FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

About Toripalimab
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. Two supplemental New Drug Applications (NDAs) of Toripalimab for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and the second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively. Both supplemental NDAs received priority review designations from the NMPA in July 2020. In addition, Toripalimab for the treatment of recurrent/metastatic nasopharyngeal carcinoma was granted the Breakthrough Therapy Designation (BTD) by the FDA in September 2020. In December 2020, Toripalimab was included in the updated National Reimbursement Drug List (NRDL) (2020 Edition).

About Combination Clinical Trial
The Combination Clinical Trial is an international, multi-center, randomized Phase III study designed to evaluate the efficacy and safety of Toripalimab in combination with Axitinib versus Pembrolizumab as a first-line treatment in patients with unresectable, locally advanced or metastatic mucosal melanoma. The trial intends to enroll 220 patients who will be randomized at 1:1 ratio into two study arms. The primary endpoint of the Combination Clinical Trial is progression-free survival (PFS). The secondary endpoints include objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety.

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