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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1400077 注射用重组抗人表皮生长因子受体2(HER2)单抗(曲妥珠单抗) trastuzumab Lyophilized Biological Products(2) New Drug Application 2014-09-12 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd Certificate Issued 2016-07-21 view
CXSL1800055 重组抗CTLA-4全人源单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2018-05-21 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd Certificate Issued 2018-10-08 view
CXSL1800077 重组抗EGFR全人源单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2018-07-25 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd Certificate Issued 2018-11-01 view
CXSL1700110 重组抗RANKL全人源单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2017-12-25 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd Certificate Issued 2018-10-08 view
CXSL1400139 重组抗人肿瘤坏死因子(TNFα)单抗注射液(阿达木单抗) adalimumab Injection Biological Products(2) New Drug Application 2015-02-03 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd Certificate Issued 2017-02-13 view
CXSL1400096 重组抗淋巴细胞瘤(CD20)单抗注射液(利妥昔单抗) rituximab Injection Biological Products(2) New Drug Application 2014-11-17 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd Certificate Issued 2016-12-08 view
CXSL1400094 重组抗血管内皮生长因子(VEGF)单抗注射液(贝伐单抗) bevacizumab Injection Biological Products(2) New Drug Application 2014-11-17 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd Certificate Issued 2016-08-23 view
CXSL1900010 重组抗血管内皮生长因子(VEGF)单抗注射液 bevacizumab Injection Biological Products(2) New Drug Application 2019-02-19 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd In Review 2019-02-18 view