GlycoNex announced on the 16th that the Phase I clinical trial of SPD8, a Denosumab biosimilar co-developed with Japan’s Mitsubishi Gas Chemical Company (MGC), has been successfully completed in Japan. The company plans to initiate a larger-scale Phase III clinical trial in the fourth quarter of this year, focusing on patients with osteoporosis.

According to the results of the Phase I trial, SPD8 has demonstrated safety and bioequivalence comparable to the original Denosumab product in a study involving healthy postmenopausal women. Following the successful assessment of safety and bioequivalence, biosimilars like SPD8 can proceed directly to Phase III clinical trials, bypassing the traditional Phase II trials. Therefore, GlycoNex is set to begin Phase III trials in the fourth quarter of 2024, evaluating the efficacy, safety, and immunogenicity of SPD8 in a larger patient population with osteoporosis.

Mei-Chun Yang, General Manager of GlycoNex, highlighted that the successful completion of the Phase I trial marks a significant milestone in the development of the Denosumab biosimilar. It also reflects GlycoNex's commitment to making advanced biologic therapies more accessible and reducing the burden on patients.

In 2023, the global sales of Denosumab, marketed under the brand names Prolia and Xgeva, reached $6.1 billion, and with the growing awareness of osteoporosis risk, the market continues to expand. GlycoNex is actively advancing its global development plans, not only targeting the Japanese market but also aiming to provide more diverse treatment options for patients worldwide. Yang expressed great excitement about the progress of SPD8 and its potential to expand GlycoNex’s future revenue streams, while also demonstrating the company’s expertise in monoclonal antibody engineering.

Resource (mandarin): 醣聯完成生物相似藥SPD8一期試驗 將啟動三期臨床