human immunoglobulin G IV (GC5101B) / GC Biopharma - LARVOL DELTA

Green Cross “FDA inspection of blood products in the third quarter and approval of hemophilia treatment in China“ (Economic Review) - "GC Green Cross is expected to achieve significant R&D performance in the second half of this year. It is expected that the US FDA will inspect 10% of the blood product IVIG-SN, and approval of the hemophilia treatment 'Greengene F' in China is expected....Green Cross said, 'The blood product IVIG-SN 10% approval process is proceeding without any problems, and an FDA factory inspection is expected around September-October this year'. Green Cross added that the approval will be decided by February 25, 2022. The approval of Greengene F, a treatment for hemophilia, in China is only pending administrative procedures. Green Cross expected approval in China within the third quarter and launch in the first half of next year."

FDA event • Non-US regulatory • Genetic Disorders • Hemophilia

Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency (clinicaltrials.gov) - P3; N=49; Completed; Sponsor: Green Cross Corporation; Recruiting ➔ Completed

Clinical • Trial completion • Human Immunodeficiency Virus • Immunology • Primary Immunodeficiency

Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency (clinicaltrials.gov) - P3; N=16; Not yet recruiting; Sponsor: Green Cross Corporation

Clinical • New P3 trial • Immunology • Pediatrics • Primary Immunodeficiency

Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: Green Cross Corporation; N=20 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Immunology • Pediatrics • Primary Immunodeficiency

Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease (clinicaltrials.gov) - P4; N=45; Completed; Sponsor: Green Cross Corporation; Recruiting ➔ Completed

Clinical • Trial completion • Hematological Disorders • Pediatrics

Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease (clinicaltrials.gov) - P4; N=45; Recruiting; Sponsor: Green Cross Corporation; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open

Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease (clinicaltrials.gov) - P4; N=45; Active, not recruiting; Sponsor: Green Cross Corporation

Clinical • New P4 trial