Adagene obtained IND clearance from China’s NMPA for ADG-138, a double-masked HER2×CD3 bispecific T-cell engager intended for advanced solid tumors. The company said it plans to start a first-in-human Phase 1 study in the fourth quarter of the current year. ADG-138 is designed to engage T cells while restricting activity through masking features, an approach commonly used to address safety considerations in early bispecific development. Adagene framed the IND clearance as a step toward clinical validation. The clearance adds to the dense HER2 bispecific pipeline buildout across China and global markets, where first-in-human readouts can quickly determine whether dosing and safety management translate into meaningful efficacy. For biotech operators, the key near-term watch items are the initial expansion cohort design, dose-escalation tolerability, and early evidence of tumor response in HER2-positive settings.