On May 27, Ge Longhui | Boan Biotech (06955.HK) announced that the company's self-developed dysulumab injection (120mg) - Boroga has been approved by the China National Drug Administration for the treatment of bone giant cell tumors that cannot be surgically removed or may cause serious functional impairment, including adults and young patients with mature bone development (defined as at least 1 mature bone and body weight greater than 45 kg).

Boroga is a biosimilar of Agave (English product name: XGEVA). Its development process strictly follows the biosimilar guidelines of China, the United States, the European Union, and Japan. Through a series of progressive studies on pharmacy, non-clinical, human pharmacokinetics, and clinical efficacy, the overall similarity with the original reference drug was scientifically and completely confirmed; the two are highly similar in quality, safety, and efficacy, with no differences in clinical significance. Boroga and Agavi were compared head-to-head in two key clinical studies in China. Among them, the results of the phase I clinical study were published in the international journal “Journal of Bone Oncology”, and the results of the phase III clinical study were presented in the form of a poster at the 2023 American Society of Clinical Oncology (ASCO) annual meeting.

The company is also promoting the marketing of Boroga in China for bone metastasis from solid tumors and multiple myeloma indications. In addition to the Chinese market, the company is also actively simultaneously promoting its international clinical trials and registration. The phase I clinical trial conducted in Europe has been completed; the European, American, and Japanese international multi-center phase III clinical trial has completed the enrollment of all subjects. After the clinical trial is completed, Boan Biotech will submit marketing applications to the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Japan Pharmaceuticals and Medical Devices Agency (PMDA) respectively, and plans to market the product in more countries and regions around the world. Bone giant cell tumor is a borderline primary bone tumor. It accounts for 13.7% to 17.3% of all primary bone tumors in China; it is locally invasive, can recur locally and metastasize far away, and is seriously life-threatening. For patients who can be surgically resected, surgery can be downgraded or even avoided after treatment with desumab; for patients who cannot be surgically resected, treatment can effectively control the disease over a long period of time and improve the quality of life. In addition to being used to treat giant cell tumors of bone, XGEVA has also been approved globally for the treatment of bone metastases from solid tumors, multiple myeloma, and malignant neoplastic hypercalcemia. With more than ten years of clinical application experience, desumab has accumulated rich clinical evidence and received drug recommendations from many authoritative guidelines at home and abroad, including the European Society of Oncology (ESMO), the US National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology (ASCO), and the Chinese Society of Clinical Oncology (CSCO).

The company believes that under the combined impetus of various factors such as huge patient demand and good clinical value, Boroga will have broad market prospects on a global scale.