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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB2300158 注射用重组人TNK组织型纤溶酶原激活剂 recombinant human tnk tissue-type plasminogen activator Lyophilized Biological Products(1) Supplementary Application 2023-09-01 Guangzhou Recomgen Biotech Co Ltd view
CXSS2200090 注射用重组人TNK组织型纤溶酶原激活剂 recombinant human tnk tissue-type plasminogen activator Lyophilized Biological Products(2.2) New Drug Application 2022-11-15 Guangzhou Recomgen Biotech Co Ltd view
CYSB2101302 注射用重组人TNK组织型纤溶酶原激活剂 recombinant human tnk tissue-type plasminogen activator Lyophilized Biological Products Supplementary Application 2021-12-28 Guangzhou Recomgen Biotech Co Ltd view
CXSB2101003 注射用重组人TNK组织型纤溶酶原激活剂 recombinant human tnk tissue-type plasminogen activator Lyophilized Biological Products Supplementary Application 2021-03-27 Guangzhou Recomgen Biotech Co Ltd view
CSL20020055 注射用重组人组织型纤溶酶原激活剂TNK突变体(rhTNK-tPA) recombinant human tnk tissue-type plasminogen activator Lyophilized Biological Products(2) New Drug Application 2002-07-30 广州铭康生物工程有限公司 Guangzhou Recomgen Biotech Co Ltd Certificate Issued 2003-03-25 view
CSL01038 注射用重组水蛭素(酵母分泌型) Lyophilized Biological Products(2) New Drug Application 2001-09-28 广州铭康生物工程有限公司 Guangzhou Recomgen Biotech Co Ltd Certificate Issued 2003-05-16 view
CXSS0900027 注射用重组人组织型纤溶酶原激活剂TNK突变体(rhTNK-tPA) recombinant human tnk tissue-type plasminogen activator Lyophilized Biological Products(7) New Drug Application 2009-09-09 广州铭康生物工程有限公司 Guangzhou Recomgen Biotech Co Ltd Certificate Issued 2015-01-26 view
CXSL1700001 注射用重组人TNK组织型纤溶酶原激活剂 recombinant human tnk tissue-type plasminogen activator Lyophilized Biological Products(7) New Drug Application 2017-02-20 广州铭康生物工程有限公司 Guangzhou Recomgen Biotech Co Ltd Certificate Issued 2017-05-26 view
CXSB1700010 注射用重组人TNK组织型纤溶酶原激活剂 recombinant human tnk tissue-type plasminogen activator Lyophilized Biological Products Supplementary Application 2017-12-08 广州铭康生物工程有限公司 Guangzhou Recomgen Biotech Co Ltd Certificate Issued 2018-07-27 view
CYSB1800218 注射用替奈普酶 tenecteplase Lyophilized Biological Products Supplementary Application 2018-10-18 广州铭康生物工程有限公司 Guangzhou Recomgen Biotech Co Ltd Certificate Issued 2019-12-20 view
CYSB2000108 注射用重组人TNK组织型纤溶酶原激活剂 recombinant human tnk tissue-type plasminogen activator Lyophilized Biological Products Supplementary Application 2020-05-28 广州铭康生物工程有限公司 Guangzhou Recomgen Biotech Co Ltd Certificate Issued 2021-01-15 view