I-Ruxolitinib

Incazelo emfushane:

Igama le-API Inkomba Umsunguli Idethi yokuphelelwa yisikhathi kwelungelo lobunikazi(e-US)
I-Ruxolitinib I-Myelofibrosis Novartis Julayi. 6, 2024


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

IMINININGWANE YOMKHIQIZO

I-Ruxolitinib iyi-molecule encane i-Janus kinase inhibitor esetshenziswa ekwelapheni i-myelofibrosis eyingozi emaphakathi noma ephezulu kanye nezinhlobo ezimelana ne-polycythemia vera nesifo se-graft-vs-host.I-Ruxolitinib ihlotshaniswa nokuphakama kwesikhashana futhi ngokuvamile okumaphakathi ku-serum aminotransferase phakathi nokwelashwa kanye nasezimweni ezingavamile zokulimala okunamandla kwesibindi okulinganiselwe, okubonakala ngokomtholampilo kanye nasezimweni zokuvuselela i-hepatitis B kubantu abathintekayo.

I-Ruxolitinib iyi-olly bioavailable Janus-associated kinase (JAK) inhibitor enemisebenzi engaba khona ye-antineoplastic kanye ne-immunomodulating.I-Ruxolitinib ibopha ngokuqondile futhi ivimbele amaprothenii-tyrosinekinases JAK 1 no-2, okungase kuholele ekunciphiseni ukuvuvukala kanye nokuvimbela ukwanda kwamaselula.Indlela ye-JAK-STAT (i-transducer yesiginali kanye ne-activator of transcription) idlala indima ebalulekile ekuboniseni ama-cytokines amaningi kanye nezici zokukhula futhi ihileleke ekwandeni kwamaselula, ukukhula, i-hematopoiesis, kanye nokusabela komzimba;I-JAK kinases ingase ilawuleke ezifweni ezivuthayo, ukuphazamiseka kwe-myeloproliferative, kanye nezifo ezihlukahlukene.

I-Ruxolitinib ai-pyrazoleifakwe esikhundleni se-1 yiqembu le-2-cyano-1-cyclopentylethyl futhi endaweni yesi-3 yiqembu le-pyrrolo[2,3-d]pyrimidin-4-yl.Isetshenziswa njengosawoti we-phosphate ekwelapheni iziguli ezine-myelofibrosis ephakathi noma engcuphe kakhulu, okuhlanganisa i-myelofibrosis eyinhloko, i-post-polycythemia vera myelofibrosis kanye ne-post-essential thrombocythemia myelofibrosis.Inendima njenge-ejenti ye-antineoplastic kanye ne-EC 2.7.10.2 (amaprotheni angaqondile-i-tyrosinekinase) inhibitor.I-nitrile, apyrrolopyrimidinekanye nelungu le-pyrazoles.

ISItifiketi

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

UKUPHATHWA KWEKHWALITHI

Quality management1

Isiphakamiso18Amaphrojekthi Wokuhlola Ukuvumelana Kwekhwalithi asegunyaziwe4, futhi6amaphrojekthi angaphansi kokugunyazwa.

Quality management2

Uhlelo lokuphatha ikhwalithi yamazwe ngamazwe oluthuthukile lwenze isisekelo esiqinile sokuthengisa.

Quality management3

Ukugadwa kwekhwalithi kusebenza kuwo wonke umjikelezo wempilo womkhiqizo ukuze kuqinisekiswe ikhwalithi nomphumela wokwelapha.

Quality management4

Ithimba Lezindaba Zokulawula Ochwepheshe lisekela izimfuno zekhwalithi ngesikhathi sokufaka isicelo nokubhaliswa.

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