China’s NMPA accepts sNDA for subcutaneous toripalimab in first-line HER2-expressing urothelial carcinoma
Shanghai Junshi Biosciences Co., Ltd. announced that the National Medical Products Administration of China (NPMA) has accepted the supplemental new drug application for toripalimab injection (subcutaneous injection) (code: JS001sc) in combination with disitamab vedotin for the treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma (UC).
The new drug application for toripalimab injection (subcutaneous administration) has been accepted in respect of all 13 approved indications of toripalimab injection (trade name: TUOYI, product code: JS001).
JS001sc is a subcutaneous injection formulation developed by the Company based on the marketed product, toripalimab injection. It is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the new drug application stage, and is expected to bring convenient administration to patients. Immuno-oncology (I-O) therapies, represented by anti-PD-1 monoclonal antibodies, have become cornerstone therapies for the treatment of various malignant tumors. However, immuno-oncology drugs currently available in China are predominantly formulated for intravenous infusion, which not only requires prolonged infusion times but also causes significant inconvenience to patients during treatment. Consequently, there is an urgent clinical need to improve the convenience of immunotherapy.
In November 2025, a multi-center, open-label, randomized controlled Phase III clinical study to compare JS001sc and toripalimab injection in combination with chemotherapy for the first-line treatment of recurrent or metastatic non-squamous non-small cell lung cancer met the primary endpoint.
In March 2026, the Phase III clinical study of JS001sc in combination with chemotherapy as a first-line treatment for non-squamous non-small-cell lung cancer was successfully selected for an oral presentation at the European Lung Cancer Congress 2026 (ELCC 2026). The study results demonstrated that the drug exposure of toripalimab subcutaneous injection was non-inferior to that of the intravenous formulation of toripalimab, with comparable clinical efficacy and safety profiles, and is expected to provide patients with a new, more convenient immunotherapy option.
In March 2026, the new drug application of JS001sc for 12 indications for the treatment of tumors was accepted by the National Medical Products Administration, making it the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the new drug application stage.
