Nirmatrelvir

Kufotokozera Kwachidule:

Dzina la API Chizindikiro Woyambitsa Tsiku Lomaliza Ntchito (The US)
Nirmatrelvir 3C-Like Protease (3CLPRO) Inhibitor Ndi SARS-Cov-2 Mpro Inhibitor    

 


Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

PRODUCT DETAIL

Nirmatrelvir ndi inhibitor ya SARS-CoV-2 main protease (Mpro), yomwe imatchedwanso 3C-like protease (3CLpro) kapena nsp5 protease. Kuletsa kwa SARS-CoV-2 Mpro kumapangitsa kuti zisakwanitse kukonza ma polyprotein precursors, kuteteza ma virus.

Nirmatrelvir inaletsa ntchito ya recombinant SARS-CoV-2 Mpro pakuyesa kwachilengedwe pazambiri zomwe zingatheke mu vivo. Nirmatrelvir idapezeka kuti imamanga mwachindunji ku SARS-CoV-2 Mpro yogwira ntchito ndi X-ray crystallography.

Ritonavir ndi HIV-1 protease inhibitor koma sagwira ntchito motsutsana ndi SARS-CoV-2 Mpro. Ritonavir imalepheretsa kagayidwe ka CYP3A-mediated ka nirmatrelvir, zomwe zimapangitsa kuchuluka kwa plasma kwa nirmatrelvir.

Mankhwalawa akulimbikitsidwa. Zapatsidwa chilolezo chogwiritsa ntchito mwadzidzidzi ndi FDA pochiza matenda ochepera mpaka pang'ono a coronavirus (COVID-19) mwa akulu ndi ana odwala (wazaka 12 ndi kupitilirapo olemera ma kilogalamu 40 kapena pafupifupi mapaundi 88) zotsatira zabwino zakuyezetsa mwachindunji kwa SARS-CoV-2, komanso omwe ali pachiwopsezo chachikulu chopitilira COVID-19, kuphatikiza kugona m'chipatala kapena kufa. Nirmatrelvir/ritonavir iyenera kuyambitsidwa posachedwa atapezeka ndi COVID-19 komanso mkati mwa masiku asanu chizindikiro chayamba.

Malangizo amachokera ku EPIC-HR, kuyesa kwachipatala kwa Phase2/3 komwe kumayesa mphamvu ya nirmaltrelivir/ritonavir vs. anthu omwe ali pachiwopsezo chodwala matenda oopsa amachepetsa chiopsezo chogonekedwa m'chipatala kapena kufa m'masiku 28 88%.

CERTIFICATE

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

KUSINTHA KWA KHALIDWE

Kasamalidwe kabwino 1

Malingaliro18Ma projekiti a Quality Consistency Evaluation omwe avomereza4,ndi6mapulojekiti akuvomerezedwa.

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Dongosolo lotsogola lapadziko lonse lapansi loyang'anira bwino layala maziko olimba pakugulitsa.

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Kuyang'anira kwabwino kumayendera nthawi yonse ya moyo wa chinthucho kuti zitsimikizire kuti zikuyenda bwino komanso zochiritsira.

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Gulu la Professional Regulatory Affairs limathandizira zofunikira pakufunsira ndikulembetsa.

MANAGEMENT ZOPHUNZITSA

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WOTHANDIZA

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Mgwirizano wapadziko lonse lapansi
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Mgwirizano wapakhomo

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