HENLIUS (02696): The application for market registration of HLX14, a biosimilar drug of Denosumab, has been accepted by the National Medical Products Administration.

HENLIUS (02696) announced that the market registration application (NDA) of HLX14 (recombinant anti-RANKL human monoclonal antibody injection) developed independently by the group has been accepted by the National Medical Products Administration (NMPA) Drug Evaluation Center. This NDA involves all indications approved for the reference drug Prolia in China (excluding Hong Kong, Macao, and Taiwan), including: the treatment of osteoporosis in postmenopausal women at high risk of fracture; significant reduction in the risk of vertebral, non-vertebral, and hip fractures in postmenopausal women; treatment of osteoporosis in men at high risk of fracture; and treatment of glucocorticoid-induced osteoporosis in individuals at high risk of fracture. The NDA for HLX14 is primarily based on data comparing HLX14 to its reference drug (Prolia), including similarity studies, non-clinical, and clinical comparative studies. These data fully demonstrate the high similarity of HLX14 to its reference drug in terms of quality, safety, and efficacy. HLX14 is an independently developed recombinant anti-RANKL human monoclonal antibody similar to the group, and in the second half of 2025, two products of HLX14 (marketed in the United States and Europe as BILDYOS and BILPREVDA, respectively) were approved for marketing in the United States, European Union, and United Kingdom, with indications covering all indications approved locally for the original products (Prolia and XGEVA). In September 2024, the NDA for HLX14 was accepted by Health Canada. According to the latest data from IQVIA MIDASTM (provided by IQVIA, a global provider of professional information and strategic consulting services for the pharmaceutical and healthcare industries), the global sales of recombinant anti-RANKL products in 2024 were approximately $7.463 billion.