The Center for Drug Evaluation (CDE) website indicates that a market filing by China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) subsidiary Shanghai JMT Biotechnology Co., Ltd for its anti-RANKL monoclonal antibody (mAb) JMT103 has been accepted for review. This next-generation RANKL antibody aims to address the shortcomings of existing marketed RANKL antibodies, particularly their immunosuppressive side effects and infection risks.
Innovation and Development
CSPC constructed a random mutant peptide library in the CDR region of denosumab and screened for RANKL antibody mutants with lower dissociation constants (Kd) and longer dissociation half-lives. This innovative approach enhances the therapeutic potential of JMT103 while improving safety profiles.
Clinical Trial Results
The company initiated the JMT103CN03 and JMT103CN03-1 studies to support the filing. The JMT103CN03 study, which yielded positive results in March this year, demonstrated that JMT103 produced good clinical efficacy with a tumor response rate of 93.5% and rapid onset. Treatment with JMT103 increased the proportion of patients with resectable giant cell tumor of bone, relieved pain levels, and improved patient quality of life. The JMT103CN03-1 study, a real-world data retrospective study, showed that the tumor response rate of JMT103 was significantly better than that of the denosumab group, with a good safety and tolerance profile.
Market Context
Xgeva/Prolia (Denosumab) is currently marketed in China, with biosimilars and biobetters in development by companies such as Qilu Pharma and Luye Pharma, awaiting regulatory approvals in the country.-Fineline Info & Tech
