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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 EnablingProduct Type: Vaccine
Recipient: Vaxess
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2022
Details:
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
Details:
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
Details:
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
Details:
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
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2021
Details:
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
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2021
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020