Ribociclib 1374639-75-4

Sharax Gaaban:

Magaca API Tilmaam Hal abuure Taariikhda Waqtiga Patent uu dhacayo (Mareykanka)
Ribociclib 1374639-75-4 HR-positive, HER2-taban Andvance ormetastaticbreast Kansarrada Novartis
Daawooyinka
Juun. 27, 2028

Faahfaahinta alaabta

Calaamadaha alaabta

FAAHFAAHINTA SOO SAARKA

Sharaxaad

Ribociclib (LEE01) waa mid si gaar ah u xannibma CDK4 / 6 oo leh qiyamka IC50 ee 10 nM iyo 39 nM, siday u kala horreeyaan, wuxuuna ka sarreeyaa 1,000-laab awood yar oo ka dhan ah wareegga 'cyclin B / CDK1'.

 

In Vitro

Ku daweynta guddi ka kooban 17 xarriiqyada unugyada neuroblastoma ee Ribociclib (LEE011) oo ku kala teedsan qiyaas afar-log ah (10 illaa 10,000 nM). Daaweynta Ribociclib waxay si weyn u xakameysaa korriinka udhaxeeya koritaanka udhaxeeya xakamaynta 12 ee khadadka unugyada 17 neuroblastoma ee la baaray (macnaheedu waa IC50 = 306±68 nM, iyadoo la tixgelinayo khadadka xasaasiga ah oo keliya, halkaas oo xasaasiyadda lagu qeexay inay tahay IC50 ka yar 1 μDaaweynta M. Ribociclib ee laba xarig oo unug neuroblastoma ah (BE2C iyo IMR5) oo leh xasaasiyad muujineysa ka-hortagga CDK4 / 6 waxay keeneysaa isku-uruurinta qiyaasta unugyada ee wajiga G0 / G1 ee wareegga unugga. Xariggan G0 / G1 wuxuu muhiim u yahay uruurinta Ribociclib ee 100 nM (p = 0.007) iyo 250 nM (p = 0.01), siday u kala horreeyaan.

 

Jiirka CB17 ee difaaca jirka qaba BE2C, NB-1643 (MYCN weynaaday, xasaasiga ah ee vitro), ama EBC1 (aan weyneyn, adkeysi u leh fitamiin) xenografts waxaa lagu daaweeyaa hal mar maalin kasta 21 maalmood Ribociclib (LEE011; 200 mg / kg) ama leh xakamaynta gawaarida. Istaraatiijiyaddan qiyaasta daawada ayaa si wanaagsan loo dulqaatay, maadaama miisaanka oo yaraada ama calaamado kale oo sun ah aan lagu arkin mid ka mid ah moodooyinka xenograft. Kobaca burooyinka si aad ah ayaa loo daahiyaa dhammaan 21ka maalmood ee daaweynta jiirka ku jira BE2C ama 1643 xenografts (labadaba, p <0.0001), in kasta oo koritaanku dib u bilaabay daaweynta ka dib.

 

Kaydinta

Budada

-20 ° C

3 sano

4 ° C

2 sano
Kala dareeraha

-80 ° C

6 bilood

-20 ° C

1 bil

 

Qaab dhismeedka kiimikada

Ribociclib 1374639-75-4

SHAHAADO

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

MAAMULKA TAYO

Quality management1

Soo jeedin 18 Mashaariicda Qiimaynta Joogtada Tayo ee la ansixiyay 4, iyo 6 mashaariicdii waa la ansixinayaa.

Quality management2

Nidaamka maaraynta tayada caalamiga ah ee horumarsan ayaa aasaas adag u dhigay iibka.

Quality management3

Kormeerka tayada ayaa maraya wareegga nolosha oo dhan ee badeecada si loo hubiyo tayada iyo saameynta daaweynta. 

Quality management4

Kooxda Xakamaynta Xirfadleyda waxay taageertaa baahiyaha tayada inta lagu jiro arjiga iyo diiwaangelinta.

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