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| 药品名称 | 批准类型 | 活性成分 | 适应症 | 上市发布公告 | 临床试验快照 | 批准日期 | 申请机构 |
|---|---|---|---|---|---|---|---|
| Wayrilz | NME | rilzabrutinib | To treat persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroids | 2025-08-29 | GENZYME CORP | ||
| Dawnzera | NME | donidalorsen | To prevent attacks of hereditary angioedema | 2025-08-21 | IONIS PHARMS INC | ||
| Brinsupri | NME | brensocatib | To treat non-cystic fibrosis bronchiectasis | 2025-08-12 | INSMED INC | ||
| Hernexeos | NME | zongertinib | To treat adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy | 2025-08-08 | BOEHRINGER INGELHEIM | ||
| Modeyso | NME | dordaviprone | To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy | 2025-08-06 | CHIMERIX | ||
| Vizz | NME | aceclidine | To treat presbyopia | 2025-07-31 | LENZ THERAP | ||
| Sephience | NME | sepiapterin | To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet | 2025-07-28 | PTC THERAP | ||
| Anzupgo | NME | delgocitinib | To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response | 2025-07-23 | LEO PHARMA AS | ||
| Ekterly | NME | sebetralstat | To treat acute attacks of hereditary angioedema | Drug Trials Snapshot | 2025-07-03 | KALVISTA | |
| Zegfrovy | NME | sunvozertinib | To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with disease progression on or after platinum-based chemotherapy | 2025-07-02 | DIZAL JIANGSU | ||
| Lynozyfic | Biologics | linvoseltamab-gcpt | To treat relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti CD38 monoclonal antibody | 2025-07-02 | RENGENERON PHARMACEUTICALS, INC. | ||
| Andembry | Biologics | garadacimab-gxii | To prevent attacks of hereditary angioedema | 2025-06-16 | CSL BEHRING LLC | ||
| Ibtrozi | NME | taletrectinib | To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer | Drug Trials Snapshot | 2025-06-11 | NUVATION | |
| Enflonsia | Biologics | clesrovimab-cfor | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season | Drug Trials Snapshot | 2025-06-09 | MERCK SHARP DOHME | |
| Tryptyr | NME | acoltremon | To treat the signs and symptoms of dry eye disease | Drug Trials Snapshot | 2025-05-28 | ALCON LABS INC | |
| Emrelis | Biologics | telisotuzumab vedotin-tllv | To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy | Drug Trials Snapshot | 2025-05-14 | ABBVIE INC | |
| Avmapki Fakzynja Co-Pack | avutometinib and defactinib | To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy | Drug Trials Snapshot | 2025-05-08 | |||
| Imaavy | Biologics | nipocalimab-aahu | To treat generalized myasthenia gravis | Drug Trials Snapshot | 2025-04-29 | JANSSEN BIOTECH | |
| penpulimab-kcqx | Biologics | penpulimab-kcqx | In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapy | Drug Trials Snapshot | 2025-04-23 | AKESO BIOPHARMA | |
| Vanrafia | NME | atrasentan | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | Drug Trials Snapshot | 2025-04-02 | NOVARTIS |
