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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    https://doi.org/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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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     
Corresponding Author(s): Wang Junzhi,Email:wangjz@nicpbp.org.cn   
Issue Date: 05 June 2012
 Cite this article:   
Kai Gao,Junzhi Wang. The biopharmaceutical industry in China: history and future perspectives[J]. Front Med, 2012, 6(2): 101-111.
 URL:  
https://academic.hep.com.cn/fmd/EN/10.1007/s11684-012-0191-9
https://academic.hep.com.cn/fmd/EN/Y2012/V6/I2/101
Fig.1  Growth of the global biopharmaceutical market 2000–2010. Data source: http://www.imshealth.com/; http://evaluatepharma.com/.
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)
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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)
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