HENLIUS's two products have been approved by the European Commission for the treatment of osteoporosis in specific populations and other indications

HENLIUS (02696.HK) announced that the marketing authorization applications (MAAs) for its products BILDYOS and BILPREVDA have been approved by the European Commission. The trademarks for these products are registered by N.V. Organon in the EU. This approval means that the two products have received centralized marketing authorization in all EU member states as well as Iceland, Liechtenstein, and Norway.

The approved indications are for all indications for Prolia and XGEVA marketed in the EU, specifically:

The indication for BILDYOS is the treatment of osteoporosis in postmenopausal women and men at high risk of fractures; treatment of bone loss associated with hormone ablation in men with high-risk prostate cancer; and treatment of bone loss related to long-term systemic glucocorticoid therapy in adult patients at high risk of fractures.

The indications for BILPREVDA include the prevention of skeletal-related events in adults with advanced bone malignancies; and treatment of patients with giant cell tumors of the bone that are not amenable to surgical resection or may lead to severe functional impairment after surgical resection, including adults and skeletally mature adolescents