Shanghai, China, June 17^th, 2022-Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first subject in an international multicentre phase 3 clinical trial for the company’s denosumab biosimilar HLX14, a recombinant anti-RANKL human monoclonal antibody injection, has been dosed in China for the treatment of postmenopausal osteoporosis in women with high fracture risks. Recently, the company has entered into a license and supply agreement with Organon LLC for the exclusive commercialization of two products, including HLX14, in ex-China countries, covering mature markets such as the United States, the European Union and Japan, as well as a number of emerging markets.

Henlius independently developed denosumab biosimilar HLX14 in accordance with the NMPA, EMA, FDA and other international biosimilar guidelines. Currently, denosumab has been approved worldwide for a range of indications such as for the treatment of postmenopausal women with osteoporosis at high risk for fracture, giant cell tumor of bone, skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, etc. HLX14 can specifically bind to RANKL (receptor activator of nuclear factor kappa B ligand) and block the interaction between RANKL and RANK, which is expressed on the surface of osteoclasts, thus inhibiting RANKL/RANK-mediated differentiation, maturation and activation of osteoclasts, thereby reducing bone resorption and the incidence of skeletal-related events^[1].

In China, osteoporosis has become a severe health problem for people over 50 years old, especially for middle and aged women. More than one third of women over 50 years old are suffering from osteoporosis^[2]. Health problems caused by osteoporosis, like facture, can result in significant loss of quality of life. Nonetheless, the percentage of patients with osteoporosis that have received standardized treatment is relatively low. With the increasing patient number and improved diagnosis of osteoporosis, the huge unmet medical needs in the treatment of osteoporosis are urgently to be addressed^[3].

Underpinned by the patient-centric strategy, Henlius has built an innovative product pipeline with high market potential targets, including PD-1/L1, LAG-3, TIGIT, BRAF, etc., and has been pushing its early R&D research capabilities further while also upgrading the technology platform. The company is currently taking effort to explore different forms of antibody conjugates based on our own core antibody technologies and by using of novel conjugating technologies. Looking forward, Henlius is actively accelerating its evolution to an innovative Biopharma and improving efficiency through innovations. The company will preserve its momentum for innovation by further strengthening the in-licensing and collaboration on external innovative assets and will continue strive for breakthroughs to bring more affordable and quality biologics to patients around the globe.

About HLX14-002-PMOP301

This randomised, double-blind, international multicentre, parallel-controlled phase 3 study aims to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with reference denosumab in postmenopausal women with osteoporosis at high risk of fracture. Eligible patients will be randomised 1:1 to receive subcutaneous injection of HLX14 or reference denosumab every six months for two cycles. The primary endpoint of this study is the percentage change in bone mineral density (BMD) at the lumbar spine from baseline to Day 365 (D365). The secondary endpoints include the percentage change in BMD at the total hip from baseline to D365; the percentage change in BMD at the femoral neck from baseline to D365; the percentage change in serum type I collagen C-telopeptide and serum procollagen type 1 N-telopeptide from baseline to D29, D92, D183, D274, and D365; as well as safety, pharmacokinetics, and immunogenicity.

Reference

[1] Romas E. Clinical applications of RANK-ligand inhibition. Intern Med J 2009;39:110–6.

[2] 2018中国骨质疏松症流行病学调查结果. http://www.nhc.gov.cn/wjw/zcjd/201810/4988546cfa1040db86c1815d3dad7a2b.shtml

[3] Clynes MA, Harvey NC, Curtis EM, Fuggle NR, Dennison EM, Cooper C. The epidemiology of osteoporosis. Br Med Bull. 2020;133(1):105-117.