Henlius biosimilar NDA for HLX14 accepted by NMPA

Shanghai Henlius Biotech, Inc. announced its New Drug Application (NDA) for HLX14, a denosumab biosimilar, has been accepted by China's National Medical Products Administration (NMPA). The NDA covers all approved indications for the reference drug Prolia® in mainland China, including osteoporosis in postmenopausal women and men at high risk of fractures, and glucocorticoid-induced osteoporosis.

The submission is based on analytical, nonclinical, and clinical comparison studies demonstrating HLX14's high similarity to its reference drug in terms of quality, safety, and efficacy. Global sales for denosumab were approximately $7.463 bn in 2024.

HLX14 products (BILDYOS® and BILPREVDA®) are expected to receive marketing approval in the United States, European Union, and United Kingdom in the second half of 2025. Additionally, new drug submissions for HLX14 were validated by Health Canada in September 2024.