SHANGHAI, November 25, 2025 — Leads & Copy — Junshi Biosciences (HKEX: 1877; SSE: 688180) has announced that its JS001sc-002-III-NSCLC study, a Phase 3 clinical trial, has achieved its primary goals.
The study, identified as NCT06505837, was designed as a multi-center, open-label, randomized Phase 3 trial. It compared the effectiveness of toripalimab injection (subcutaneous injection), codenamed JS001sc, against the standard toripalimab injection, codenamed JS001, both in combination with chemotherapy. The target patient group was those with recurrent or metastatic non-squamous non-small-cell lung cancer (NSQ-NSCLC).
Junshi Biosciences intends to file a new drug application (NDA) with regulatory bodies soon, based on the study’s findings.
Data from GLOBOCAN 2022 indicates that in China alone, there were 1.06 million new cases of lung cancer in 2022, accounting for 22.0% of all new cancer cases. Lung cancer-related deaths reached 0.73 million, representing 28.5% of all cancer-related deaths in China. Non-small cell lung cancer (NSCLC) is the most common type, making up approximately 85% of all lung cancer cases, with non-squamous NSCLC accounting for around 65% of these.
Immunotherapy, particularly through anti-PD-1 monoclonal antibodies, has become a key treatment in oncology. It’s used across nearly all stages of cancer treatment, from early-stage adjuvant/neoadjuvant treatments to late-stage therapies for advanced tumors. However, in China, most immunotherapy drugs require intravenous administration, leading to long infusion times and patient inconvenience.
The JS001sc-002-III-NSCLC study, led by Professor Lin WU from Hunan Cancer Hospital, sought to address the need for more convenient administration methods. The study compared the drug exposure, efficacy, and safety of JS001sc combined with chemotherapy versus JS001 plus chemotherapy, in treating recurrent or metastatic NSQ-NSCLC. Results indicated that JS001sc achieved non-inferior drug exposure compared to the standard toripalimab injection, with similar efficacy and safety results. Detailed study data are slated for presentation at an upcoming international academic conference.
Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, noted that toripalimab has already been approved for 12 indications in China. He highlighted the challenges of frequent intravenous catheterization and lengthy infusions faced by patients undergoing immunotherapy. Dr. Zou stated that the success of the JS001sc Phase 3 study signifies a crucial advancement in immunotherapy, shifting the focus towards patient convenience while maintaining treatment effectiveness. The goal is to simplify treatment procedures, reduce the burden on patients and healthcare resources, and improve treatment accessibility. Junshi Biosciences is focused on getting JS001sc’s NDA approved for all approved indications of JS001.
JS001sc is a subcutaneous injection formulation of toripalimab injection, developed by Junshi Biosciences. It is the first domestic anti-PD-1 monoclonal antibody subcutaneous formulation to reach Phase 3 clinical trials. The recent Phase 3 clinical study demonstrated that JS001sc met its primary endpoints, offering a potentially more convenient administration method for patients.
Founded in December 2012, Junshi Biosciences is committed to creating innovative therapies. The company has over 50 drug candidates in development, targeting cancer, autoimmune conditions, metabolic, neurological, and infectious diseases. Five of Junshi Biosciences’ products have been approved in China and internationally, including toripalimab, China’s first domestically produced anti-PD-1 monoclonal antibody, approved in over 40 countries. Junshi Biosciences also contributed to developing therapies for COVID-19, including etesevimab and MINDEWEI®.
With the mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences has approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.).
Contact Information:
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-6105 8800
PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800
Source: Junshi Biosciences
