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Henlius Denosumab Biosimilar HLX14 Received Clinical Trial Approval in Australia for the Phase 3 MRCT

2022-07-19


Shanghai, China, Jul, 19th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the international multicentre phase 3 clinical trial for the company’s denosumab biosimilar HLX14, a recombinant anti-RANKL human monoclonal antibody injection, for the treatment of postmenopausal osteoporosis in women with high fracture risks has been approved by the relevant Human Research Ethics Committee (“HREC”), and Clinical Trial Notification (“CTN”) has been acknowledged by the Therapeutic Goods Administration (“TGA”), Australia.

 

Health problems caused by osteoporosis, like fractures, can result in significant loss of quality of life. Generally, osteoporosis is underdiagnosed due to the lack of overt symptoms. Worldwide, one in five men and one in three women, over the age of 50, will suffer a fracture due to osteoporosis[1] and the proportion increases with age[2]. The diagnostic rate and the percentage of patients with osteoporosis that have received standardized treatment are relatively low[3]. With an aging population, these numbers will rise[2] and the huge unmet medical needs in the treatment of osteoporosis urgently to be addressed. According to the Australian Bureau of Statistics (ABS) 2020–21 National Health Survey, the number of women over the age of 45 in Australia with osteoporosis is about 695,000, accounting for about 13% of the total population, while the prevalence of osteoporosis in women over the age of 65 is as high as 24.5%[4].

 

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 tumour of bone, skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours, 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[5].

 

Recently, the first patient was dosed for this international multicentre phase 3 clinical trial in China. In the future, Henlius will continue to accelerate the launch of this clinical trial in Australia and other countries and regions to further compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with reference denosumab in postmenopausal women with osteoporosis at high risk of fracture.


Reference

[1] International Osteoporosis Foundation. Facts and Statistics. https://www.iofbonehealth.org/facts-statistics.

[2] Australian Institute of Health and Welfare by Australian Government https://www.aihw.gov.au/reports/chronic-musculoskeletal-conditions/osteoporosis/contents/what-is-osteoporosis

[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.

[4] Australian Bureau of Statistics. Health Conditions Prevalence. https://www.abs.gov.au/statistics/health/health-conditions-and-risks/health-conditions-prevalence/2020-21/TABLE%202%20Long-term%20health%20conditions%20by%20age%20and%20sex.xlsx

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