HENLIUS (02696) announced that the company has recently received approval letters from the U.S. Food and Drug Administration (FDA), granting approval for the Biologics License Applications (BLA) of two products: BILDYOS® and BILPREVDA®. These brand names are registered trademarks of N.V. Organon in the United States.

The approved indications specifically include:

Product One: BILDYOS® (60 mg/mL): (1) Treatment of osteoporosis in postmenopausal women at high risk for fracture; (2) Treatment to increase bone mass in men with osteoporosis at high risk for fracture; (3) Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; (4) Treatment to increase bone mass in men with non-metastatic prostate cancer receiving androgen deprivation therapy who are at high risk for fracture; (5) Treatment to increase bone mass in women with breast cancer receiving adjuvant aromatase inhibitor therapy who are at high risk for fracture.

Product Two: BILPREVDA® (120 mg/1.7 mL): (1) Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; (2) Treatment of giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity in adults and skeletally mature adolescents; (3) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

The FDA approval was primarily based on a comprehensive review of comparative study data between HLX14 (denosumab) and its reference drug (Prolia®), including analytical similarity studies and clinical comparative studies. These study data fully demonstrated the high degree of similarity between HLX14 and its reference drug in terms of quality, safety, and efficacy.

According to the FDA industry guidance "Scientific Considerations in Demonstrating Biosimilarity to a Reference Drug," HLX14 has been approved for all indications currently approved for the reference drugs Prolia® and XGEVA® in the United States.

Additionally, the company's HLX14-related manufacturing sites and facilities underwent FDA Pre-License Inspection (PLI), and these manufacturing sites and facilities all comply with FDA cGMP requirements.

Following the approval of BILDYOS® and BILPREVDA® for market launch, the company now has a cumulative total of six products approved for overseas markets and three products approved in the United States, further deepening its global commercialization footprint.

This approval represents another recognition of the company's products by major international markets, which will further advance the company's internationalization strategy and enhance the international influence of its products.