Sep, 2023. the class 1 new drug Narlumosbart for Injection(JMT103) developed by Shanghai JMT-Bio Technology Co. Ltd is approved by China NMPA . This drug is indicated for the treatment for adult patients with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Narlumosbart Injection is a recombinant human anti-receptor activator of NF-κB ligand (RANKL) monoclonal antibody. It can inhibit the activity of RANKL through specifically binding to RANKL on the cell membrane, thereby inhibiting its involvement in mediating osteolysis and tumor growth. The marketing of this drug provides a new treatment option for patients. Narlumosbart for Injection is the first IgG4 subtype fully human monoclonal antibody against RANKL filing BLA in the world. At present, denosumab, an IgG2 subtype, is the only marketed drug against the same target in the world.
Compared with denosumab, Narlumosbart for Injection has significant enhancement in uniformity and quality controllability. Subcutaneous injection is used to administer the Product. It can block the binding of RANKL to the membrane RANK receptors of cells such as osteoclast precursor cells, osteoclasts and osteoclast-like giant cells so as to inhibit the differentiation, maturation and functional activity of the above cells mediated by RANKL-RANK signaling pathway. It is expected to treat diseases associated with the activation of RANKL-RANK signaling pathway, such as giant cell tumor of bone, osteoporosis, tumor bone metastasis.
The BLA for Narlumosbart for Injection is mainly based on two pivotal clinical studies in the treatment of unresectable or surgically difficult giant cell tumor of bone. The clinical studies demonstrated that Narlumosbart for Injection had a better clinical efficacy in the treatment of unresectable or surgically difficult giant cell tumor of bone with a tumor response rate of 93.5%, and a trend higher than that of the denosumab group.
At the same time, Narlumosbart for Injection showed a good safety profile with controllable safety risks.
About Shanghai JMT-Bio
Shanghai JMT-Bio is a biopharmaceutical company engaged in the R&D of target tumor antigens and novel monoclonal antibodies for the immunotherapy of multiple types of cancers.