bcgamenodepositbonus| Bo 'an Bio (06955.HK) Denosumab Injection in Oncology Field (Bloga?) Approved for marketing for the treatment of giant cell tumors of bone that are unresectable or that may cause severe dysfunction by surgical resection
Gelonghui, May 27th (06955.HK) announced that the company independently developed desumab injection (120mg)-Broca in the field of tumor.Bcgamenodepositbonus? It has been approved by China's State Drug Administration to market for the treatment of giant cell tumors of bone that are unresectable or surgically removed that may cause severe dysfunction, including adults and adolescent patients with mature bones (defined as at least 1 mature long bone and weight ≥ 45kg).
BrocaBcgamenodepositbonus? Is it Angarve? (English trade name: XGEVA?) The research and development process of biological similar drugs strictly follows the relevant guiding principles of biological similar drugs in China, the United States, the European Union and Japan, through a series of progressive studies on pharmacy, non-clinical, human pharmacokinetics and clinical effectiveness, scientific and complete confirmationBcgamenodepositbonusThe overall similarity between it and the original reference drug; they are highly similar in quality, safety and effectiveness, and there is no difference in clinical significance. Broca? With Angarve? In two key clinical studies in ChinaBcgamenodepositbonusThe results of phase Ⅰ clinical study were published in the international journal Journal of Bone Oncology, and the results of phase Ⅲ clinical study were presented as a wall post at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2023.
The company is also promoting Broca? For the listing of solid tumor bone metastasis and multiple myeloma indications in China. Outside the Chinese market, the company is also actively promoting its international clinical and registration. The phase Ⅰ clinical trial in Europe has been completed; the European, American and Japanese international multicenter phase Ⅲ clinical trial has been completed and all subjects have been enrolled. After the completion of the clinical trial, Boan Biology will submit listing applications to the European Drug Administration (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceutical and Medical device complex (PMDA), respectively, and plan to market the product in more countries and regions around the world. Giant cell tumor of bone is a borderline primary bone tumor, accounting for 13.7%-17.3% of all primary bone tumors in China. It has local invasiveness, local recurrence and distant metastasis, and can be life-threatening. For patients who can be resectable, after treatment with deschumab, surgical degradation can be achieved, and even surgery can be avoided; for patients who cannot be resectable, treatment can effectively control the disease for a long time and improve the quality of life. Besides being used in the treatment of giant cell tumor of bone, XGEVA? It has also been approved worldwide for the treatment of solid tumor bone metastasis and multiple myeloma and malignant hypercalcemia. With more than ten years of clinical application experience, desumumab has accumulated rich clinical evidence and has been recommended by many authoritative guidelines at home and abroad, including European Society of Oncology (ESMO), National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), Chinese Society of Clinical Oncology (CSCO) and so on.
The company believes that Broca is driven by a variety of factors, such as huge patient demand and good clinical value. It will have a broad market prospect all over the world.
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