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Lead Product(s): Regdanvimab
Therapeutic Area: Infections and Infectious Diseases Product Name: CT-P59
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2021
Details:
This review is in addition to the ongoing rolling review of regdanvimab for the treatment of confirmed COVID-19 in patients who do not require supplemental oxygen therapy and are at high risk for progressing to severe COVID-19 and/or hospitalisation.
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Lead Product(s): Regdanvimab
Therapeutic Area: Infections and Infectious Diseases Product Name: CT-P59
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 11, 2021
Details:
CT-P59 demonstrated neutralising capability against key emerging mutations, including the UK variant in addition to six variant genome mutations of SARS-CoV-2.
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Lead Product(s): Regdanvimab
Therapeutic Area: Infections and Infectious Diseases Product Name: CT-P59
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2021
Details:
CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over.
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Lead Product(s): CT-P59
Therapeutic Area: Infections and Infectious Diseases Product Name: CT-P59
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2020
Details:
Celltrion plans to initiate a global Phase III clinical trial, a pivotal part of the study in more than 10 countries to obtain more comprehensive safety and efficacy results of CT-P59.
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Lead Product(s): CT-P59
Therapeutic Area: Infections and Infectious Diseases Product Name: CT-P59
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 25, 2020
Details:
The global Phase II clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with SARS-CoV-2 infection.
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Lead Product(s): CT-P59
Therapeutic Area: Infections and Infectious Diseases Product Name: CT-P59
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2020
Details:
The global Phase I clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the safety, tolerability and antiviral effect of CT-P59.
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Lead Product(s): CT-P59
Therapeutic Area: Infections and Infectious Diseases Product Name: CT-P59
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
The post-exposure prophylaxis clinical trial will evaluate the preventive effect and safety of CT-P59 and whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human cells.
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Lead Product(s): CT-P59
Therapeutic Area: Infections and Infectious Diseases Product Name: CT-P59
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020
Details:
Following positive interim results of the Phase I clinical trial of CT-P591, the Korean Ministry of Food and Drug Safety (MFDS) has approved Celltrion’s IND application to initiate a Phase II/III pivotal trial of the potential treatment in mild-to-moderate patients.
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Lead Product(s): ChAdOx1 nCoV-19
Therapeutic Area: Infections and Infectious Diseases Product Name: AZD1222
Highest Development Status: Phase II/ Phase III Product Type: Vaccine
Partner/Sponsor/Collaborator: AstraZeneca PLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration July 21, 2020
Details:
SK Biosciences will start producing undiluted solutions of the AstraZeneca’s experimental COVID-19 vaccine after discussing production plans with AstraZeneca.
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