Denosumab

Exclusive rights granted for the development and commercialization of GlycoNex’s denosumab biosimilar, SPD8 NEW TAIPEI CITY, Taiwan I January 6, 2025 I GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced a licensing agreement for its denosumab biosimilar, SPD8. This marks GlycoNex’s strategic progress and a significant milestone in its global expansion strategy. Under the terms of the agreement, the licensee will obtain rights to develop, secure regulatory approval for, and commercialize SPD8 in the designated market. The licensing agreement includes milestone payments tied to the development and commercialization progress of SPD8, further supporting GlycoNex’s global business operations. SPD8 is a biosimilar to Prolia and Xgeva (denosumab), a widely used treatment to prevent osteoporosis and skeletal-related events in patients with bone metastases from solid tumors. Following the successful completion of Phase 1 clinical trials that confirmed its safety and pharmacokinetic equivalence to the reference drug, SPD8 has entered Phase 3 clinical trial in December 2024. “We are thrilled to collaborate with a renowned pharmaceutical partner,” said Dr. Mei-Chun Yang, CEO of GlycoNex. “This agreement reinforces our commitment to expanding global access to innovative therapies and establishes a strong foundation for our growth.” Denosumab, marketed as Prolia and Xgeva, is a leading therapy for managing osteoporosis and complications associated with bone metastases in cancer patients. In 2023, global sales of denosumab products reached USD 6.1 billion, underscoring the strong demand for treatments addressing skeletal-related events. As aging population and cancer prevalence continues to rise, the need for biosimilars like SPD8 is expected to grow, presenting a significant opportunity in the global market. In addition to advancing SPD8, GlycoNex is committed to strengthening its global strategy through innovative therapeutics. The company is actively pursuing partnerships to expand denosumab’s applications and recently announced a collaboration with Sterling Pharma Solutions to manufacture antibody-drug conjugates for clinical development. This multifaceted approach highlights GlycoNex’s dedication to addressing unmet medical needs through cutting-edge science and strategic alliances. About GlycoNex Inc. GlycoNex Inc. is a clinical-stage biotechnology company focused on the development of glycan-directed cancer immunotherapies that effectively inhibit tumor growth while minimizing side effects. GlycoNex possesses a robust pipeline led by GNX102, a humanized monoclonal antibody (mAb) designed to target abnormal sugar molecules in cancer cells.  GNX102 has successfully completed Phase 1 clinical trials with data demonstrating excellent safety and promising efficacy. GlycoNex is also advancing a portfolio of antibody-drug conjugates (ADCs) that precisely attack cancer cells while sparing healthy tissue. GlycoNex is headquartered in New Taipei City, Taiwan. For more information, visit http://www.glyconex.com.tw . SOURCE: GlycoNex

TUESDAY, Jan. 7, 2025 -- For dialysis-dependent patients treated for osteoporosis , denosumab is associated with a greater preventive effect on fractures but an increased risk for major adverse cardiovascular events (MACE) compared with oral bisphosphonates, according to a study published online Jan. 7 in the Annals of Internal Medicine . Soichiro Masuda, M.D., Ph.D., from Kyoto City Hospital in Japan, and colleagues examined the risk for cardiovascular events and fracture prevention effects with denosumab versus oral bisphosphonates in dialysis-dependent patients in an observational study using data from a Japanese administrative claims database. The study included 1,032 patients: 658 denosumab users and 374 oral bisphosphonate users. The researchers found that for MACE, the weighted three-year risk difference was 8.2 percent, with a weighted three-year risk ratio of 1.36 (95 percent confidence interval, 0.99 to 1.87). For composite fractures, the weighted three-year risk difference was −5.3 percent, and the weighted three-year risk ratio was 0.55 (95 percent confidence interval, 0.28 to 0.93). "Given the high risk for cardiovascular events associated with denosumab in dialysis-dependent patients, comparative effectiveness and safety of these medications should be confirmed in future studies," the authors write.