NEW TAIPEI CITY, Taiwan — June 11, 2026 — GlycoNex, Inc. (TWO:4168) today announced that its denosumab biosimilar candidate, SPD8, has been unblinded in its pivotal Phase 3 trial in Japan with positive top-line results, successfully meeting the primary endpoint and confirming clinical comparability to the reference product.
SPD8 is a biosimilar candidate to denosumab — originally marketed by Amgen as Prolia (osteoporosis) and Xgeva (cancer-related skeletal events) — a fully human IgG2 monoclonal antibody targeting RANKL. The Phase 3 trial, conducted in Japan and co-developed with Mitsubishi Gas Chemical, evaluated clinical equivalence with reference denosumab in patients with osteoporosis, using percent change in bone mineral density as the primary endpoint. Enrollment completed in October 2025.
With positive top-line results in hand, GlycoNex plans to submit a Biologics License Application (BLA) to Japan's PMDA in the third quarter of 2026, with anticipated approvals in Japan in the third quarter of 2027 and in Taiwan in the fourth quarter of 2027.