Announcement • Jul 21
Shanghai Junshi Biosciences Co., Ltd. Receives Acceptance Of Supplemental Application For Toripalimab In Combination With Chemotherapy As Perioperative Treatment For Resectable Stage II-III NSCLC Patients
Shanghai Junshi Biosciences Co., Ltd. has recently received the Acceptance Notice («?????») issued by the National Medical Products Administration. The supplemental application for the revised indication of toripalimab (trade name: TUOYI®, product code: JS001) in combination with platinum-containing chemotherapy as perioperative treatment and subsequently, monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage II-III non-small cell lung cancer (“NSCLC”) has been accepted. The indication in the application is expanded from adult patients with resectable stage IIIA-IIIB NSCLC to adult patients with resectable stage II-III NSCLC. Drug name: Toripalimab Injection. Application matter: Supplemental Application for Domestic Production of Pharmaceutical Product. Acceptance Nos.: CYSB2600212, CYSB2600213. Applicant: Shanghai Junshi Biosciences Co., Ltd. Review conclusion: It is decided to be accepted upon review according to the requirements of Article 32 of the Administrative License Law of the People’s Republic of China («????????????»). Lung cancer is currently a malignant tumor with the highest prevalence and mortality rate in the world. According to data released by National Clinical Research Center for Cancer, in 2024, there were approximately 1,180,000 new lung cancer cases in China, accounting for 22.83% of all new cancer cases in China; there were approximately 740,000 lung cancer deaths in China, representing 28.79% of all cancer deaths in China. Amongst these patients, 20%-25% were surgically resectable at first diagnosis, but even after radical surgical treatment, 30%-55% of such patients suffered from post-surgical recurrence and death. Radical surgery in combination with chemotherapy is a way to prevent recurrence, but chemotherapy, as preoperative neoadjuvant or postoperative adjuvant therapy, has limited clinical benefit and can only raise the 5-year survival rate of patients by approximately 5%. Immunotherapy represented by PD-(L)1 inhibitors has been transforming the landscape of cancer treatment. It has a long-term effect in respect of tumor control or elimination by relieving the immune suppression of immune cells by tumor cells and reactivating the patients’ own immune cells to kill the tumor. PD-1/PD-L1 inhibitors have been recommended by authoritative lung cancer treatment guidelines both domestically and internationally as one of the standard perioperative treatments for resectable stage II-III NSCLC. The supplemental application is principally based on the NEOTORCH (NCT04158440), a randomized, double-blind, placebo-controlled phase III clinical study aiming to compare the efficacy and safety of toripalimab or placebo in combination with chemotherapy as perioperative treatment for resectable stage II/III NSCLC patients. The study included a total of 501 patients with resectable stage II-III NSCLC. The primary endpoints are event-free survival (“EFS”) in patients with stage III and stage II-III disease as assessed by researchers, and major pathological response (“MPR”) rate in patients with stage III and stage II-III disease as assessed by the Blind Independent Pathology Review Committee (“BIPR”). The secondary endpoints include overall survival (“OS”), EFS as assessed by Independent Review Committee (IRC), pathological complete remission (“pCR”) rate, disease free survival (DFS) and safety. In January 2023, the EFS interim analysis of patients with resectable stage III NSCLC of NEOTORCH met the primary endpoint. The latest study results were presented as oral presentation at the April 2023 session of the American Society of Clinical Oncology (ASCO) Plenary Series and the 2023 ASCO Annual Meeting. NEOTORCH was the world’s first phase III clinical study of an anti-PD-1 monoclonal antibody for NSCLC perioperative treatment (including neoadjuvant and adjuvant) with positive EFS results published in the Journal of the American Medical Association (JAMA), a leading international journal in January 2024. The results showed that compared to perioperative chemotherapy alone, toripalimab in combination with chemotherapy as perioperative treatment led to a significant improvement in EFS (median EFS: not reached vs. 15.1 months, P<0.001), reduced risk of disease recurrence, progression events or death by 60% (HR=0.40, 95% CI: 0.28-0.57). The OS in the toripalimab in combination with chemotherapy group showed a clear trend toward improved outcomes (HR=0.62, 95% CI: 0.38-1.00). Toripalimab in combination with chemotherapy as perioperative treatment increased the pCR rate to nearly 25-fold (pCR rate: 24.8% vs. 1.0%) and the MPR rate to nearly 6-fold (MPR rate: 48.5% vs. 8.4%). In December 2023, based on the results of the interim analysis of NEOTORCH, the supplemental new drug application for the new indication of toripalimab in combination with platinum-containing doublet chemotherapy for perioperative treatment of resectable stage IIIA-IIIB NSCLC patients was approved. It was the first approved perioperative therapy for lung cancer domestically and the second one worldwide, and has been included in the National Reimbursement Drug List (2025).
