GMAX BIOPHARM


Associated tags: DKD, Fibrosis, IND, ETB, ESRD, Kidney disease, Eta, Inflammation, Hypertensive emergency, Patient, Trial of the century, Eras, PAH, Health, ERA, US, Proteinuria, G protein-coupled receptor, Extracellular matrix, Chronic kidney disease

Locations: CHINA, USA

The World's First ETa-specific Monoclonal Antibody: Gmax Biopharm's GMA131 Approved by the US FDA for Clinical Study on (DKD) Diabetic Kidney Disease

Retrieved on: 
Monday, November 14, 2022
DKD, Health, Kidney, Edema, IDF, Diabetes, Obesity, Chronic kidney disease, Extracellular matrix, G protein-coupled receptor, Proteinuria, US, ERA, PAH, Fibrosis, Eras, Trial of the century, Patient, Hypertensive emergency, Inflammation, Eta, Kidney disease, ESRD, ETB, IND, Pharmaceutical industry

announced today that its application of investigation of New Drug (IND) for GMA131 injection, the first global ETa-specific monoclonal antibody, was approved by the US FDA on Nov 11, 2022 for clinical study on diabetic kidney disease (DKD).

Key Points: 
  • announced today that its application of investigation of New Drug (IND) for GMA131 injection, the first global ETa-specific monoclonal antibody, was approved by the US FDA on Nov 11, 2022 for clinical study on diabetic kidney disease (DKD).
  • Dr. Shuqian Jing, Founder and Chairman of Gmax Biopharm, said, "GMA131 is the first genuine ETa-specific monoclonal antibody developed by Gmax Biopharm.
  • GMA131 is the same molecule as GMA301 which is currently in a Phase Ib trial of pulmonary arterial hypertension (PAH) in China/USA.
  • DKD, the leading cause of chronic kidney disease and end stage renal disease (ESRD), is one of the most important complications of diabetes.