Maiweijian® is one of the first-tier denosumab biosimilars (120mg) approved for marketing in China. It was first approved in March 2024 for the treatment of giant cell tumor of bone that is unresectable or where surgical resection may lead to severe functional impairment, including in adults and skeletally mature adolescents (defined as having at least one mature long bone and weighing ≥45 kg). In August 2025, the product received registration approval from the Drug Regulatory Authority of Pakistan, becoming the first denosumab biosimilar in the oncology field approved in Pakistan, and began supply that year. The company has signed formal cooperation agreements for this product in 33 countries, including Brazil, Colombia, Indonesia, Singapore, Pakistan, Thailand, Egypt, Peru, Saudi Arabia, Vietnam, and Malaysia, and has submitted registration application documents to 8 countries, including Jordan, Egypt, and Brazil.
Due to its favorable therapeutic effects, denosumab is recommended by multiple expert consensus statements or treatment guidelines. As one of the first-tier denosumab biosimilars (120mg) approved in China, Maiweijian® has a clear first-mover advantage. Additionally, compared with bisphosphonates, which are commonly used in clinical treatment, the advantages of denosumab include:
- Targeted action: It specifically binds to RANKL to block the RANKL/RANK/OPG signaling pathway, thereby preventing and treating skeletal-related events (SREs) from bone metastases;
- Significantly superior clinical efficacy compared to bisphosphonates, and it remains effective in patients who have failed bisphosphonate therapy;
- Good safety profile: It is not cleared through the kidneys, and patients receiving denosumab experience fewer renal toxic 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 comparison studies in patients with solid tumor bone metastases, the company comprehensively and systematically demonstrated the similarity of this product to the original drug in terms of pharmacokinetics, pharmacodynamics, clinical efficacy, and safety.
About Mabwell
Mabwell (688062.SH, 02493.HK) is an innovative biopharmaceutical company with a full industry chain layout. Always adhering to the vision of “Turning Innovation into Reality” and fulfilling the mission of “Exploring Life, Benefiting Health,” the company provides patients with better efficacy and more accessible innovative biologics through original innovation, addressing unmet clinical needs globally. Since its establishment in 2017, Mabwell has built an innovation system covering the entire drug development cycle, starting from antibody drug target discovery and molecular discovery, and encompassing druggability research, preclinical research, clinical research, and production transformation, achieving a full industry chain layout integrating R&D, production, and marketing. We focus on oncology and age-related diseases, involving therapeutic areas such as oncology, autoimmune diseases, bone diseases, ophthalmology, hematology, and cardiovascular diseases. Leveraging internationally leading proprietary technology platforms and R&D innovation capabilities, we have established a rich and competitive pipeline. Currently, we have 16 key products at various stages, including preclinical, clinical, or marketing stages, comprising 12 innovative products and 4 biosimilars. Among them, 4 products are on the market, 1 product is under marketing review, and 2 products are in Phase III pivotal registration clinical trials. The company independently undertakes 1 National “Major New Drug Creation” Major Science and Technology Project, 2 National Key R&D Programs, and multiple provincial and municipal science and technology innovation projects. Mabwell is innovation-oriented and emphasizes industrial transformation. Its antibody and recombinant protein drug industrialization base, compliant with China NMPA, US FDA, and EU EMA GMP standards, has been put into operation in Taizhou, Jiangsu, and has passed the EU QP audit. Large-scale commercial production bases in Jinshan, Shanghai, and Taizhou, Jiangsu, are under construction. For more information, please visit: www.mabwell.com.
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