Weekly Digest - May 2024

Weekly Digest - May 2024

06 May 2024: Innovent Receives NMPA Breakthrough Therapy Designation for IBI343 (Anti-Claudin18.2 ADC) as Monotherapy for Advanced Gastric Cancer

  • China’s NMPA grants BTD to IBI343 as monotherapy for treating claudin18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma (GC) patients in 2L+ treatment setting
  • The BTD for IBI343 was based on ongoing Phase 1 trial (NCT05458219), showing favorable safety, tolerability, and promising antitumor effects
  • Innovent is preparing for a registrational Phase 3 multi-regional clinical trial (MRCT), NCT06238843 to be initiated soon

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