On December 17, 2018, the National Medical Products Administration (NMPA) of China approved Toripalimab injection (trade name: Tuoyi), China's first anti-PD-1 monoclonal antibody developed by Junshi Biosciences, for marketing. This is an innovative biological product developed independently by a Chinese enterprise with completely intellectual property rights. It is indicated for treating locally advanced or metastatic melanoma after previous treatment failure with the standard of care.

The current research focus for tumor immunotherapy is mainly on immune-checkpoint inhibitors (CPIs), such as anti-programmed death-1 (PD-1) receptor. CPIs are different from traditional chemotherapy and targeted therapy, mainly by overcoming the immunosuppression in patients and by reactivating patients' own immune cells to kill the tumor. Toripalimab was a humanized anti-PD-1 monoclonal antibody originally developed by Suzhou Union biopharmaceutical Co., Ltd. It blocks the binding of tumor cell surface-expressed PD-L1 with PD-1 molecule on the surface of T-lymphocyte, thus relieves the T cell suppression by tumor cells, enable the T cells to activate and kill the tumor cells.

Melanoma incidence has been increasing rapidly in China in recent years, one of the malignant tumors with fast incidence growth. There are about 20,000 new diagnostics each year in China. Furthermore, the mortality rate for melanoma is also increasing rapidly each year. It has become one of the several diseases that seriously impact the health and lives of Chinese patients. Before the approval of Toripalimab, there is not any effective standard treatment for melanoma patients who failed in the first-line treatment. The clinical trial data from Toripalimab showed that the objective remission rate, disease control rate, and 1-year survival rate for the patients with unresectable or metastatic melanoma who had previously failed systemic treatment were 17.3%, 57.5%, and 69.3%, respectively. The marketing approval for Toripalimab significantly expands the treatment option for melanoma patients in China.

As the first approved, listed, and commercialize anti-PD1 monoclonal antibody developed by a Chinese biotech company, Toripalimab has been supported by multiple major project fundings from the National Science and Technology. The clinical trials for Toripalimab were initiated in early 2016, with over more than 20 clinical trials are currently in progress, including parallel clinical trials in the United States. In March 2018, the application for listing registration was officially accepted by the NMPA of China, priority review was granted and approval review was accelerated. The applicant received timely communication and guidance from the relevant authorities, the Center for Drug Evaluation, National Institutes for Food and Drug Control, and other relevant regulatory agencies, who collaborated and resolved promptly any technical problems encountered during the review. Furthermore, all these regulatory agencies provided the applicant on priority to technical review, on-site inspection, and laboratory inspection. Toripalimab was granted conditional approval for market registration on December 17, 2018, based on the efficacy data from the phase II clinical study in advanced melanoma patients in China and safety data from 7 clinical studies completed by the applicant.