Pharma Focus Asia

Junshi Biosciences Receives Approval for Toripalimab as a First-Line Therapy for Advanced Triple-Negative Breast Cancer

Wednesday, June 26, 2024

Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading biopharmaceutical company focused on innovation, has received approval from China's National Medical Products Administration (NMPA) for toripalimab (product code: JS001) in combination with paclitaxel for treating recurrent or metastatic triple-negative breast cancer (TNBC) in its first-line setting.

TNBC is a particularly aggressive form of breast cancer lacking effective targeted therapies, traditionally managed with chemotherapy, which has limited efficacy. The approval stems from the positive outcomes of the TORCHLIGHT study (NCT04085276), a Phase III clinical trial conducted across 56 centers in China. The study demonstrated that toripalimab, an anti-PD-1 monoclonal antibody, significantly improved progression-free survival (PFS) and showed promising trends in overall survival (OS) when combined with paclitaxel compared to paclitaxel alone.

Published interim results from the TORCHLIGHT study in Nature Medicine highlighted that toripalimab extended median PFS to 8.4 months and median OS to 32.8 months, marking a significant advancement in TNBC immunotherapy in China. Toripalimab's safety profile remained consistent with prior findings.

Junshi Biosciences, emphasized the approval's importance in meeting the unmet medical needs of TNBC patients in China. Toripalimab now boasts ten approved indications in China and continues to be studied globally across various tumor types.

Toripalimab functions by blocking PD-1 interactions with its ligands, thereby enhancing the immune system's ability to combat cancer cells. Its extensive clinical program includes studies in lung cancer, nasopharyngeal carcinoma, and other cancers worldwide.

This milestone underscores Junshi Biosciences' dedication to advancing cancer treatment through innovative immunotherapies, providing new hope for patients facing challenging cancers like TNBC



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