Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab

SHANGHAI, China, July 11, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application for toripalimab, the company’s anti-PD-1 monoclonal antibody, in combination with axitinib for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma (“RCC”), has been accepted by the National Medical Products Administration (“NMPA”).

Globally, renal carcinoma is the third most common type of malignancy in the urinary system, and RCC accounts for 80%-90% of all cases. According to data published in the Chinese Medical Journal, in 2022, there were approximately 77,000 new cases of renal carcinoma and 46,000 deaths due to this disease in China. Approximately one-third of the renal carcinoma patients had distant metastasis at initial diagnosis, while 20%-50% of the patients with localized tumors developed distant metastases after nephrectomy. According to the risk classification of the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), patients with low, medium and high-risk metastatic RCC who were receiving anti-vascular targeted treatment demonstrated median overall survival (“OS”) rates of 35.3, 16.6 and 5.4 months, respectively. Therefore, the need for new treatment options is more urgent for patients with medium and high-risk advanced RCC compared to low-risk patients.

This supplemental new drug application is mainly based on the RENOTORCH study (NCT04394975). As the first pivotal phase 3 study of immunotherapy for patients with advanced RCC in China, RENOTORCH is a multi-center, randomized, open-label, active-controlled study aiming to evaluate the efficacy and safety of toripalimab in combination with axitinib versus sunitinib monotherapy for the first-line treatment of patients with intermediate to high-risk unresectable or metastatic RCC. The study was jointly led by principal investigators Professor Jun GUO of the Peking University Cancer Hospital and Professor Yiran HUANG of Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine.