Filing to Japan's PMDA
GlycoNex, Inc., a clinical-stage biotechnology company listed on the Taipei Exchange under 4168, said it has submitted a marketing authorization application to Japan's Pharmaceuticals and Medical Devices Agency for SPD8, a denosumab biosimilar candidate it co-developed with Mitsubishi Gas Chemical.
Decision possible at end of 2027
Subject to regulatory review and approval, SPD8 could be approved in Japan as early as the end of 2027, which would clear the way for a commercial launch, the company said. Preparations for a regulatory submission in Taiwan are also underway, it said, and strategies for Taiwan and other markets will be set according to local requirements.
Phase 3 met primary endpoint
The submission follows positive topline results from a randomized, double-blind, multicenter Phase 3 trial in Japan that enrolled 266 patients with osteoporosis. GlycoNex said the study met its primary endpoint by showing therapeutic equivalence to reference denosumab, measured by the percentage change from baseline in lumbar spine bone mineral density at Month 12.
Rights outside Japan retained
GlycoNex said it holds sales, distribution and commercialization rights to SPD8 in all markets outside Japan and is actively seeking partners in those markets. Dr. Mei-Chun Yang, the company's president and CEO, said in the release that the Japanese submission was a milestone in efforts to bring SPD8 to patients and to build a recurring revenue stream, and that experience gained through SPD8 would help advance a second biosimilar program, SSR. The company said that if approved, SPD8 could broaden access to an established biologic treatment for osteoporosis.