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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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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.