By Fineline Cube 
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its Loqtorzi (toripalimab). The PD-1 inhibitor is now approved for the treatment of first-line unresectable or metastatic melanoma, marking its twelfth approved indication in China.
Clinical Trial Results
The approval is supported by positive results from the MELATORCH study, a multicenter, randomized, open-label, positive-controlled Phase III clinical study. The study compared the efficacy and safety of toripalimab versus dacarbazine in treatment-naive patients with unresectable or metastatic melanoma.
Key Findings
The results demonstrated that toripalimab significantly prolonged progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR), with a median PFS of 2.3 months compared to 2.1 months for dacarbazine. This represents a 29.2% reduction in the risk of disease progression or mortality. Additionally, toripalimab showed a favorable safety profile.-Fineline Info & Tech