HENLIUS (02696) announced that the European Commission has recently approved the Marketing Authorization Applications (MAAs) for two products, BILDYOS® and BILPREVDA®. These brand names are registered trademarks of N.V. Organon in the European Union. This approval grants centralized marketing authorization for BILDYOS® and BILPREVDA® across all EU member states as well as Iceland, Liechtenstein, and Norway (each being European Economic Area countries).

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

Product One - BILDYOS® (60 mg/mL): (1) Treatment of osteoporosis in postmenopausal women and men at high risk of fracture; (2) Treatment of bone loss associated with hormone ablation in men with prostate cancer at high risk of fracture; and (3) Treatment of bone loss associated with long-term systemic glucocorticosteroid treatment in adult patients at high risk of fracture.

Product Two - BILPREVDA® (120 mg/1.7 mL): (1) Prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression, or bone surgery) in adults with advanced malignancies involving bone; and (2) Treatment of giant cell tumor of bone in patients where surgical resection is not feasible or where surgical resection is likely to result in severe morbidity, including adults and skeletally mature adolescents.

This approval is primarily based on a comprehensive review of comparative study data between HLX14 (denosumab) and its reference product (Prolia®), including analytical similarity studies and clinical comparative studies. These studies fully demonstrated the high similarity between HLX14 and its reference product in terms of quality, safety, and efficacy. The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) Biosimilar Guideline (CHMP/437/04 Rev1) allows extrapolation of relevant clinical safety and efficacy data to other approved indications of the reference product.

In June 2025, the Group received two GMP certificates from the Belgian Federal Agency for Medicines and Health Products, confirming that HLX14-related production lines comply with EU GMP standards. Additionally, in July 2025, HLX14 received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending approval of the Marketing Authorization Applications (MAAs) for BILDYOS® and BILPREVDA®.

Following the previous approval in the United States, this EU approval of BILDYOS® and BILPREVDA® represents another recognition of the Group's products in major international markets, further advancing the company's international expansion strategy and enhancing the global influence of its products.