SHANGHAI, May 26, 2026 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that a randomized, double-blind, placebo-controlled, multi-center phase III clinical study ("NEOTORCH", NCT04158440) of the company's product toripalimab in combination with platinum-containing doublet chemotherapy as perioperative treatment for resectable stage II-III non-small cell lung cancer ("NSCLC") patients has finished its final analysis. The primary endpoints of event-free survival ("EFS") and major pathological response ("MPR") rate in the stage II-III population, as well as the MPR rate in the stage III population, met the pre-defined efficacy boundary. Junshi Biosciences now plans to submit a supplemental new drug application ("sNDA") for the product to regulatory authorities in the near future. Toripalimab combined with chemotherapy has already been approved for perioperative treatment of patients with resectable stage III NSCLC, and this new sNDA will aim to expand the approval to perioperative treatment of resectable stage II-III NSCLC.

Lung cancer is a malignant tumor with the highest prevalence and mortality rate in the world. According to data released by GLOBOCAN, in 2022, 1.06 million new lung cancer cases were reported in China, accounting for 22.0% of the nation's new cancer cases; in the same year, China also reported 0.73 million lung cancer deaths, representing 28.5% of cancer deaths nationwide.

Amongst these cases, 20%-25% were surgically resectable at first diagnosis, but even after radical surgical treatment, 30%-55% of the patients suffered from post-surgical recurrence and death. Radical surgery in combination with chemotherapy is one way to prevent recurrence, but chemotherapy, as preoperative neoadjuvant or postoperative adjuvant therapy, has limited clinical benefits and can only raise the 5-year survival rate by approximately 5%.

Recently, immunotherapy represented by PD-(L)1 inhibitors has been transforming the landscape of cancer treatment. PD-(L)1 inhibitors have displayed long-term effects in tumor control and/or elimination. Tumor cells exploit the PD-1 and PD-L1/PD-L2 binding process, but PD-(L)1 inhibitors stop immune evasion and suppression, reactivating the patients' own immune cells to kill the tumor. Many authoritative lung cancer treatment guidelines both domestically and internationally recommend PD-(L)1 inhibitors as one of the standard perioperative treatments for resectable stage II-III NSCLC.

NEOTORCH is 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. Led by principal investigator Professor Shun LU of Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, the study enrolled a total of 501 patients with resectable stage II-III NSCLC. The primary endpoints are EFS in patients with stage III and stage II-III disease as assessed by researchers, and 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 OS, EFS as assessed by the Independent Review Committee (IRC), pathological complete remission rate (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 through oral presentation at the April 2023 session of the American Society of Clinical Oncology (ASCO) Plenary Session and the 2023 ASCO Annual Meeting. NEOTORCH was the world's first phase 3 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) 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). Meanwhile, 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).

Moreover, 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%). The primary endpoint of the final analysis will be presented at an upcoming international academic conference.

In December 2023, based on the NEOTORCH interim analysis results, 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 by the NMPA. It was the first domestically approved perioperative therapy for lung cancer in China, and the second worldwide.***