Boan Biotech announced today that China’s National Medical Products Administration (NMPA) has approved the supplemental application for Boluojia® (denosumab injection 120 mg) for the treatment of patients with bone metastases from solid tumors or multiple myeloma, to delay or reduce the risk of skeletal-related events (SREs), which include pathological fractures, spinal cord compression, and bone-directed radiation or surgery.
These are the new indications approved for Boluojia, a biosimilar to Xgeva®. The product was first approved in China in May 2024 for the treatment of giant cell tumor of bone. The company is also accelerating the launch of Boluojia in more countries and regions worldwide.
Denosumab is a preferred bone-targeted therapy, and Boluojia has high biosimilarity to Xgeva
Bone is one of the most common sites for the metastasis of malignancies.1 Over 80% of bone metastases originate from breast, prostate, lung, thyroid, and kidney tumors.2 SREs such as pathological fractures and spinal cord compression are common complications of bone metastasis. They significantly reduce the quality of life for patients and compromise their clinical prognosis.2 Furthermore, over 80% of patients with multiple myeloma, the second most common and currently incurable hematologic malignancy, will develop myeloma bone disease, which significantly undermines patient survival and quality of life.3
The active ingredient of Boluojia is denosumab, a fully human IgG2 anti-RANKL monoclonal antibody. Denosumab inhibits osteoclast formation, function, and survival by blocking the RANKL-RANK interaction, thereby effectively preventing and reducing the risk of SREs.2 As the drug is not subject to renal clearance, no dose adjustment is required for patients with renal impairment. Furthermore, it can be conveniently administered via subcutaneous injection.4 Supported by robust clinical evidence, denosumab is recommended as a first-line therapy for reducing or delaying SREs by multiple authoritative guidelines, including those of the European Society for Medical Oncology (ESMO), the U.S. National Comprehensive Cancer Network (NCCN), and the Chinese Society of Clinical Oncology (CSCO).5,6,7
Boan Biotech developed Boluojia strictly in accordance with the biosimilar guidelines of China, the U.S., the EU, and Japan. Its similarity to the reference product Xgeva has been demonstrated through a series of studies, including pharmaceutical, non-clinical, human pharmacokinetic, and clinical studies. In particular, Boluojia has been shown to be highly similar to the reference product in terms of quality, efficacy, safety, and immunogenicity, with no clinically meaningful differences. The results of two pivotal clinical studies in China comparing Boluojia with the reference product were published in the Journal of Bone Oncology,8,9 and the results of a Phase 3 clinical trial were presented as a poster at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Commercializing Boluojia in China and international markets to address patient needs
Driven by strong patient demand and well-established clinical value, denosumab demonstrates broad and promising market prospects worldwide. Publicly available data show that global sales of Xgeva in 2025 were approximately USD 2.084 billion,10 of which approximately USD 306 million was generated in China, representing a year-on-year increase of 36.4% from 2024.11
An international multicenter Phase 3 clinical trial has been completed for Boluojia in Europe, the U.S., and Japan, and the marketing authorization application for the drug in the U.K. is under review. Boan Biotech further plans to submit marketing authorization applications for Boluojia in the U.S., the EU, Japan, and other high-potential international markets.
Boan Biotech adopts a two-pronged approach to commercialize Boluojia: in-house sales & marketing + partnership building. In the Chinese mainland, the company has an experienced sales & marketing team and a robust sales network spanning over 3,000 hospitals and other medical facilities. With the approval of the new indications, Boluojia will complement the oncology portfolio of Boan Biotech, which includes Boyounuo® (bevacizumab injection), and strengthen the company’s presence in this therapeutic area. In the Hong Kong and Macao SARs, the company has partnered with Kexing Biopharm Co., Ltd. (Kexing Biopharm) to commercialize Boluojia. Overseas, it is expanding the footprint of the drug through partnerships as well. Specifically, the company has granted Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF) exclusive rights to commercialize Boluojia in the U.S., and has partnered with Shanghai Pharmaceutical Co., Ltd. (Shaphar) and Pharmacare to commercialize the drug in some Southeast Asian countries and some Latin American countries respectively.
Jiang Hua, Chairlady and Chief Executive Officer at Boan Biotech, said:“The approval of the new indications for Boluojia has extended the application of the drug into the new frontiers where there is an even stronger demand for it from patients, and this marks a new phase for us in commercializing the product in China. The newly approved indications apply to patients covered by our existing oncology sales network and our established sales channels for Boyounuo, and this will create a strong synergy for our entire oncology portfolio. Beyond China, Boluojia is one of the first drugs of strategic significance for us to expand globally. We are working closely with our international partners to accelerate its marketing authorization abroad, driven by our commitment to delivering high-quality biologics to patients around the world.”
References：
1.Wang M, Xia F, Wei Y, Wei X. Molecular mechanisms and clinical management of cancer bone metastasis. Bone Res. 2020;8:30. doi: 10.1038/s41413-020-00105-1.
2.Breast Cancer Expert Group of Oncologist Branch of Chinese Medical Doctor Association, International Medical Exchange Branch of China Anti-Cancer Association. Consensus on the safety of bone-modifying agents in the treatment of bone metastases from malignant tumors (2024 edition) [J]. Chinese Journal of Oncology, 2024, 46(7): 637-645.
3.Orthopaedic Oncology and Bone Metastasis Committee of China Anti-Cancer Association. Expert consensus on surgical treatment of multiple myeloma bone disease (2022 edition) [J]. Chinese Journal of Clinical Oncology, 2022, 49(13): 649-659.
4.Denosumab Injection Package Insert.
5.GENNARI A, ANDRE F, BARRIOS C H, et al. 2021. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol [J], 32: 1475-1495.
6.NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer.Version5.2026—March 13,2026.
7.Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of prostate cancer 2023.
8.Ding Y, Liu Y, Dou C, et al. A randomized trial comparing LY01011, biosimilar candidate, with the reference product denosumab (Xgeva®) in healthy Chinese subjects. J Bone Oncol. 2023;42:100499.
9.Zhao M, Hu X, Zhuang P, et al. A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumors. J Bone Oncol. 2025;51:100661. doi: 10.1016/j.jbo.2025.100661.
10.Amgen 2025 Annual Report.
11.BeOne Medicines Ltd., 2025 Annual Report.
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