March 1st Week, 2025 ⭐ Regulatory Events 🎯 China’s NMPA granted Breakthrough Therapy Designation (BTD) to CARsgen Therapeutics’ satricabtagene autoleucel (satri-cel; CT041; an autologous, anti-CLDN18.2 CAR-T) for the treatment of Claudin18.2-positive ≥third-line G/GEJ cancer (Ref 1) ❓ What are CARsgen’s next steps in advancing satri-cel? Has CARsgen obtained similar designations in other markets? 🎯 The US FDA accepted Bioheng Therapeutics’ IND application for CTD402 (anti-