Albany, NY -- (SBWIRE) -- 11/26/2014 -- The Chinese 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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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.

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However, as compared with products from leading bio-pharmaceutical enterprises in the United States and Europe, domestic recombinant protein drugs are still characterized by low-end technologies and largely remain in common short-acting areas. And foreign brands still prevail in the markets of recombinant insulin, rhIFN, recombinant coagulation factor and recombinant human follicle-stimulating hormone (rhFSH).

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1. Recombinant Insulin Market. In 2013,foreign brands such asNovo Nordisk’s insulin aspart and insulin detemir, Sanofi’s insulin glargine, Eli Lilly’s insulin lispro accounted for 91.4% of recombinant insulin market of Chinese sample hospitals, while domestic insulin e.g. insulin glargine and insulin lispro of Gan & Lee Pharmaceuticals, recombinant insulin of Tonghua Dongbao Pharmaceuticaland animal insulin of Wanbang Biopharmaceuticalswas at a distinct disadvantage, whereas insulin analog products of Gan & Lee are still in the process of development, with huge potential for growth in the future.

2. rhIFN-?Market.Roche's PEG-IFN?-2a, MSD’s PEG-IFN?-2a and IFN-?-2a, and other imported products still dominate Chinese interferon market, sweeping as much as 70.7% of recombinant interferon market of sample hospitals in 2013; while more than a dozen local companies like Shanghai Huaxin High Biotechnology Inc., Beijing Tri-Prime Genetic Engineering Co., Ltd. and Anhui Anke Biotechnology (Group) Co., Ltd.mainly produce ordinary short-acting products, which lack strong competitiveness compared with PEG-Intron products (long-acting interferon)with better anti-hepatitisvirus effect.

Moreover, there is no domestic recombinant protein drug in such markets as rhIFN-?, rhFSH, recombinant coagulation factor VIIa and factorVIIIyet.

Based on support from favorable policies, R&D ability enhancement as well as being optimistic about market prospects, a large number of biotech companies are vigorously developing long-acting, high-end protein drugs.

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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-rhIFN?and Dongbao Pharmaceutical’sultrolente insulin (insulin glargine)were both approved for clinical application. So far,PEG-GCSF of Jiangsu Hengrui Medicine Co., Ltd., PEG-rhIFN?of 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 available on the market in 2015.

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