CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for narlumosbart (JMT103), an anti-RANKL monoclonal antibody (mAb), to treat giant cell tumors of bone that are inoperable or may lead to severe dysfunction.
Supporting Studies and Clinical Efficacy
The approval is supported by the pivotal Phase II JMT103CN03 study and the real-world JMT103CN03-1 study, which demonstrated JMT103’s clinical efficacy in treating giant cell tumors of bone that are unresectable or difficult to operate. The clinical trial results showed a tumor response rate of 93.3%, highlighting the drug’s potential in improving patient outcomes. Additionally, JMT103 has been found to have a good safety profile and controllable safety risks.
JMT103’s Superiority and Mechanism of Action
As the world’s first RANKL antibody, JMT103 is noted for its superiority over Xgeva/Prolia (denosumab) in terms of homogeneity and quality control. The subcutaneously injected product works by blocking the binding of RANKL to the membrane receptor RANK on osteoclast precursor cells, osteoclasts, osteoclast-like giant cells, and other cells. This inhibition disrupts the differentiation, maturation, and functional activity of these cells mediated by the RANKL-RANK signaling pathway, offering a promising treatment for diseases related to the activation of this pathway, including giant cell tumors of bone, osteoporosis, and tumor bone metastasis.-Fineline Info & Tech
