NEW TAIPEI CITY, Taiwan, June 11, 2026
GlycoNex, Inc. (GNX) announced positive topline results from its Phase III clinical trial of SPD8, a denosumab biosimilar co-developed with Mitsubishi Gas Chemical, marking a significant milestone in the company’s biosimilar development strategy. The study successfully achieved its primary endpoint, demonstrating therapeutic equivalence to Prolia®, the reference denosumab product used for osteoporosis treatment. The positive outcome supports planned regulatory submissions in Japan and Taiwan and positions GlycoNex to enter the rapidly expanding global market for osteoporosis and oncology-related bone disease therapies. With denosumab products generating approximately US$6.5 billion in global sales in 2025, the successful completion of the Phase III program strengthens GlycoNex’s ambitions to become a significant player in the biosimilar market while providing patients with more affordable long-term treatment options.
Phase III Study Confirms Therapeutic Equivalence to Prolia®
The pivotal Phase III trial was designed as a randomized, double-blind, multicenter study conducted across Japan and enrolled 266 patients with osteoporosis. Participants were randomly assigned in a 1:1 ratio to receive either SPD8 or the reference denosumab product through subcutaneous injection every six months for a total of two doses. The primary endpoint evaluated the percentage change from baseline in lumbar spine bone mineral density (BMD) after 12 months of treatment.
Statistical analysis demonstrated that the difference between SPD8 and the reference product, together with the corresponding 95% confidence interval, met all pre-specified equivalence criteria established before study unblinding. These findings confirm that SPD8 delivers comparable clinical efficacy to the originator product and support its advancement toward regulatory approval. GlycoNex expects to complete the final clinical study report by September 2026 and proceed with marketing authorization applications in Japan during the third quarter of 2026.
Dual-Indication Strategy Expands Commercial Potential
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A key differentiator of GlycoNex’s development strategy is its dual-indication approach, targeting both osteoporosis and oncology-related bone disease. SPD8 is being developed as a biosimilar to both Prolia®, indicated for osteoporosis treatment, and Xgeva®, used to prevent skeletal-related events in patients with bone metastases from solid tumors. The company has already completed the necessary comparative quality assessments and supporting development package required for both indications.
GlycoNex plans to submit separate marketing authorization applications to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for both therapeutic uses. This broader strategy significantly expands the product’s commercial opportunity and positions SPD8 to compete in multiple high-value healthcare markets where demand for cost-effective biologic therapies continues to increase.
Addressing Growing Demand for Long-Term Bone Health Therapies
The successful Phase III outcome comes at a time of increasing global demand for osteoporosis and bone health treatments driven by aging populations and rising healthcare needs. Denosumab is a monoclonal antibody that targets RANKL, a critical regulator of osteoclast formation and bone resorption. By inhibiting RANKL activity, denosumab helps increase bone mineral density, reduce fracture risk, and improve long-term skeletal health. Because osteoporosis is a chronic disease requiring ongoing treatment, maintaining uninterrupted access to therapy remains essential for patient outcomes.
GlycoNex believes SPD8 can provide a high-quality, reliable, and more affordable alternative to branded biologics, supporting broader patient access worldwide. The company is actively pursuing regional licensing and commercialization partnerships to support future market expansion and ensure global supply readiness. As biosimilars continue to reshape healthcare economics, SPD8 represents an important addition to the next generation of cost-effective biologic therapies.
Source: GlycoNex press release
