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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 |
|---|---|---|---|---|---|---|---|
| 761464 | BLA | DATROWAY | DATOPOTAMAB DERUXTECAN-DLNK | INJECTABLE;INJECTION | 2025-06-23 | DAIICHI SANKYO INC | |
| 761449 | BLA | TYENNE | TOCILIZUMAB-AAZG | INJECTABLE;SUBCUTANEOUS | 2025-03-14 | FRESENIUS KABI USA | |
| 761432 | BLA | ENFLONSIA | CLESROVIMAB-CFOR | INJECTION;SOLUTION | 2025-06-09 | MERCK SHARP DOHME | |
| 761430 | BLA | IMAAVY | NIPOCALIMAB-AAHU | INJECTABLE;INJECTION | 2025-04-29 | JANSSEN BIOTECH | |
| 761429 | BLA | OPDIVO QVANTIG | NIVOLUMAB;HYALURONIDASE-NVHY | 玻璃酸酶;纳武利尤单抗 | INJECTABLE;INJECTION | 2024-12-27 | BRISTOL-MYERS SQUIBB |
| 761425 | BLA | PYZCHIVA | USTEKINUMAB-TTWE | INJECTABLE;SUBCUTANEOUS | 2024-06-28 | SAMSUNG BIOEPIS CO LTD | |
| 761420 | BLA | AVTOZMA | TOCILIZUMAB-ANOH | INJECTABLE;INTRAVENOUS | 2025-01-24 | CELLTRION INC | |
| 761419 | BLA | STARJEMZA | ustekinumab-hmny | INJECTABLE;SUBCUTANEOUS | 2025-05-22 | BIO-THERA SOLUTIONS LTD | |
| 761417 | BLA | TEVIMBRA | TISLELIZUMAB-JSGR | INJECTABLE;INTRAVENOUS | 2024-12-26 | BEIGENE | |
| 761416 | BLA | ZIIHERA | ZANIDATAMAB-HRII | 泽尼达妥单抗 | INJECTABLE;INJECTION | 2024-11-20 | JAZZ PHARMS |
| 761411 | BLA | NIKTIMVO | axatilimab-csfr | 艾克利单抗 | INJECTABLE;INTRAVENOUS | 2024-08-14 | INCYTE CORP |
| 761406 | BLA | YESINTEK | USTEKINUMAB-KFCE | INJECTABLE;INJECTION | 2025-04-30 | BIOCON BIOLOGICS INC | |
| 761404 | BLA | OSENVELT | DENOSUMAB-BMWO | INJECTABLE;INJECTION | 2025-02-28 | CELLTRION INC | |
| 761400 | BLA | LYNOZYFIC | LINVOSELTAMAB-GCPT | SOLUTION; INJECTION | 2025-07-02 | RENGENERON PHARMACEUTICALS, INC. | |
| 761399 | BLA | OMLYCLO | OMALIZUMAB-IGEC | INJECTABLE;INJECTION | 2025-03-07 | CELLTRION INC | |
| 761398 | BLA | DENOSUMAB-BNHT | DENOSUMAB-BNHT | INJECTION | 2025-03-25 | FRESENIUS KABI USA LLC | |
| 761394 | BLA | DATROWAY | DATOPOTAMAB DERUXTECAN-DLNK | INJECTABLE; IV (INFUSION) | 2025-01-17 | DAIICHI SANKYO INC | |
| 761392 | BLA | XBRYK | DENOSUMAB-DSSB | INJECTABLE;SUBCUTANEOUS | 2025-02-13 | SAMSUNG BIOEPIS CO LTD | |
| 761391 | BLA | NEMLUVIO | NEMOLIZUMAB-ILTO | INJECTABLE;INJECTION | 2024-12-13 | GALDERMA LABS LP | |
| 761390 | BLA | NEMLUVIO | NEMOLIZUMAB-ILTO | INJECTABLE;INJECTION | GALDERMA LABS LP |
