GlycoNex Announces Japanese Regulatory Submission for Denosumab…

GlycoNex Announces Japanese Regulatory Submission for Denosumab Biosimilar SPD8

Nov 8, 2026, 8:02 PM EST

Distributed by Times Beats · Originally issued via PR Newswire

Key points

GlycoNex, Inc. announced on Nov. 8, 2026 that a marketing authorization application for SPD8, a denosumab biosimilar candidate co-developed with Mitsubishi Gas Chemical, has been submitted to Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The company says SPD8 could receive approval in Japan as early as the end of 2027, subject to regulatory review.

A marketing authorization application for SPD8, a denosumab biosimilar candidate co-developed by GlycoNex and Mitsubishi Gas Chemical (MGC), has been submitted to Japan's PMDA.
The company says approval in Japan could come as early as the end of 2027, subject to regulatory review.
The submission follows a Phase 3 trial in Japan of 266 patients with osteoporosis that met its primary endpoint of therapeutic equivalence to reference denosumab, based on percentage change in lumbar spine bone mineral density at Month 12.
GlycoNex retains sales, distribution and commercialization rights to SPD8 outside Japan and is seeking commercialization partners in those markets.
Preparations for a regulatory submission in Taiwan are underway.

The submission affects osteoporosis patients and prescribers in Japan, where SPD8 could become an additional denosumab option if approved by PMDA. GlycoNex retains rights to SPD8 outside Japan and says it is seeking commercialization partners in those markets, while preparing a submission in Taiwan.

Automated summary prepared by Times Beats from the release below, which follows as issued.

Regulatory decision in Japan anticipated as early as the end of 2027, subject to PMDA review; GlycoNex continues to seek partners for markets outside Japan

NEW TAIPEI CITY, Nov. 8, 2026 — GlycoNex, Inc. (TPEx: 4168), a clinical-stage biotechnology company developing glycan-directed antibody-drug conjugates (ADCs), and biosimilars, today announced that a marketing authorization 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. Preparations for a regulatory submission in Taiwan are also underway.

"The Japanese submission is a major milestone in our efforts to bring SPD8 to patients and establish a recurring revenue stream for GlycoNex," said Dr. Mei-Chun Yang, President and CEO of GlycoNex. "The experience gained through SPD8 will help us advance our second biosimilar program, SSR, while strengthening the development and commercialization capabilities that also support our innovative drug pipeline. Subject to approval, we look forward to working with our partners to make SPD8 available as an additional treatment option for patients with osteoporosis in Japan."

The submission follows positive topline results from SPD8's randomized, double-blind, multicenter Phase 3 trial 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 retains sales, distribution and commercialization rights to SPD8 in all markets outside Japan and is actively seeking commercialization partners in these markets. Regulatory strategies for Taiwan and other markets will be determined in accordance with local requirements.

GlycoNex plans to work with its partners to support the Japanese regulatory review and prepare for a potential commercial launch, subject to approval.

Advancing SPD8 toward commercialization is part of GlycoNex's strategy to build a sustainable biosimilars business alongside its glycan-directed ADC pipeline. 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.

www.glyconex.com.tw

SOURCE GlycoNex, Inc.