Clinical-stage biotechnology company GlycoNex Inc (TPEx:4168) announced on Sunday that a marketing authorisation application for SPD8, its denosumab biosimilar candidate co-developed with Mitsubishi Gas Chemical (MGC), has been submitted to Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

Subject to regulatory review and approval, SPD8 could receive approval in Japan as early as the end of 2027, paving the way for commercial launch. GlycoNex is also preparing for a regulatory submission in Taiwan.

The submission in Japan follows positive topline results from a randomised, double-blind, multicentre Phase 3 trial of SPD8 in Japan. The study enrolled 266 patients with osteoporosis and met its primary endpoint, demonstrating therapeutic equivalence to reference denosumab based on the percentage change from baseline in lumbar spine bone mineral density at Month 12.

GlycoNex holds sales, distribution and commercialisation rights to SPD8 in all markets outside Japan, and is actively seeking commercialisation partners in these markets. Regulatory strategies for Taiwan and other markets will be determined in accordance with local requirements.

If approved, SPD8 could broaden access to an established biologic treatment for osteoporosis, while providing a commercial foundation for the company's continued pipeline development.