Jingu Finance | Boan Bio (06955) announced that its independently developed tumor drug DiShuDanKang injection (120mg) - Boluja has been approved for listing by the China National Medical Products Administration for the treatment of inoperable or potentially surgically resectable giant cell tumors of bone that may cause severe functional impairment, including adult and adolescent patients with bone development maturity (defined as at least 1 mature long bone and body weight ≥45kg).
Boluja is a biosimilar to Angavi (English commodity name: XGEVA). Its development process strictly follows the biosimilar guidance principles of China, the United States, the European Union, and Japan. Through a series of progressive research in pharmacology, non-clinical, human pharmacokinetics, and clinical efficacy, it has scientifically and comprehensively demonstrated overall similarity with the reference drug. The two are highly similar in terms of quality, safety, and efficacy, with no clinically significant differences. Boluja and Angavi conducted a head-to-head comparison in two key clinical studies in China, with the results of the phase I clinical study published in the international journal "Journal of Bone Oncology" and the results of the phase III clinical study presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting in the form of a wall poster. The Company is also promoting the listing of Boluja in China for the treatment of solid tumor bone metastasis and multiple myeloma indications.