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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1400119 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-01-06 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd Certificate Issued 2016-10-11 view
CXSL2100076 LY01015注射液 Nivolumab Injection Biological Products(3.3) New Drug Application 2021-02-27 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd In Review 2021-02-26 view
CXSL1900071 重组人血管内皮生长因子受体-抗体融合蛋白注射液 Injection Biological Products(7) New Drug Application 2019-07-09 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd In Review 2019-07-08 view
CXSL2100075 LY01015注射液 Nivolumab Injection Biological Products(3.3) New Drug Application 2021-02-27 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd In Review 2021-02-26 view
CXSL1800132 重组人血管内皮生长因子受体-抗体融合蛋白眼用注射液 Injection Biological Products(15) New Drug Application 2019-01-04 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd In Review 2019-01-02 view
CXSL1600099 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2016-12-05 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd Certificate Issued 2017-06-20 view
CXSB2000038 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(3.3) Supplementary Application 2020-08-04 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd In Review 2020-08-03 view
CXSL1600080 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2016-10-11 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd Certificate Issued 2017-06-09 view
CXSL1900072 重组人血管内皮生长因子受体-抗体融合蛋白注射液 Injection Biological Products(7) New Drug Application 2019-07-09 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd In Review 2019-07-08 view