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

Bo 'an Biotech (06955) issued an announcementbaccaratmassenaThe 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 unresectable or surgically resectable may lead to severe dysfunction., including adults and adolescent patients with skeletal maturity (defined as at least one mature long bone and a weight ≥45kg).

Bologa ® is an English trade name for Angavi ®baccaratmassena: XGEVA®) biosimilar drugs, its research and development process strictly follows the guiding principles related to biosimilar drugs of China, the United States, the European Union, and Japan, and through a series of gradual and progressive studies of pharmacy, non-clinical, human pharmacokinetics, and clinical effectiveness, scientifically and completely confirm its overall similarity with the original reference drug; the two are highly similar in quality, safety and effectiveness, and there are no clinical significance differences. 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.