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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2100022 JMT601注射液 JMT-601 Injection Biological Products(1) New Drug Application 2021-01-20 上海津曼特生物科技有限公司 Shanghai GeneMab Biological Technology Co Ltd In Review 2021-01-19 view
CXSL2000379 重组人源化抗表皮生长因子受体单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2021-01-01 上海津曼特生物科技有限公司 Shanghai GeneMab Biological Technology Co Ltd In Review 2020-12-31 view
CXSL1600053 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2016-08-11 上海津曼特生物科技有限公司 Shanghai GeneMab Biological Technology Co Ltd Certificate Issued 2017-03-15 view
CXSL1600051 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2016-08-11 上海津曼特生物科技有限公司 Shanghai GeneMab Biological Technology Co Ltd Certificate Issued 2017-07-06 view
CXSL1500034 重组人源化抗表皮生长因子受体单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-07-23 上海津曼特生物科技有限公司 Shanghai GeneMab Biological Technology Co Ltd Certificate Issued 2016-05-31 view