AIDEXI®(Disitamab Vedotin): A 10-Year Development Journey and Its CMC Strategy for Accelerated BLA Filing

Time: 12:00 pm
day: day 2 track 3


• Disitamab vedotin was the first ADC drug approved for clinical trials as well as for clinical applications in China. • Its efficacy has been validated in multiple indications (gastric cancer, urothelial cancer, and breast cancer) with a favorable safety profile. • This presentation will show non-clinical and clinical data in developing Disitamab vedotin and will share the strategy applied for the accelerated BLA filing in China.