SHANGHAI, China, July 21, 2026
Junshi Biosciences has announced that the National Medical Products Administration (NMPA) has accepted a supplemental application seeking to expand the indication for toripalimab in combination with platinum-containing chemotherapy as perioperative treatment, followed by adjuvant toripalimab monotherapy, for adult patients with resectable Stage II-III non-small cell lung cancer (NSCLC). The application aims to broaden the current approval from Stage IIIA-IIIB NSCLC to include Stage II-III disease, potentially extending access to immunotherapy for a larger population of patients with surgically resectable lung cancer. The submission is supported by the Phase 3 NEOTORCH clinical trial, which demonstrated substantial improvements in event-free survival (EFS), major pathological response (MPR), and pathological complete response (pCR) compared with chemotherapy alone. The regulatory milestone further strengthens toripalimab’s position as one of China’s leading anti-PD-1 immunotherapies for lung cancer and reflects the continued evolution of perioperative immunotherapy in early-stage NSCLC.
Phase 3 NEOTORCH Trial Delivers Strong Clinical Outcomes
The supplemental application is primarily supported by results from the NEOTORCH Phase 3 randomized, double-blind, placebo-controlled clinical trial, which enrolled 501 patients with resectable Stage II-III NSCLC. The study compared toripalimab plus platinum-based chemotherapy against chemotherapy alone as perioperative treatment. Clinical findings demonstrated that patients receiving the immunotherapy combination experienced a 60% reduction in the risk of disease recurrence, progression, or death, with median event-free survival not reached compared with 15.1 months in the chemotherapy-only group. Additionally, pathological complete response rates increased nearly 25-fold, while major pathological response rates improved almost six-fold, highlighting the significant anti-tumor activity achieved through perioperative PD-1 blockade. Researchers also observed a positive trend toward improved overall survival, reinforcing the clinical benefit of combining immunotherapy with chemotherapy before and after surgery.
Surgical Outcomes Reinforce Perioperative Benefits
Further evidence supporting the application comes from the recently published NEOTORCH surgical outcomes analysis, which evaluated patients undergoing surgery following perioperative treatment. The analysis demonstrated that toripalimab plus chemotherapy significantly reduced surgery cancellation rates, allowing more patients to proceed to potentially curative surgical resection without increasing perioperative complications or introducing new safety concerns. Among patients completing surgery, the immunotherapy regimen achieved substantially higher tumor downstaging and lymph node downstaging rates while delivering additional improvements in event-free survival. These findings highlight the potential role of perioperative immunotherapy in improving both surgical feasibility and long-term disease control, supporting growing international interest in integrating PD-1 inhibitors into earlier stages of lung cancer treatment.
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Expanding Access to PD-1 Immunotherapy
Toripalimab is a proprietary anti-PD-1 monoclonal antibody developed by Junshi Biosciences to restore anti-tumor immune activity by blocking interactions between PD-1, PD-L1, and PD-L2. The therapy has become one of China’s most extensively studied immuno-oncology agents, with more than 40 company-sponsored clinical studies evaluating its use across multiple solid tumor types. The product currently holds numerous approved indications in China and has received regulatory approvals in nearly 50 countries and regions, including the United States, European Union, and several Asia-Pacific markets. If approved, the expanded indication for Stage II-III NSCLC would allow a broader population of patients with resectable lung cancer to benefit from evidence-based perioperative immunotherapy, reinforcing Junshi Biosciences’ leadership in advancing innovative immune checkpoint inhibitors for global oncology care.
Source: Junshi Biosciences Press release
