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Lead Product(s): Human immune globulin
Therapeutic Area: Immunology Product Name: GC5107
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2021
Details:
GC Pharma had submitted its Biologics License Application (BLA) for 'GC5107 (Immune Globulin Intravenous (Human),10% Liquid) to the United States Food and Drug Administration (FDA).
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Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: CT-P17
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2020
Details:
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of CT-P17 (adalimumab biosimilar) for the treatment of multiple chronic inflammatory diseases.
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Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: CT-P17
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
Results demonstrated CT-P17 has equivalent efficacy to reference adalimumab - the ACR20 response rate at week 24 was 82.7% for both CT-P17 and reference adalimumab.
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Lead Product(s): Omalizumab
Therapeutic Area: Immunology Product Name: CT-P39
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
Details:
The Korean drug authority has given clearance to Celltrion's CT-P39 to start a phase 3 clinical trial in Korea. CT-P39 is a protein replica of Xolair, aimed at being a more affordable solution to allergic asthma and chronic spontaneous urticaria.
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