Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : GC5107
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Correcting and Replacing GC Pharma Receives Complete Response Letter From the U.S. FDA For 'GC5107'
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.
Product Name : GC5107
Product Type : Antibody
Upfront Cash : Inapplicable
February 28, 2022
Lead Product(s) : GC5107
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hyper Immunoglobulin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
GC Pharma Completes phase 2 trial of COVID-19 plasma Therapy Treatment
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...
Product Name : GC5131A
Product Type : Antibody
Upfront Cash : Inapplicable
June 01, 2021
Lead Product(s) : Hyper Immunoglobulin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : GC5107
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
US FDA Accepts GC Pharma’s Biologics License Application for Immune Globulin 'GC5107'
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.
Product Name : GC5107
Product Type : Antibody
Upfront Cash : Inapplicable
May 05, 2021
Lead Product(s) : GC5107
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : GC5107
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
GC Pharma Submits Biologics License Application to US FDA for Immune Globulin 'GC5107'
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).
Product Name : GC5107
Product Type : Antibody
Upfront Cash : Inapplicable
February 26, 2021
Lead Product(s) : GC5107
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Idursulfase Beta
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Hunterase
Product Type : Enzyme
Upfront Cash : Inapplicable
January 22, 2021
Lead Product(s) : Idursulfase Beta
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hyper Immunoglobulin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
GC Pharma Speeds Up Developing Covid-19 Plasma Therapy
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.
Product Name : GC5131A
Product Type : Antibody
Upfront Cash : Inapplicable
September 21, 2020
Lead Product(s) : Hyper Immunoglobulin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable