Maiwei Biopharmaceutical (688062.SH), an innovative biopharmaceutical company with a full-industry chain layout, announced that the National Medical Products Administration (NMPA) has accepted the supplemental application for adding indications for Maiweijian® (denosumab injection, R&D code: 9MW0321), independently developed by its wholly-owned subsidiary Taikang Biopharmaceutical , for the treatment of bone metastases of solid tumors and multiple myeloma (for the treatment of patients with bone metastases of solid tumors or multiple myeloma, to delay or reduce the risk of bone-related events (pathological fractures, spinal cord compression, bone radiotherapy or bone surgery)).

Maiweijian® is the first denosumab biosimilar (120mg) approved for marketing in China . It was first approved in March 2024 for the treatment of giant cell tumors of bone that are unresectable or whose surgical resection would result in severe functional impairment, including adults and skeletally mature (defined as at least one mature long bone and a weight ≥45kg) adolescents. In August 2025, the product received registration approval from the Pakistan Drug Regulatory Authority, becoming the first denosumab biosimilar approved in Pakistan for the oncology field, and is now available for shipment. The company has signed formal cooperation agreements for this product in 33 countries, including Brazil, Saudi Arabia, and Indonesia, and has submitted registration applications to 8 countries.

Denosumab is recommended by multiple expert consensus statements and treatment guidelines due to its good therapeutic effect. As the first denosumab biosimilar (120mg) to be marketed in China, Maiweijian® has a significant first-mover advantage. Furthermore, compared with bisphosphonates, a commonly used clinical treatment, denosumab has the following advantages:
1) It has a targeted effect and can play a role in the prevention and treatment of bone metastasis SREs by specifically binding to RANKL and blocking the RANKL/RANK/OPG signaling pathway;
2) The clinical efficacy is significantly better than that of bisphosphonates, and it is still effective in patients who have failed bisphosphonate treatment;
3) It has a good safety profile, is not cleared by the kidneys, and patients using denosumab experience fewer nephrotoxic side effects.

Previously, Maiwei Bio published the results of its Phase I and Phase III clinical studies of the product in the journals *International Immunopharmacology* and *JAMA Oncology*, respectively. Through head-to-head pharmacokinetic comparisons and clinical efficacy comparisons in patients with bone metastases from solid tumors, the study comprehensively and systematically demonstrated the similarity of the product to the original drug in terms of pharmacokinetics, pharmacodynamics, clinical efficacy, and safety.

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