Webinar Invitation: Accelerating Globalized CMC Filing Strategy for ADC IND: Key Insights and Best Practices
Can one ADC CMC package meet the IND expectations of both the FDA and NMPA?
As more ADC programs pursue parallel IND filings in the US and China, regulatory alignment needs to begin long before submission. Differences in CMC expectations can create gaps that surface late, leading to avoidable rework and delays.
Join AsymBio’s upcoming webinar to explore what the FDA and NMPA expect at IND—and how a harmonized development package and filing strategy can streamline dual submissions.
Key Learning Objectives
- Understand why parallel US–China IND filing is becoming increasingly common for ADC programs.
- Clarify CMC expectations at IND: what is required and what can wait.
- Identify key technical differences between FDA and NMPA requirements.
- Explore how one harmonized package and a dossier adaptable for English and Chinese submissions can support both markets.
Speaker
Xia Meng
Head of Regulatory CMC, AsymBio
With 14 years of experience in biologics CMC, Xia has worked across analytical development, CMC review at the CDE, and regulatory strategy. She has contributed to more than 60 antibody, recombinant protein, and ADC programs, with particular expertise in control strategy and multi-market filing harmonization.
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