Mabwell Biopharmaceutical (688062.SH, 02493.HK), an innovative biopharmaceutical company with a full-industry-chain layout, announced that its wholly-owned subsidiary, Taikang Biopharmaceutical, has received approval from the National Medical Products Administration for its supplemental application to add the indications for 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) for its independently developed Mabwelljian® (Denosumab injection, R&D code: 9MW0321) .

Mabwelljian® is the first denosumab biosimilar (120mg) to be 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 began supplying it 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 applications to 8 countries, including Jordan, Egypt, and Brazil.

Denosumab is recommended by multiple expert consensus statements and treatment guidelines due to its good therapeutic effect. As one of the first denosumab biosimilars (120mg) to be launched in China, Mabwelljian® has a significant first-mover advantage. Furthermore, compared with bisphosphonates, commonly used in 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, Mabwell 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.

About Mabwell Biotechnology

Mabwell Biopharmaceuticals (688062.SH, 02493.HK) is an innovative biopharmaceutical company with a full-industry-chain layout. Adhering to the vision of "turning innovation from dreams into reality" and the mission of "exploring life and benefiting health," Mabwell Biopharmaceuticals provides patients with more effective and accessible innovative biological drugs through original innovation, meeting unmet clinical needs globally. Since its establishment in 2017, Mabwell Biopharmaceuticals has built an innovative system covering the entire drug development cycle, starting with antibody drug target discovery and molecular discovery, encompassing drug development research, preclinical research, clinical research, and production translation. This has resulted in a full-industry-chain layout integrating R&D, production, and marketing. We focus on oncology and age-related diseases, covering therapeutic areas such as oncology, autoimmune diseases, bone diseases, ophthalmology, hematology, and cardiovascular diseases. Leveraging our internationally leading specialized technology platform and R&D innovation capabilities, we have established a rich and competitive pipeline. Currently, the company has 16 key products in preclinical, clinical, or market-ready stages, including 12 innovative products and 4 biosimilars. Of these, 4 are marketed, 1 is under market review, and 2 are in Phase III pivotal registration clinical trials. The company has independently undertaken 1 National Major New Drug Development Project, 2 National Key R&D Programs, and multiple provincial and municipal science and technology innovation projects. Mabwell Biotech is innovation-driven and focuses on industrial transformation. Its antibody and recombinant protein drug industrialization base, compliant with China's NMPA, the US FDA, and the EU EMA GMP standards, is already operational in Taizhou, Jiangsu Province, and has passed the EU QP audit. Large-scale commercial production bases in Jinshan, Shanghai, and Taizhou, Jiangsu Province, are under construction. For more information, please visit: www.mabwell.com.

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