Shanghai, China – December 2, 2025 – Henlius (2696.HK) announced today that the New Drug Application (NDA) for its independently developed Denosumab biosimilar HLX14 in the 60 mg/mL formulation (recombinant anti-RANKL human monoclonal antibody injection), has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The indications involved in the NDA encompass all approved and marketed indications for the reference drug Prolia® in Chinese mainland, encompassing the treatment of osteoporosis in postmenopausal women, men, and glucocorticoid-induced patients, all at high risk of fracture. HLX14 has already received marketing approvals in the United States, European Union, and the United Kingdom, making it the first Denosumab developed in China to successfully enter international markets.
Data shows that the morbidity rate of osteoporosis among women over 50 years old in China is as high as 32.1%[1], meaning that more than one-third of postmenopausal women are deeply affected by it; while the morbidity rate among men of the same age group is 6.46%[2],[3]. In addition, long-term use of glucocorticoids leading to osteoporosis is also the primary cause of secondary osteoporosis, with unmet therapeutic needs.
HLX14 is a denosumab biosimilar independently developed by Henlius in accordance with the NMPA, EMA, FDA, and other international biosimilar guidelines. The NDA of HLX14 was based on the data generated by HLX14 in comparison with its reference drug Prolia®, which includes analytical similarity studies, nonclinical and clinical comparison studies. These data demonstrated that HLX14 is highly similar to its reference drug in terms of quality, safety and efficacy.
In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including HLX14. The agreement covers exclusive global commercialization rights except for China. In the second half of 2025, the two products of HLX14, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7mL), received approvals from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), becoming the first “China-developed” Denosumab to achieve global market entry.
Looking ahead, Henlius remains committed to addressing clinical needs by providing high-quality, affordable biopharmaceuticals and expanding patient access to effective treatment options worldwide.
【Reference】
[1] 国家卫健委《中国骨质疏松症流行病学调查报告》（2023）
[2] 李梅, 章振林, 夏维波. 应重视常见疾病男性骨质疏松症的诊断与治疗. 中华骨质疏松和骨矿盐疾病杂志, 2022, 15(5): 449-454. doi:10.3969/j.issn.1674-2591.2022.05.002
[3] 中华医学会骨质疏松和骨矿盐疾病分会. 男性骨质疏松症诊疗指南. 中华骨质疏松和骨矿盐疾病杂志, 2020, 13(5): 381-395. doi:10.3969/j.issn.1674-2591.2020.05.001