NEW TAIPEI CITY – November 08, 2026 -- GlycoNex (TPEx: 4168) has submitted a marketing authorization application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for SPD8, its denosumab biosimilar candidate, with approval possible as early as the end of 2027.
The timeline is subject to PMDA review. SPD8 was co-developed with Mitsubishi Gas Chemical (MGC). Preparations for a separate submission in Taiwan are also underway.
Phase 3 trial in 266 osteoporosis patients met its primary endpoint
The filing follows positive topline results from a randomized, double-blind, multicenter Phase 3 trial in Japan. The study enrolled 266 patients with osteoporosis. It demonstrated therapeutic equivalence to reference denosumab, measured by the percentage change from baseline in lumbar spine bone mineral density at Month 12.
GlycoNex holds all rights outside Japan and is seeking partners
GlycoNex retains sales, distribution and commercialization rights to SPD8 in every market outside Japan and is actively looking for commercialization partners there. Regulatory strategies for Taiwan and other markets will follow local requirements. In Japan, the company plans to work with its partners to support the review and prepare for a potential launch.
Biosimilar revenue is meant to fund the glycan-directed ADC pipeline
CEO Dr. Mei-Chun Yang described the submission as a step toward establishing a recurring revenue stream for the clinical-stage company. GlycoNex also develops glycan-directed antibody-drug conjugates (ADCs). Yang said experience from SPD8 will help advance its second biosimilar program, SSR, and strengthen development and commercialization capabilities that also support the innovative drug pipeline.
If approved, SPD8 would give the company a commercial base for continued pipeline development.