Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for its injectable monoclonal antibody TAB009/JS009, targeting CD112R, in advanced solid tumors. The company also plans to initiate a US trial for its XPO1 inhibitor JS110 after gaining FDA approval.
TAB009/JS009 Study
- Mechanism: TAB009/JS009 binds CD112R with high affinity, blocking its signaling pathway and promoting T/NK cell activation.
- Preclinical Data: Combined with anti-TIGIT mAb JS006, it showed synergistic anti-tumor effects. The addition of PD-1 inhibitor Tuoyi (toripalimab) further enhanced efficacy.
- Global Status: JS009 has no similar marketed products and received US clinical trial approval in April 2023.
JS110 Development
- Mechanism: JS110 inhibits XPO1, enhancing tumor suppressor proteins like p53.
- Preclinical Data: Demonstrated tumor growth inhibition in vitro and in animal models, either alone or in combination.
- Clinical Progress: Approved in China in April 2022, JS110 is in Phase I trials (NCT04991129).-Fineline Info & Tech
