- History
- Institutions
On June 19, 2014, It gained registered number of pure approval ----- GSYJX(Z) Zi 2014 No. 3401104 of treponema pallidum antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On June 19, 2014, It gained registered number of pure approval ----- GSYJX(Z) Zi 2014 No. 3401110 of Hepatitis E Virus IGG antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On June 19, 2014, It gained registered number of pure approval ----- GSYJX(Z) Zi 2014 No. 3401108 of Hepatitis B virus antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On June 19, 2014, It gained registered number of pure approval ----- GSYJX(Z) Zi 2014 No. 3401105 of Hepatitis B virus core antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On June 19, 2014, It gained registered number of pure approval ----- GSYJX(Z) Zi 2014 No. 3401103 of Hepatitis B e antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On June 19, 2014, It gained registered number of pure approval ----- GSYJX(Z) Zi 2014 No. 3401107 of Hepatitis B e Antigen detection kit (chemiluminescent method) approved by the State Food and Drug Administration
On June 19, 2014, It gained registered number of pure approval ----- GSYJX(Z) Zi 2014 No. 3401106 of hepatitis B surface antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration
In September, 2013, the construction of new plant located in Huairou Park, Zhongguancun Science and Technology Park, Beijing City starts, covers an area of 10000 square meters and the construction area of 3000 square meters.
On May 17, 2013, It gained registered number of pure approval ----- GSYJX(Z) Zi 2013 No. 3400730 of rubella virus IGM antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On April 24, 2013, it gained registered number of pure approval ----- GSYJX (Z) Zi 2013 No. 3400613 of rubella virus IGG antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration
On March 7, 2013, It gained registered number of total prostate pure approval ----- GSYJX(Z) Zi 2013 No. 3400366 of different sex Antigen specific antigen quantification detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On March 7, 2013, It gained registered number of pure approval ----- GSYJX(Z) Zi 2013 No. 3400364 of Cancer Embryo Antigen quantification detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On March 7, 2013, It gained registered number of pure approval ----- GSYJX(Z) Zi 2013 No. 3400365 of Alpha fetal protein quantification detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
on March 7, 2013, It gained registered number of pure approval ----- GSYJX(Z) Zi 2013 No. 3400349 of Toxoplasma gondii IGG antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration
on March 7, 2013, It gained registered number of pure approval ----- GSYJX(Z) Zi 2013 No. 3400348 of Toxoplasma gondii IGM antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On March 7, 2013, It gained registered number of pure approval ----- GSYJX(Z) Zi 2013 No. 3400347 of herpes simplex virus II type IGG antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On March 7, 2013, It gained registered number of pure approval ----- GSYJX(Z) Zi 2013 No. 3400350 of herpes simplex virus II type IGM antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On January 21, 2013, It gained registered number of pure approval ----- GSYJX(Z) Zi 2013 No. 3400104 of cytomegalovirus IGG antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On January 21, 2013, It gained registered number of pure approval ----- GSYJX(Z) Zi 2013 No. 3400102 of cytomegalovirus IGM antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On January 21, 2013, It gained registered number of pure approval ----- GSYJX(Z) Zi 2013 No. 3400101 of herpes simplex virus I type IGG antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration.
On January 21, 2013, It gained registered number of pure approval ----- GSYJX(Z) Zi 2013 No. 3400103 of herpes simplex virus I type IGM antibody detection kit (chemiluminescent method) approved by the State Food and Drug Administration
On November 9, 2012, It gained registered number of approval ----- GSYJX(Z) Zi 2012 No. 2400864 of troponin I/ MB isoenzyme of creatine phosphokinase /myoglobin 3 in 1 detection kit (colloidal gold method) approved by the Beijing Food and Drug Administration.
on Sep. 11, 2012, It gained registered number of approval ----- GSYJX (Z) Zi 2012 No. 3401203 of troponin I detection kit (colloidal gold method) approved by the Beijing Food and Drug Administration.
On Sep. 11, 2012, It gained registered number of approval ----- GSYJX(Z) Zi 2012 No. 3401203 of proGRP pro-gastrin-releasing peptide detection kit (euzyme linked immunosorbent assay) approved by the State Food and Drug Administration on.
In April, 2011, obtained Medical Device Manufacturing License.
In December, 2010, obtained the Drug Manufacturing Certificate
In December, 2010, passed GMP Re-certification
In 2008, It won the production license of the diagnostic reagents of hepatitis e virus IgM antibody diagnostic reagent kit (euzyme linked immunosorbent assay).
In 2006, Urine microalbumin diagnostic kit developed under its cooperation with the Institute of Gerontology of the Ministry of Health won the production license from the State Food and Drug Administration.
In 2006, Hepatitis B virus (HBV) marker diagnostic kit (colloidal gold method) developed under its cooperation with Nantong Egens Biotechnology Co., Ltd. in 2006 won the new-drug certificate and production license issued by the State Food and Drug Administration.
In 2006, Human immunodeficiency virus (HIV) 1+2 type antibody / P24 antigen diagnostic kit developed under its cooperation with Professor Mao Panyong of the Whole Army Institute of Infectious Diseases of the People's Republic of China was the first one to win the drug production licenses from the State Food and Drug Administration; and gained innovation funds supporting for small and medium-sized technology-based enterprise of the Ministry of Science and Technology.
In April, 2006, obtained Medical Device Manufacturing License.
In January, 2006, obtained the Drug Manufacturing Certificate.
In April, 2005, passed the GMP certification.
In 2005, It as well as Chinese Peking Union Medical College succeeded to jointly develop SARS coronavirus nucleocapsid protein monoclonal antibody and the article was published in phase 2, volume 36 of the "Journal of Anatomy"2005.
On January 1, 2004, The Ministry of Health of the General Logistics Department of the People's Republic of China implemented enterprise restructuring and asset reorganization on according to relative national regulations to establish Beijing Kewei Clinical Diagnostic Reagent Co., Ltd. with mechanism of modern enterprise, and meanwhile the company moved to the new production place – No.19 West Gucheng Street, Shijingshan District, Beijing City.
In 1999, The research of total anti hepatitis C virus (HCV) wins the third prize of the Chinese People Liberation Army Scientific and Technological Progress.
In 1998, Comparative study on antigenicity of synthetic peptides HIV wins the third prize of the Chinese People Liberation Army Scientific and Technological Progress.
In 1998, The product is listed in the international network of quality products.
In 1998, The factory covering an area of 1000 square meters was built, which is in line with GMP standard at that time.
In 1997, It first launches antibody ELISA of hepatitis E virus at home. Professor Rong Guangya and senior engineer Zhou Jiguang published several research papers about Hepatitis E virus on magazines like "The Chinese Journal of Medical Inspection", "The Chinese Experiment and Clinical Virology".
In 1995, It is the first to get manufacturing license for antibody ELISA of hepatitis C virus.
In 1992, Development and broad application of IgM antibody ELISA of hepatitis A virus wins the second prize of national scientific and technological progress.
In 1990, It is the first to get the new drugs certificate for the core antibody ELISA of hepatitis B virus.
In 1990, It is the first to get the new drugs certificate for IgM antibody ELISA of hepatitis A virus.
In March, 1990, Set up reagent factory of clinical diagnosis in Beijing, this first launches the ELISA of hepatitis B series at home.
In 1987, Establish Hybridoma cell line of anti-HBc monoclonal antibody, which wins the third prize of National Scientific and Technological Progress, as well as the second prize of the Chinese People Liberation Army Scientific and Technological Progress.
In 1985, Hybridoma cell line of anti-HBc monoclonal antibody is firstly awarded at home, and ELISA has been established for clinical diagnosis. It wins the second prize of the Chinese People Liberation Army scientific and technological progress.
In 1985, Research and application of monoclonal antibodies in hepatitis B virus series win the second prize of national scientific and technological progress.
In 1980, Hepatitis B core antigen is developed successfully. It is verified by National Institute for the Control of Pharmaceutical and Biological Products and recommended as the first national reference. It also filled in a gap at home in this field, and was awarded the Second Price of Scientific and Technological Achievements by the Ministry of Health.
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EGENS Organization Structure