Gelonghui, April 5, 丨 Fu Hong Han Lin (02696.HK) announced that recently, an international multicenter phase 3 clinical study of the desumab biosimilar drug HLX14 (recombinant anti-RANKL whole human monoclonal antibody injection) (HLX14) independently developed by the company to treat osteoporosis in postmenopausal women with a high risk of fractures reached the main research end.
This study is a randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical trial to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 and original desulumab (Prolia) in postmenopausal women with osteoporosis at high risk of fractures. Eligible subjects were randomly divided into two groups at a 1:1 ratio and treated with 60 mg of HLX14 or original desulumab (Prolia) every six months. The main endpoints of the study were the rate of change in lumbar bone density (BMD) from baseline to week 52 (D365) of central imaging, and the percentage change in serum collagen C-terminal peptide (s-CTX) from baseline to week 26 (D183) - the area under the time curve (AUEC0-26W). Secondary endpoints include other efficacy evaluations and pharmacodynamic characteristics, incidence of concomitant events, safety, pharmacokinetic characteristics, and immunogenicity. The main end of this study has been reached.
HLX14 is a desulumab biosimilar drug independently developed by the company. It is intended to treat osteoporosis in postmenopausal women with a high risk of fractures and/or other indications consistent with the original drug label. Currently, desulumab, the original research drug of HLX14, has been approved in many countries and regions under different trade names for a series of different indications, such as osteoporosis in postmenopausal women with a high risk of fractures. In June 2022, the company and Organon LLC (Organon & Co. , a wholly-owned subsidiary) signed an agreement to grant it an exclusive license for it and its subsidiaries to commercialize HLX14 on a global scale other than within China, Hong Kong, Macao and Taiwan regions. In January 2024, a phase 1 clinical study of HLX14 in Chinese male health subjects was successfully completed.