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Henlius' Denosumab Biosimilar Application Is Accepted by NMPA


China’s National Medical Products Administration (NMPA) has accepted Henlius Biotech’s new drug application for its denosumab biosimilar, hlx14.

Shanghai, China-based Henlius Biotech said its investigational new drug application for a denosumab biosimilar has been accepted by the National Medical Products Administration (NMPA) of China. The agent is indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture.

The biosimilar, HLX14, is a recombinant anti-receptor activator of nuclear factor kappa B ligand (RANKL) human monoclonal antibody injection. The reference product is Prolia.

HLX14 can specifically bind to RANKL and block the interaction between RANKL and RANK, which is expressed on the surface of osteoclasts, thus inhibiting RANKL/RANK-mediated differentiation, and maturation and activation of osteoclasts, thereby reducing bone resorption and the incidence of skeletal-related events.

The Henlius pipeline includes the biosimilars HLX03, an adalimumab injection, and HLX02, trastuzumab for injection, which currently are in the new drug application stage with the NMPA.

The originator drug Prolia has been approved in the United States and Europe for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. It is also indicated for patients with giant cell tumor of bone and patients with osteoporosis at high risk for fracture.

Denosumab can increase the bone density and reduce the risk of fracture. In China, denosumab has already been approved for giant cell tumor of bone that is unresectable or in cases where surgical resection is likely to lead to severe morbidity. But indications for osteoporosis have not been approved yet.

“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,” Henlius said in a statement.

The company notes that osteoporosis leads to loss of quality of life and the population of patients in China who have access to standard of care is low, which means there is a large and urgent unmet need in the treatment of this condition.

Denosumab also has a US indication for the treatment of bone metastasis from solid tumors, Henlius said. In breast cancer, the relative incidence of bone metastasis is 65% to 75%; prostate cancer, 65% to 75%; thyroid cancer, 60%; lung, 30% to 40%, bladder, 40%; renal cell cancer, 20% to 25%; and melanoma, 14% to 45%.

In the United States, denosumab is also indicated for giant cell tumor of bone, which, globally, accounts for 4% to 5% of primary bone tumors. In China, however, giant cell tumor accounts for 20% of primary bone tumors.

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