BOAN BIOTECH (06955) announced that China's National Medical Products Administration has approved a supplemental application for a new indication of BOLUOGA® (Denosumab Injection 120mg). The approval is for the treatment of patients with bone metastases from solid tumors or multiple myeloma, aiming to delay or reduce the risk of skeletal-related events such as pathological fractures, spinal cord compression, radiation to bone, or bone surgery.
BOLUOGA® is a biosimilar to XGEVA®, developed independently based on the company's global strategy. 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 market launch process for BOLUOGA® in more countries and regions worldwide.
Bone metastasis is one of the most common sites for malignant tumor spread, with over 80% of bone metastases originating from breast, prostate, lung, thyroid, and kidney cancers. Skeletal-related events are common complications of bone metastasis, including pathological fractures and spinal cord compression, which can significantly reduce patients' quality of life and affect prognosis. Multiple myeloma is the second most common hematologic malignancy and currently remains incurable. Over 80% of patients develop myeloma bone disease during the course of the illness, severely impacting their quality of life and survival rates.
The active ingredient of BOLUOGA® is denosumab, a fully human monoclonal immunoglobulin G2 antibody against RANK ligand. Denosumab works by blocking the RANKL/RANK interaction, inhibiting the formation, function, and survival of osteoclasts, thereby effectively preventing and reducing the risk of skeletal-related events. The drug is not cleared by the kidneys, so no dose adjustment is required for patients with renal impairment. Its subcutaneous injection administration offers good convenience in clinical application.
Supported by substantial evidence, denosumab is recommended as a first-line treatment for reducing and delaying skeletal-related events in guidelines issued by authoritative academic institutions such as the European Society for Medical Oncology (ESMO), the National Comprehensive Cancer Network (NCCN), and the Chinese Society of Clinical Oncology (CSCO).
The development process for BOLUOGA® strictly adhered to biosimilar guidelines from China, the United States, the European Union, and Japan. Through a series of progressive studies encompassing pharmaceutical science, non-clinical research, human pharmacokinetics, and clinical research, its overall similarity to the reference product was scientifically and comprehensively confirmed. The two are highly similar in quality, efficacy, safety, and immunogenicity, with no clinically meaningful differences.
The results of two key clinical studies for BOLUOGA® and the reference product in China have been published in the international journal *Journal of Bone Oncology*. The Phase III clinical study results were also selected for presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
Given the broad patient need and clear clinical value, denosumab demonstrates extensive market potential globally. Public data shows that XGEVA® achieved global sales of approximately $2.084 billion in 2025, with sales in the Chinese market reaching about $306 million, a year-on-year increase of 36.4% from 2024. Currently, BOLUOGA® has successfully completed an international multi-center Phase III clinical trial conducted in Europe, the United States, and Japan. Its marketing authorization application in the United Kingdom is also under review. The company plans to proceed with marketing applications for this product in the United States, the European Union, Japan, and other high-potential international markets.
Regarding the commercialization strategy for BOLUOGA®, the company employs a dual-drive approach of "self-operation + collaboration." In mainland China, the company's in-house sales team possesses extensive marketing experience, with a sales network covering over 3,000 hospitals and medical institutions. With the approval of this new indication, BOLUOGA® will form a more synergistic product portfolio with the company's other oncology drug, BYVONDA® (Bevacizumab Injection), to jointly deepen efforts in the field of cancer treatment. In the Hong Kong and Macao regions of China, the company has entered into a commercialization partnership with Sinovac Biotech for BOLUOGA®. For overseas markets, the company is collaborating with global partners to expand into more regions. This includes authorizing Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. for exclusive promotion of BOLUOGA® in the United States, partnering with Shanghai Pharmaceutical Holding Co., Ltd. to develop markets in several Southeast Asian countries, and collaborating with PHARMACARE to cover parts of Latin America.