China NMPA Accepts Junshi Biosciences' Melanoma sNDA

The China National Medical Products Administration (NMPA) has begun reviewing a supplemental new drug application (sNDA) submitted by Junshi Biosciences for toripalimab (marketed as TUOYI) to address unresectable or metastatic melanoma. This sNDA is supported by the findings of the MELATORCH study, a Phase III clinical trial that showed favorable results for toripalimab in comparison to dacarbazine.

The MELATORCH study was a multicenter, randomized, open-label, positive-controlled trial designed to evaluate the efficacy and safety of toripalimab in combination with dacarbazine as a first-line treatment for patients with unresectable or metastatic melanoma who had not received prior systemic treatment. The study was conducted across 11 clinical centers in China.

In September 2023, the trial reached its primary endpoint, which was progression-free survival (PFS). The patients who were treated with toripalimab exhibited a significant extension of PFS compared to those treated with dacarbazine alone. Additionally, the safety profile of toripalimab was consistent with previous studies, with no new safety issues being identified.

Toripalimab is an anti-PD-1 monoclonal antibody. It works by blocking the interactions of PD-1 with its ligands PD-L1 and PD-L2, thereby enhancing the immune system's ability to destroy cancer cells.

Dr. Jianjun ZOU, the General Manager and CEO of Junshi Biosciences, emphasized the significance of this development, stating: “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 a related development, in June 2024, the NMPA approved the use of toripalimab injection, in combination with paclitaxel injection (albumin-bound), for the first-line treatment of recurrent or metastatic triple-negative breast cancer. This approval further solidifies Junshi Biosciences’ commitment to providing innovative cancer therapies.