crashbandicoot™4it'sabouttime| Fuhong Hanlius (02696.HK): Marketing authorization applications (MAAs) for denosumab biosimilar HLX14 were accepted by the European Medicines Agency (EMA)

Glonghui May 24 丨 Fuhong Hanlius (02696crashbandicoot™4it'sabouttime.HK) issued an announcementcrashbandicoot™4it'sabouttimeRecently, two marketing authorization applications (MAAs) for the company's independently developed Prolia® and Xgeva®(denosumab) biosimilar HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection)("HLX14") were accepted by the European Medicines Agency (EMA).

The indications for this two marketing authorization applications (MAAs) are all indications for which Prolia® and Xgeva®(denosumab) have been approved for marketing in the European Union, including: (1) Treatment of osteoporosis in postmenopausal women and men at high risk of fracture,(2) Treatment of hormone ablation-related bone loss in men with prostate cancer at high risk of fracture,(3) Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at high risk of fracture,(4) Prevention of bone related events in advanced bone malignancies in adults, and (5) Treatment of patients with giant cell tumors of bone that are unresectable or may lead to severe dysfunction after surgical resection, including adults and osseally mature adolescent patients.