Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the supplemental application for MAIWEIJIAN (Denosumab Injection, R&D code: 9MW0321), which was independently developed by its wholly-owned subsidiary T-mab, has been approved by the National Medical Products Administration (NMPA) for additional indications of bone metastases from solid tumors and multiple myeloma (for the treatment of patients with bone metastases from solid tumors or patients with multiple myeloma, to delay or reduce the risk of skeletal-related events (pathological fracture, spinal cord compression, bone radiotherapy, or bone surgery)) .

MAIWEIJIAN is one of the first-tier approved biosimilars of Xgeva® in China. Marketing authorization application of MAIWEIJIAN was approved by the NMPA on March 2024 for the treatment of unresectable giant cell tumor of bone or cases where surgical resection may cause severe dysfunction, including adult patients and skeletally mature adolescent patients (defined as having at least 1 mature long bone and a body weight of ≥45kg). In terms of overseas commercialization, in August 2025, the product received registration approval from the Drug Regulatory Authority of Pakistan, marking the first biosimilar of Xgeva® approved in Pakistan, and the product has already been supplied in the country. Mabwell has signed formal cooperation agreements for 9MW0321 with 33 countries including Brazil, Colombia, Indonesia, Singapore, Pakistan, Thailand, Egypt, Peru, Saudi Arabia, Vietnam, and Malaysia. Registration applications have been submitted to 8 countries such as Jordan, Egypt, and Brazil.

Due to its satisfactory therapeutic efficacy, denosumab is recommended by multiple expert consensuses or in clinical treatment guidelines. As one of the first-tier biosimilars of Xgeva® marketed in China, MAIWEIJIAN boasts prominent first-mover advantages. Compared with bisphosphonates commonly used in clinical practice, denosumab has the following strengths:

1.   It features targeted action. It specifically binds to RANKL to block the RANKL/RANK/OPG signaling pathway, thereby preventing and treating skeletal-related events caused by bone metastasis;

2.   Its clinical efficacy is markedly superior to that of bisphosphonates, and it remains effective in patients with treatment failure after bisphosphonate therapy;

3.   It enjoys favorable safety profiles as it is not eliminated via renal pathways, leading to a lower incidence of nephrotoxic adverse reactions in patients treated with denosumab.

Previously,Mabwell successively published the Phase I and Phase III clinical research findings of denosumab biosimilar in International Immunopharmacology and JAMA Oncology, one of top-tier international journals, respectively. Through “head-to-head” pharmacokinetic comparison and clinical efficacy comparison studies conducted in patients with solid tumor bone metastases, the similarities between 9MW0321 and the reference original drug in terms of pharmacokinetics, pharmacodynamics, clinical efficacy and safety have been fully and systematically verified.