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申请号 | 申请类型 | 商品名 | 活性成分 | 中文活性成分 | 剂型/给药途径 | 批准日期 | 申请机构 |
---|---|---|---|---|---|---|---|
761362 | BLA | JUBBONTI | DENOSUMAB-BBDZ | INJECTABLE;SUBCUTANEOUS | 2024-03-05 | SANDOZ INC | |
761358 | BLA | ZYMFENTRA | INFLIXIMAB-DYYB | 英夫利西单抗 | INJECTABLE;INJECTION | 2023-10-20 | CELLTRION |
761355 | BLA | EYLEA HD | AFLIBERCEPT | 阿柏西普 | INJECTABLE;INJECTION | REGENERON PHARMACEUTICALS | |
761354 | BLA | TOFIDENCE | TOCILIZUMAB-BAVI | 托西利珠单抗 | INJECTABLE;INJECTION | 2023-09-29 | BIOGEN MA |
761349 | BLA | COSENTYX | SECUKINUMAB | 司库奇尤单抗 | INJECTABLE;INJECTION | NOVARTIS PHARMS CORP | |
761345 | BLA | ELREXFIO | ELRANATAMAB | SOLUTION;INJECTION | 2023-08-14 | PFIZER INC | |
761342 | BLA | TALVEY | TALQUETAMAB-TGVS | 塔奎妥单抗 | INJECTABLE;INJECTION | 2023-08-09 | JANSSEN BIOTECH |
761339 | BLA | VEOPOZ | POZELIMAB-BBFG | 帕泽利单抗 | INJECTABLE;INJECTION | 2023-08-18 | REGENERON PHARMACEUTICALS |
761334 | BLA | ZYNYZ | RETIFANLIMAB-DLWR | 瑞弗利单抗 | INJECTABLE;INTRAVENOUS | 2023-03-22 | INCYTE CORP |
761331 | BLA | WEZLANA | USTEKINUMAB-AUUB | 乌司奴单抗 | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 2023-10-31 | AMGEN INC |
761328 | BLA | BEYFORTUS | NIRSEVIMAB-ALIP | 尼塞韦单抗 | INJECTABLE;INJECTION | ASTRAZENECA AB | |
761324 | BLA | EPKINLY | EPCORITAMAB-BYSP | 艾可瑞妥单抗 | INJECTABLE;SUBCUTANEOUS | 2023-05-19 | GENMAB US, INC. |
761322 | BLA | TYRUKO | NATALIZUMAB-SZTN | 那他珠单抗 | INJECTABLE;INJECTION | 2023-08-24 | SANDOZ INC |
761310 | BLA | ELAHERE | MIRVETUXIMAB SORAVTANSINE-GYNX | 索米妥昔单抗 | INJECTABLE;INJECTION | 2022-11-14 | IMMUNOGEN INC |
761309 | BLA | COLUMVI | GLOFITAMAB-GXBM | 格菲妥单抗 | INJECTABLE;INJECTION | 2023-06-15 | GENENTECH INC |
761304 | BLA | VYVGART HYTRULO | EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC | 艾加莫德α;玻璃酸酶 | INJECTABLE;INJECTION | ARGENX BV | |
761299 | BLA | SIMLANDI | ADALIMUMAB-RYVK | INJECTABLE;INJECTION | 2024-02-23 | ALVOTECH USA INC | |
761291 | BLA | TECVAYLI | TECLISTAMAB-CQYV | 特立妥单抗 | INJECTABLE;INJECTION | JANSSEN BIOTECH | |
761289 | BLA | IMJUDO | TREMELIMUMAB-ACTL | 曲美木单抗 | INJECTABLE;INTRAVENOUS | ASTRAZENECA AB | |
761286 | BLA | RYSTIGGO | ROZANOLIXIZUMAB-NOLI | 罗扎利昔组单抗 | INJECTABLE;SUBCUTANEOUS | 2023-06-26 | UCB INC |