| 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 |
|---|---|---|---|---|---|---|---|
| 761116 | BLA | ELZONRIS | TAGRAXOFUSP-ERZS | * | SOLUTION;INJECTION | 2018-12-21 | STEMLINE THERAPEEUTICS INC |
| 761112 | BLA | CABLIVI | CAPLACIZUMAB-YHDP | 卡拉西组单抗-YHDP | INJECTABLE;INJECTION | 2019-02-06 | ABLYNX NV |
| 761108 | BLA | ULTOMIRIS | RAVULIZUMAB-CWVZ | 长春夫利*-CWVZ | INJECTABLE;INJECTION | 2018-12-21 | ALEXION PHARM |
| 761107 | BLA | GAMIFANT | EMAPALUMAB-LZSG | 依马利人单抗-LZSG | INJECTABLE;INJECTION | 2018-11-20 | NOVIMMUNE S.A. |
| 761106 | BLA | HERCEPTIN HYLECTA | TRASTUZUMAB;HYALURONIDASE-OYSK | INJECTABLE;SUBCUTANEOUS | 2019-02-28 | GENENTECH INC | |
| 761104 | BLA | LUMOXITI | MOXETUMOMAB PASUDOTOX-TDFK | 帕西妥莫单抗-TDFK | INJECTABLE;INJECTION | 2018-09-13 | ASTRAZENECA AB |
| 761102 | BLA | ASPARLAS | CALASPARGASE PEGOL-MKNL | 培戈卡门冬酶-MKNL | INJECTABLE;INTRAVENOUS | 2018-12-20 | SERVIER PHARMA LLC |
| 761100 | BLA | ONTRUZANT | TRASTUZUMAB-DTTB | 曲司珠单抗-DTTB | INJECTABLE;INJECTION | 2019-01-18 | SAMSUNG BIOEPIS CO LTD |
| 761097 | BLA | LIBTAYO | CEMIPLIMAB-RWLC | -RWLC* | INJECTABLE;INTRAVENOUS | 2018-09-28 | REGENERON PHARMACEUTICALS |
| 761094 | BLA | OXERVATE | CENEGERMIN-BKBJ | 塞奈吉明-BKBJ | SOLUTION;OPHTHALMIC | 2018-08-22 | DOMPE FARMACEUTICI |
| 761092 | BLA | REVCOVI | ELAPEGADEMASE-LVLR | 依拉培加酶-LVLR | INJECTABLE;INJECTION | 2018-10-05 | LEADIANT BIOSCI INC |
| 761091 | BLA | HERZUMA | TRASTUZUMAB-PKRB | 曲司珠单抗-PKRB | INJECTABLE;INJECTION | 2018-12-14 | CELLTRION INC |
| 761090 | BLA | TAKHZYRO | LANADELUMAB (SHP643) | 拉那芦人单抗* | INJECTABLE;INJECTION | 2018-08-23 | DYAX CORP. |
| 761089 | BLA | AJOVY | FREMANEZUMAB-VFRM | 夫瑞奈组单抗-VFRM | INJECTABLE;INJECTION | 2018-09-14 | TEVA PHARMS USA |
| 761088 | BLA | TRUXIMA | RITUXIMAB-ABBS | 利妥昔单抗-ABBS | INJECTABLE;INJECTION | 2018-11-28 | CELLTRION INC |
| 761085 | BLA | JEUVEAU | PRABOTULINUMTOXINA-XVFS | INJECTABLE;INJECTION | 2019-02-01 | EVOLUS INC | |
| 761083 | BLA | HEMLIBRA | EMICIZUMAB | 依米赛珠单抗* | INJECTABLE;INJECTION | 2017-11-16 | GENENTECH INC |
| 761081 | BLA | TRAZIMERA | TRASTUZUMAB-QYYP | INJECTABLE;INJECTION | 2019-03-11 | PFIZER INC | |
| 761080 | BLA | NIVESTYM | FILGRASTIM-AAFI | 非格司亭 | VIAL;SINGLE-DOSE | 2018-07-20 | HOSPIRA INC |
| 761079 | BLA | PALYNZIQ | PEGVALIASE-PQPZ | 培伐利酶-PQPZ | INJECTABLE;INJECTION | 2018-05-24 | BIOMARIN PHARM |