Junshi Biosciences (HKG: 1877, SHA: 688180), a China-based biopharmaceutical company, has held a national market launch meeting for its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in China. The drug received its sixth indication approval last month for treating NSCLC tumors with no EGFR/ALK mutations, in combination with chemotherapy.
Previous Approvals and Milestones
Toripalimab was the first domestic PD-1 inhibitor approved in China (in December 2018) as a second-line treatment for melanoma. Subsequent approvals included its use as a second-line treatment for nasopharyngeal carcinoma (NPC) in February 2021, for locally advanced or metastatic urothelial cancer (UC) in April 2021, as a first-line treatment for NPC in November 2021, and as a first-line treatment for esophageal squamous cell carcinoma (ESCC) in May 2022. The drug was also included in the National Reimbursement Drug List (NRDL) for NPC and UC indications last year.
Global Recognition and Development
In the US, Junshi has obtained significant regulatory milestones for toripalimab, including two breakthrough therapy designations (BTDs), one fast-track status, and one priority review status. Additionally, the drug has received five orphan drug designations (ODDs) for its use in treating mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma, esophageal cancer, and small-cell lung cancer.-Fineline Info & Tech
