GlycoNex's SPD8 Phase 3 Trial Meets Primary Endpoint, Plans Taiwan Drug Approval Application Next Year

Taiwan's GlycoNex announced on the 11th that the Phase 3 clinical trial of SPD8, a Denosumab biosimilar for reducing bone loss co-developed with Japan's Mitsubishi Gas Chemical, has completed unblinding. The results met the pre-defined equivalence criteria. The company plans to complete the trial report in September and apply for drug approval in Japan. Simultaneously, it plans to apply for drug approval in Taiwan next year, with a target of launching sales by the end of 2027.

In a press release issued today, GlycoNex stated that Denosumab is a core medication in global orthopedics and oncology supportive care, with clinical applications spanning two major markets: 'Prolia for treating osteoporosis' and 'Xgeva for preventing skeletal-related events caused by cancer bone metastases.'

The drug's mechanism of action directly targets the root cause of bone loss by precisely blocking RANKL (a key protein that promotes the formation and activation of osteoclasts), thereby reducing bone loss, increasing bone density, and lowering fracture risk.

From the early stages of R&D, GlycoNex's SPD8 adopted a dual-indication strategy, simultaneously targeting the clinical applications of both Prolia and Xgeva. GlycoNex stated that the quality analysis comparisons and development data preparation for both indications are complete, and it will submit two drug approval applications to Japan's PMDA.

GlycoNex also stated that it is planning for local manufacturing in Taiwan. As Denosumab is a biologic that requires long-term, regular administration, recent global pharmaceutical supply chain events have shown that a supply system heavily reliant on imported biologics may face shortage risks due to external factors.

GlycoNex pointed out that the local manufacturing strategy aligns with the government's policy direction of promoting self-sufficiency in the supply of key biologics. Against the backdrop of Taiwan's aging population and rising demand for osteoporosis treatment, this strategy aims to provide patients with long-term medication options.