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Find Clinical Drug Pipeline Developments & Deals by GC Pharma
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.
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.
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.
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.
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).
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.
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.
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.