Adagene Clears NMPA Hurdle for Novel HER2xCD3 T-Cell Engager…

Event summary

Adagene's ADG138, a double-masked HER2xCD3 bispecific T-cell engager, received NMPA IND clearance for a Phase 1 study in China, set to begin Q4 2026.
ADG138 uses Adagene's SAFEbody® technology to reduce systemic toxicity and enhance tumor selectivity.
Preclinical data showed tumor regression in Enhertu-resistant models and synergy with checkpoint inhibitors.
Phase 1 trial will evaluate safety and preliminary efficacy in advanced solid tumors.

The big picture

Adagene's NMPA clearance for ADG138 marks a strategic milestone in the development of next-generation T-cell engagers with reduced toxicity. The approval positions Adagene to challenge established players like Enhertu in the HER2-targeted oncology space, leveraging its proprietary SAFEbody technology to address unmet needs in solid tumors. The Phase 1 trial will be a critical test of whether the preclinical promise translates into clinical success.

What we're watching

Clinical Execution: Whether ADG138 can replicate preclinical efficacy in human trials, particularly in Enhertu-resistant tumors.
Regulatory Momentum: The pace at which Adagene advances ADG138 through Phase 1 and potential global expansion beyond China.
Competitive Positioning: How ADG138 differentiates itself in the crowded HER2-targeted therapy space, especially against Enhertu.