Adagene Secures NMPA Clearance to Launch Phase 1 Trial 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, a double-masked HER2xCD3 T-cell engager, with dosing expected to start in China in Q4 2026.
Key Events · Product Development and Regulatory · ADAG
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NMPA Clears IND for ADG138
China's NMPA approved Adagene's investigational new drug application for ADG138, a double-masked HER2xCD3 bispecific T-cell engager built on the SAFEbody platform.
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Phase 1 Trial to Start Q4 2026
Adagene expects to initiate a first-in-human Phase 1 study of ADG138 in patients with advanced solid tumors in China in the fourth quarter of 2026.
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Preclinical Differentiation
ADG138 showed tumor regression in HER2-high and HER2-low models, including Enhertu-resistant tumors, and synergy with anti-CTLA-4, anti-PD-1, or anti-CD137 antibodies.
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Pipeline Expansion Beyond Muzastotug
This is Adagene's second clinical-stage program, broadening the pipeline beyond lead asset muzastotug (ADG126) and demonstrating the SAFEbody platform's applicability to T-cell engagers.
Analysis · ADAG · Life Sciences
China's NMPA has cleared Adagene's IND for ADG138, a novel double-masked bispecific T-cell engager targeting HER2 and CD3. This milestone expands the company's clinical pipeline beyond its lead asset muzastotug and validates the SAFEbody platform in a second modality. A first-in-human Phase 1 study in advanced solid tumors is expected to begin in Q4 2026. Preclinical data demonstrated tumor regression in Enhertu-resistant models and synergy with checkpoint inhibitors, suggesting a differentiated profile for HER2-expressing cancers.
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At the time of this filing, 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 filing was assessed with positive market sentiment and an importance score of 7 out of 10.