I-Vericiguat

Incazelo emfushane:

Igama le-API Inkomba Umsunguli Idethi yokuphelelwa yisikhathi kwelungelo lobunikazi(e-US)
I-Vericiguat Ukuhluleka kwenhliziyo Bayer kanye ne-MSD Meyi.24, 2031


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

IMINININGWANE YOMKHIQIZO

I-Vericiguat iyi-apyrazolopyridineleyo5-fluoro-1H-pyrazolo[3,4-b]pyridinelapho i-amino hydrogen esendaweni 1 ithathelwe indawo yiqembu le-2-fluorobenzyl kanyei-hydrogenendaweni yesi-3 ifakwe i-4,6-diamino-5--[(methoxycarbonyl)amino]pyrimidin-2-yl iqembu.Iyancibilikai-guanylatei-cyclase stimulator esetshenziselwa ukwelapha ukwehluleka kwenhliziyo okungapheli.Inendima njenge-solublei-guanylatei-cyclase activator, i-agent ye-vasodilator kanye ne-ejenti ye-antihypertensive.Kuyi-i-aminopyrimidine, apyrazolopyridine, i-carbamate ester kanye nenhlanganisela ye-organofluorine.

I-Vericiguat ingaphansi kophenyo esivivinyweni somtholampilo i-NCT02861534 (Ucwaningo Lwe-Vericiguat Kubahlanganyeli Abanenhliziyo Ehluleka Ngengxenye Eyehlisiwe Yokukhipha (HFrEF) (MK-1242-001)).

I-Vericiguat iyi-SolubleI-GuanylateI-Cyclase Stimulator.Indlela yokusebenza ye-vericiguat injenge-aI-GuanylateI-Cyclase Stimulator.

I-Vericiguat umuthi osetshenziselwa ukuphatha nokwelapha ukwehluleka kwenhliziyo nge-fraction encishisiwe ye-ejection (HFrEF).Iwusizo ekuhlulekeni kwenhliziyo okuba kubi kakhulu, ukuhluleka kwenhliziyo okusanda kuncishiswa.I-Vericiguat ayikwendisi isikhathi sokuphila kodwa ivimbela ukulashwa kabusha.Lo msebenzi uveza izinkomba, indlela yokwenza, umthamo, kanye nendlela yokuphatha ithimba labachwepheshe, imiphumela emibi, ukuphikisana, nokuhlola okuningana ukusekela ubufakazi bokuthi umuthi uwusizo ku-HFrEF.

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.

UKUPHATHWA KOMKHIQIZO

cpf5
cpf6

I-Korea Countec Bottled Packaging Line

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I-Taiwan CVC Bottled Packaging Line

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I-Italy CAM Board Packaging Line

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Umshini Wokuhlanganisa we-Fette waseJalimane

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I-Japan Viswill Tablet Detector

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I-DCS Control Room

UZAkwethu

Ukubambisana kwamazwe ngamazwe
International cooperation
Ukubambisana kwasekhaya
Domestic cooperation

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