Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the National Medical Products Administration (NMPA) has accepted supplemental Biologics License Application for MAIWEIJIAN (denosumab injection, R&D code: 9MW0321), a product developed by its wholly-owned subsidiary T-mab, for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

MAIWEIJIAN is the first denosumab biosimilar (120mg) approved to market in China. It was initially approved in March 2024 for the treatment of adults and skeletally mature adolescents (defined as at least 1 mature long bone and weighing ≥ 45 kg) with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. In August 2025, the product received approval from the Drug Regulatory Authority of Pakistan as the country's first denosumab biosimilar (120mg), and supply has now commenced. Mabwell has signed formal cooperation agreements for this product in 33 countries, including Brazil, Saudi Arabia, and Indonesia, and has submitted registration applications in 8 countries.

Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines. As the first denosumab biosimilar (120mg) launched in China, MAIWEIJIAN possesses early-mover advantages. Compared with bisphosphonates commonly used in clinical treatment, denosumab has the following advantages:

1.   Targeted action – It specifically binds to RANKL, blocking the RANKL/RANK/OPG signaling pathway, thereby preventing and treating SREs caused by bone metastases.

2.   Superior clinical efficacy – It demonstrates significantly better clinical efficacy than bisphosphonates and remains effective in patients who have failed bisphosphonate therapy.

3.   Favorable safety profile – It is not cleared by the kidneys, and patients receiving denosumab experience fewer renal toxicity side effects.

Previously, Mabwell published the Phase I and Phase III clinical study results of this product in International Immunopharmacology and the top-tier international journal JAMA Oncology, respectively. Through head-to-head pharmacokinetic comparisons and clinical efficacy studies in patients with bone metastases from solid tumors, the product has been systematically and comprehensively demonstrated to be similar to the reference product in terms of pharmacokinetics, pharmacodynamics, clinical efficacy, and safety.