Hualan Biological Engineering Inc.

Xinxiang, China

Hualan Biological Engineering Inc.

Xinxiang, China
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China's blood product market size mushroomed in 2016 under the impetus of liberalization of limited-price policy, price rises in varying degrees and lot release volume growth for blood products in 2015, estimated to reach RMB23.8 billion throughout the year, up 16.7% from 2015. China's blood product industry will develop at full speed boosted by downstream demand, accompanied by a steady rise in the number of plasma stations and consolidated profit margin improvement of plasma. The market size is expected to hit RMB47.5 billion in 2021. Main features of blood product industry in China 2016 are shown as below: 1. As plasma supply increases, supply-demand balance can be seen in 2025 China's plasma collection volume has been increasing over recent years driven by blood product price deregulation and accelerated establishment of new plasma stations. In 2016, 6,964 tons of plasma was collected in China, up 19.8% year on year. Despite continuous growth, plasma collection volume still cannot meet the ever-increasing market demand. In the future, China will see plasma collection volume shooting up propelled by a growing number of plasma collection stations and is expected to achieve balance between plasma supply and demand in 2025. 2. A steady increase in lot release volume of main products So far, Chinese blood products are still dominated by human albumin and human immunoglobulin for intravenous injection, which take an over 70% blood product market share. In 2016, human albumin and human immunoglobulin (pH4) for intravenous injection registered respective lot release volumes of 39.31 million bottles (10g/bottle) and 10.89 million bottles (2.5g/bottle), up 17.8% and 27.4% respectively year on year. In addition, lot release volumes of domestic blood products in short supply such as blood coagulation factor VIII, human immunoglobulin and human prothrombin complex also witnessed substantial growth in 2016, respectively 38.0%, 143.8% and 20%. 3. R&D efforts intensified for new products; comprehensive utilization of plasma to be raised At present, Chinese blood product enterprises can separate a maximum of 11 varieties of blood products from the plasma, 3-4 varieties for general firms, indicating an extremely low rate of comprehensive utilization of plasmas. To solve the problem, Chinese blood product enterprises are accelerating the development of new products, hoping to improve comprehensive utilization of plasma. Blood coagulation factor VIII, for example, Guizhou Taibang Biological Products Co., Ltd., Jiangxi Boya Bio-Pharmaceutical Co., Ltd., Beijing Tiantan Biological Products Co., Ltd., Zhenxing Biopharmaceutical & Chemical Co., Ltd., Wuhan Zhongyuan Ruide Biological Products Co., Ltd. etc. are actively conducting clinical trials of blood coagulation factor VIII and expected to achieve mass production in next two years. 4 Plasma-oriented pattern continues Blood product industry relies heavily on plasma materials - the number of plasma stations directly influences plasma collection volume, which then affects raw material supply of blood product enterprises. Therefore, the number of plasma stations and plasma collection volume determine corporate position in industry. There are over 30 blood product manufacturing enterprises in China, but only more than 20 are able to maintain normal production. Among them, Hualan Biological Engineering,Inc., Shanghai RAAS Blood Products Co., Ltd. and China Biologic Products, Inc. boast relatively high volume of plasma collection, altogether accounting for 39.6% of total plasma collections in 2016. The report highlights the following: - Analysis on development of China blood product industry, including status quo, policy environment, market supply & demand, market size, market structure and competition pattern; - Analysis on 8 market segments of China blood product industry, including development status, competition pattern and trends; - Analysis on 13 major enterprises, including operation, blood product business, etc.; - Summary & forecast and trends. - The Chinese Version of this Report is Available on Request. 1 Overview of Truck Industry 1.1 Definition and Classification 1.2 Introduction of Technologies 1.3 Latest Policies during 2016-2017 1.3.1 Enforcement of National V Emission Standards 1.3.2 GB1589 Standards and "921 New Reform" 1.3.3 Ban on Low-Speed Trucks 1.3.4 Compulsory Installation of ABS Device for Trucks 1.3.5 Yellow Label' Vehicle Elimination Continues 1.4 Self-driving and Connected Truck 1.4.1 Truck Self-driving 1.4.2 Truck Telematics 2 Truck Market as a Whole 2.1 Ownership 2.2 Production and Sales 2.2.1 Production 2.2.2 Sales 2.3 Market Structure 2.4 Import & Export 2.5 Competitive Pattern 3 Truck Market Segments 3.1 Heavy Truck 3.1.1 Production and Sales 3.1.2 Competitive Landscape 3.1.3 Natural Gas Heavy Truck 3.1.4 High-end Heavy Truck 3.2 Medium Truck 3.2.1 Production and Sales 3.2.2 Competitive Landscape 3.3 Light Truck 3.3.1 Production and Sales 3.3.2 Competitive Landscape 3.4 Mini Truck 3.4.1 Production and Sales 3.4.2 Competitive Landscape 5 Key Companies 5.1 FAW Jiefang Automotive Co., Ltd. 5.1.1 Profile 5.1.2 Production and Sales 5.1.3 Launch of New Products 5.1.4 Manufacturing Bases 5.1.5 Developments 5.2 China National Heavy Duty Truck Group Co., Ltd. (SINOTRUK) 5.2.1 Profile 5.2.2 Operation 5.2.3 Production and Sales 5.2.4 Heavy-duty Truck Business 5.3 Dongfeng Motor Corporation 5.3.1 Profile 5.3.2 Operation 5.3.3 Truck Business 5.3.4 Capacity Distribution 5.3.5 Developments 5.4 Beiqi Foton Motor Co., Ltd. 5.4.1 Profile 5.4.2 Operation 5.4.3 Heavy-duty Truck Business 5.4.4 Production Capacity 5.4.5 Progress in Launch of New Products 5.5 Shaanxi Automobile Group Co., Ltd. 5.5.1 Profile 5.5.2 Major Products 5.5.3 Heavy-duty Truck Business 5.5.4 Developments 5.6 Anhui Jianghuai Automobile Group Corp.,Ltd. 5.6.1 Profile 5.6.2 Operation 5.6.3 Production and Sales 5.6.4 Capacity Distribution 5.6.5 Developments 5.7 Hualing Xingma Automobile (Group) Co., Ltd. 5.7.1 Profile 5.7.2 Operation 5.7.3 Truck Business 5.7.4 Production and Sales 5.8 QingLing Motors (Group) Co., Ltd. 5.8.1 Profile 5.8.2 Operation 5.8.3 Truck Business 5.9 Jiangling Motors Co., Group 5.9.1 Profile 5.9.2 Jiangling Holdings Limited 5.9.3 Production and Sales 5.9.4 Capacity Distribution 5.9.5 Developments 5.10 SAIC GM Wuling (SGMW) 5.10.1 Profile 5.10.2 Key Business 5.10.3 Production and Sales 5.10.4 Manufacturing Bases 5.11 SAIC-IVECO Hongyan 5.11.1 Profile 5.11.2 Heavy-duty Truck Business 5.11.3 Sales Goal for 2017 5.12 Hubei Tri-Ring Special Vehicle Co., Ltd. 5.12.1 Profile 5.12.2 Truck Business 5.12.3 Production and Sales 5.12.4 Developments 5.13 XCMG Automobile 5.13.1 Profile 5.13.2 Heavy-duty Truck Business 5.13.3 Capacity Distribution 5.14 GAC HINO Motors Co., Ltd. 5.14.1 Profile 5.14.2 Operation 5.14.3 Heavy-duty Truck Business 5.14.4 Production Capacity 5.15 Zhejiang Feidie Automobile Manufacturing Co., Ltd. 5.15.1 Profile 5.15.2 Truck Business 5.16 Baotou Bei Ben Heavy-Duty Truck Co., Ltd. 5.16.1 Profile 5.16.2 Heavy-duty Truck Business 5.17 Shanxi Dayun Automobile Manufacturing Co., Ltd 5.17.1 Profile 5.17.2 Truck Business List of Charts - Classification of Truck (Freight Vehicle) - Applications of Truck - Technology Introduction of Key Heavy Truck Manufacturers in China - Schedule for Implementation of China's Motor Vehicle National V Emission Standards - Comparison of China's National IV and V Emission Standards - Standards for Identifying Oversize and Overload of Highway Freight Vehicles (in 6-axle case) - Policies and Regulations on Commercial Vehicle Telematics - Survey on Truck Telematics at Home and Abroad - China's Truck Ownership, 2010-2021E - China's Truck Output, 2010-2021E - China's Truck Sales, 2010-2021E - China's Truck Output and Growth Rate by Product, 2016-2017 - China's Truck Sales and Growth Rate by Product, 2016-2017 - China's Monthly Truck Exports, 2016 - China's Monthly Truck Imports, 2016 - Sales Volume and Market Share of Top10 Truck Manufacturers in China, 2016-2017 - China's Complete Heavy Truck Output and Sales Volume, 2010-2021E - China's Incomplete Heavy Truck Output and Sales Volume, 2010-2021E - China's Semi-trailer Towing Vehicle Output and Sales Volume, 2010-2021E - Sales Volume and Market Share of Top10 Complete Heavy Truck Manufacturers in China, 2016-2017 - Sales Volume and Market Share of Top10 Incomplete Heavy Truck Enterprises in China, 2016-2017 - Sales Volume and Market Share of Top10 Semi-trailer Towing Vehicle Manufacturers in China, 2016-2017 - Sales Volume of Natural Gas Heavy Trucks in China, 2014-2021E - Major Natural Gas Heavy Truck Manufacturers in China - High-end Heavy Trucks Launched by Enterprises in China - China's Complete Medium Truck Output and Sales Volume, 2010-2021E - China's Incomplete Medium Truck Output and Sales Volume, 2010-2021E - Sales Volume and Market Share of Top10 Complete Medium Truck Manufacturers in China, 2016-2017 - Sales Volume and Market Share of Top10 Incomplete Medium Truck Manufacturers in China, 2016-2017 - China's Complete Light Truck Output and Sales Volume, 2010-2021E - China's Incomplete Light Truck Output and Sales Volume, 2010-2021E - Sales Volume and Market Share of Top10 Complete Light Truck Manufacturers in China, 2016-2017 - Sales Volume and Market Share of Top10 Incomplete Light Truck Manufacturers in China, 2016-2017 - China's Complete Mini Truck Output and Sales Volume, 2010-2021E - China's Incomplete Mini Truck Output and Sales Volume, 2010-2021E - Sales Volume and Market Share of Top10 Complete Mini Truck Manufacturers in China, 2016-2017 - Automotive Industry Chain - Cost Structure of Truck Industry - Transmission Supply of Major Heavy Truck Manufacturers in China - China's Galvanized Sheet (Strip) Output and Sales Volume, 2010-2017 - China's (Shanghai) Galvanized Coil Price, 2014-2017 - China's Cold-rolled Thin Sheet Output and Sales Volume, 2010-2017 - China's (Shanghai, Tianjin, Guangzhou) Cold-rolled Coil Price, 2016-2017 - China's Natural Rubber Spot and Future Price, 2012-2017 - China's Investment in Fixed Assets, 2010-2017 - China's Investment in Real Estate Development, 2010-2017 - China's New Housing Start Area and Sales Area, 2005-2017 - China's Highway Freight Volume and Turnover, 2005-2017 - FAW Jiefang Automotive's Heavy Truck Output and Sales Volume, 2010-2017 - FAW Jiefang Automotive's Medium Truck Output and Sales Volume, 2010-2017 - FAW Jiefang Automotive's Light Truck Output and Sales Volume, 2010-2017 - FAW Jiefang Automotive's Mini Truck Output and Sales Volume, 2010-2017 - Main Natural Gas Trucks of FAW Jiefang Automotive - Main Truck Production Bases of FAW Group - Sinotruk's Revenue and Net Income, 2010-2016 - Sinotruk's Gross Margin, 2010-2016 - Sinotruk's Revenue Structure by Business, 2016 - Sinotruk's Heavy Truck Output and Sales Volume, 2010-2017 - Sinotruk's Medium Truck Output and Sales Volume, 2010-2017 - Sinotruk's Light Truck Output and Sales Volume, 2010-2017 - Sinotruk's Heavy Truck Product Family Genealogy - Sinotruk's Main Product Configuration - Dongfeng Motor's Revenue and Net Income, 2011-2016 - Dongfeng Motor's Gross Profit and Gross Margin, 2011-2016 - Dongfeng Motor's Revenue Breakdown by Business, 2015-2016 - Dongfeng Motor's Heavy Truck Output and Sales Volume, 2010-2017 - Dongfeng Motor's Medium Truck Output and Sales Volume, 2010-2017 - Dongfeng Motor's Light Truck Output and Sales Volume, 2010-2017 - Dongfeng Motor's Mini Truck Output and Sales Volume, 2010-2017 - Truck Capacity Distribution of Dongfeng Motor - Beiqi Foton Motor's Revenue and Net Income, 2010-2016 - Beiqi Foton Motor's Gross Margin, 2010-2016 - Beiqi Foton Motor's Revenue Breakdown and Gross Margin by Business, 2014-2016 - Heavy Truck Output and Sales Volume of BAIC Group (Beiqi Foton Motor), 2010-2017 - Medium Truck Output and Sales Volume of BAIC Group (Beiqi Foton Motor), 2010-2017 - BAIC Group's Light Truck Output and Sales Volume, 2010-2017 - BAIC Group's Mini Truck Output and Sales Volume, 2010-2017 - Truck Capacity Distribution of Beiqi Foton Motor - Capacity of Beijing Foton Daimler, 2016 - Main Heavy Trucks of Shaanxi Automobile Group - Shaanxi Automobile Group's Heavy Truck Output and Sales Volume, 2010-2017 - Shaanxi Automobile Group's Medium Truck Output and Sales Volume, 2010-2017 - Shaanxi Automobile Group's Light Truck Output and Sales Volume, 2010-2017 - JAC's Revenue and Net Income, 2010-2016 - JAC's Gross Margin, 2010-2016 - JAC's Revenue Structure and Gross Margin by Product, 2016 - JAC's Heavy Truck Output and Sales Volume, 2010-2017 - JAC's Medium Truck Output and Sales Volume, 2010-2017 - JAC's Light Truck Output and Sales Volume, 2010-2017 - Truck Capacity Distribution of JAC, 2016 - Hualing Xingma Automobile's Assets and Net Income, 2012-2016 - Hualing Xingma Automobile's Products Series - Hualing Xingma Automobile's Truck Output and Sales Volume, 2015-2016 - Hualing Xingma Automobile's Truck Sales at Home and Abroad, 2015-2016 - Qingling Motors' Revenue and Net Income, 2010-2016 - Qingling Motors' Gross Margin, 2010-2016 - Qingling Motors' Revenue Breakdown by Product, 2015-2016 - Qingling Motors' Heavy Truck Output and Sales Volume, 2010-2017 - Qingling Motors' Medium Truck Output and Sales Volume, 2010-2017 - Qingling Motors' Light Truck Output and Sales Volume, 2010-2017 - Jiangling Motors' Revenue and Net Income, 2010-2016 - Jiangling Motors' Gross Margin, 2010-2016 - Jiangling Motors' Revenue Structure by Product, 2015-2016 - Jiangling Motors' Light Truck Output and Sales Volume, 2010-2017 - Truck Capacity Distribution of Jiangling Motors, 2016 - Development History of SAIC GM Wuling - Main Trucks (Mini Trucks) of SAIC GM Wuling - SAIC GM Wuling's Mini Truck Output and Sales Volume, 2010-2017 - Distribution of SAIC GM Wuling's Production Bases - SAIC-IVECO Hongyan's Heavy Truck Output and Sales Volume, 2010-2017 - SAIC-IVECO Hongyan's Sales Target, 2017 - Main Heavy Trucks of Hubei Tri-Ring Special Vehicle - Hubei Tri-Ring Special Vehicle's Heavy Truck Output and Sales Volume, 2010-2017 - Hubei Tri-Ring Special Vehicle's Medium Truck Output and Sales Volume, 2010-2017 - Hubei Tri-Ring Special Vehicle's Light Truck Output and Sales Volume, 2010-2017 - XCMG Automobile's Heavy Truck Output and Sales Volume, 2010-2017 - Truck Capacity Distribution of XCMG Automobile, 2016 - GAC Hino Motors' Assets, Liabilities, and Revenue, 2012-2016 - GAC Hino Motors' Heavy Truck Output and Sales Volume, 2010-2017 - GAC Hino Motors' Capacity, 2016 - Zhejiang Feidie Automobile Manufacturing's Heavy Truck Output and Sales Volume, 2010-2017 - Zhejiang Feidie Automobile Manufacturing's Medium Truck Output and Sales Volume, 2010-2017 - Zhejiang Feidie Automobile Manufacturing's Light Truck Output and Sales Volume, 2010-2017 - Baotou Bei Ben Heavy-Duty Truck's Truck Output and Sales Volume, 2010-2017 - Shanxi Dayun Automobile Manufacturing's Heavy Truck Output and Sales Volume, 2010-2017 - Shanxi Dayun Automobile Manufacturing's Medium Truck Output and Sales Volume, 2010-2017 - Shanxi Dayun Automobile Manufacturing's Light Truck Output and Sales Volume, 2010-2017 - Truck Sales Growth in China, 2011-2021E - China's Truck Market Structure, 2010-2021E - Market Share of Top10 Truck Manufacturers in China, 2016 - Beijing Tiantan Biological Products Co., Ltd. (TIANTANBIO) - China Biologic Products, Inc. (NASDAQ: CBPO) - Green Cross China - Guizhou Taibang Biological Products Co., Ltd. - Hualan Biological Engineering,Inc. - Humanwell Healthcare Group Co., Ltd. - Jiangxi Boya Bio-Pharmaceutical Co., Ltd. - Shandong Taibang Biological Products Co., Ltd. - Shanghai Institute of Biological Products Co., Ltd. - Shanghai RAAS Blood Products Co., Ltd. - Shanxi Kangbao Biological Product Co., Ltd. - Shenzhen Weiguang Biological Products Co., Ltd. - Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. - Walvax Biotechnology Co, Ltd. - Xi'an Huitian Blood Products Co., Ltd. - Zhenxing Biopharmaceutical & Chemical Co., Ltd. For more information about this report visit http://www.researchandmarkets.com/research/2dng4t/china_blood Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/china-blood-product-industry-report-2017-product-market-size-expected-to-hit-rmb475-billion-in-2021---research-and-markets-300459175.html


— The Global Fibrinogen Concentrate Market Research Report 2017 is a professional and in-depth study on the current state of the fibrinogen concentrate market. Annual estimates and forecasts are provided for the period 2016 through 2021. Also, a six-year historic analysis is provided for these markets. The global fibrinogen concentrate industry has reached the value of approximately 480.72 million USD in 2015 and is expected to reach 904.47 million USD by 2021, at a CAGR of 10.67% during the forecast period, 2016 to 2021. Companies profiled in this report are CSL Behring, Baxter, Johnson & Johnson (Ethicon), LFB Group, ProFibrix BV (The Medicines Company), Shanghai RAAS, Jiangxi Boya Bio-Pharmaceutical, Hualan Biological Engineering, Harbin Pacific Biopharmaceutical, Greencross, Shanghai XinXing Medical and more. Analysis by Product Types, with production, revenue, price, market share and growth rate of each type, can be divided into • Human Fibrinogen Concentrate • Animal Fibrinogen Concentrate Analysis by Applications, this report focuses on consumption, market share and growth rate of Fibrinogen Concentrate in each application, can be divided into • Congenital Fibrinogen Deficiency • Surgical Procedures (Trauma Patients, Cardiovascular Surgery Patients, PPH Patients, Plastic Surgery Patients) Table of Contents: 1 Fibrinogen Concentrate Market Overview 2 Global Fibrinogen Concentrate Market Competition by Manufacturers 3 Global Fibrinogen Concentrate Capacity, Production, Revenue (Value) by Regions (2012-2017) 4 Global Fibrinogen Concentrate Supply (Production), Consumption, Export, Import by Regions (2012-2017) 5 Global Fibrinogen Concentrate Production, Revenue (Value), Price Trend by Types 6 Global Fibrinogen Concentrate Market Analysis by Applications 7 Global Fibrinogen Concentrate Manufacturers Profiles/Analysis 8 Fibrinogen Concentrate Manufacturing Cost Analysis 9 Industrial Chain, Sourcing Strategy and Downstream Buyers 10 Marketing Strategy Analysis, Distributors/Traders 11 Market Effect Factors Analysis 12 Global Fibrinogen Concentrate Market Forecast (2017-2022) 13 Research Findings and Conclusion 14 Appendix Inquire more about this report at: https://www.themarketreports.com/report/ask-your-query/524744 For more information, please visit https://www.themarketreports.com/report/global-fibrinogen-concentrate-market-research-report-2017-348526272


Wu X.,Peking University | Wu X.,National Institutes for Food and Drug Control | Mao Q.,National Institutes for Food and Drug Control | Yao X.,National Institutes for Food and Drug Control | And 11 more authors.
PLoS ONE | Year: 2013

The level of neutralizing antibodies (NtAb) induced by vaccine inoculation is an important endpoint to evaluate the efficacy of EV71 vaccine. In order to evaluate the efficacy of EV71 vaccine, here, we reported the development of a novel pseudovirus system expression firefly luciferase (PVLA) for the quantitative measurement of NtAb. We first evaluated and validated the sensitivity and specificity of the PVLA method. A total of 326 serum samples from an epidemiological survey and 144 serum specimens from 3 clinical trials of EV71 vaccines were used, and the level of each specimen's neutralizing antibodies (NtAb) was measured in parallel using both the conventional CPE-based and PVLA-based assay. Against the standard neutralization assay based on the inhibition of the cytopathic effect (CPE), the sensitivity and specificity of the PVLA method are 98% and 96%, respectively. Then, we tested the potential interference of NtAb against hepatitis A virus, Polio-I, Polio-II, and Polio-III standard antisera (WHO) and goat anti-G10/CA16 serum, the PVLA based assay showed no cross-reactivity with NtAb against other specific sera. Importantly, unlike CPE based method, no live replication-competent EV71 is used during the measurement. Taken together, PVLA is a rapid and specific assay with higher sensitivity and accuracy. It could serve as a valuable tool in assessing the efficacy of EV71 vaccines in clinical trials and disease surveillance in epidemiology studies. © 2013 Wu et al.


Mao Q.,National Institutes for Food and Drug Control | Dong C.,Chinese Academy of Sciences | Li X.,National Vaccine and Serum Institute | Gao Q.,Sinovac Biotech | And 11 more authors.
PLoS ONE | Year: 2012

Background: Enterovirus 71 (EV71) is the major causative agent of hand, foot, and mouth disease (HFMD). Three inactivated EV71 whole-virus vaccines of different strains developed by different manufacturers in mainland China have recently entered clinical trials. Although several studies on these vaccines have been published, a study directly comparing the immunogenicity and protective effects among them has not been carried out, which makes evaluating their relative effectiveness difficult. Thus, properly comparing newly developed vaccines has become a priority, especially in China. Methods and Findings: This comparative immunogenicity study was carried out on vaccine strains (both live and inactivated), final container products (FCPs) without adjuvant, and corresponding FCPs containing adjuvant (FCP-As) produced by three manufacturers. These vaccines were evaluated by neutralizing antibody (NAb) responses induced by the same or different dosages at one or multiple time points post-immunization. The protective efficacy of the three vaccines was also determined in one-day-old ICR mice born to immunized female mice. Survival rates were observed in these suckling mice after challenge with 20 LD50 of EV71/048M3C2. Three FCP-As, in a dose of 200 U, generated nearly 100% NAb positivity rates and similar geometric mean titers (GMTs), especially at 14-21 days post-inoculation. However, the dynamic NAb responses were different among three vaccine strains or three FCPs. The FCP-As at the lowest dose used in clinical trials (162 U) showed good protective effects in suckling mice against lethal challenge (90-100% survival), while the ED50 of NAb responses and protective effects varied among three FCP-As. Conclusions: These studies establish a standard method for measuring the immunogenicity of EV71 vaccines in mice. The data generated from our mouse model study indicated a clear dose-response relationship, which is important for vaccine quality control and assessment, especially for predicting protective efficacy in humans when combined with future clinical trial results. © 2012 Mao et al.


Liang Z.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | Mao Q.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | Gao Q.,Sinovac Biotech | Li X.,National Vaccine and Serum Institute | And 8 more authors.
Vaccine | Year: 2011

Enterovirus 71 (EV71) is a highly infectious agent that causes hand-foot-mouth disease (HFMD) in humans. Effective vaccination against EV71 infection is critically important, given the recent outbreak of HFMD in the Asia-Pacific region, where it has shown significant mortality and morbidity. There is currently no approved anti-viral therapy available to treat the disease. While several vaccine manufacturers are actively developing EV71 vaccines, there are no international reference standards available to conduct quality control on EV71 vaccines or to assess the effectiveness of EV71 vaccines in immunized populations. In the current report, antigen reference standard based on the C4 subtype of the EV71 vaccine strain was developed. In addition, neutralizing antibody (NTAb) reference panels were analyzed and standards with various neutralizing titers were selected. These reference antigens were used to calibrate vaccine samples from several producers and found that five EV71 antigens and the national reference standards showed good linearity and parallelism. Moreover, mice immunized with various vaccines at doses standardized by these national references showed comparable NTAb responses. Finally, the national NTAb reference panels were found to effectively reduce assay discrepancy between different labs. Taken together, these national reference standards are highly valuable for the standardization and evaluation of EV71 vaccines. © 2011 Elsevier Ltd.


Lu P.,Nanjing Agricultural University | Zheng L.-Q.,Yunnan University | Zheng L.-Q.,Hualan Biological Engineering Inc | Sun J.-J.,Nanjing Agricultural University | And 4 more authors.
International Journal of Systematic and Evolutionary Microbiology | Year: 2012

The taxonomic status of a methyl-parathion-degrading strain, OP-1T, isolated from a wastewater-treatment system in China, was determined using a polyphasic approach. The rod-shaped cells were Gram-staining-negative, non-spore-forming and non-motile. Phylogenetic analysis based on 16S rRNA gene sequences indicated that the novel strain belonged to the genus Burkholderia, as it appeared closely related to Burkholderia glathei ATCC 29195T (97.4 % sequence similarity), Burkholderia sordidicola KCTC 12081T (96.5 %) and Burkholderia bryophila LMG 23644T (96.3 %). The major cellular fatty acids, C16: 0, C17: 0 cyclo and C18: 1ω7c, were also similar to those found in established members of the genus Burkholderia. The genomic DNA G+C content of strain OP-1T was 59.4 mol%. The level of DNA-DNA relatedness between the novel strain and the closest recognized species, Burkholderia glathei ATCC 29195T, was only 30 %. Based on the phenotypic, genotypic and phylogenetic evidence, strain OP-1T represents a novel species of the genus Burkholderia, for which the name Burkholderia zhejiangensis sp. nov. is proposed. The type strain is OP-1T (= CCTCC AB 2010354T = KCTC 23300T). © 2012 IUMS.


Chen X.,CAS Institute of Process Engineering | Chen X.,University of Chinese Academy of Sciences | Liu Y.,Beijing University of Chemical Technology | Wang L.,CAS Institute of Process Engineering | And 9 more authors.
Molecular Pharmaceutics | Year: 2014

Surface-engineered particulate delivery systems for vaccine administration have been widely investigated in experimental and clinical studies. However, little is known about charge-coated microspheres as potential recombinant subunit protein antigen delivery systems in terms of adsorption and related immune responses. In the present study, cationic polymers, including chitosan (CS), chitosan chloride (CSC), and polyethylenimine (PEI), were used to coat PLA microspheres to build positively charged surfaces. Antigen adsorption capacity was enhanced with increased surface charge of coated microspheres. In macrophages, HBsAg adsorbed on the surface of cationic microspheres specifically enhanced antigen uptake and augmented CD86, MHC I, and MHC II expression and IL-1β, IL-6, TNF-α, and IL-12 release. Antigens were more likely to localize independent of lysosomes after phagocytosis in antigen-attached cationic microsphere formulations. After intraperitoneal immunization, cationic microsphere-based vaccine formulations generated a rapid and efficient humoral immune response and cytokine release as compared with aluminum-adsorbed vaccine and free antigens in vivo. Moreover, microspheres coated with cationic polymers with relatively high positive charges and higher antigen adsorption exhibited strong stimulation of the Th1 response. In conclusion, PLA microspheres coated with cationic polymers may be a potential recombinant antigen delivery system to induce strong cell and humoral immune responses. © 2014 American Chemical Society.

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