GlycoNex Submits Denosumab Biosimilar SPD8 for Regulatory Approval in Japan

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GlycoNex Submits Denosumab Biosimilar SPD8 for Regulatory Approval in Japan

GlycoNex, a clinical-stage biotechnology company developing glycan-directed antibody-drug conjugates (ADCs) and biosimilars, has submitted a marketing authorisation application for SPD8, its denosumab biosimilar candidate co-developed with Mitsubishi Gas Chemical (MGC), to Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

Subject to regulatory review and approval, SPD8 could receive marketing approval in Japan by the end of 2027, paving the way for its commercial launch. The company is also preparing a regulatory submission in Taiwan.

The application follows positive topline results from a randomised, double-blind, multicentre Phase III clinical trial conducted 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.

Dr. Mei-Chun Yang, President and CEO of GlycoNex, said, "The Japanese submission is a major milestone in our efforts to bring SPD8 to patients and establish a recurring revenue stream for GlycoNex. The experience gained through SPD8 will help us advance our second biosimilar program, SSR, while strengthening the development and commercialisation 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."

Under the agreement, GlycoNex retains sales, distribution and commercialisation rights to SPD8 in all markets outside Japan. The company is seeking commercialisation partners in these territories, while regulatory strategies for Taiwan and other markets will be determined according to 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.

The advancement of SPD8 towards commercialisation forms part of GlycoNex's strategy to establish a biosimilars business alongside its glycan-directed ADC pipeline. If approved, the candidate could expand access to denosumab-based treatment for osteoporosis in Japan while providing the company with a potential recurring revenue stream to support its broader drug development programmes.

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Antibody-drug conjugates Biosimilars GlycoNex Japan Japan Pharmaceuticals and Medical Devices Agency PMDA SPD8 Taiwan

More news about: biotechnology | Published by Abha Rustagi | November - 09 - 2026

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