Junshi Biosciences (01877.HK): Toripalimab NSCLC Indication Supplemental Application Accepted; Expanded from Stage IIIA-IIIB to Stage II-III
NewTimeSpace News: Shanghai Junshi Biosciences Co., Ltd. (stock code: 1877) issued a voluntary announcement on July 21, disclosing that the supplemental application for toripalimab combined with chemotherapy for perioperative treatment of patients with resectable stage II-III non-small cell lung cancer has been accepted.
The Board is pleased to announce that recently, the Company received the "Acceptance Notice" issued by the National Medical Products Administration. The supplemental application for the revision of the indication of toripalimab (trade name: Tuoyi®, product code: JS001) combined with platinum-containing chemotherapy for perioperative treatment, followed by this product as monotherapy for adjuvant treatment, for adult patients with resectable stage II-III non-small cell lung cancer ("NSCLC") has been accepted. This application expands the indication from adult patients with resectable stage IIIA-IIIB NSCLC to adult patients with resectable stage II-III NSCLC.
This supplemental application is primarily based on the NEOTORCH study (NCT04158440), a randomized, double-blind, placebo-controlled Phase III clinical study designed to compare the efficacy and safety of toripalimab or placebo combined with chemotherapy for perioperative treatment in patients with stage II/III resectable NSCLC. Led by Professor Lu Shun from Shanghai Chest Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, the study enrolled a total of 501 patients with stage II-III resectable NSCLC. Primary endpoints included event-free survival ("EFS") assessed by investigators in stage III and stage II-III patients, and major pathological response rate ("MPR rate") assessed by blinded independent central pathology ("BIPR") in stage III and stage II-III patients. Secondary endpoints included overall survival ("OS"), EFS assessed by independent review committee (IRC), complete pathological response rate ("pCR rate"), disease-free survival (DFS), and safety.
In January 2023, the EFS interim analysis of stage III resectable NSCLC patients in the NEOTORCH study reached the primary study endpoint. The latest research results were presented orally at the ASCO Plenary Series April Meeting and ASCO Annual Meeting in 2023, and published in January 2024 in the Journal of the American Medical Association (JAMA), becoming the world's first Phase III clinical study of an anti-PD-1 monoclonal antibody for NSCLC perioperative treatment (covering neoadjuvant and adjuvant therapy) to achieve a positive EFS result. Results showed that toripalimab combined with chemotherapy for perioperative treatment significantly prolonged EFS compared with perioperative chemotherapy alone (median EFS: not reached vs. 15.1 months, P<0.001), reducing the risk of disease recurrence, progression, or death by 60% (HR=0.40, 95%CI: 0.28-0.57). Meanwhile, the OS of the toripalimab combined with chemotherapy group also showed a clear trend of benefit.
In December 2023, based on the interim analysis results of the NEOTORCH study, the new indication marketing application for toripalimab combined with platinum-containing doublet chemotherapy for perioperative treatment of patients with resectable stage IIIA-IIIB NSCLC was approved, becoming the first approved lung cancer perioperative therapy in China and the second globally. It has been included in the "National Reimbursement Drug List (2025)" and received the highest level recommendation in the 2024 edition of the "CSCO Guidelines for Diagnosis and Treatment of Non-Small Cell Lung Cancer."
In May 2026, the NEOTORCH study completed final analysis, with the primary study endpoints of EFS and MPR rate in the stage II-III population, and MPR rate in the stage III population, all reaching the pre-specified superiority boundaries.
In July 2026, the post-hoc analysis results of surgical outcomes of stage III patients receiving toripalimab combined with chemotherapy for perioperative treatment of resectable NSCLC in the NEOTORCH study were formally published in JAMA Surgery, a top international journal in the surgical field. This analysis focused on stage III NSCLC patients who completed surgery in the NEOTORCH study, systematically evaluating the impact of perioperative toripalimab combined with chemotherapy on surgical implementation, complications, and survival outcomes. Results showed that toripalimab combined with chemotherapy significantly reduced the surgery cancellation rate (17.8% vs. 26.7%, p=0.03), enabling more patients to receive surgical resection opportunities without increasing perioperative risks or new safety signals.
Toripalimab injection is the first domestically produced anti-PD-1 monoclonal antibody drug approved for marketing in China targeting PD-1, and has won the "China Patent Gold Award," the highest honor in the national patent field. To date, the Company has initiated more than 40 clinical studies covering over 15 indications globally (including China, the United States, Europe, and Southeast Asia). As of the date of this announcement, 13 indications of toripalimab have been approved in mainland China. In December 2020, toripalimab injection first passed national medical insurance negotiation; currently, 12 approved indications have been included in the National Reimbursement Drug List, making it the only anti-PD-1 monoclonal antibody in the National Reimbursement Drug List for the treatment of renal cell carcinoma, triple-negative breast cancer, and melanoma. Three indications of toripalimab for the treatment of advanced nasopharyngeal carcinoma and esophageal squamous cell carcinoma have been approved in Hong Kong, China.
In terms of international layout, as of the date of this announcement, toripalimab has been approved for marketing in nearly 50 countries and regions including the United States, the European Union, India, the United Kingdom, Australia, Singapore, Malaysia, and South Africa, and is under regulatory review in multiple countries and regions worldwide.
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