Weekly Digest - Mar 2024

27 Feb 2024: 9MW2821 Receives Fast Track Designation from FDA

  • The FDA grants Fast Track Designation to 9MW2821, a new ADC drug by Mabwell, targeting Nectin-4 for advanced esophageal squamous cell carcinoma treatment
  • 9MW2821 utilizes Mabwell’s ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, binding to Nectin-4 and inducing tumor cell apoptosis, marking China’s first clinical-stage Nectin-4-targeting ADC
  • In a Phase II clinical trial with 30 advanced esophageal carcinoma patients at 1.25 mg/kg dose, 9MW2821 demonstrated a 30% ORR and a 73.3% DCR
  • 9MW2821 is also the first to disclose preliminary clinical efficacy data for the indication of cervical cancer among drugs with the same target in the world

For full story click here

Share this