GlycoNex Announces Last Patient Dosed in Phase 3 Trial of SPD8, a Denosumab Biosimilar for Osteoporosis
Topline data expected in second quarter 2026
NEW TAIPEI CITY, Taiwan, Oct. 29, 2025 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the last patient has received the final dose in its Phase 3 clinical study of SPD8, a biosimilar to denosumab for the treatment of osteoporosis. Developed in collaboration with Mitsubishi Gas Chemical (MGC), SPD8 is designed to address complications associated with bone metastases in patients with solid tumors and osteoporosis-related conditions. Dosing of the final patient marks a significant milestone for the program, positioning GNX to report top-line results from the study in the second quarter of 2026.
The randomized, multicenter, double-blind, parallel-group study is evaluating the pharmokinetic equivalence, efficacy, and safety of SPD8 compared to denosumab in postmenopausal women with primary osteoporosis from solid tumors . The resulting data generated will support global registration. The SPD8 program reflects GNX's broader strategy of leveraging its expertise in complex antibody manufacturing to deliver high-quality biosimilars in parallel with its efforts to develop novel glycan-directed antibody-drug conjugates.
"Achieving 'last patient, last dose' in our SPD8 Phase 3 study represents a critical milestone for GlycoNex," said Dr. Mei-Chun Yang, CEO of GlycoNex. "With the trial now moving into its final phase of analysis, we are focused on advancing SPD8 toward regulatory submission and delivering a cost-effective alternative to patients who rely on denosumab therapy."
Denosumab (marketed as Prolia®/Xgeva®) generated $6.60 billion in global 2024 sales, underscoring sustained demand in osteoporosis and oncology-related bone indications. SPD8 has the potential to broaden patient access in areas where cost remains a barrier. SPD8 has already been out-licensed for certain territories, and GlycoNex remains in discussions with multiple additional companies regarding territory-specific development and commercialization collaborations.
About GlycoNex Inc.
GlycoNex Inc. is a clinical-stage biotechnology company focused on the development of glycan-directed cancer immunotherapies that effectively inhibit tumor growth while minimizing side effects. GlycoNex possesses a robust pipeline led by GNX102, a humanized monoclonal antibody (mAb) designed to target abnormal sugar molecules in cancer cells. GNX102 has successfully completed Phase 1 clinical trials with data demonstrating excellent safety and promising efficacy. GlycoNex is also advancing a portfolio of antibody-drug conjugates (ADCs) that precisely attack cancer cells while sparing healthy tissue, including GNX1021, its novel ADC that targets branched Lewis B/Y (bLeB/Y). GlycoNex is headquartered in New Taipei City, Taiwan. For more information, visit http://www.glyconex.com.tw.
Contacts for GlycoNex, Inc.
Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish dirish@tiberend.com
Media Relations
Eric Reiss
ereiss@tiberend.com
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SOURCE GlycoNex, Inc.