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GC Pharma
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South Korea
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107 Ihyeon-ro 30-beongil, Giheung-gu, Yongin-si, Gyeonggi-do
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+82-31-260-9300
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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 EnablingProduct 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 IIIProduct 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: DiscoveryProduct 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 IIProduct 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 IIIProduct 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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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 IIIProduct 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: ApprovedProduct 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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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 IIProduct 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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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 IIProduct 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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