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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2000339 SKB337注射液 SKB337 Injection Biological Products(1) New Drug Application 2020-12-14 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2020-12-03 view
CXSL2000108 KL-A289注射液 KL-A289 Injection Biological Products(1) New Drug Application 2020-05-22 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd;Anyuan Pharmaceutical Technology (Shanghai) Co Ltd In Review 2020-05-20 view
CXSL2000010 注射用SKB264 sacituzumab tirumotecan Lyophilized Biological Products(1) New Drug Application 2020-01-21 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2020-01-20 view
CXSL1900067 KL-A293注射液 KL-A293 Injection Biological Products(1) New Drug Application 2019-07-09 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd;Anyuan Pharmaceutical Technology (Shanghai) Co Ltd In Review 2019-07-08 view
CXSL1700085 注射用A166 Lyophilized Biological Products(1) New Drug Application 2017-08-28 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd Certificate Issued 2018-05-17 view
CXSL1700026 KL-A167注射液 tagitanlimab Injection Biological Products(1) New Drug Application 2017-04-13 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd Certificate Issued 2017-09-27 view
CXSL1700008 注射用重组人血小板生成素拟肽-Fc融合蛋白 Biological Products(7) New Drug Application 2017-03-30 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd Certificate Issued 2018-07-27 view
CXSL1600119 重组抗VEGFR2全人源单克隆抗体注射液 Recombinant anti-VEGFR2 human monoclonal antibody Injection Biological Products(2) New Drug Application 2017-01-26 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd Certificate Issued 2018-03-20 view
CXSB2000009 重组抗VEGFR2全人源单克隆抗体注射液 Recombinant anti-VEGFR2 human monoclonal antibody Injection Biological Products Supplementary Application 2020-04-23 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2020-04-22 view
CXHL2100103 KL210122片 KL-210122 Tablet Chemical Drugs(1) New Drug Application 2021-02-09 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2021-02-08 view
CXHL2100102 KL210122片 KL-210122 Tablet Chemical Drugs(1) New Drug Application 2021-02-09 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2021-02-08 view
CXHL2100101 KL210122片 KL-210122 Tablet Chemical Drugs(1) New Drug Application 2021-02-09 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2021-02-08 view
CXHL1900157 KL060332胶囊 KL-060332 Capsule Chemical Drugs(1) New Drug Application 2019-05-09 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2019-05-07 view
CXHL1900156 KL060332胶囊 KL-060332 Capsule Chemical Drugs(1) New Drug Application 2019-05-09 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2019-05-07 view
CXHL1900155 KL060332胶囊 KL-060332 Capsule Chemical Drugs(1) New Drug Application 2019-05-09 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2019-05-07 view
CXHL1900154 KL060332胶囊 KL-060332 Capsule Chemical Drugs(1) New Drug Application 2019-05-09 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2019-05-07 view
CXHL1900153 KL060332 KL-060332 Active ingredient Chemical Drugs(1) New Drug Application 2019-05-09 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2019-05-07 view
CXHL1800058 KL280006注射液 KL280006 Injection Chemical Drugs(1) New Drug Application 2018-04-21 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd Certificate Issued 2018-07-24 view
CXHL1800057 KL280006注射液 KL280006 Injection Chemical Drugs(1) New Drug Application 2018-04-21 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd Certificate Issued 2018-07-24 view
CXHL1800056 KL280006 KL280006 Active ingredient Chemical Drugs(1) New Drug Application 2018-04-21 四川科伦博泰生物医药股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co Ltd In Review 2018-04-19 view