China National Biotec Group Company Ltd

Beijing, China

China National Biotec Group Company Ltd

Beijing, China
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Zhang M.,China National Biotec Group Company Ltd | Kang G.-D.,China National Biotec Group Company Ltd | Ma Y.-L.,China National Biotec Group Company Ltd | Zhang Z.-L.,China National Biotec Group Company Ltd | And 6 more authors.
Chinese Journal of Biologicals | Year: 2016

Objective To perforin post-inarketing study on the clinical safety of recombinant hepatitis H (rHB) vaccine (Saccharomyces cerevisiae) in newliorns. Methods A cohort study on rHB vaccine (5. cerevisiae) was conducted. Newl>oms from April 1 to August 30, 2015 in Nantong City, Jiangsu Province, China were immunized with the vaccine according to the schedule in national EPI. The data on vaccination and the safety after vaccination were collected through the Individual Information System of Vaccination in Children in Jiangsu Province and the AKFI Information System to evaluate the safety of the vaccine. Results A total of 37 cases of AKFI were reported during the period, indicating an incidence rate of 40. 93/100 000. No severe adverse events or severe unexpected events were observed. Of the 37 cases, 32 were general reactions, while 5 were abnormal events, and no accidental or psychogenic reactions were reported. A portion of 67. 57% of the general reactions were fever, especially those occurred after the 3rd dose, with an incidence rate of 69. 84 / 100 000. The abnormal reactions included two eases of allergic rash, one case of urticaria and one ease of febrile convulsion. The 37 cases of AEFI events mainly occurred within 30 min to 24 h after vaccination, with good prognosis. Conclusion The rHB vaccine (5. cerevisiae) showed good safety in newborns.


Su J.,Chinese Institute of Materia Medica | Tang Y.,Chinese Institute of Materia Medica | Shen H.,Changchun Key gen Biological Products Co. | Zhang J.,Chinese Institute of Materia Medica | And 6 more authors.
Chinese Journal of Microbiology and Immunology (China) | Year: 2016

Objective: To evaluate the immunogenicity and safety of a booster dose of Japanese encephalitis vaccine co-administrated with live attenuated varicella vaccine and to provide a scientific basis and guidance for the feasibility of combined vaccination of the two vaccines. Methods: A total of 439 children who met the inclusion and exclusion criteria received either a booster dose of Japanese encephalitis vaccine (JEV) alone (n=200) or a booster dose of Japanese encephalitis vaccine co-administered with live attenuated varicella vaccine (JEV+ LAV) (n=239). Serum samples were collected from each subject before and 35 to 42 days after the second immunization of JEV for the detection of antibodies against Japanese encephalitis. Seroconversion rates, geometric mean antibody titers (GMT) and adverse event rates were compared between the two groups. Results: There were significant differences in the seroconversion rates between JEV and JEV+ LAV groups before the booster vaccination (89.78% vs 63.06%, χ2=38.797, P<0.001). The GMT of JE neutralizing antibodies was 1:19.117 in JEV group and 1:7.129 in JEV+ LAV group before the booster dose of JEV (t=6.618, P<0.001). The seroconversion rates were 96.774% in JEV group and 97.297% in JEV+ LAV group after immunization with no significant differences between them (χ2=0.097, P=0.755). The GMT of JE neutralizing antibodies in JEV group was significantly higher than that of JEV+ LAV group after the second immunization of JEV (1:453.693 vs 1:285.692, t=3.548, P<0.001). Stratification analysis was also conducted among non-susceptible and susceptible population. Both of the two populations showed no significant differences in the seroconversion rate and GMT between the two groups before and after the booster dose vaccination. Safety analysis showed that the adverse event rates of JEV and JEV+ LAV groups were 8.0% and 12.6%, respectively, with no significant differences between them (χ2=2.405, P=0.121). No serious adverse events were observed. Conclusion: Co-administration of Japanese encephalitis vaccine with live attenuated varicella vaccine did not impact the immunogenicity of Japanese encephalitis vaccine and was well tolerated. Copyright © 2016 by the Chinese Medical Association.


Chen H.,China National Biotec Group Company Ltd | Guo S.,Beijing Tiantan Biological Products | Chang G.,U.S. Center for Disease Control and Prevention | Ma Y.,China National Biotec Group Company Ltd | And 5 more authors.
Chinese Journal of Microbiology and Immunology (China) | Year: 2016

Objective: To evaluate the immunogenicity of a 20 μg/dose of hepatitis B vaccine made by recombinant deoxyribonucleic acid techniques in Saccharomyces cerevisiae (Hep B-SCY) in post-marketing stage among people aged 16 years and above. Methods: This study recruited 4 636 healthy subjects aged 16 years and above, who were negative for hepatitis B surface antigen (HBsAg) and the antibodies to HBsAg (anti-HBs) in them were lower than 100 mIU/ml. The subjects were intramuscularly immunized with 20 μg/dose of Hep B-SCY vaccine on a three-dose schedule (vaccination at months 0, 1 and 6). The levels of anti-HBs were detected by chemiluminescence microparticle immunoassay (CMIA). Results: The anti-HBs immune success rates and the geometric mean concentrations (GMCs) in subjects whose pre-immune anti-HBs titers were <100 mIU/ml and ≥10 mIU/ml were respectively 90.24%(703/779), 1 314.35 mIU/ml and 97.82%(449/459), 2 065.96 mIU/ml after 30 to 45 days of vaccination with 1 or 2 doses of the Hep B-SCY vaccine (20 μg/dose). The antibody positive conversion rates, the highly response rates and the GMCs in subjects of pre-immune anti-HBs<10 mIU/ml were respectively 69.16%(74/107), 50.47%(54/107), 47.68 mIU/ml; 86.13%(1 975/2 293), 56.43%(1 294/2 293), 147.94 mIU/ml and 98.72%(1 844/1 868), 87.53%(1 635/1 868), 649.15 mIU/ml after 30 to 45 days of vaccination with 1, 2 or 3 doses of the Hep B-SCY vaccine. Conclusion: The post-marketing surveillance indicated that the three-dose schedule (vaccination at months 0, 1 and 6) of Hep B-SCY (20 μg /dose) showed good immunogenicity in healthy people aged 16 years and above. Copyright © 2016 by the Chinese Medical Association.


Zhao Z.,China Institute of Technology | Wang X.,China Institute of Technology | Wang H.,China Institute of Technology | Liu F.,China Institute of Technology | And 5 more authors.
Chinese Journal of Microbiology and Immunology (China) | Year: 2014

Objective: To prepare a human meningococcal reference serum and standardize IgG concentrations to capsular polysaccharides and in vitro bactericidal activities of the reference serum against serogroup A, C, Y and W135 strains. Methods: Twenty healthy adults were recruited and given one dose of immunization with tetravalent (serogroups A, C, Y and W135) meningococcal polysaccharide vaccine. Plasma samples were collected and gone through a series of process treatments including defibrination, filtration, and lyophilization to prepare the meningococcal reference serum Men10. The IgG concentrations of Men10 to capsular polysaccharides of serogroups A, C, Y and W135 were calibrated by using an internation-al reference serum CDC1992 as the standard in enzyme-linked immunosorbent assay (ELISA). Provisional IgG concentrations of Men10 were intensively validated by testing a panel of 12 calibration serum samples from Centers for Disease Control and Prevention, USA (US CDC) and a panel of 56 serum samples immunized with A, C, Y and W135 meningococcal polysaccharide vaccine from Lanzhou Institute of Biological Products Co., Ltd. (LIBP) with the assays using Men10 and CDC1992 as the standard and/or test samples, respectively. The bactericidal titers against serogroup A, C, Y and W135 strains were measured by serum bactericidal assay (SBA). Results: Four thousand vials (0.5 ml/vial) of lyophilized human meningococcal reference serum Men10 were successfully prepared with 2.5% of residual moisture. Reference serum Men10 was sterile and free from contamination by hepatitis B virus, hepatitis C virus, human immunodeficiency virus and syphilis. Provisional IgG concentration of Men10 to capsular polysaccharide of serogroups A, C, Y and W135 was calibrated by using CDC1992 as the standard. Furthermore, IgG concentrations of both panels of 12 CDC calibration serum samples and 56 LIBP serum samples calibrated by using Men10 as the standard correlated well with those by using CDC1992 as the standard (r=0.99, P<0.05). The IgG concentrations of CDC1992 as calibrated by using Men10 as the standard showed significant correlation with its previously determined values with variation <10%. SBA titers for serotype A, C, Y and W135 strains were established as well. Conclusion: A panel of new human meningococcal reference serum Men10 with accurately calibrated IgG concentration against capsular polysaccharide of serogroups A, C, Y and W135 as well as SBA titers was successfully established. Copyright © 2014 by the Chinese Medical Association.


Chen H.,China National Biotec Group Company Ltd | Liu X.,China National Biotec Group Company Ltd | Shen H.,Changchun Keygen Biological Products Co. | Ma F.,U.S. Center for Disease Control and Prevention | And 6 more authors.
Chinese Journal of Microbiology and Immunology (China) | Year: 2016

Objective: To evaluate the effectiveness and safety of varicella attenuated live vaccine (VarV) produced by A Co. Ltd. Methods: We selected 3 provinces in China and enrolled 15002 children aged 3-<11 in this random, multicenter study. Participants were randomly divided into two groups; the experimental group and the control group. Every varicella case was collected and recorded to calculate the vaccine efficacy. Vaccine safety was assessed by means of spontaneous report and regular follow-up visits. Results: During the observation period, the incidence of varicella was 0.147% in the experimental group and 1.155% in the control group (P<0.001). The vaccine efficacy was 87.27%. The adverse reaction rate after vaccination was lower than the rates reported in other literatures. Conclusion: The VarV produced by A Co., Ltd. in China was effective and safe in preventing varicella. Copyright © 2016 by the Chinese Medical Association.


Liu F.,Lanzhou Institute of Biological Products Co. | Hou Y.,Lanzhou Institute of Biological Products Co. | Wu B.,Lanzhou Institute of Biological Products Co. | Liu J.,Lanzhou Institute of Biological Products Co. | And 6 more authors.
Chinese Journal of Microbiology and Immunology (China) | Year: 2014

Objective: To monitor and analyze the antigenicity of Streptococcus pneumonia polysaccharide, its derivatives and conjugates by three immunological assays. Methods: Inhibition ELISA and rate nephelometry (RN) were established for this study. Antigenicity of serotype 23F pneumococcal conjugates and their intermediates were analyzed by double immunodiffusion assay, inhibition ELISA and RN. The results derived from three assays were comparatively analyzed to evaluate the changes of antigenicity during the preparing process of serotype 23F conjugate. Results: Double immunodiffusion assay, inhibition ELISA and RN were all applicable to antigenicity analysis during the process of conjugate preparation. Inhibition ELISA could quantitatively detect a slight difference of polysaccharide antigenicity during the preparing process. Conclusion: The antigenicity of polysaccharide during the preparing process of pneumococcal conjugates could be analytically monitored by using three immunological assays. This study provided evidence for successfully using immunological assays as the quality control means during the preparing process of pneumococcal conjugates. Copyright © 2014 by the Chinese Medical Association.


Shi Z.,Sichuan University | Shi Z.,Guizhou Normal University | An N.,Sichuan University | Lu B.M.,Sichuan University | And 8 more authors.
Cell Proliferation | Year: 2014

Objectives: Protein kinases orchestrate activation of signalling cascades in response to extra- and intracellular stimuli for regulation of cell proliferation. They are directly involved in a variety of diseases, particularly cancers. Systems biology approaches have become increasingly important in understanding regulatory frameworks in cancer, and thus may facilitate future anti-cancer discoveries. Moreover, it has been suggested and confirmed that high-throughput virtual screening provides a novel, effective way to reveal small molecule protein kinase inhibitors. Accordingly, we aimed to identify kinase targets and novel kinase inhibitors. Materials and methods: A series of bioinformatics methods, such as network construction, molecular docking and microarray analyses were performed. Results: In this study, we computationally constructed the appropriate global human protein-protein interaction network with data from online databases, and then modified it into a kinase-related apoptotic protein-protein interaction network. Subsequently, we identified several kinases as potential drug targets according to their differential expression observed by microarray analyses. Then, we predicted relevant microRNAs, which could target the above-mentioned kinases. Ultimately, we virtually screened a number of small molecule natural products from Traditional Chinese Medicine (TCM)@Taiwan database and identified a number of compounds that are able to target polo-like kinase 1, cyclin-dependent kinase 1 and cyclin-dependent kinase 2 in HeLa cervical carcinoma cells. Conclusions: Taken together, all these findings might hopefully facilitate discovery of new kinase inhibitors that could be promising candidates for anti-cancer drug development. © 2014 John Wiley & Sons Ltd.


Li A.-N.,The First Laboratory of Lanzhou Institute of Biological Products Co. | Hu H.,The First Laboratory of Lanzhou Institute of Biological Products Co. | Zhu Y.-Z.,The First Laboratory of Lanzhou Institute of Biological Products Co. | Luo S.-Q.,The First Laboratory of Lanzhou Institute of Biological Products Co. | And 6 more authors.
Chinese Journal of New Drugs | Year: 2016

Objective: To develop a nuclear magnetic resonance (NMR) method for analysis of residual pyridine borane (Py-BH3) content in pneumococcal polysaccharide derivatives. Methods: The pulse program was zgpr (water suppression experiment).1H-NMR spectra were collected at 298 K with a 7 211 Hz spectral width, 2.272 s acquisition time and 2 s relaxation delay, accumulating 512 scans. The spectra were weighted with 1.0 Hz line broadening and Fourier transformed. For data acquisition and processing, Topspin version 3.0 software was used. The method was developed and verified for specificity, detection limit and robustness. Results: Using the developed method, the solvent for determination of residual Py-BH3 content showed no interference to the component to be tested. Py-BH3 and pneumococcal polysaccharide derivatives showed distinguished characteristic peaks by NMR detection, and the peaks were completely separated after the test substances were mixed together, indicating high specificity. Py-BH3 signals could be detected clearly within the Py-BH3 concentration of 1%~0.01%, and good signal-noise ratio (S/N) was obtained. The limit of detection was 0.02%. Chemical shift and S/N did not change significantly when test temperature was changed, indicating good robustness. Conclusion: The developed NMR method shows high specificity and robustness for detection of residual Py-BH3 content in pneumococcal polysaccharide derivatives, which is suitable for the test of pneumococcal conjugate vaccine. © 2016, Chinese Journal of New Drugs Co. Ltd. All right reserved.


Liu X.-Q.,China National Biotec Group Company Ltd | Ma Y.-L.,China National Biotec Group Company Ltd | Yang Z.-N.,China National Biotec Group Company Ltd | Zhang M.,China National Biotec Group Company Ltd | And 3 more authors.
Chinese Journal of Biologicals | Year: 2015

Objective: To evaluate the safety of influenza vaecinetsplit virion) manufactured by Beijing Tiantan Biological Products Co., Ltd, in population at ages of more than 60 years during 2011 ∼ 2012 in Beijing City. Methods: The data on adverse events following immunization (AEFIs) cases in people at ages of more than 60 years in Beijing City during 2011 to 2012, after free vaccination with influenza vaccine (split virion), were collected by AEFI information system, and analyzed by descriptive methodology. Results: Of the 536 812 recipients of vaccine manufactured by Beijing Tiantan Biological Products Co., Ltd, 10 cases of AEFIs were reported, including 6 cases of adverse reactions (3 cases of general reactions and 3 cases of abnormal reactions), indicating an incidence of adverse reactions of 1. 12/100 000. However, of the 701 820 recipients of vaccines by other manufacturers, 21 cases of AEFIs were reported, including 10 cases of adverse reactions (6 cases of general reactions and 4 cases of abnormal reactions), indicating an incidence of adverse reactions of 1. 42/100 000. No significant differences were observed in reported incidences of total adverse reactions, general reactions and abnormal reactions (P> 0. 05). Conclusion: The influenza vaccine (split virion) manufactured by Beijing Tiantan Biological Products Co., Ltd showed high safety, which might be used for the prevention of influenza in the relevant population.


Jia T.,China National Biotec Group Company Ltd | Wang R.,China National Biotec Group Company Ltd
Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine] | Year: 2016

Mother-to-child transmission (MTCT) is the main way to transmit hepatitis B virus (HBV), and it is also the biggest contributor to high prevalence of hepatitis B in high endemic areas. Therefore, preventing MTCT may result in the decline of HBV positive ratio foundationally. Hepatitis B vaccination is currently recognized as the most economic, effective and safe measure to prevent MTCT. The key strategies in the future to prevent MTCT should be to enhance the screening of hepatitis B surface antigen, to provide the infants born to surface antigen positive mother with hepatitis B vaccine combine with hepatitis B immunoglobulin(HBIG), and to monitor the effect of the intervention.

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