BOAN BIOTECH (06955): Darzalex Injection Bolgajay granted new indication in China for the treatment of solid tumor bone metastasis and multiple myeloma.

Boan Biotech (06955) announced that the National Medical Products Administration of China has approved the supplemental application for the new indication of Boluga (denosumab injection 120mg), for the treatment of solid tumor bone metastasis patients or multiple myeloma patients, to delay or reduce the risk of bone-related events (pathological fractures, spinal cord compression, bone radiation therapy or bone surgery). Boluga is a biosimilar of XGEVA (denosumab) developed independently by the company based on their global strategic development. The product was first approved for marketing in China in May 2024 for the treatment of giant cell tumors. The company is also accelerating the process of launching Boluga in more countries and regions globally. Bone metastasis is one of the most common sites of cancer metastasis, with over 80% of bone metastases originating from breast cancer, prostate cancer, lung cancer, thyroid cancer, and kidney cancer. Bone-related events are common complications of bone metastasis, including pathological fractures, spinal cord compression, which significantly reduce patients' quality of life and prognosis. Multiple myeloma is the second most common malignant tumor of the hematopoietic system, currently incurable with over 80% of patients developing bone disease, severely affecting the survival quality and rate of patients. The active ingredient in Boluga is denosumab, a fully human monoclonal antibody of immunoglobulin G2 against RANK ligand. Denosumab blocks the RANKL/RANK interaction, inhibits the formation, function, and survival of osteoclasts, effectively preventing and reducing the risk of bone-related events. The drug is not cleared by the kidneys, so there is no need to adjust the dose for patients with renal impairment; its subcutaneous injection route provides convenience in clinical application. With ample evidence supporting its efficacy, denosumab is recommended as a first-line therapy to reduce and delay the occurrence of bone-related events by the European Society for Medical Oncology (ESMO), the National Comprehensive Cancer Network (NCCN), the Chinese Society of Clinical Oncology (CSCO), and other authoritative academic institutions domestically and internationally. The development of Boluga strictly follows the biosimilar guidelines of China, the United States, the European Union, and Japan, completing a series of progressively rigorous studies in pharmacy, non-clinical research, human pharmacokinetics, and clinical research, scientifically and thoroughly demonstrating its overall similarity to the reference product in terms of quality, efficacy, safety, and immunogenicity, with no clinically meaningful differences between them. Two key clinical research results of Boluga and the reference product have been published in the international journal "Journal of Bone Oncology," with the Phase III clinical research results also included in the poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Based on extensive patient demand and clear clinical value, denosumab has shown broad market potential globally. Public data shows that by 2025, XGEVA achieved global sales of approximately $2.084 billion, with sales in the Chinese market reaching around $306 million, a 36.4% year-on-year increase from 2024. Currently, Boluga has successfully completed international multicenter Phase III clinical trials in Europe, the United States, and Japan, with its marketing application under review in the UK. The company plans to submit marketing applications for the product in the United States, the European Union, Japan, and other high-potential international markets. In terms of the commercial layout of Boluga, the company adopts a dual-drive strategy of "self-operated + cooperation." In mainland China, the company's self-operated team has rich marketing experience, covering sales networks of over 3,000 hospitals and medical institutions. With the approval of the new indication, Boluga will form a more synergistic product combination with the company's other oncology drug Bowell (bevacizumab injection), jointly deepening the field of oncology treatment. In Hong Kong and Macau, the company has entered into a commercialization partnership for Boluga with Kexing Biopharm. As for the overseas market, the company is expanding into more regions through partnerships with global partners, including the exclusive promotion of Boluga in the United States by Nanjing King-Friend Biochemical Pharmaceutical and the development of multiple markets in Southeast Asia in collaboration with United Pharm Holdings, as well as cooperation with PHARMACARE to cover certain countries in Latin America.