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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 |
---|---|---|---|---|---|---|---|
761425 | BLA | PYZCHIVA | USTEKINUMAB-TTWE | INJECTABLE;SUBCUTANEOUS | 2024-06-28 | SAMSUNG BIOEPIS CO LTD | |
761416 | BLA | ZIIHERA | ZANIDATAMAB-HRII | INJECTABLE;INJECTION | 2024-11-20 | JAZZ PHARMS | |
761411 | BLA | NIKTIMVO | axatilimab-csfr | INJECTABLE;INTRAVENOUS | 2024-08-14 | INCYTE CORP | |
761390 | BLA | NEMLUVIO | NEMOLIZUMAB-ILTO | INJECTABLE;INJECTION | 2024-08-12 | GALDERMA LABS LP | |
761388 | BLA | PIASKY | CROVALIMAB-AKKZ | INJECTABLE;INTRAVENOUS | 2024-06-20 | GENENTECH INC | |
761382 | BLA | ENZEEVU | AFLIBERCEPT-ABZV | INJECTABLE;INJECTION | 2024-08-09 | SANDOZ INC | |
761379 | BLA | OTULFI | USTEKINUMAB-AAUZ | INJECTABLE;INJECTION | 2024-09-27 | FRESENIUS KABI USA | |
761378 | BLA | AHZANTIVE | AFLIBERCEPT-MRBB | INJECTABLE;INJECTION | 2024-06-28 | FORMYCON AG | |
761373 | BLA | PYZCHIVA | USTEKINUMAB-TTWE | INJECTABLE;INJECTION | 2024-06-28 | SAMSUNG BIOEPIS CO LTD | |
761371 | BLA | OCREVUS ZUNOVO | OCRELIZUMAB AND HYALURONIDASE-OCSQ | INJECTABLE;INJECTION | 2024-09-13 | GENENTECH INC | |
761369 | BLA | HYMPAVZI | MARSTACIMAB-HNCQ | INJECTABLE;SUBCUTANEOUS | 2024-10-11 | PFIZER INC | |
761365 | BLA | VYLOY | ZOLBETUXIMAB-CLZB | INJECTABLE;INJECTION | 2024-10-18 | ASTELLAS | |
761364 | BLA | IMULDOSA | USTEKINUMAB-SRLF | INJECTABLE;INTRAVENOUS | ACCORD BIOPHARMA INC. | ||
761363 | BLA | WINREVAIR | SOTATERCEPT-CSRK | INJECTABLE;INJECTION | 2024-03-26 | MERCK SHARP DOHME | |
761362 | BLA | JUBBONTI | DENOSUMAB-BBDZ | INJECTABLE;SUBCUTANEOUS | SANDOZ INC | ||
761359 | BLA | ENTYVIO | VEDOLIZUMAB | 维得利珠单抗 | INJECTABLE;INTRAVENOUS | 2024-04-18 | TAKEDA PHARMS USA |
761358 | BLA | ZYMFENTRA | INFLIXIMAB-DYYB | 英夫利西单抗 | INJECTABLE;INJECTION | CELLTRION | |
761355 | BLA | EYLEA HD | AFLIBERCEPT | 阿柏西普 | INJECTABLE;INJECTION | REGENERON PHARMACEUTICALS | |
761354 | BLA | TOFIDENCE | TOCILIZUMAB-BAVI | 托珠单抗 | INJECTABLE;INJECTION | 2023-09-29 | BIOGEN MA |
761350 | BLA | OPUVIZ | AFLIBERCEPT-YSZY | INJECTABLE;INJECTION | 2024-05-20 | SAMSUNG BIOEPIS CO LTD |