theincrediblecrashdummies| Bo 'an Biotech (06955): Denosumab Injection in Oncology Field (120mg)-Bloga? Approved for listing by the State Food and Drug Administration
editor 2024-05-27 13:54:32 Home 34
Zhitong Finance APP Newstheincrediblecrashdummies, Bo 'an Biotech (06955) issued an announcementtheincrediblecrashdummiesThe company's independently developed denosumab injection (120mg)-Bologa in the oncology field has been approved for marketing by the State Food and Drug Administration of China for the treatment of giant cell tumors of bone that are not surgically resectable 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 a biosimilar of XGEVA (English trade name: XGEVA). Its research and development process strictly follows the relevant 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 effectiveness, it has scientifically and completely confirmed its overall similarity to the original reference drug; the two are highly similar in quality, safety and effectiveness, and there are no differences in clinical significance. Bologa and Angavi conducted head-to-head comparisons 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 the 2023 American Clinical Oncology Society (ASCO) Annual Meeting. It is displayed in the form of a poster. The company is also promoting the listing of Boroga in China for the indications of bone metastases from solid tumors and multiple myeloma.
Outside the Chinese market, the company is also actively promoting its international clinical and registration simultaneously. The Phase 1 clinical trial conducted in Europe has been completed; the European, American and Japanese international multi-center Phase 3 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 Administration (EMA), the U.S. Food and Drug Administration (FDA), and the Japan Pharmaceutical and Medical Devices Corporation (PMDA) respectively, and plans to market the product in more countries and regions around the world.
The announcement said that driven by multiple factors such as huge patient needs and good clinical value, Bologatheincrediblecrashdummies? It will have broad market prospects on a global scale.