JUNSHI BIO (01877): Toripalimab Receives Conventional Approval from the National Medical Products Administration for the Treatment of Locally Advanced or Metastatic Urothelial Carcinoma That Has Failed Platinum-Containing Chemotherapy

JUNSHI BIO (01877) announced that recently, the Company received the "Drug Supplementary Application Approval Notice" issued upon review and approval by the National Medical Products Administration (NMPA), approving the indication of toripalimab injection (trade name: TUOYI, product code: JS001) as a monotherapy for patients with locally advanced or metastatic urothelial carcinoma that has failed platinum-containing chemotherapy, including disease progression within 12 months of neoadjuvant or adjuvant chemotherapy, with the approval converted from conditional approval to conventional approval. Urothelial carcinoma is one of the top ten most common malignant tumors worldwide, with its incidence and mortality rates in China increasing year by year, seriously threatening patients' lives and health, and representing a huge unmet clinical need. In April 2021, based on a multicenter, single-arm, open-label, Phase II clinical trial (POLARIS-03 study, NCT03113266), toripalimab received conditional marketing approval from the NMPA for second-line and above treatment of advanced urothelial carcinoma, making it the first immunotherapy drug approved in China for an unselected population indication in advanced urothelial carcinoma. This conventional approval was primarily based on the RC48-C016 study (NCT05302284), a multicenter, randomized, open-label, active-controlled Phase III clinical study designed to compare the efficacy and safety of toripalimab combined with disitamab vedotin versus gemcitabine combined with cisplatin/carboplatin in patients with HER2 (human epidermal growth factor receptor-2) expressing (defined as HER2 IHC 1+, 2+, or 3+) locally advanced or metastatic urothelial carcinoma who had not previously received systemic anti-tumor therapy. The study was led by Professor Guo Jun of Peking University Cancer Hospital and Professor Zhou Aiping of Cancer Hospital Chinese Academy of Medical Sciences as principal investigators, and was conducted at 74 clinical centers nationwide. In October 2025, the results of the RC48-C016 study were published in The New England Journal of Medicine (NEJM) and simultaneously presented as an oral presentation at the Presidential Session of the 2025 European Society for Medical Oncology (ESMO) Annual Congress (abstract number: #LBA7). The results showed that the primary endpoints of progression-free survival ("PFS", based on independent imaging assessment) and overall survival (OS) achieved "dual endpoint positive results." Compared with traditional chemotherapy, first-line treatment with toripalimab combined with disitamab vedotin for HER2-expressing advanced urothelial carcinoma doubled median PFS (13.1 months vs. 6.5 months, hazard ratio HR=0.36, 95% CI: 0.28-0.46; p<0.0001), significantly extended median OS (31.5 months vs. 16.9 months, HR=0.54, 95% CI: 0.41-0.73; p<0.0001), substantially improved objective response rate (ORR) (76.1% vs. 50.2%), and extended median duration of response several-fold (14.6 months vs. 5.6 months). The combination therapy group showed substantially improved safety compared with traditional chemotherapy. As of the date of this announcement, TUOYI has been approved for 13 indications in mainland China, of which 12 have been included in the National Reimbursement Drug List, making it the only anti-PD-1 monoclonal antibody drug in the list for the treatment of renal cell carcinoma, triple-negative breast cancer, and melanoma.