#Taiwan #New Taipei City #GlycoNex #SPD8 #Denosumab

GlycoNex Announces Successful Patient Dosing Completion in Epic Phase 3 Study of SPD8

GlycoNex, Inc., a clinical-stage biotechnology firm based in New Taipei City, Taiwan, has announced a significant achievement: the last patient has been dosed in the Phase 3 clinical trial of SPD8, a biosimilar of denosumab. This milestone is critical as it sets the stage for the subsequent analysis phase, with top-line results anticipated in the second quarter of 2026.

The Phase 3 trial is designed to rigorously assess the pharmacokinetic equivalence, efficacy, and safety of SPD8 when compared to the original denosumab, targeting postmenopausal women with primary osteoporosis stemming from solid tumors. This robust, multicenter, double-blind study highlights GlycoNex's commitment to tackling osteoporosis and its related complications, particularly in patients with advanced cancer.

Developed in collaboration with Mitsubishi Gas Chemical (MGC), SPD8 aims to provide an essential alternative for patients facing the burden of high costs associated with denosumab therapies. The market for denosumab, branded as Prolia and Xgeva, has seen impressive growth, with total sales reaching approximately $6.60 billion globally in 2024. This statistic underscores an ongoing demand in treating both osteoporosis and oncology-related bone issues, making the introduction of SPD8 all the more crucial.

Dr. Mei-Chun Yang, CEO of GlycoNex, expressed the significance of this moment, stating, "Achieving 'last patient, last dose' in our SPD8 Phase 3 study represents a critical milestone for GlycoNex. With the trial now moving into its final phase of analysis, we are focused on advancing SPD8 toward regulatory submission and delivering a cost-effective alternative to patients who rely on denosumab therapy."

The completion of patient dosing not only signifies progress in the trial but also aligns with GlycoNex's broader strategy. The company is leveraging its expertise in complex antibody manufacturing to deliver high-quality biosimilars. Their efforts are complemented by ongoing work to develop innovative glycan-directed antibody-drug conjugates.

In line with its forward-thinking approach, GlycoNex has already out-licensed SPD8 for specific territories and continues to engage in discussions with numerous companies about the development and commercialization of its products in different regions. This partnership strategy is expected to enhance access to SPD8, particularly in markets where cost has historically posed a significant barrier to patient care.

In conclusion, GlycoNex's completion of the patient dosing phase in its Phase 3 trial of SPD8 opens the door to potentially transformative changes in osteoporosis treatment. As the company gears up for further regulatory processes, the biopharmaceutical landscape eagerly awaits the forthcoming results of this pivotal study, which could redefine accessibility to effective treatment for osteoporosis and related conditions from solid tumors.

For continuous updates on GlycoNex and its groundbreaking work in biotechnology, visit the company’s website at www.glyconex.com.tw.