X
[{"orgOrder":0,"company":"SK Bioscience","sponsor":"AstraZeneca","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"South Korea's SK Bioscience in Deal with AstraZeneca on Vaccine","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Vaccine","graph2":"SK Bioscience"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Receives Korean MFDS Approval to Initiate Phase II\/III Pivotal Trial of CT-P59","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Initiates Post-Exposure Prophylaxis Clinical Trial of an Anti-COVID-19 Monoclonal Antibody Treatment Candidate, CT-P59","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Presents Efficacy and Safety Data for Potential COVID-19 Treatment Candidate CT-P59 in Patients with Mild Symptoms","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Completes Enrolment for Global Phase II Clinical Trial with Covid-19 Treatment Candidate CT-P59","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Submits Application for Conditional Marketing Authorisation of Its COVID-19 Treatment Candidate CT-P59 to the Korean MFDS","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Group Announces Positive top-line Efficacy and Safety Data From Global Phase II\/III trial of COVID-19 Treatment Candidate CT-P59","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Develops Tailored Neutralising Antibody Cocktail Treatment with CT-P59 to Tackle COVID-19 Variant Spread","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EMA Review of Regdanvimab for COVID-19 to Support National Decisions on Early Use","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Announces Positive Top-Line Results from Global Phase III Trial of Regdanvimab (CT-P59)","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"}]
Find Clinical Drug Development Pipelines & Deals | PipelineProspector
Filters
Details:
Top-line results also showed CT-P59 to have a positive safety profile, with no clinically meaningful differences between patients treated with CT-P59 (40mg/kg) and placebo-treated patients.
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
June 14, 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.
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:
CT-P59 demonstrated neutralising capability against key emerging mutations, including the UK variant in addition to six variant genome mutations of SARS-CoV-2.
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 (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.
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:
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.
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:
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.
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 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.
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 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.
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:
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.
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:
SK Biosciences will start producing undiluted solutions of the AstraZeneca’s experimental COVID-19 vaccine after discussing production plans with AstraZeneca.
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
Deal Size: Undisclosed
Upfront Cash: Undisclosed
Deal Type: Collaboration
July 21, 2020