SunHo Received U.S. FDA IND Approval to Initiate Phase I Clinical Trials of IBB0979 as Innovative Immunocytokine
On October 28, 2022, SunHo received the IND approval from the U.S. Food and Drug Administration ("FDA") that IBB0979, the world's first immunocytokine in the same class, has been approved for clinical trials in the treatment of advanced malignant solid tumors. This is the 3rd innovative immunocytokine generated from the AIC? platform after IAP0971 and IAE0972 to be approved for clinical trials in the U.S., demonstrating the accumulation and innovation of SunHo in the field of immunocytokines.
About SunHo
SunHo is a clinical-stage biopharmaceutical company dedicated to the discovery, development, manufacturing, and commercialization of innovative immunocytokines and bifunctional antibody fusion proteins in the fields of cancer immunotherapy and autoimmune diseases.
Sunho has developed proprietary and patented Armed ImmunoCytokine Platform (AIC?), Armed Innate Effector Multispecific Platform (AIM?), and ADCC Enhanced Antibody Platform (AEA?). With profound understanding of immunology and tumor microenvironment, SunHo strives to identify and meet the most critical clinical needs, as evidenced by their pipeline of over 20 truly innovative and differentiated products, of which 4 are undergoing clinical trials, 4 in IND application and 6 are at the pre-clinical stage.
SunHo’s GMP facilities offer manufacture solutions from drug substance (DS) to drug product (DP) production. 1× 1000 L and 3× 200 L GMP bioreactor lines are available for DS production, and another 2x5000 L lines are coming soon. 1× liquid filling line and 1× lyophilization line also cater to the need of aseptic processing of biologics (liquid and lyophilized preparations) for clinical trials and commercialization. The quality management system of SunHo lives up to the expectations of U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and China's National Medicinal Products Administration (NMPA).