Antengene Announces Claudin 18.2 Antibody-Drug Conjugate ATG-022 Granted Orphan Drug Designations by the U.S. FDA for the Treatment of Gastric and Pancreatic Cancers
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Tuesday, May 23, 2023
Pancreatic cancer, Prevalence, ODD, New Drug Application, NDA, Cancer, Hubli railway division, Cell, Claudin, Patient, Cell polarity, Hematology, National Medical Products Administration, ADC, Diagnosis, Rare, FDA, Stomach, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NMPA, Food, Cell adhesion, Pharmaceutical industry
To date, Antengene has received 3 ODDs from the FDA for two of its in-house products.
Key Points:
- To date, Antengene has received 3 ODDs from the FDA for two of its in-house products.
- Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions.
- The Claudin 18.2 isoform is overexpressed in various primary malignant tumors including gastric, esophageal and pancreatic cancers.
- Moving forward, Antengene will work closely with regulators and clinical investigators to advance the CLINCH trial and fully assess ATG-022's therapeutic potential for solid tumors."