(RTTNews) - Shanghai Junshi Biosciences Co., Ltd. (1877.HK), a biopharmaceutical company, announced that the Chinese regulatory authority, National Medical Products Administration, has accepted a supplemental biologics license application for Toripalimab in combination with platinum-based chemotherapy, followed by toripalimab monotherapy, as perioperative treatment for patients with resectable stage II-III non-small cell lung cancer.
Toripalimab is an anti-PD-1 monoclonal antibody designed to block PD-1 interactions with PD-L1 and PD-L2, enhancing the immune system's ability to recognise and destroy tumor cells.
Toripalimab is currently approved and marketed in China under the brand name TUOYI for twelve indications across multiple cancers, including melanoma, nasopharyngeal carcinoma (NPC), urothelial carcinoma (UC), esophageal squamous cell carcinoma (ESCC), non-squamous non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), extensive-stage small cell lung cancer (ES-SCLC), triple-negative breast cancer (TNBC), and hepatocellular carcinoma (HCC).
Internationally, toripalimab has been approved in nearly 50 countries and regions, including the U.S., EU, UK, India, Australia, Singapore, Malaysia, and South Africa, with additional regulatory reviews ongoing.
The submission is supported by results from the Phase III NEOTORCH trial, a randomized, double-blind, placebo-controlled study evaluating perioperative toripalimab plus chemotherapy in patients with resectable stage II/III NSCLC. The study enrolled 501 patients and evaluated event-free survival (EFS) and major pathological response (MPR) as its primary endpoints.
The secondary endpoints included overall survival (OS), EFS as assessed by the Independent Review Committee (IRC), pathological complete remission rate (pCR rate), disease-free survival (DFS) and safety.
According to the company, the final analysis completed in May 2026 met the pre-defined efficacy boundaries, with the primary endpoints of EFS and MPR achieved in the stage II-III population, while the MPR endpoint was also met in the stage III population. A separate analysis of stage III patients who underwent surgery evaluated the effects of perioperative toripalimab plus chemotherapy on surgical feasibility, complications, survival, and other clinical outcomes.
Attributable to Junshi, toripalimab plus chemotherapy reduced the surgery cancellation rate to 17.8%, compared to 26.7% in chemotherapy alone, enabling more patients to undergo surgical resection without increasing perioperative risks or introducing new safety concerns.
Among 314 patients who underwent surgery, the combination achieved higher tumor downstaging (80.7% vs. 50.7%) and lymph node downstaging (67.5% vs. 48.6%) rates. Patients who achieved tumor or lymph node downstaging also experienced significantly longer EFS than those receiving chemotherapy alone.
The company also highlighted previously reported interim results from January 2023, when the Phase III NEOTORCH trial met its primary endpoint of event-free survival at an interim analysis in patients with resectable stage III NSCLC.
The results demonstrated that median event-free survival was not reached with perioperative toripalimab plus chemotherapy, compared with 15.1 months for perioperative chemotherapy alone.
Furthermore, the regimen reduced the risk of disease recurrence, progression, or death by 60%, while overall survival showed a favorable trend. In addition, toripalimab increased the pathological complete response rate by nearly 25-fold and the major pathological response rate by nearly six-fold compared with chemotherapy alone.
Junshi shares closed Wednesday at 19.210 Hong Kong Dollars, down 1.94% on the Hong Kong Stock Exchange.
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