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Henlius Received IND Approval for Denosumab Biosimilar HLX14 from NMPA

Shanghai, China, May 27, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that an investigational new drug (IND) application has been approved by the National Medical Products Administration (NMPA) of HLX14, a recombinant anti-RANKL fully human monoclonal antibody injection, for the treatment of postmenopausal women with osteoporosis at high risk for fracture. HLX14 is a Denosumab biosimilar independently developed by Henlius. 

Nowadays, the serious problem of osteoporosis is arising throughout the world. Among all countries, China has the largest population that is suffering from osteoporosis, which mainly occurs in postmenopausal women and elderly people[1]. Health problems caused by osteoporosis, like fracture, 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 of osteoporosis in China, the huge unmet medical needs in standardized treatment of osteoporosis are urgently to be addressed[2].

RANKL (receptor activator of nuclear factor kappa B ligand) is a member of the tumour necrosis factor (TNF) ligand superfamily. RANKL has been identified to be essential for the function and survival of osteoclasts, the cells responsible for bone resorption. By binding to RANKL, HLX14 can prevent it from activating its receptor, RANK, on the surface of osteoclasts and their precursors, thus inhibiting RANKL/RANK-mediated differentiation, maturation and activation of osteoclasts, decreasing bone resorption, increasing bone mineral density and reducing the risk of fracture[3].

In accordance with Chinese Biosimilar Guidelines and EMA Guideline on Similar Biological Medicinal Products, HLX14 has been developed strictly following the principles of stepwise development, comparability and similarity assessment and has been compared with the original drug Denosumab via a series of head-to-head pre-clinical studies. As a result, HLX14 was shown to be in high similarity to Denosumab in preclinical pharmacology, toxicology and pharmacokinetic studies, suggesting potential benefits for osteoporosis patients at high risk of fracture.

Henlius has proactively built a diversified and high-quality product pipeline covering several monoclonal antibody biosimilars that are expected to be commercialised in the near future. In addition to汉利康®(HLX01, rituximab), which has been launched commercially, two products (HLX02 trastuzumab and HLX03 adalimumab) of Henlius are under New Drug Application (NDA) review and have the potential to be launched within 2020. In addition to helping Henlius to further expand the extensive portfolio,the development of HLX14 is also an active attempt to enlarge the company's  layout in different disease areas.

Besides, Henlius is also actively developing a versatile in-house combination therapy portfolio with a focus on anti-PD-1/PD-L1 mAbs to capture future immuno-oncology opportunities. Looking forward, Henlius will continue advancing the development of innovative biologics on the basis of its established and integrated innovation platform, underscoring its long-term commitment to providing affordable and effective therapies for patients worldwide.


[1] Romas E. Clinical applications of RANK-ligand inhibition. Intern Med J 2009;39:110–6.
[2] Globaldata disease report, 2018中国骨质疏松流行病学调查
[3] Lin X, Xiong D, Peng Y-Q, et al. Epidemiology and management of osteoporosis in the People’s Republic of China: current perspectives. Clin Interv Aging. 2015;10:1017–1033.