Junshi Biosciences Receives NMPA Approval for Fourth-Generation EGFR Inhibitor WJ13404

Shanghai-based biotech Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for WJ13404, a fourth-generation EGFR inhibitor developed in collaboration with Wigen Biomedicine. This approval positions Junshi Biosciences at the forefront of advanced non-small cell lung cancer (NSCLC) treatment research.

Mechanism and Development
JS113, the experimental drug in question, is an original epidermal growth factor receptor (EGFR) inhibitor. It is being developed to treat NSCLC with EGFR mutations and other solid tumors. Pre-clinical studies have demonstrated its effectiveness against primary and acquired EGFR mutations that are insensitive to third-generation EGFR inhibitors. These mutations include del19/T790M/c797s and L858R/T790M/c797s co-mutations. Additionally, JS113 shows activity against some TKI-resistant bypass activation targets and immunosuppressive targets while being highly selective for wild-type EGFR.

Strategic Collaboration
The development of WJ13404 represents a strategic collaboration between Junshi Biosciences and Wigen Biomedicine. This partnership combines Junshi’s clinical development expertise with Wigen’s innovative drug discovery capabilities, creating a powerful synergy for advancing NSCLC treatment options.-Fineline Info & Tech