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[{"orgOrder":0,"company":"GC Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GC Pharma Speeds Up Developing Covid-19 Plasma Therapy","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"GC Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GC Pharma Completes phase 2 trial of COVID-19 plasma Therapy Treatment","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"GC Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GC Pharma Announces Marketing Approval for Hunterase ICV Injection 15 mg for Mucopolysaccharidosis Type II","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"GC Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GC Pharma Submits Biologics License Application to US FDA for Immune Globulin 'GC5107'","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"GC Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Accepts GC Pharma\u2019s Biologics License Application for Immune Globulin 'GC5107'","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"GC Pharma","sponsor":"Mirum Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$5.0 million","newsHeadline":"Mirum Pharmaceuticals and GC Pharma Ink Exclusive Licensing Agreement to Develop and Commercialize Maralixibat for Rare Liver Diseases","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"GC Pharma","sponsor":"GC Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"GC Pharma and Tottori University Enter Research Collaboration and License Agreement for Development of GM1 Gangliosidosis Chaperone Therapy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Discovery","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Discovery"},{"orgOrder":0,"company":"GC Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Correcting and Replacing GC Pharma Receives Complete Response Letter From the U.S. FDA For 'GC5107'","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"GC Pharma","sponsor":"Vaxess","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vaxess Announces Production of The First GMP Batch of MIMIX\u2122 Technology Vaccine Patches for an Upcoming Phase 1 Seasonal Influenza Clinical Trial; Clinical Entry Expected This Summer Based on a Successful February Pre-CTA Meeting With Health Canada","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"IND Enabling"}]

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            Details:

            In preclinical studies of MIMIX-Flu, combines GC’s commercial seasonal influenza vaccine antigen with Vaxess’s innovative MIMIX patch-based intradermal controlled release delivery system, have demonstrated dose sparing and improved immunogenicity.

            Lead Product(s): VX103

            Therapeutic Area: Infections and Infectious Diseases Product Name: MIMIX-Flu

            Highest Development Status: IND Enabling Product Type: Vaccine

            Recipient: Vaxess

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 05, 2022

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            The company has confirmed that GC Pharma submitted all required documents for its BLA. ‘GC5107’ demonstrated positive results in a Phase III study in North America, meeting its primary efficacy and safety endpoints for FDA guidance requirement.

            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 28, 2022

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            The chaperone therapy is a latest molecular therapeutic approach to lysosomal diseases using small molecules that stabilize the mutant enzyme proteins. Deal aims to accelerate global development of the chaperone therapy, leveraging expertise and resources of both parties.

            Lead Product(s): Chaperone Therapy

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Discovery Product Type: Small molecule

            Recipient: Tottori University

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration August 02, 2021

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            Under the terms of the licensing agreement, GC Pharma has obtained the exclusive right to develop and commercialize maralixibat within South Korea for ALGS, PFIC, and BA.

            Lead Product(s): Maralixibat

            Therapeutic Area: Genetic Disease Product Name: LUM001

            Highest Development Status: Phase II Product Type: Small molecule

            Recipient: Mirum Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: $5.0 million

            Deal Type: Licensing Agreement July 26, 2021

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            GC5107 (Immune Globulin Intravenous (Human),10% Liquid)’ intended for the treatment of Primary Humoral Immunodeficiency (PI), a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.

            Lead Product(s): GC5107

            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 May 05, 2021

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            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).

            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

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            The newly approved Hunterase ICV Injection 15 mg, developed by GC Pharma, is delivered directly to the cerebral ventricles, allowing it to reach the cells of the brain and central nervous system.

            Lead Product(s): Idursulfase beta

            Therapeutic Area: Genetic Disease Product Name: Hunterase

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 22, 2021

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            Details:

            The plasma therapy, known as GC5131A, is a type of hyperimmune globulin drug that uses blood plasma taken from people who have fully recovered from COVID-19. GC Pharma has completed phase two clinical trials of its plasma therapy treatment for the novel coronavirus.

            Lead Product(s): Hyper-immunoglobulin

            Therapeutic Area: Infections and Infectious Diseases Product Name: GC5131A

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 06, 2021

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            Details:

            The study aims to assess the efficacy and safety of GC5131A and find the appropriate dose with 60 high-risk elderly patients who have pneumonia or underlying diseases.

            Lead Product(s): Hyper-immunoglobulin

            Therapeutic Area: Infections and Infectious Diseases Product Name: GC5131A

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2020

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