JUNSHI BIO (01877): The supplemental application for the use of Tropil Single Top Antibody in combination with chemotherapy for adjuvant therapy in patients with resectable stage II-III non-small cell lung cancer has been accepted.

JUNSHI BIO (01877) announced that Shanghai JUNSHI BIO Pharmaceutical Technology Co., Ltd. (hereinafter referred to as the "company") has received an "Acceptance Letter" approved and issued by the National Medical Products Administration for the supplemental application for the revised indication of the use of Tepurinib Monoclonal Antibody (trade name: Tuyi, product code: JS001) in combination with platinum-based chemotherapy for neoadjuvant therapy for operable stage II-III non-small cell lung cancer (NSCLC) adult patients, followed by the use of this product as adjuvant therapy. The indication for this application has been expanded from adult patients with operable stages IIIA-IIIB NSCLC to adult patients with operable stages II-III NSCLC. Lung cancer is currently the leading malignant tumor in terms of incidence and mortality globally. According to data released by the National Clinical Medical Research Center for Cancer, the number of new cases of lung cancer in China is estimated to be approximately 1.18 million in 2024, accounting for 22.83% of the new cancer cases in China. The number of deaths from lung cancer in China is estimated to be around 740,000, accounting for 28.79% of cancer-related deaths in China. Among these, 20-25% of patients are eligible for surgical resection at initial diagnosis, but even with curative surgical treatment, 30-55% of patients still experience recurrence and death post-operatively. Adjuvant chemotherapy following curative surgery is one of the means to prevent disease recurrence, but the clinical benefit of chemotherapy as neoadjuvant or adjuvant therapy is limited, only increasing the 5-year survival rate of patients by about 5%. In recent years, immunotherapy, represented by PD-(L)1 inhibitors, has been changing the landscape of cancer treatment. It can release the immune suppression of tumor cells by immune cells, reactivating the patient's own immune cells to kill tumors and achieve long-term control or elimination of tumors. PD-1/PD-L1 inhibitors have been recommended as one of the standard neoadjuvant therapies for operable stages II-III NSCLC in domestic and international authoritative lung cancer treatment guidelines. This supplemental application is mainly based on the NEOTORCH study (NCT04158440), a randomized, double-blind, placebo-controlled Phase III clinical study aimed at comparing the efficacy and safety of Tepurinib monoclonal antibody or placebo in combination with chemotherapy for neoadjuvant therapy in patients with operable stages II/III NSCLC. The study, led by Professor Lu Shun of the Department of Thoracic Surgery at Shanghai Jiao Tong University School of Medicine, has enrolled a total of 501 patients with operable stages II-III NSCLC. The primary endpoints include the investigator-assessed Event-Free Survival (EFS) in patients with stages III and II-III, and the Major Pathological Response rate (MPR rate) assessed by the blind independent central pathologist (BIPR) in patients with stages III and II-III. Secondary endpoints include overall survival (OS), EFS assessed by the Independent Review Committee (IRC), complete pathological response rate (pCR rate), Disease-Free Survival (DFS), and safety. In January 2023, the NEOTORCH study's midterm analysis of EFS in patients with operable stage III NSCLC reached the primary study endpoint. The latest research results were announced in the April meeting series of the American Society of Clinical Oncology (ASCO) in 2023 and at the ASCO annual meeting in oral presentation form. In January 2024, the results were published in the main journal of the Journal of the American Medical Association (JAMA), making it the first Phase III clinical study globally to achieve positive EFS results for the use of anti-PD-1 monoclonal antibody in neoadjuvant therapy for non-small cell lung cancer (including neoadjuvant and adjuvant therapy). The results showed that Tepurinib in combination with chemotherapy for neoadjuvant therapy significantly prolonged EFS compared to neoadjuvant chemotherapy alone, extending median EFS to 15.1 months from not being reached (P<0.001) and reducing the risk of disease recurrence, progression, or death by 60% (HR = 0.40, 95% CI: 0.28-0.57). Additionally, the Tepurinib monoclonal antibody in combination with chemotherapy group showed a significant trend of benefit in OS (HR = 0.62, 95% CI: 0.38-1.00). Furthermore, Tepurinib monoclonal antibody in combination with neoadjuvant chemotherapy increased the pCR rate nearly 25 times (pCR rate: 24.8% vs. 1.0%) and the MPR rate nearly 6 times (MPR rate: 48.5% vs. 8.4%). In December 2023, based on the interim analysis of the NEOTORCH study, the new indication application for the use of Tepurinib monoclonal antibody in combination with platinum-based double chemotherapy for neoadjuvant therapy in patients with operable stages IIIA-IIIB NSCLC was approved for marketing. This is the first and second globally approved neoadjuvant therapy for lung cancer and has been included in the National Medical Insurance Directory (2025). This therapy also received the highest level of recommendation in the 2024 edition of the Chinese Society of Clinical Oncology (CSCO) Non-Small Cell Lung Cancer Diagnosis and Treatment Guidelines. In May 2026, the NEOTORCH study completed its final analysis, and the primary study endpoints for the II-III population's EFS, MPR rate, and the III population's MPR rate all reached the predetermined boundary for efficacy. In July 2026, the postoperative outcome analysis results of the NEOTORCH study on the use of Tepurinib monoclonal antibody in combination with chemotherapy for neoadjuvant therapy in stage III patients with resectable NSCLC were formally published in the top international journal in the field of surgery, the Journal of the American Medical Association Surgery (JAMA Surgery). This analysis focused on the stage III NSCLC patients who underwent surgery in the NEOTORCH study and systematically evaluated the impact of neoadjuvant Tepurinib monoclonal antibody in combination with chemotherapy on surgical implementation, complications, and survival outcomes. The results showed that Tepurinib monoclonal antibody combined with chemotherapy significantly reduced the rate of surgery cancellations (17.8% vs. 26.7%, p = 0.03), giving more patients the opportunity for surgical resection, without increasing perioperative risks or new safety signals. Among the 314 patients who underwent surgery, Tepurinib monoclonal antibody in combination with chemotherapy effectively achieved tumor and lymph node downsizing (tumor downsizing rate: 80.7% vs. 50.7%, lymph node downsizing rate: 67.5% vs. 48.6%), improving patient EFS benefit (HR = 0.50, 95% CI: 0.33-0.74; p <0.001). In patients achieving tumor downsizing or lymph node downsizing, Tepurinib monoclonal antibody in combination with chemotherapy significantly improved EFS compared to placebo in both groups (HR both 0.45, p = 0.002 and p = 0.009). Tepurinib monoclonal antibody injection is the first domestically produced monoclonal antibody drug in China targeting PD-1 to be approved for marketing. It has previously won the highest award in the field of national patents, the "China Patent Gold Award," and has conducted over 40 company-initiated clinical studies covering more than 15 indications globally (including China, the United States, Europe, Southeast Asia, etc.). Key registration clinical studies evaluating the safety and efficacy of Tepurinib monoclonal antibody within multiple tumor types have been ongoing or completed. As of the date of this announcement, Tepurinib monoclonal antibody has been approved for 13 indications in mainland China. In December 2020, Tepurinib monoclonal antibody injection was initially approved through national medical insurance negotiations, with 12 indications approved for inclusion in the national medical insurance directory, being the only anti-PD-1 monoclonal antibody used for kidney cancer, triple-negative breast cancer, and melanoma treatment in the national medical insurance directory. Three indications for the use of Tepurinib monoclonal antibody in the treatment of advanced nasopharyngeal carcinoma and esophageal squamous cell carcinoma have been approved in Hong Kong, China. Internationally, as of the date of this announcement, Tepurinib monoclonal antibody has been approved for marketing in nearly 50 countries and regions, including the United States, European Union, India, United Kingdom, Australia, Singapore, Malaysia, South Africa, etc., and is undergoing market evaluations in various countries and regions globally.