GlycoNex, Inc. 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.
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