Nirmatrelvir

Tsanangudzo Pfupi

Zita reAPI Indication Innovator Patent Expiry Date (The US)
Nirmatrelvir 3C-Senge Protease (3CLPRO) Inhibitor uye SARS-Cov-2 Mpro Inhibitor    

 


Product Detail

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PRODUCT DETAIL

Nirmatrelvir inhibitor yeSARS-CoV-2 main protease (Mpro), inonziwo 3C-like protease (3CLpro) kana nsp5 protease. Inhibition yeSARS-CoV-2 Mpro inoita kuti isakwanise kugadzirisa mapolyprotein precursors, kudzivirira kudzokororwa kwehutachiona.

Nirmatrelvir yakavharira chiitiko chezve recombinant SARS-CoV-2 Mpro mune biochemical assay pazvimiro zvinogoneka mu vivo. Nirmatrelvir yakawanikwa ichisunga yakananga kuSARS-CoV-2 Mpro inoshanda saiti neX-ray crystallography.

Ritonavir ndeye HIV-1 protease inhibitor asi haishande kurwisa SARS-CoV-2 Mpro. Ritonavir inhibits the CYP3A-mediated metabolism ye nirmatrelvir, zvichiita kuti kuwedzera kweplasma ye nirmatrelvir.

Mushonga uyu unokurudzirwa. Yakapihwa mvumo yekushandiswa kwechimbichimbi neFDA yekurapa zvinyoro-kusvika-zvine mwero coronavirus chirwere (COVID-19) muvakuru uye varwere vevana (makore gumi nemaviri ekuberekwa zvichikwira anorema angangoita makumi mana makirogiramu kana makumi masere nemasere makirogiramu) mhedzisiro yakanaka yeyakananga SARS-CoV-2 kuyedzwa, uye vari panjodzi huru yekufambira mberi kune yakanyanya COVID-19, kusanganisira kuchipatara kana kufa. Nirmatrelvir/ritonavir inofanira kutangwa nekukasika mushure mekuongororwa kweCCIDID-19 uye mukati memazuva mashanu ekutanga kwechiratidzo.

Zvinokurudzirwa zvinobva paEPIC-HR, chirongwa chePhase2/3 randomized Clinical control test kuongorora kushanda kwenirmaltrelivir/ritonavir vs. vanhu vari panjodzi yekuenderera mberi nechirwere chakakomba vakaderedza njodzi yekurara muchipatara kana kufa kuburikidza nemazuva makumi maviri nemasere 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

HUNHU MANAGEMENT

Hunhu manejimendi1

Proposal18Quality Consistency Evaluation mapurojekiti akatenderwa4,uye6mapurojekiti ari pasi pekubvumidzwa.

Hunhu manejimendi2

Yepamberi yepasirese yemhando manejimendi system yakaisa hwaro hwakasimba hwekutengesa.

Hunhu hutongi3

Kutariswa kwemhando yepamusoro kunomhanya kuburikidza nehupenyu hwese kutenderera kwechigadzirwa kuti ive nechokwadi chemhando uye yekurapa maitiro.

Hunhu manejimendi4

Professional Regulatory Affairs timu inotsigira zvinodiwa zvemhando panguva yekushandisa uye kunyoreswa.

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PARTNER

Kudyidzana kwenyika dzakawanda
Kudyidzana kwenyika dzakawanda
Kushandira pamwe kwemumba
Kushandira pamwe kwemumba

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