Bictegravir 1611493-60-7

Tsanangudzo Pfupi

Zita reAPI Indication Innovator Patent Expiry Date (The US)
Bictegravir 1611493-60-7 Hutachiona hweHIV-1 Gilead Sciences Zvita 19, 2033


Product Detail

Product Tags

PRODUCT DETAIL

Tsanangudzo

Bictegravir chinyorwa, chine simba inhibitor yeHIV-1 integrase ine IC50 ye7.5 nM.

In Vitro

Bictegravir (BIC) inovharisa basa rekutamisa tambo neIC50 ye7.5± 0.3 nM.Zvinei nekudzivirirwa kwayo kwe strand transfer chiitiko, Bictegravir inhibitor isina kusimba ye3.'-kugadzirisa basa reHIV-1 IN, ine IC50 ye241±51 nM.Bictegravir inowedzera kuunganidza 2-LTR madenderedzwa ~ 5-fold maererano nekutonga-kunyombwa uye inoderedza huwandu hwechokwadi hwekubatanidza zvigadzirwa mumasero ane utachiona ne100-fold.Bictegravir inodzivirira kudzokororwa kweHIV-1 mune ese MT-2 uye MT-4 maseru ane EC50s e1.5 uye 2.4 nM, zvichiteerana.Bictegravir inoratidza zvine simba antiviral mhedzisiro mune ese ekutanga CD4+ T lymphocytes uye monocyte-inotorwa macrophages, ine EC50s ye1.5±0.3 nM uye 6.6±4.1 nM, zvichiteerana, izvo zvinofananidzwa nemaitiro anowanikwa muT-cell mitsara[1].

MCE haina kuzvimiririra yakasimbisa chokwadi chenzira idzi.Ndedzekureva chete.

Nhamba yeNCT Sponsor Condition Zuva Rokutanga

Phase

NCT03998176 Yunivhesiti yeNebraska | Giriyedhi Sayenzi HIV-1-utachiona Gumiguru 9, 2019

Chikamu chechina

NCT03789968 Thomas Jefferson University | Yunivhesiti yeMaryland, College Park | Indiana University Hutano | The Brooklyn Hospital Center | University of Illinois kuChicago | Nova Southeastern University | University of California, San Francisco HIV+AIDS Gunyana 1, 2019
NCT04249037 Yunivhesiti yeColorado, Denver | Giriyedhi Sayenzi HIV+AIDS Kurume 1, 2020

Hazvigoneke

NCT04132674 Vancouver Infectious Diseases Center Human Immunodeficiency Virus I Infection | Kushandisa Zvinodhaka Mbudzi 26, 2018

Chikamu chechina

NCT04054089 Cristina Mussini | Yunivhesiti yeModena uye Reggio Emilia Hutachiona hweHIV Gunyana 2019

Chikamu chechina

NCT04155554 Azienda Ospedaliera Universitaria Senese|Catholic University of the Sacred Heart|Ospedale Policlinico San Martino|Azienda Ospedaliera San Paolo|Ospedale Amedeo di Savoia HIV-1-utachiona Ndira 29, 2020

Phase 3

NCT02275065 Gilead Sciences Hutachiona hweHIV-1 Gumiguru 2014

Phase 1

NCT03711253 Yunivhesiti yeSouthern California Acute HIV Infection Gumiguru 14, 2019

Chikamu chechina

NCT02400307 Gilead Sciences HIV Kubvumbi 17, 2015

Phase 1

NCT03499483 Fenway Community Health Kudzivirira HIV Ndira 24, 2019

Chikamu chechina

NCT03502005 Midland Research Group, Inc.|Gilead Sayenzi Human Immunodeficiency Virus Kurume 1, 2018

Chikamu chechina

Chimiro chemakemikari

Bictegravir-1611493-60-7

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

Quality management1

Proposal18Quality Consistency Evaluation mapurojekiti akatenderwa4,uye6mapurojekiti ari pasi pekubvumidzwa.

Quality management2

Yepamberi yepasirese yemhando manejimendi system yakaisa hwaro hwakasimba hwekutengesa.

Quality management3

Kutariswa kwemhando yepamusoro kunofamba kuburikidza nehupenyu hwese kutenderera kwechigadzirwa kuti ive nechokwadi chemhando nekurapa.

Quality management4

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

KUTUNGAMIRIRA KWEKUGARA

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Korea Countec Bottled Packaging Line

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Taiwan CVC Bottled Packaging Line

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Italy CAM Board Packaging Line

cpf11

German Fette Compacting Machine

cpf12

Japan Viswill Tablet Detector

cpf14-1

DCS Control Room

PARTNER

Kudyidzana kwenyika dzose
International cooperation
Kushandira pamwe kwemumba
Domestic cooperation

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