streppoker| Bo 'an Bio: Denosumab Injection (120mg) in the Oncology Field-Bloga ® has been approved by the State Food and Drug Administration for marketing

Boan Biotech (06955) announced that the company's independently developed denosumab injection (120mg)-Bloga ® in the oncology field has been approved by the State Food and Drug Administration of China for the treatment of giant cell tumors of bone that are not surgically resectable or surgical resection may cause severe dysfunction, including adults and adolescent patients with mature bones (defined as at least one mature long bone and a weight ≥45kg).

Bloga ® is a biosimilar of XGEVA ® (English trade name: XGEVA®). Its research and development process strictly follows the guiding principles related to biosimilars of China, the United States, the European Union, and Japan. It has been scientifically and completely confirmed through a series of progressive studies on pharmacokinetics and clinical effectiveness in pharmacy, non-clinical, and human body.streppokerThe overall similarity between the two and the original reference drug was analyzed; the two are highly similar in terms of quality, safety and effectiveness, and there is no clinically significant difference. Bloga ® and Angavi ® were compared head-to-head in two key clinical studies in China. 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 published in 2023. It was displayed in the form of a poster at the American Society of Clinical Oncology (ASCO) annual meeting. The company is also promoting the launch of Bloga ® in China for the indications of bone metastases from solid tumors and multiple myeloma.