Beijing Time, April 25, 2025 – Junshi Biosciences (1877.HK, [688180.SH](688180.SH)) announced that the new indication application for toripalimab injection (Tuoyi®), an anti-PD-1 monoclonal antibody independently developed by the company, for the first-line treatment of unresectable or metastatic melanoma has been recently approved by the National Medical Products Administration (NMPA). This marks the 12th indication approved for toripalimab in mainland China.
Disease Background
Melanoma is the most malignant type of skin cancer. In 2022, there were approximately 332,000 new cases and 59,000 deaths from melanoma globally¹. Although melanoma is relatively rare in China, it has a high fatality rate: about 9,000 new cases and nearly 5,000 deaths were reported in 2022, and its incidence has been increasing year by year.
Since 2018, domestic anti-PD-1 monoclonal antibodies have been approved for the second-line and beyond treatment of advanced melanoma and widely applied in clinical practice. However, up to now, the standard first-line treatment for advanced melanoma in China has been dominated by conventional chemotherapy or targeted therapy (only applicable to patients harboring BRAF V600 mutations), and no domestic anti-PD-1 monoclonal antibody has been approved for this indication. Therefore, there is an urgent clinical need for first-line immunotherapy among patients with advanced melanoma in China.
Basis for the Approval of the New Indication
The approval of this new indication is mainly based on the data from a multicenter, randomized, open-label, active-controlled Phase III clinical trial (MELATORCH study, NCT03430297).
As the first pivotal registration clinical study of PD-(L)1 inhibitors for the first-line treatment of advanced melanoma in China to achieve positive results, the MELATORCH study was led by Professor Guo Jun from Peking University Cancer Hospital as the Principal Investigator (PI) and conducted at 11 clinical centers nationwide. The study aimed to compare the efficacy and safety of toripalimab versus dacarbazine in patients with unresectable or metastatic melanoma who had not received prior systemic anti-tumor therapy.
