ABOUT THE EVENT
Date: Thursday, November 19, 2026 11am–12pm EST
Event Location: Virtual
ADCs are oncology’s fastest-growing modality, and China-originated molecules now file NMPA and FDA INDs in parallel. Yet every ADC is a synergy of a potent small-molecule warhead and an antibody carrier, which must be evaluated through two different regulatory lenses.
This webinar decodes what each agency really expects at IND, exposes the gaps that silently delay programs, and shows how one development package, one filing strategy, and a configurable English/Chinese dossier can turn two regulatory systems into one faster path to the clinic.
Key Learning Objectives
- The ADC approval landscape and why dual China–US IND filing is now the default
- CMC expectations at IND: what is required and what can wait
- China vs. US technical differences and why finding them only at filing time is expensive
- A harmonized platform: one package, one strategy, and a configurable dossier language
