NMPA Accepts for Review Henlius' NDA for 120 mg HLX14, China’s First Domestically Developed Denosumab to Enter Global Markets

September 11, 2026 , Henlius (2696.HK) today announced that the New Drug Application (NDA) for 120 mg/1.7 mL strength of its self-developed denosumab biosimilar, HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection), has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The NDA covers all indications for which the reference product denosumab has been approved in the Chinese mainland. These include the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors or multiple myeloma, by delaying or reducing the risk of SREs, as well as the treatment of patients with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Previously, the NDA for HLX14 (60 mg/1.0 mL) was accepted for review in China in December 2025. Notably, two products of HLX14 have already been approved in the U.S., the EU, the UK, and Canada, making HLX14 the first China-developed denosumab biosimilar to successfully enter international markets. Bone metastasis is a common complication of advanced malignancies. Breast, prostate, lung, thyroid, and kidney cancers account for more than 80% of bone metastases among malignant tumors.1 Up to 90% of patients with multiple myeloma develop bone lesions.2 Once bone metastasis occurs, it may lead to a range of serious SREs, including pathological fractures, spinal cord compression, radiation therapy to bone, or bone surgery. These events may also be accompanied by severe bone pain, substantially impairing patients’ quality of life and survival. Giant cell tumor of bone is an intermediate bone tumor characterized by local aggressiveness, a high risk of recurrence, and occasional distant metastasis. It most commonly affects young adults aged 20 to 40 years.3 Surgical resection is the standard treatment; however, effective treatment options remain limited for patients with tumors located in sites unsuitable for surgery, such as the skull, spine, or intra-articular regions, or for those unable to tolerate surgery. HLX14 is a denosumab biosimilar independently developed by Henlius in accordance with biosimilar regulatory guidelines in China, the EU, and the U.S. The NDA for HLX14 was primarily based on data generated from HLX14 compared with its reference product, including analytical similarity studies as well as non-clinical and clinical comparative studies. These data demonstrated that HLX14 at the 120 mg (1.7 mL) strength is highly similar to its reference drug in terms of quality, safety, and efficacy. In December 2025, the NMPA accepted the NDA for HLX14 in the 60 mg/mL formulation. The proposed indications include the treatment of osteoporosis in postmenopausal women, men, and glucocorticoid-induced patients, all at high risk of fracture, covering all indications approved in Chinese mainland for the reference product. As part of its global strategy, Henlius entered into a license and supply agreement with Organon in 2022, granting Organon exclusive commercialization rights outside China for several biosimilars, including HLX14. The agreement covers markets including the U.S., the EU, and Canada. In the second half of 2025, the two products of HLX14 products, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), received approvals from the U.S. Food and Drug Administration (FDA), the European Commission (EC), and the UK Medicines and Healthcare products Regulatory Agency (MHRA). In March 2026, HLX14 further expanded its global presence with the launch of BILDYOS® (60 mg/mL) and TUZEMTY® (120 mg/1.7 mL) in Canada, further enhancing patient access to treatment worldwide. Looking ahead, Henlius remains committed to delivering high-quality and affordable biologic medicines, bringing quality and accessible treatment options to more patients around the world. 参考文献 References 1.中华医学会骨科学分会骨肿瘤学组.骨转移瘤外科治疗专家共识[J].中国医学前沿杂志：电子版, 2010,2(02):65-73. 2. Roodman, G.D. (2010), Pathogenesis of myeloma bone disease. J. Cell. Biochem., 109: 283-291. https://doi.org/10.1002/jcb.22403 3.中华医学会骨科学分会骨肿瘤学组.中华骨科杂志,2018,38(14):833-840.

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