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%).<\/p>\n
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.<\/p>\n
In May 2026, the NEOTORCH finished the final analysis. The primary endpoints of EFS and 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.<\/p>\n
In July 2026, the full results of a post hoc analysis of surgical outcomes from the NEOTORCH of toripalimab in combination with chemotherapy for perioperative treatment of resectable stage III NSCLC patients were officially published in JAMA Surgery<\/em>, a leading international journal in the field of surgery. The analysis focused on stage III NSCLC patients who underwent surgery in the NEOTORCH and systematically evaluated the effects of toripalimab in combination with chemotherapy as perioperative treatment on surgical feasibility, complications, survival and other outcomes.<\/p>\n The results demonstrated that toripalimab in combination with chemotherapy significantly reduced the surgery cancellation rate (17.8% vs. 26.7%; p=0.03), thereby enabling more patients to undergo surgical resection without increasing perioperative risks or giving rise to any new safety signals. Among the 314 patients who completed surgery, compared with placebo in combination with chemotherapy, toripalimab in combination with chemotherapy effectively achieved higher rates of tumor downstaging and lymph node downstaging (tumor downstaging rate: 80.7% vs. 50.7%, lymph node downstaging rate: 67.5% vs. 48.6%), and improved the EFS benefit of the patients (HR=0.50, 95% CI: 0.33-0.74; p0.001). Among the patients who achieved tumor downstaging or lymph node downstaging, toripalimab in combination with chemotherapy significantly improved EFS compared with placebo in combination with chemotherapy (HR=0.45 for both, p=0.002 and p=0.009).<\/p>\n About Toripalimab<\/strong><\/p>\n Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune systems ability to attack and kill tumor cells.<\/p>\n More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.<\/p>\n In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI\u00ae<\/sup>). Currently, there are twelve approved indications for toripalimab in the Chinese mainland:<\/p>\n The first 12 indications have been included in the National Reimbursement Drug List (NRDL) (2025 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, RCC and TNBC. Toripalimab for the treatment of advanced NPC and ESCC was approved in Hong Kong SAR, China.<\/p>\n Internationally, 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 also under review for marketing in various countries and regions worldwide.<\/p>\n About Junshi Biosciences<\/strong><\/p>\n Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. With our outstanding capacity for innovative drug discovery, strong biotechnology R&D capability, and large-scale production capacity, we have successfully developed a drug candidate portfolio with global competitiveness and a well-structured research pipeline, which covers therapeutic areas including cancer, autoimmune, metabolic, and infectious diseases. Our innovative field spans cutting-edge therapeutic modalities, including mAbs, small-molecule drugs, ADCs, bsAb\/msAb, fusion proteins, nucleic acid drugs and vaccines. Five of the companys products have received marketing authorizations in China and international markets, one of which is toripalimab, Chinas domestically developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in nearly 50 countries and regions including China, the US, and Europe.<\/p>\n With a mission of providing patients with world-class, trustworthy, affordable, and innovative drugs, Junshi Biosciences is In China, For Global. At present, the company boasts nearly 3,000 employees mainly in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou). For more information, please visit: http:\/\/www.junshipharma.com.<\/p>\n Junshi Biosciences Contact Information<\/strong><\/p>\n IR Team: PR Team:\n
Junshi Biosciences
info@junshipharma.com<\/a>
+ 86 021-6105 8800<\/p>\n
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com<\/a>
+ 86 021-6105 8800<\/p>\n
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