GlycoNex, a Taiwan-based biopharmaceutical company, announced that its antibody-drug conjugate (ADC) GNX1021, developed in collaboration with OP NanoPharma, has successfully completed pre-fill testing for clinical trial use. The results confirmed process stability and product quality in accordance with international standards. In July, GLP toxicology studies in rats and cynomolgus monkeys were also initiated, with completion expected by the fourth quarter of this year. The company plans to submit clinical trial applications to the health authorities in Taiwan and Japan in the first quarter of 2026, with the goal of launching a Phase I clinical trial in the second quarter of 2026.

GNX1021 targets a specific glycan marker (bLeB/Y), which has demonstrated potent tumor-suppressing effects across multiple animal models. It can effectively distinguish patient groups who are negative for HER2 and CLDN18, offering a new therapeutic option for gastric cancer patients who are currently underserved by existing targeted therapies. GlycoNex also plans to explore additional indications for GNX1021 to expand its potential patient population and increase the likelihood of clinical development success.

Given Asia’s emergence as a global hub for new drug development in recent years, GlycoNex is actively strengthening its presence in the Asian market and seeking strategic partners to advance licensing deals and international collaborations. The company is also showcasing its latest R&D achievements in the fields of anti-glycan antibody drugs and biosimilars.

Dr. Mei-Chun Yang, CEO of GlycoNex, stated, “We look forward to engaging in in-depth discussions with potential partners to accelerate the international expansion and clinical advancement of GlycoNex’s pipeline, bringing new therapeutic options to patients worldwide.”

Resource: 醣聯開拓胃癌標靶抗體藥物GNX1021，目標明年Q2啟動一期臨床試驗