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[ Junshi Biosciences (01877.HK): Toripalimab NSCLC Indication Supplemental Application Accepted; Expanded from Stage IIIA-IIIB to Stage II-III ] NewTimeSpace News: On July 21, Junshi Biosciences announced that the supplemental application for the revision of the indication of toripalimab (Tuoyi®, JS001) combined with platinum-containing chemotherapy for perioperative treatment followed by monotherapy adjuvant treatment for adult patients with resectable stage II-III NSCLC has been accepted by the NMPA, expanding the indication from stage IIIA-IIIB to stage II-III. The supplemental application is primarily based on the NEOTORCH study (NCT04158440), a Phase III clinical study led by Professor Lu Shun with 501 enrolled patients. The EFS interim analysis reached the primary endpoint in January 2023, and the stage IIIA-IIIB indication was approved in December 2023 (China's first and the world's second lung cancer perioperative therapy). The final analysis was completed in May 2026 with all primary endpoints reaching pre-specified superiority boundaries. The July 2026 JAMA Surgery publication of post-hoc surgical outcome analysis showed that combination therapy significantly reduced the surgery cancellation rate (17.8% vs. 26.7%). As of the announcement date, toripalimab has 13 approved indications in mainland China, 12 included in the National Reimbursement Drug List, and has been approved in nearly 50 countries and regions globally.
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JUNSHI BIO01877.HK
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