On December 17, 2018, the National Medical Products Administration (NMPA) granted conditional approval for the market launch of Toripalimab Injection (brand name: Tuoyi), the first domestically developed Programmed Death-1 (PD-1) monoclonal antibody in China. Supported by the Major New Drug Creation and Development Program, a National Science and Technology Major Project, this drug is an innovative biological product independently developed by Suzhou Junshi Biosciences Co., Ltd. with full independent intellectual property rights. As the first domestically produced PD-1-targeted monoclonal antibody in China, it is indicated for the treatment of locally advanced or metastatic melanoma in patients who have failed prior standard therapy.
In recent years, melanoma has shown a rapid growth trend in China, ranking among the malignant tumors with the fastest-increasing incidence, with approximately 20,000 new cases reported annually. Its mortality rate has also been rising rapidly year by year, making it a disease that seriously endangers the health of Chinese people. In terms of treatment, there is currently a lack of effective standard treatment options for melanoma patients who have failed first-line therapy.
Toripalimab is a fully human monoclonal antibody against the PD-1 receptor. It works by blocking the PD-1 receptor on T lymphocytes, inhibiting its binding to PD-L1 on the surface of tumor cells, and relieving the immune suppression of immune cells exerted by tumor cells. This restores the anti-tumor immune function of immune cells to kill tumor cells.
Clinical trial results of the drug showed that in patients with unresectable or metastatic melanoma who had failed prior systemic therapy, the Objective Response Rate (ORR) reached 17.3%, the Disease Control Rate (DCR) reached 57.5%, and the 1-year survival rate reached 69.3%. In addition, multiple clinical indications of the drug are under development, with Phase III clinical trials ongoing for indications including hepatocellular carcinoma and nasopharyngeal carcinoma. The approval and launch of this drug are of positive significance for expanding clinical medication options for cancer patients in China, marking China’s official entry into the era of immunotherapy.
