China Genetic Engineering Drug Industry Report, 2011-2012
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China gets a late start in developing genetic engineering drug industry, but has achieved leapfrog advance. At present, China has at least one hundred enterprises involved in genetic engineering drugs. In recent years, the compound growth rate of genetic engineering drug market in China is as high as 49%, with an average gross margin of more than 80%. However, the technology strength and efficacy of locally produced genetic engineering drugs are relatively weak. In particular, the pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) for injection of CSPC Pharmaceutical Group Limited that approved for marketing in March 2012 is the only homemade long-acting protein product. Still, due to the impetus of huge market capacity as well as a package of preferential policies, many domestic enterprises, including GeneScience Pharmaceuticals, Amoytop and Anhui Anke Biotechnology, are accelerating the industrialized research of long-acting protein drugs.

Monoclonal antibody is one of the most promising genetic engineering drugs. As of May 2012, SFDA approved the marketing of a total of 18 monoclonal antibody drugs. Among these drugs, nearly 60% are foreign brands including Roche, Merck and Novartis with the combined sales accounting for three fourths of the Chinese monoclonal antibody drug market. However, with the marketing of monoclonal antibody drugs made by companies such as Shanghai CP Guojian Pharmaceutical and Biotech Pharmaceutical, the market share of homemade monoclonal antibody industry is on the rise gradually.

In addition, recombinant human erythropoietin, recombinant human interferon, recombinant human growth hormone, recombinant human granulocyte-colony stimulating factor and recombinant human insulin are among the important genetic engineering drugs. As of late 2011, China had roughly 20 recombinant EPO manufacturers that approved for marketing of related products. In particular, as former EPO preparation exporters to China, enterprises including America-based Amgen and Germany-based Boehringer Mannheim GmbH have withdrawn from the Chinese market owning to low price competition. Presently, the Chinese EPO market is dominated by domestic manufacturers including 3SBio Inc. and DIAO Group. In 2011, the sales of 3SBio Inc. accounted for 42.7% in China’s EPO market. As such, impacted by channel, price competition and other factors, recombinant human growth hormone and recombinant human granulocyte-colony stimulating factor markets are also dominated by domestic enterprises.

In the recombinant human interferon market, the high-performance long-acting interferon of Schering-Plough and Roche still maintained huge consumption in Chinese market in spite of the high prices. In recent years, the market share of imported long-acting interferon has remained at 60% or so in China.

Moreover, due to improving economic level and raising awareness of people, foreign-branded recombinant human insulin in Chinese market are predominant, occupying 90% market share in the corresponding period.

Although China lags behind in terms of the overall level of genetic engineering drugs, the industry has accumulated rich R&D and industrialization experience as well as capital reserves. Thus, with a host of genetic engineering drug patents to become due, Chinese enterprises, such as Walvax, are committed to the industrialization research of monoclonal antibody, long-acting recombinant protein drugs and other generic drugs with high technical barriers. On April 26th, 2012, Walvax announced to invest in Shanghai Fengmao in next four years to develop and produce genetic engineering generic drugs including rituximab, bevacizumab, adalimumab, panitumumab, denosumab and long-acting EPO.
1 Profile of Biopharmaceutical Industry
1.1 Definition and Classification
1.2 Genetic Engineering Drugs

2 Overview of China Genetic Engineering Drug Industry
2.1 Global Market
2.2 Development Status
2.3 Competition Pattern
2.4 Prospects and Dynamics

3 Genetic Engineering Drug Market Segments in China
3.1 Monoclonal Antibody
3.1.1 Status Quo
3.1.2 Competition Pattern
3.1.3 Prospects and Dynamics
3.2 Recombinant Human Erythropoietin
3.2.1 Status Quo
3.2.2 Competition Pattern
3.2.3 Prospects and Dynamics
3.3 Recombinant Human Interferon
3.3.1 Status Quo
3.3.2 Competition Pattern
3.3.3 Prospects and Dynamics
3.4 Recombinant Human Growth Hormone
3.4.1 Status Quo
3.4.2 Competition Pattern
3.4.3 Prospects and Dynamics
3.5 Recombinant Human Insulin
3.5.1 Status Quo
3.5.2 Competition Pattern
3.5.3 Prospects and Dynamics
3.6 Others
3.6.1 Recombinant Human Coagulation Factor
3.6.2 Recombinant Human Granulocyte-Colony Stimulating Factor
3.6.3 Interleukin

4 Key Manufacturers in China
4.1 Shanghai Lansheng Guojian Pharmaceutical Co., Ltd
4.1.1 Profile
4.1.2 Shanghai CP Guojian Pharmaceutical Co., Ltd
4.2 Biotech Pharmaceutical Co., Ltd
4.2.1 Profile
4.2.2 Competition Advantages
4.2.3 R&D of Monoclonal Antibody Drugs
4.3 Anhui Anke Biotechnology (Group) Co., Ltd
4.3.1 Profile
4.3.2 Operation
4.3.3 Revenue Structure
4.3.4 Gross Margin
4.3.5 Clients and Suppliers
4.3.6 R&D and Investment
4.3.7 Genetic Engineering Drugs
4.4 GeneScience Pharmaceuticals Co., Ltd
4.4.1 Profile
4.4.2 Operation
4.4.3 R&D and Investment
4.5 Beijing SL Pharmaceutical Co., Ltd
4.5.1 Profile
4.5.2 Operation
4.5.3 Revenue Structure
4.5.4 Gross Margin
4.5.5 R&D and Investment
4.5.6 Genetic Engineering Drugs
4.6 Jiangsu Sihuan Bioengineering Co., Ltd
4.6.1 Profile
4.6.2 Operation
4.6.3 Genetic Engineering Drugs
4.6.4 Beijing Four Rings Bio-Pharmaceutical Co., Ltd
4.7 Shenzhen Neptunus Interlong Bio-Technique Co., Ltd
4.7.1 Profile
4.7.2 Operation
4.7.3 Genetic Engineering Drugs
4.8 3SBio Inc.
4.8.1 Profile
4.8.2 Operation
4.8.3 Revenue Structure
4.8.4 R&D and Investment
4.9 Tonghua Dongbao Pharmaceutical Co., Ltd
4.9.1 Profile
4.9.2 Operation
4.9.3 Revenue Structure
4.9.4 Gross Margin
4.9.5 Clients and Suppliers
4.9.6 Genetic Engineering Drugs
Classification of Biopharmaceutical Products
Classification of Genetic Engineering Drugs
Sales of Amgen’s Four Genetic Engineering Drugs, 2009-2011
R&D Cost of Main Biopharmaceutical Enterprises in the World, 2009-2011
Competition Pattern of Genetic Engineering Drugs in China, 2011
Comparison between China, USA and Japan by Commercialization Schedule of Some Genetic Engineering Protein Drugs
Expiration Date of Main Genetic Engineering Drug Patents in the World
Monoclonal Antibody Drugs Approved for Marketing in China, As of 2012
Sales of Monoclonal Antibody Drugs in China, 2008-2011
Some Listed Companies Investing in Monoclonal Antibody Industry in China, 2009-2012
Sales Volume and Value of EPO in China, 1999-2011
Competition Pattern of EPO in China (by Sales Volume or Value), 2007-2011
Market Size of rh-IFN in China, 2006-2011
Market Share of Major rh-IFN Injection Enterprises in China by Sales, 2006-2008
Market Capacity Forecast of rh-IFN for Hepatitis Therapy in China
Comparison Between Long-acting IFN and Conventional IFN
Market Share of Major rh-GH Enterprises in China, 2006-2008
Market Capacity Forecast of rh-GH for Short Stature Therapy in China
Market Prices of Common Insulin Products in China, 2010-2011
Lot Release Volume and Its Growth Rate of Coagulation Factor VIII in China, 2008-2011 Market Share of rhG-CSF Enterprises in China, 2010
Major Monoclonal Antibody Product Line under Research of Shanghai Lansheng Guojian Pharmaceutical
Revenue and Net Income of Shanghai CP Guojian Pharmaceutical, 2008-2010
Monoclonal Antibody Product Series under Research of Shanghai CP Guojian Pharmaceutical
Under-research Monoclonal Antibody Projects of Beijing Biotech
Revenue and Profit of ANKE BIO, 2007-2011
ANKE BIO’s Revenue Breakdown by Industry, 2007-2012
ANKE BIO’s Revenue Percentage by Industry, 2007-2012
ANKE BIO’s Revenue Breakdown by Region, 2007-2011
ANKE BIO’s Revenue Percentage by Region, 2007-2011
ANKE BIO’s Gross Margin by Industry, 2007-2011
ANKE BIO’s Revenue from Top 5 Clients and % of Total Revenue, 2007-2011
Name List and Revenue Contribution of ANKE BIO’s Top 5 Clients, 2011
ANKE BIO’s Procurement from Top 5 Suppliers and % of Total Procurement, 2007-2011
R&D Costs and % of Total Revenue of ANKE BIO, 2007-2011
ANKE BIO’s Revenue from Interferon and Growth Hormone, 2007-2011
ANKE BIO’s Gross Margin from Interferon and Growth Hormone, 2007-2011
Revenue and Operating Income of GenSci, 2009-2011
Research Schedule of GenSci’s Genetic Engineering Drugs, As of 2011
Revenue and Operating Income of SL Pharmaceutical, 2007-2012
SL Pharmaceutical’s Revenue and Procurement from Top5 Clients and Suppliers, 2008-2011
SL Pharmaceutical’s Revenue Breakdown by Products, 2008-2011
SL Pharmaceutical’s Revenue Percentage by Products, 2008-2011
SL Pharmaceutical’s Revenue Breakdown by Region, 2008-2011
SL Pharmaceutical’s Gross Margin by Products, 2008-2011
R&D Costs and % of Total Revenue of SL Pharmaceutical, 2008-2011
Revenue and Operating Income of Sihuan Bioengineering, 2008-2012
Sihuan Bioengineering’s Operating Revenue by Region, 2008-2011
Sihuan Bioengineering’s Revenue from Interleukin and EPO, 2008-2011
Sihuan Bioengineering’s Gross Margin from Interleukin and EPO, 2008-2011
Revenue and Profit of Beijing Four Rings, 2008-2011
Revenue and Profit of Neptunus Interlong Bio-Technique, 2008-2012
Neptunus Interlong Bio-Technique’s Revenue Breakdown by Business, 2008-2011
Products List of 3SBio Inc.
Revenue and Profit of 3SBio Inc., 2007-2012
3SBio Inc.’s Revenue Breakdown by Product/Region, 2009-2012
3SBio Inc.’s Revenue Percentage by Products, 2009-2011
3SBio Inc.’s Revenue Percentage by Region, 2009-2012
R&D Cost of 3SBio Inc. by Products, 2009-2011
Research Schedule of 3SBio Inc. , As of Mar., 2012
Revenue and Profit of THDB, 2008-2012
THDB’s Revenue Breakdown by Products, 2008-2011
THDB’s Revenue Percentage by Products, 2008-2011
THDB’s Revenue Breakdown by Region, 2008-2011
THDB’s Revenue Percentage by Region, 2008-2011
THDB’s Gross Margin by Products, 2008-2011
THDB’s Revenue from Top 5 Clients and % of Total Revenue, 2008-2011
Name List and Revenue Contribution of THDB’s Top 5 Clients, 2011
Revenue and Gross Margin of THDB’s Recombinant Human Insulin, 2008-2011
Research Schedule of Amoytop Biotech’s Long-acting Recombinant Protein Drugs, As of 2011

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