JUNSHI BIO (01877) announced that the final analysis of its randomized, double-blind, placebo-controlled, multicenter Phase III clinical study (referred to as the "NEOTORCH study," NCT04158440) for toripalimab (brand name: Tuoyi®, product code: JS001) in combination with platinum-based doublet chemotherapy as perioperative treatment for patients with resectable stage II-III non-small cell lung cancer (NSCLC) has been completed. The study achieved the protocol-prespecified superiority thresholds for all primary endpoints: event-free survival (EFS) in the stage II-III population, major pathological response (MPR) rate in the stage II-III population, and MPR rate in the stage III population. The company plans to submit a supplemental application for the product to regulatory authorities in the near future, seeking to expand the approved indication from perioperative treatment for resectable stage III NSCLC to perioperative treatment for resectable stage II-III NSCLC. Given the lengthy drug development cycles, multiple regulatory review stages, and potential uncertainties, investors are advised to exercise caution and carefully consider investment risks. Toripalimab injection is the first domestically developed anti-PD-1 monoclonal antibody approved for marketing in China. It has been honored with the highest national patent award, the "China Patent Gold Award." To date, over 40 company-sponsored clinical studies covering more than 15 indications have been conducted globally, including in China, the United States, Europe, and Southeast Asia. Ongoing or completed key registrational clinical studies are evaluating the safety and efficacy of toripalimab across multiple tumor types. As of the date of this announcement, toripalimab has been approved for 13 indications in mainland China. In December 2020, toripalimab injection was first included in China's National Reimbursement Drug List (NRDL) through national price negotiations. Currently, 12 approved indications are included in the NRDL, making it the only anti-PD-1 monoclonal antibody in the NRDL for the treatment of renal cell carcinoma, triple-negative breast cancer, and melanoma. Toripalimab has also been approved for three indications in Hong Kong, China, for the treatment of advanced nasopharyngeal carcinoma and esophageal squamous cell carcinoma. Regarding international expansion, as of the date of this announcement, toripalimab has received marketing approval in over 40 countries and regions, including the United States, the European Union, India, the United Kingdom, Australia, and Singapore, and is under regulatory review for marketing authorization in numerous other countries and regions worldwide.
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