Systimmune received FDA IND clearance for SI-B037, a bispecific antibody designed to target immunosuppression and additional synergistic mechanisms. The clearance puts the program on track for clinical progression as developers continue to expand immune-modulating bispecifics beyond conventional targets. Adagene also obtained IND clearance in China for ADG-138, a double-masked HER2×CD3 bispecific T-cell engager for advanced solid tumors. Adagene said it expects to start a first-in-human Phase 1 trial in the fourth quarter. The two regulatory moves underscore how rapidly bispecific T-cell engager pipelines are advancing in both the U.S. and China, with masked designs continuing to be a common strategy for managing safety and activation control.