The China National Medical Products Administration (NMPA) has accepted for review Junshi Biosciences’ supplemental new drug application (sNDA) for toripalimab (TUOYI) to treat unresectable or metastatic melanoma.

This sNDA is underpinned by the results of the MELATORCH study, a Phase III clinical trial demonstrating positive outcomes for toripalimab in comparison to dacarbazine.

The multicentre, randomised, open-label, positive-controlled study assessed the efficacy and safety of toripalimab plus dacarbazine as a first-line treatment for unresectable or metastatic melanoma in systemic treatment-naïve patients.

It was carried out at 11 clinical centres across China.

In September 2023, the trial met its primary endpoint of progression-free survival (PFS).

Patients treated with toripalimab experienced a significant prolongation of PFS compared to those receiving dacarbazine.

The safety profile of toripalimab was consistent with previous studies, with no new safety concerns identified.

Toripalimab is an anti-PD-1 monoclonal antibody designed to hinder the interactions of PD-1 with its ligands PD-L1 and PD-L2, enhancing the immune system's capability to eliminate tumour cells.

Junshi Biosciences general manager and CEO Dr Jianjun ZOU stated: “In 2018, toripalimab made history as the first domestically developed anti-PD-1 monoclonal antibody approved for second-line and beyond treatment of advanced melanoma, leaving its brilliant mark in China’s pharmaceutical and biotech development.

“Today, our efforts continue with the NMPA’s acceptance of the 12th sNDA for toripalimab, and toripalimab is poised to become China’s first immunotherapy for melanoma. We will work closely with regulatory authorities to provide better clinical treatments to patients as soon as possible.”

In June 2024, the NMPA approved Junshi Biosciences’ toripalimab injection, combined with paclitaxel injection (albumin-bound), for the first-line treatment of recurrent or metastatic triple-negative breast cancer.