Mabpharm Limited announced that the National Medical Products Administration of China has approved the clinical trial application of CMAB807X for treatment of tumor bone metastasis.CMAB807X (Denosumab) is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand), which is a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. CMAB807 prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bones.

CMAB807 is currently under phase III clinical trials for osteoporosis. CMAB807X is a dosage form of CMAB807 for the treatment of tumor bone metastasis. It is expected that CMAB807X can be used for treatment of tumor bone metastasis and giant bone cell tumor and prevent skeletal-related events in patients with solid tumor bone metastases and multiple myeloma after its new drug application is approved by the NMPA.