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During 2005-2013, sales of recombinant protein drugs available in Chinese sample hospitals grew at a CAGR of 19.1%, and it is projected that China will see its actual demand for recombinant protein drugs exceed RMB40 billion in 2014.
Albany, NY (PRWEB) November 20, 2014
The following is a list of notable proteins that are generated from recombinant DNA, using biomolecular engineering, focusing on those that are used in human and veterinary medicine. In many cases, recombinant human proteins have replaced the original animal-derived version used in medicine. The prefix "rh" for "recombinant human" appears less and less in the literature.
China recombinant protein drug market has been expanding rapidly owing to the improvement of demand rigidity, consumption ability and the like. During 2005-2013, sales of recombinant protein drugs available in Chinese sample hospitals grew at a CAGR of 19.1%, and it is projected that China will see its actual demand for recombinant protein drugs exceed RMB40 billion in 2014.
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Human recombinants that largely replaced animal or harvested from human types:
-Human growth hormone (rHGH) Humatrope from Lilly and Serostim from Serono replaced cadaver harvested human growth hormone
-Biosynthetic human insulin (BHI) Humulin from Lilly and Novolin from Novo Nordisk among others; largely replaced bovine and porcine insulin for human therapy. Some prefer to continue using the animal-sourced preparations, as there is some evidence that synthetic insulin varieties are more likely to induce hypoglycemia unawareness. Remaining manufacturers of highly purified animal-sourced insulin include the U.K.'s Wockhardt Ltd. (headquartered in India), Argentina's Laboratorios Beta S.A., and China's Wanbang Biopharma Co.
-Follicle-stimulating hormone (FSH) as a recombinant gonadotropin preparation replaced Serono's Pergonal which was previously isolated from post-menopausal female urine
-Factor VIII Kogenate from Bayer replaced blood harvested factor VIII
The start of recombinant protein drugs in China is not late and common drugs are diversified in variety, for example, recombinant human erythropoietin (rhEPO), recombinant human granulocyte colony-stimulating factor (rhG-CSF) and recombinant human interferon (rhIFN) have gained market approval in the 1990s. Moreover, in 2013, domestic rhG-CSF, rhEPO and recombinant human growth hormone (rhGH) with price advantage took a respective share of 82.1%, 88.5% and 90.2% in Chinese sample hospitals, and recombinant human interleukin-2/11(rhIL-2/11) was fully localized.
Sample of Table of Content:
1. Overview of Recombinant Protein Drug Industry
1.1 Definition
1.2 Classification
2. Development of Recombinant Protein Drugs in China
2.1 Market Worldwide
2.2 Market Segments Worldwide
2.2.1 Insulin
2.2.2 Recombinant Human Interferon (rhIFN)
2.2.3Recombinant Human Erythropoietin (rhEPO)
2.2.4 Recombinant Human Granulocyte Colony-stimulating Factor (rhG-CSF)
2.2.5Recombinant Human Growth Hormone (rhGH)
2.2.6 Recombinant Human Follicle-stimulating Hormone (rhFSH)
2.3 Market in China
2.3.1 Market Size
2.3.2 Competition Pattern
2.4 Prospects
2.4.1 Market Worldwide
2.4.2 Market in China
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In August 2014, PEG-rhGHof GeneScience Pharmaceuticals Co., Ltd. (GenSci, a subsidy of Changchun High & New Technology Industry (Group) Inc.) obtained the GMP certificate and could formally go on sale; however, as PEG-rhGHbelongs to national new First-in-Class drugs, a phase IV clinical trial is a must, and mass production is expected to begin in 2016. In June 2014, Anke Biotechnology’s PEG-rhIFNαand Dongbao Pharmaceutical’sultrolente insulin (insulin glargine)were both approved for clinical application. So far,PEG-GCSF of Jiangsu Hengrui Medicine Co., Ltd., PEG-rhIFNαof Xiamen Amoytop Biotech Co., Ltd. (a subsidiary of Dongbao Pharmaceutical) and rhFSH of GenSci have all declared for production and are expected to be approved and availableon the market in 2015.
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