GlycoNex and Hokkaido University Hospital Launch Study to Advance Glycan-Directed ADC Development in Gastric Cancer

Collaboration builds clinical foundation for GNX1021, a first-in-class glycan-directed ADC being developed for gastric cancer patients 

NEW TAIPEI CITY, Taiwan, Nov. 24, 2025 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced a collaborative research agreement with Hokkaido University Hospital to support the development of its next-generation antibody-drug conjugate (ADC) GNX1021 in gastric cancer patients and lay the groundwork for future clinical trials in Japan. As part of the effort, the two parties will conduct a retrospective study evaluating the expression of branched Lewis B/Y (bLeB/Y) glycan antigen in gastric cancer patients and assess its association with established clinical biomarkers.

According to the National Cancer Center Japan (NCC), gastric cancer is the third most common cancer and the fourth leading cause of cancer-related deaths in Japan. In 2024, it is projected to account for 115,100 new cases and 39,900 deaths, highlighting the urgent need for new treatment options. Through this collaboration, GlycoNex and Hokkaido University Hospital will evaluate the prevalence and distribution of bLeB/Y expression in these Japanese gastric cancer patients and compare it to established clinical biomarkers, including HER2, CLDN18, PD-L1, and MMR. The goal is to better define the patient population most likely to benefit from GNX1021 treatment, ultimately enhancing the probability of clinical success.

"Our collaboration with Hokkaido University Hospital marks an important step in understanding how bLeB/Y expression can guide treatment strategies for gastric cancer patients," said Dr. Mei-Chun Yang, CEO of GlycoNex. "By building a stronger scientific foundation for GNX1021, we aim to advance the development of glycan-directed therapies that expand treatment options beyond today's HER2- and CLDN18-based approaches, ultimately addressing significant unmet needs in oncology."

GNX1021 has demonstrated potent tumor-suppressive activity across multiple preclinical gastric cancer models, including settings resistant to existing HER2- and CLDN18-targeted therapies. Building on these findings, GlycoNex has advanced the program through pre-fill and toxicology testing and is preparing for regulatory submissions in Taiwan and Japan. Phase I clinical trials are planned to begin in 2026, with the goal of delivering a novel treatment option for gastric cancer patients who remain underserved by current targeted approaches.

About GlycoNex, Inc.
GlycoNex Inc. (4168) is a clinical-stage biotechnology company developing glycan-directed antibody-drug conjugates (ADCs) and high-quality biosimilars to advance next-generation biologic therapies. The company's lead program, GNX1021, is a first-in class glycan-directed ADC targeting the branched Lewis B/Y (bLeB/Y) antigen, which has demonstrated potent tumor-suppressive activity in preclinical studies and is expected to enter clinical evaluation in 2026. In parallel, GlycoNex is advancing SPD8, a denosumab biosimilar currently in Phase 3 clinical development for osteoporosis, reflecting the company's deep capabilities in complex antibody manufacturing. By integrating its proprietary glycan-targeting technology with proven biologics development, GlycoNex is building a scalable platform to deliver innovative and accessible treatments for patients worldwide. For more information, visit http://www.glyconex.com.tw.

Contacts for GlycoNex, Inc.
Tiberend Strategic Advisors, Inc.

Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
[email protected] 

Media Relations
Eric Reiss
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SOURCE GlycoNex, Inc.