NEW TAIPEI CITY, June 10, 2026 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the Phase III clinical trial for SPD8, a Denosumab biosimilar co-developed with Mitsubishi Gas Chemical, has successfully met its primary endpoint. Statistical analysis confirms that SPD8 demonstrated therapeutic equivalence to the reference drug, Prolia® (marketed as Pralia® in Japan). The company expects to finalize the clinical study report by the end of September, followed by a drug approval application in Japan. Japan MAA submission expected in third quarter 2026. An application for marketing authorization in Taiwan is scheduled for next year, with a target launch date by the end of 2027.
The SPD8 Phase III clinical trial was a randomized, double-blind, multicenter study conducted in Japan, enrolling a total of 266 subjects. The treatment period was 12 months. Subjects were randomized in a 1:1 ratio to receive either SPD8 or the reference product, administered as a subcutaneous injection once every six months for a total of two doses, followed by evaluation through Month 12.
The primary efficacy endpoint was the percent change from baseline in lumbar spine bone mineral density (BMD) at Month 12. The study was designed to evaluate the therapeutic equivalence of SPD8 and the reference product in subjects with osteoporosis. The analysis showed that the between-group difference in the primary efficacy endpoint, together with its 95% confidence interval, met the pre-specified equivalence criteria defined prior to unblinding.
GlycoNex adopted a dual-indication strategy for SPD8, targeting both osteoporosis and bone metastasis indications corresponding to the originator products Prolia® and Xgeva®, respectively. The company has completed the required quality comparative analyses and development data package for both indications and plans to submit two marketing authorization applications to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) this year.
Denosumab is a biologic therapy that requires long-term, scheduled administration, and treatment interruption may compromise bone protection. Against the backdrop of global population aging and increasing demand for osteoporosis care, GlycoNex aims to provide patients with a high-quality, consistent, and affordable long-term treatment option. The company is actively seeking regional licensing and distribution partners worldwide to support future market access and supply.
About Denosumab
Denosumab is an anti-RANKL monoclonal antibody used across two major therapeutic areas. It is marketed as Prolia® for the treatment of osteoporosis and as Xgeva® for the prevention of skeletal-related events in patients with bone metastases from solid tumors. By targeting RANKL, a key mediator of osteoclast formation and activation, denosumab helps reduce bone resorption, increase bone mineral density, and lower fracture-related risk. According to Amgen's 2025 full-year financial results, global sales of denosumab products reached approximately US$6.5 billion, reflecting its established role in long-term osteoporosis management and oncology-related bone care.
About GlycoNex Inc.
GlycoNex Inc. is a clinical-stage biotechnology company headquartered in New Taipei City, Taiwan, focused on glycan-directed antibody-drug conjugates (ADCs) and biosimilars. Leveraging its expertise in glyco-science, antibody engineering, and biologics development, GlycoNex is advancing its lead ADC program, GNX1021, which has received PMDA approval to initiate a Phase 1 clinical trial in Japan. The company is also developing SPD8, a denosumab biosimilar in collaboration with Mitsubishi Gas Chemical (MGC), which has completed Phase III clinical study and is preparing for marketing authorization application (MAA).
For more information, visit https://www.glyconex.com.tw/index.php/en-us/
SOURCE GlycoNex, Inc.
