JUNSHI BIO (01877): The application for the marketing approval of Teripulimab Injection (subcutaneous injection) has been accepted.

JUNSHI BIO (01877) announced that recently, Shanghai JUNSHI BIO Pharmaceutical Technology Co., Ltd. (hereinafter referred to as the "Company") has received the "Acceptance Notification" issued by the National Medical Products Administration for the market application of 12 indications for the company's product Tropilimab Injection (Subcutaneous Injection) (code: JS001sc) used in tumor treatment. Due to the long research and development cycle of drugs and multiple approval steps, it is susceptible to uncertainties. The approval of this market application is uncertain, so investors are advised to make decisions cautiously and be aware of investment risks. JS001sc is a subcutaneous injection formulation developed by the company based on the already marketed product Tropilimab Injection (code: JS001). It is the first domestically developed PD-1 monoclonal antibody subcutaneous injection formulation to enter the market application stage, bringing convenience in medication for patients. The 12 indications in this JS001sc market application are all the indications that Tropilimab Injection is currently approved for in mainland China. According to the data released by GLOBOCAN2022, in 2022, there were 4.8247 million new cancer cases and 2.5742 million deaths in China. Immune-oncology therapy (I-O) represented by PD-1 monoclonal antibodies has become a cornerstone therapy for various malignant tumors such as lung cancer, breast cancer, liver cancer, esophageal cancer, and nasopharyngeal cancer. It covers the entire treatment process for cancer patients, including adjuvant/neoadjuvant therapy for early-stage tumors, consolidation therapy after radical chemotherapy for locally advanced tumors, and first-line to last-line therapy for advanced tumors. Currently, intravenous infusion formulations are predominantly used for immunotherapy drugs in China, but they are time-consuming and inconvenient for patients, creating a pressing need for improved convenience in immunotherapy treatment. This market application is mainly based on the JS001sc-002-III-NSCLC study (NCT06505837), a multicenter, open-label, randomized phase III clinical study led by Professor Wu Lin from Hunan Cancer Hospital. It aims to compare the drug exposure, efficacy, and safety of JS001sc and JS001 combined with chemotherapy in recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC). The results show that the drug exposure of JS001sc is non-inferior to that of JS001, and their efficacy and safety are similar. This study is the first phase III clinical study of a domestically produced PD-1 subcutaneous formulation, and detailed data will be presented at an upcoming international academic conference.