China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its market filing for JMT103, an anti-RANKL monoclonal antibody (mAb) developed by subsidiary Shanghai JMT Biotechnology Co., Ltd, has been prioritized for review by the Center for Drug Evaluation (CDE). The drug is designed to address deficiencies in existing RANKL antibodies, such as immunosuppression and infection risks.
Study Highlights
- JMT103CN03 Trial: Results in March 2024 showed a 93.5% tumor response rate and rapid onset, increasing the proportion of patients with resectable giant cell tumors of bone. Pain levels were reduced, and quality of life improved.
- JMT103CN03-1 Study: A real-world data retrospective analysis found JMT103’s tumor response rate surpassed that of denosumab, with favorable safety and tolerability.
Competitor Context
Xgeva/Prolia (denosumab) is marketed in China, with biosimilars and biobetters under development. Qilu Pharma and Luye Pharma’s biosimilars are awaiting regulatory approvals.-Fineline Info & Tech
