China Rapid Delivery for Canagliflozin Nejm - Bictegravir 1611493-60-7 – CPF manufacturers and suppliers

Rapid Delivery for Canagliflozin Nejm - Bictegravir 1611493-60-7 – CPF

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Rapid Delivery for Canagliflozin Nejm - Bictegravir 1611493-60-7 – CPF Detail:

Description

Bictegravir is a novel, potent inhibitor of HIV-1 integrase with an IC50 of 7.5 nM.

In Vitro

Bictegravir (BIC) inhibits the strand transfer activity with an IC50 of 7.5± 0.3 nM. Relative to its inhibition of strand transfer activity, Bictegravir is a much weaker inhibitor of 3′-processing activity of HIV-1 IN, with an IC50 of 241±51 nM. Bictegravir enhances the accumulation of 2-LTR circles ~5-fold relative to the mock-treated control and reduces the amount of authentic integration products in infected cells by 100-fold. Bictegravir potently inhibits HIV-1 replication in both MT-2 and MT-4 cells with EC50s of 1.5 and 2.4 nM, respectively. Bictegravir exhibits potent antiviral effects in both primary CD4+ T lymphocytes and monocyte-derived macrophages, with EC50s of 1.5±0.3 nM and 6.6±4.1 nM, respectively, which are comparable to values obtained in T-cell lines[1].

MCE has not independently confirmed the accuracy of these methods. They are for reference only.

NCT Number	Sponsor	Condition	Start Date	Phase
NCT03998176	University of Nebraska\|Gilead Sciences	HIV-1-infection	October 9, 2019	Phase 4
NCT03789968	Thomas Jefferson University\|University of Maryland, College Park\|Indiana University Health\|The Brooklyn Hospital Center\|University of Illinois at Chicago\|Nova Southeastern University\|University of California, San Francisco	HIV+AIDS	September 1, 2019
NCT04249037	University of Colorado, Denver\|Gilead Sciences	HIV+AIDS	March 1, 2020	Not Applicable
NCT04132674	Vancouver Infectious Diseases Centre	Human Immunodeficiency Virus I Infection\|Drug Use	November 26, 2018	Phase 4
NCT04054089	Cristina Mussini\|University of Modena and Reggio Emilia	HIV Infections	September 2019	Phase 4
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-infection	January 29, 2020	Phase 3
NCT02275065	Gilead Sciences	HIV-1 Infection	October 2014	Phase 1
NCT03711253	University of Southern California	Acute HIV Infection	October 14, 2019	Phase 4
NCT02400307	Gilead Sciences	HIV	April 17, 2015	Phase 1
NCT03499483	Fenway Community Health	HIV Prevention	January 24, 2019	Phase 4
NCT03502005	Midland Research Group, Inc.\|Gilead Sciences	Human Immunodeficiency Virus	March 1, 2018	Phase 4

Chemical structure

Bictegravir-1611493-60-7

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

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Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

Quality management2

Advanced international quality management system has laid solid foundation for sales.

Quality management3

Quality supervision runs through the whole life cycle of the product to ensure the quality and therapeutic effect.

Quality management4

Professional Regulatory Affairs team supports the quality demands during the application and registration.

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