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Weekly Digest - October 2024
8 Oct 2024: CSPC Pharmaceutical announces CPO301 receives Fast Track Designation (FTD) from US FDA
- CSPC Pharmaceutical Group’s CPO301, a first-in-class ADC, received Fast Track Designation from the US FDA for treating recurrent or metastatic squamous NSCLC with EGFR overexpression after platinum-based chemotherapy and anti-PD-(L1) therapy
- CPO301 showed encouraging efficacy and satisfactory safety and tolerability in Phase I studies in both China and the US involving patients with recurrent or metastatic squamous NSCLC
- This is the second Fast Track Designation granted by the US FDA for CPO301, with the first designation aimed at patients with metastatic NSCLC with EGFR mutations who are relapsed/refractory to or ineligible for EGFR targeting therapies
