JUNSHI BIO (01877): Marketing application accepted for new indication of toripalimab injection (subcutaneous) as first-line treatment for HER2-expressing urothelial carcinoma

JUNSHI BIO (01877) announced that recently, the company received the "Acceptance Notice" issued upon approval by the National Medical Products Administration. The marketing application for a new indication of the company's product toripalimab injection (subcutaneous) (code: JS001sc) in combination with disitamab vedotin for the treatment of HER2-expressing (HER2 expression defined as HER2 immunohistochemistry results of 1+, 2+, or 3+) locally advanced or metastatic urothelial carcinoma has been accepted. The marketing applications of toripalimab injection (subcutaneous) for all 13 approved indications of toripalimab injection (trade name: Tuoyi, code: JS001) have all been accepted. In March 2026, the Phase III clinical study of JS001sc in combination with chemotherapy as first-line treatment for non-squamous non-small cell lung cancer was successfully selected for an oral presentation at the 2026 European Lung Cancer Congress (ELCC2026). The study results showed that the drug exposure of JS001sc was non-inferior to that of JS001, and the two were similar in both clinical efficacy and safety, and JS001sc is expected to provide patients with a more convenient new immunotherapy option. In March 2026, the marketing applications of JS001sc for 12 oncology indications were accepted by the National Medical Products Administration, making it the first domestic anti-PD-1 monoclonal antibody subcutaneous formulation to enter the marketing application stage.