NMPA Clears Adagene's IND for ADG138, a Double-Masked HER2xCD3 T-Cell Engager
ADAG has more than doubled off its 52-week low of $1.3 on light trading volume (0.3× avg).
Summary
Adagene received NMPA clearance to begin a Phase 1 trial for ADG138, its double-masked HER2xCD3 bispecific T-cell engager, with dosing expected to start in China in Q4 2026. This is the first clinical-stage asset from the SAFEbody platform targeting solid tumors via T-cell engagement, and preclinical data showed activity in Enhertu-resistant models. The clearance validates the platform's expansion beyond the lead asset muzastotug and adds a new near-term clinical catalyst. With $127.9M in cash and runway into late 2028, the company can fund this trial without immediate financing risk. Watch for first patient dosing in Q4 2026 and initial safety data in 2027.
At the time of this announcement, ADAG was trading at $3.21 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $215.5M. The 52-week trading range was $1.30 to $4.85. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.