HENLIUS (02696) announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for its self-developed denosumab biosimilar HLX14 (recombinant fully human anti-RANKL monoclonal antibody injection). The NDA covers all indications approved in China (excluding Hong Kong, Macau, and Taiwan) for the reference drug Prolia®, including: treatment of osteoporosis in postmenopausal women at high risk of fracture; reduction of vertebral, non-vertebral, and hip fracture risks in postmenopausal women; treatment of osteoporosis in men at high fracture risk; and management of glucocorticoid-induced osteoporosis in high-risk patients.

The NDA submission is supported by comprehensive data from analytical similarity studies, non-clinical comparisons, and clinical trials, demonstrating high similarity between HLX14 and Prolia® in quality, safety, and efficacy. HLX14 is HENLIUS' proprietary denosumab biosimilar. In the second half of 2025, two HLX14 products (marketed as BILDYOS® and BILPREVDA® in the U.S. and EU) received approvals in the U.S., EU, and UK, covering all indications approved for the originator products (Prolia® and XGEVA®) in those regions. In September 2024, Health Canada accepted the New Drug Submissions (NDSs) for HLX14.

According to IQVIA MIDASTM data, global sales of denosumab products reached approximately $7.463 billion in 2024.