Shanghai Junshi Biosciences announced that China's National Medicines Administration (NMPA) has accepted new drug registration applications (NDA) for toripalimab subcutaneous injection (code JS001sc).[3] These applications cover 12 indications for the treatment of tumors.[3] Toripalimab is the first homegrown anti-PD-1 monoclonal antibody drug approved for sale in China under the name TUOYI®.[1][3] Currently, toripalimab has ten approved indications in mainland China, including the treatment of melanoma, nasopharyngeal carcinoma, and others.[5] The JS001sc-002-III-NSCLC study confirmed that subcutaneous administration achieves statistically non-inferior drug exposure to intravenous administration, with comparable efficacy and safety.[3] Toripalimab is approved in more than 40 countries and regions, including China, the US, and Europe.[3][5] All ten indications are included in the 2024 National Reimbursable Drug List (NRDL).[4][5]