GlycoNex Announces First Patient Dosed in Phase 3 Clinical Trial for Denosumab Biosimilar

GlycoNex developing denosumab biosimilar, SPD8, for the treatment of osteoporosis

NEW TAIPEI CITY, Taiwan, Dec. 17, 2024 /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 that the first patient has been dosed in the Phase 3 clinical trial of its denosumab biosimilar, SPD8. This marks the initiation of a pivotal trial to evaluate SPD8 for the treatment of osteoporosis, with unblinded results expected in the second quarter of 2026.

SPD8, co-developed with Mitsubishi Gas Chemical Company (MGC), is a biosimilar to Xgeva and Prolia (denosumab), a widely used therapy to prevent skeletal-related events in patients with bone metastases from solid tumors as well as osteoporosis. Phase 1 clinical trials confirmed SPD8's safety and pharmacokinetic equivalence to the reference drug, enabling this critical next step in development. To support the trial and regulatory submission efforts, GlycoNex and EirGenix, Inc.—Taiwan's largest CDMO—have established a production agreement for the large-scale manufacturing of SPD8.

"The initiation of this Phase 3 trial and the dosing of the first patient are significant achievements in the development of SPD8," said Dr. Mei-Chun Yang, CEO of GlycoNex. "As the demand for osteoporosis treatments continues to grow, we are committed to providing affordable and effective options that improve patient care worldwide."

Denosumab, marketed as Xgeva and Prolia, is a leading treatment for bone loss and cancer-related skeletal complications. In 2023, global sales of denosumab products reached USD 6.1 billion, highlighting the need for cost-effective biosimilar alternatives. With osteoporosis prevalence rising and an aging population in Asia, SPD8 is poised to address this growing demand.

In addition to advancing SPD8, GlycoNex continues to expand its oncology pipeline. The company's lead monoclonal antibody, GNX102, has completed Phase 1 clinical trials, demonstrating excellent safety and tolerability. GlycoNex is also preparing GNX102 for development as an antibody-drug conjugate (ADC) through a collaboration with Sterling Pharma Solutions. These initiatives underscore GlycoNex's expertise in advancing impactful therapies for global health challenges.

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. 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
[email protected]  

Media Relations
Eric Reiss
[email protected]

SOURCE GlycoNex, Inc.