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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSB2100011 重组胰高血糖素样肽-1-Fc融合蛋白注射液 SAL-015 Injection Biological Products(原7) Supplementary Application 2021-02-06 信立泰(成都)生物技术有限公司 Chengdu Jinkai Biotech Co Ltd In Review 2021-02-05 view
CXSB2100010 重组胰高血糖素样肽-1-Fc融合蛋白注射液 SAL-015 Injection Biological Products(原7) Supplementary Application 2021-02-06 信立泰(成都)生物技术有限公司 Chengdu Jinkai Biotech Co Ltd In Review 2021-02-05 view
CXSL2000162 重组人神经调节蛋白1-抗HER3抗体融合蛋白注射液 Injection Biological Products(1) New Drug Application 2020-06-30 信立泰(成都)生物技术有限公司 Chengdu Jinkai Biotech Co Ltd In Review 2020-06-29 view
CXSL1900107 重组抗RANKL全人源单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2019-09-28 信立泰(成都)生物技术有限公司 Chengdu Jinkai Biotech Co Ltd In Review 2019-09-26 view
CXSL1900102 重组全人源抗PCSK9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2019-09-10 信立泰(成都)生物技术有限公司 Chengdu Jinkai Biotech Co Ltd In Review 2019-09-09 view