The Chinese Society of Clinical Oncology (CSCO) Annual Meeting was recently held, during which the updated version of the CSCO Guidelines series was released. Mabwell's MW032 (Denosumab injection, trade name: Maiweijian) has been included in the CSCO Guidelines for the Diagnosis and Treatment of Breast Cancer (2024 edition).

According to the 2024 edition guidelines, denosumab has been included in the IA level recommendation for the treatment of bone metastases from breast cancer. The guidelines state that studies have shown the denosumab biosimilar (MW032) to be similar to the originator product in terms of effectiveness, safety, and population pharmacokinetics in patients with solid tumors that have metastasized to the bone. Therefore, for patients in need of bone-modifying agents, the denosumab biosimilar can also be considered. [1]

About MW032
MW032 (Maiweijian) is a 120mg denosumab biosimilar developed by Mabwell. It received marketing approval in China on March 29, 2024. The Phase III clinical study results of MW032 were published in the JAMA Oncology [2]. The study comprehensively and systematically demonstrated the equivalence of MW032 to the originator denosumab in terms of clinical efficacy for the treatment of solid tumors with bone metastases. Additionally, MW032 showed similarity to the originator in terms of safety, immunogenicity, and population pharmacokinetics.

References:
[1] Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Breast Cancer (2024 edition)
[2] Zhang S, et al. JAMA Oncol. 2024 Feb 8:e236520.