
Sep 23, 2026
Adagene (NASDAQ: ADAG) Obtains NMPA IND Approval for ADG138 Phase 1 Trial in Advanced Solid Tumors
Adagene Inc. has received IND approval from China's NMPA for ADG138, a drug designed for advanced solid tumors. The company plans to initiate a first-in-human Phase 1 clinical trial in China in Q4 2026 to assess its safety, preliminary efficacy, and determine the optimal dose for Phase 2 development. Preclinical studies have shown ADG138's effectiveness in resistant tumor models and synergistic anti-tumor effects in combination therapies.
Company relevance
100.00%
Company sentiment
Bullish
Overall sentiment
Bullish
Sep 22, 2026
Adagene advancing HER2 bispecific TCE into clinic in China
Adagene Inc. has received NMPA clearance for its investigational new drug application for ADG138, a HER2×CD3 bispecific T-cell engager. This approval allows the company to initiate a first-in-human Phase I study in China for patients with advanced solid tumors, expected to begin in Q4 2026. ADG138 utilizes Adagene's SAFEbody precision masking technology on both binding arms, designed to limit off-target activity and systemic cytokine release, offering a differentiated approach from conventional bispecific T-cell engagers.
Company relevance
100.00%
Company sentiment
Bullish
Overall sentiment
Bullish