China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that its PD-1 inhibitor Toripalimab (trade name: Tuoyi) has received orphan drug designation (ODD) from the European Committee (EC) for the treatment of nasopharyngeal carcinoma (NPC). This marks the sixth ODD for Toripalimab in the US and Europe, following previous designations for melanoma, NPC, soft tissue sarcoma, esophageal cancer, and small cell lung cancer.
Drug Profile
Toripalimab is currently under investigation in over 30 clinical studies globally, assessing its safety and efficacy in various cancers, including lung, nasopharyngeal, esophageal, stomach, bladder, breast, liver, kidney, and skin cancers.
Approvals and Reimbursement
- China Approvals:
- December 2018: Second-line treatment for melanoma.
- February 2021: Second-line treatment for NPC.
- April 2021: Locally advanced or metastatic urothelial cancer (UC) in previously treated patients.
- November 2021: First-line treatment for NPC.
- May 2022: Unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC) in combination with chemotherapy.
- Reimbursement: Toripalimab was included in China’s National Reimbursement Drug List (NRDL) for NPC and UC indications in 2021.
- Pending Approvals: The drug is awaiting regulatory decisions in China for the first-line treatment of advanced non-small cell lung cancer (NSCLC) in combination with chemotherapy.-Fineline Info & Tech
