GlycoNex Files SPD8 Denosumab Biosimilar With Japan's PMDA
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.