Taiwan-based pharmaceutical company GlycoNex Inc (TWO:4168) announced on Wednesday that the Phase III clinical trial for SPD8, a Denosumab biosimilar co-developed with Mitsubishi Gas Chemical, successfully met its primary endpoint.

Statistical analysis confirms that SPD8 demonstrated therapeutic equivalence to the reference drug, Prolia (marketed as Pralia in Japan). The company expects to finalise the clinical study report by the end of September, followed by a drug approval application in Japan. Japan MAA submission is expected in third quarter 2026. An application for marketing authorisation in Taiwan is scheduled for next year, with a target launch date by the end of 2027.

The SPD8 Phase III clinical trial was a randomised, double-blind, multicentre study, conducted in Japan, involving a total of 266 subjects. The treatment period was 12 months. Subjects were randomised in a 1:1 ratio to receive either SPD8 or the reference product, administered as a subcutaneous injection once every six months for a total of two doses, followed by evaluation to Month 12.

According to the company, the primary efficacy endpoint was the percentage change from baseline in lumbar spine bone mineral density (BMD) at Month 12. The study was designed to evaluate the therapeutic equivalence of SPD8 and the reference product in subjects with osteoporosis. The analysis showed that the between-group difference in the primary efficacy endpoint, together with its 95% confidence interval, met the pre-specified equivalence criteria defined prior to unblinding.

GlycoNex is seeking regional licensing and distribution partners worldwide to support future market access and supply.