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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
Tryptyr NME acoltremon To treat the signs and symptoms of dry eye disease 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 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 2025-05-08
Imaavy Biologics nipocalimab-aahu To treat generalized myasthenia gravis 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 2025-04-23 AKESO BIOPHARMA
Vanrafia NME atrasentan To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression 2025-04-02 NOVARTIS
Qfitlia NME fitusiran To prevent or reduce the frequency of bleeding episodes in hemophilia A or B Press Release 2025-03-28 GENZYME CORP
Blujepa NME gepotidacin To treat uncomplicated urinary tract infections 2025-03-25 GLAXOSMITHKLINE
Romvimza NME vimseltinib To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity 2025-02-14 DECIPHERA PHARMS
Gomekli NME mirdametinib To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection 2025-02-11 SPRINGWORKS
Journavx NME suzetrigine To treat moderate to severe acute pain Press Release 2025-01-30 VERTEX PHARMS INC
Grafapex NME treosulfan For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome 2025-01-21 MEDEXUS
Datroway Biologics datopotamab deruxtecan-dlnk To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease 2025-01-17 DAIICHI SANKYO INC
Alhemo Biologics concizumab-mtci For routine prophylaxis to prevent bleeding episodes in hemophilia A and B 2024-12-20 NOVO NORDISK INC
Alyftrek NME vanzacaftor, tezacaftor, and deutivacaftor To treat cystic fibrosis 2024-12-20 VERTEX PHARMS INC
Tryngolza NME olezarsen To treat familial chylomicronemia syndrome 2024-12-19 IONIS PHARMS INC
Ensacove NME ensartinib To treat non-small cell lung cancer 2024-12-18 XCOVERY
Crenessity NME crinecerfont To treat classic congenital adrenal hyperplasia Press Release 2024-12-13 NEUROCRINE
Unloxcyt NME cosibelimab-ipdl To treat cutaneous squamous cell carcinoma 2024-12-13 CHECKPOINT THERAPEUTICS INC
Bizengri Biologics zenocutuzumab-zbco To treat non-small cell lung cancer and pancreatic adenocarcinoma 2024-12-04 MERUS N.V.