineE. coliDiabetesInjections
Recombinant human insulin lisproE. coliDiabetesInjections
Recombinant human insulin aspartE. coliDiabetesInjections
Recombinant enzymes*Recombinant staphylokinaseE. coliThrombolytic therapy for acute ST-segment elevation myocardial infarctionInjections
(n= 5)Recombinant streptokinaseE. coliThrombotic diseases such as acute myocardial infarctionInjections
ReteplaseE. coliFor the rescue of acute myocardial infarction or pulmonary embolism, or for the treatment of thrombotic diseases in peripheral vessels.Injections
Recombinant human tissue-type plasminogen kinase derivativeE. coliAcute myocardial infarctionInjections
Recombinant human pro-urokinaseCHO cellsThrombolytic therapy for acute ST-segment elevation myocardial infarctionInjections
Therapeutic monoclonal antibodiesAnti-human T cell CD3 monoclonal antibodyHybridoma cellsFor the treatment and prevention of acute rejection in organs (e.g., kidney) recipientsInjections
(n= 7)Anti-human interleukin-8 monoclonal antibodyHybridoma cellsPsoriasisCreams
Iodine [131I] tumor necrosis therapy monoclonal antibody injectionHybridoma cellsTumorsInjections
*Metuximab monoclonal antibody injection LicartinSP2/0 cellsFor HAb18G/CD147 antigen/primary liver cancerInjections
Recombinant humanized anti-human epidermal growth factor receptor monoclonal antibody injectionNimotuzumabNS0 cellsFor epidermal growth factor receptor/nasopharyngeal carcinomaInjections
Recombinant human tumor necrosis α receptor Fc fusion proteinCHO cellsModerate-to-severe active rheumatoid arthritis, moderate-to-severe plaque psoriasis, active ankylosing spondylitisInjections
Recombinant humanized anti-CD25 monoclonal antibody injectionCHO cellsFor the treatment and prevention of acute rejection and side-effects during kidney transplantationInjections
Others*Recombinant human endostatin injectionE. coliNon-small-cell lung cancerInjections
(n= 3)Recombinant human brain natriuretic peptideE. coliAcute compensatory heart failureInjections
Recombinant human thymopeptidesE. coliT cell deficiency, autoimmune diseasesInjections
Gene therapy*Recombinant human Ad-p53 injection (Gendicine)293 cellsAdvanced nasopharyngeal carcinomaInjections
(n= 2)*Recombinant human adenovirus type 5 injection (Oncorine)293 cellsAdvanced nasopharyngeal carcinomaInjections
Recombinant vaccinesRecombinant hepatitis B vaccineYeastsFor the prevention of hepatitis BInjections
(n= 4)Recombinant B-subunit/inactivated cell oral cholera vaccineE. coliFor the prevention of choleraEnteric capsules
*Recombinant Helicobacter pylori vaccineE. coliFor the prevention of Helicobacter pylori infectionInjections
*Recombinant hepatitis E vaccineE. coliFor the prevention of hepatitis EInjections
Tab.1  Biopharmaceuticals licensed in the Chinese market (as of December 2011)
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 on January 18, 2012)
5 (Access on January 18, 2012)
6 on January 18, 2012)
7 (Access on January 18, 2012)
8 (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 (Access on January 18, 2012)
11 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
doi: 10.1038/nbt1026 pmid:15529164
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
doi: 10.1016/S0140-6736(10)61030-6 pmid:20728932
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
doi: 10.1111/j.1365-2559.2010.03494.x pmid:20459566
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
doi: 10.1158/0008-5472.CAN-06-3998 pmid:17638916
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
doi: 10.1002/1097-0320(20010801)44:4<338::AID-CYTO1125>3.0.CO;2-V pmid:11500850
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
doi: 10.1002/eji.200535490 pmid:16619287
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
doi: 10.1016/j.vaccine.2010.09.093 pmid:20937312
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
doi: 10.1371/journal.pone.0002565 pmid:18596958
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, D?ffinger 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
doi: 10.1038/ni.1914 pmid:20676093
25 Giamas G, Filipovi? 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
doi: 10.1038/nm.2351 pmid:21602804
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
doi: 10.1038/nm.2369 pmid:21572428
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
doi: 10.1038/nm.2245 pmid:21102461
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
doi: 10.1124/jpet.109.158816 pmid:19828879
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