On April 8, kidney cancer is the third most common malignancy of the urinary system worldwide, and renal cell carcinoma (RCC) accounts for 80%–90% of all kidney cancer cases.

　　On the 8th, reporters learned that the toripalimab injection (Tuoyi®), independently developed by an innovative Chinese pharmaceutical company, has been approved by the National Medical Products Administration for the first-line treatment of renal cell carcinoma. Going forward, toripalimab injection (Tuoyi®) in combination with axitinib can be used for the first-line treatment of patients with intermediate- or high-risk unresectable or metastatic renal cell carcinoma. Previously, no immunotherapy for kidney cancer had been approved in China.

　　Professor Huang Yiran of Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine said that day: "Treatment options for advanced kidney cancer are limited, and the prognosis for intermediate- and high-risk patients in particular is very poor. The approval of the toripalimab plus axitinib regimen fills the gap in first-line immunotherapy for kidney cancer in the Chinese population. Compared with targeted monotherapy, the toripalimab targeted-immunotherapy combination can significantly improve patients' PFS (progression-free survival), bringing good news to the many patients with advanced kidney cancer in China."

　　It is reported that about one-third of kidney cancer patients already have distant tumor metastasis at initial diagnosis, while 20%–50% of localized patients still develop distant tumor metastasis after undergoing nephrectomy. Based on the risk classification of the International Metastatic Renal Cell Carcinoma Database Consortium, the median overall survival (OS) of low-, intermediate-, and high-risk patients with metastatic RCC receiving anti-angiogenic targeted therapy was 35.3, 16.6, and 5.4 months, respectively. Therefore, compared with low-risk patients, intermediate- and high-risk patients with advanced RCC have a more urgent clinical need for novel treatment regimens.

　　It is reported that the approval of this new indication is mainly based on the results of a multicenter, randomized, open-label, active-controlled Phase III clinical study. This RENOTORCH study, with Professor Guo Jun of Peking University Cancer Hospital and Professor Huang Yiran of Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine as principal investigators, was conducted at 47 clinical centers nationwide and is a key Phase III clinical study of immunotherapy for advanced kidney cancer.

　　Professor Guo Jun of Peking University Cancer Hospital said: "At the global level, targeted combined immunotherapy has become the standard treatment for advanced kidney cancer. But in China, no related therapy had been approved in this field. The approval of this new indication for toripalimab opens a new chapter for targeted-immunotherapy combinations for advanced kidney cancer in China, will completely rewrite the clinical practice for advanced kidney cancer in China, and, more importantly, can bring new treatment options to intermediate- and high-risk patients."

　　Dr. Zou Jianjun, General Manager and Chief Executive Officer of Junshi Biosciences, said: "The company will continue to base itself on the clinical needs of the Chinese people, continuously invest in innovative R&D, and enable Chinese patients to achieve a better quality of life and longer-term survival benefits."