Junshi Biosciences (688180.SH) announced that its product, toripalimab injection (subcutaneous) (code: JS001sc), has met the primary endpoint in a multicenter, open-label, randomized controlled Phase III clinical study (JS001sc-002-III-NSCLC, NCT06505837). The trial compared JS001sc with toripalimab injection (brand name: Tuoyi®, code: JS001) combined with chemotherapy as a first-line treatment for recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC). The company plans to submit a marketing authorization application for JS001sc to regulatory authorities soon.
JS001sc is a subcutaneous formulation developed based on the marketed toripalimab injection. It is the first domestically developed anti-PD-1 monoclonal antibody subcutaneous preparation to enter Phase III clinical trials, potentially offering greater convenience for patients. As of the announcement date, the Phase III study evaluating JS001sc versus toripalimab injection plus chemotherapy for first-line treatment of recurrent or metastatic non-squamous NSCLC has successfully achieved its primary endpoint.
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