I-FDA ivuma i-ibutinib yokwelapha isifo esingamahlalakhona se-graft-versus-host (cGVHD) ezinganeni

Ngo-Agasti 24, 2022, i-US Food and Drug Administration (FDA) yavuma i-ibutinib yokwelapha iziguli zezingane ezingaphezu konyaka owodwa ezinesifo esingamahlalakhona se-graft-versus-host (cGVHD) ezithola ukwelashwa kwesistimu okunemigqa eminingi noma ngaphezulu ngemuva kokwehluleka. Isibonakaliso esivunyelwe ikakhulukazi singesezingane, ngesilinganiso sokuphendula esiphelele esingu-60% esontweni lama-25, kanti ukwakheka kwemithi kufaka phakathi ama-capsule, amaphilisi kanye nokumiswa ngomlomo.

I-Ibrutinib, i-BTK inhibitor eyasungulwa yi-Pharmacyclics/Johnson & Johnson, iyi-kinase inhibitor eyayivunyelwe ngaphambilini ekwelapheni i-chronic lymphocytic leukemia kanye ne-cell lymphoma nezinye izifo.

I-Suntech igxile ekuthuthukisweni nasekukhiqizweni kwemithi exubile kanye nama-API kusetshenziswa ubuchwepheshe obuluhlaza. Njengamanje, inkampani yethu ithuthukise imikhiqizo emithathu exubile ye-ibrutinib okuhlanganisa i-C AS: 143900-44-1, C AS: 330792-70-6, C AS: 330786-24-8, yonke eye yathengiswa ekukhiqizweni kwezimboni ze-GMP. Phakathi kwazo, i-intermediate ye-C AS: 143900-44-1 ikhiqizwa ubuchwepheshe bamakhemikhali-ama-enzyme, obunezinzuzo zokuvikelwa kwemvelo okuluhlaza, intengo ephansi kanye nekhwalithi ephezulu. Siyakwamukela ukubonisana nokubambisana!