GlycoNex Begins Phase 3 Trial Dosing for Denosumab Biosimilar

GlycoNex, Inc., a biotechnology company based in New Taipei City, Taiwan, has achieved a significant milestone with the commencement of a Phase 3 clinical trial for its denosumab biosimilar, SPD8. This trial marks a pivotal point in evaluating SPD8's effectiveness in treating osteoporosis. The initial dosing of the first patient signifies the start of this crucial research phase, with results that remain undisclosed anticipated by the second quarter of 2026.

SPD8 has been developed in collaboration with Mitsubishi Gas Chemical Company and serves as a biosimilar to existing treatments Xgeva and Prolia, which are commonly used to prevent skeletal complications in patients with bone metastases and osteoporosis. The successful completion of Phase 1 clinical trials confirmed that SPD8 is both safe and comparable in pharmacokinetics to the original drug, which facilitated its advancement to the current Phase 3 trial. To support this development, GlycoNex has entered into a production agreement with EirGenix, Inc., Taiwan's largest contract development and manufacturing organization, to enable large-scale production of SPD8.

Dr. Mei-Chun Yang, CEO of GlycoNex, emphasized the importance of this trial, stating that the increasing demand for osteoporosis treatments has driven the company's commitment to developing affordable and effective therapeutic options. With the global sales of denosumab products reaching USD 6.1 billion in 2023, the development of cost-efficient biosimilars like SPD8 is crucial, especially given the rising incidence of osteoporosis and the aging population in Asia.

Beyond SPD8, GlycoNex is also expanding its efforts in oncology. The company's leading monoclonal antibody, GNX102, has shown excellent safety and tolerability in Phase 1 clinical trials. GlycoNex is preparing to develop GNX102 into an antibody-drug conjugate, partnering with Sterling Pharma Solutions to further this endeavor. These initiatives reflect GlycoNex's commitment to advancing significant therapies to address global health challenges.

GlycoNex is focused on developing glycan-targeted cancer immunotherapies that aim to effectively curb tumor growth while minimizing adverse effects. The company boasts a strong pipeline, with GNX102 positioned as a prominent humanized monoclonal antibody designed to target specific sugar molecules present in cancer cells. The successful Phase 1 trials for GNX102 have shown promising safety and efficacy data, underscoring the potential of GlycoNex's innovative approaches. Additionally, GlycoNex is working on a range of antibody-drug conjugates designed to precisely target cancer cells while sparing healthy tissue.

GlycoNex's headquarters are located in New Taipei City, Taiwan. Through its ongoing research and collaborations, GlycoNex continues to push the boundaries of biotechnology, aiming to deliver impactful therapies that address pressing health issues across the globe. With its innovative projects like SPD8 and GNX102, GlycoNex is well-positioned to make significant contributions to the fields of osteoporosis treatment and oncology.