Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application (“sNDA”) for toripalimab (trade name: TUOYI^®) in combination with disitamab vedotin, an antibody-drug conjugate (“ADC”) developed by RemeGen Co., Ltd. as the treatment of HER2-expressing (HER2 expression is defined as a HER2 immunohistochemistry test result of 1+, 2+, or 3+) locally advanced or metastatic urothelial carcinoma (“UC”), has been accepted by the National Medical Products Administration (“NMPA”). This is toripalimab’s 13th application for marketing submitted in the Chinese mainland.

UC is one of the ten most prevalent malignant tumors in the world, and in China, its incidence and mortality rates continue rising annually. According to the latest data from the National Cancer Center, in 2022, the number of new cases of UC in China reached 92,900, and the number of deaths reached over 40,000. UC is a serious threat to the life and health of patients, and there are huge unmet clinical needs.

In 2021, toripalimab was approved for the second-line and above treatment of advanced UC, becoming the first immunotherapy drug approved for non-selective, population-based indications of advanced UC in China. Over the past 5 years, the emergence of PD-(L)1 monoclonal antibodies and novel ADCs has been continuously reshaping the treatment landscape for advanced UC. Compared with conventional chemotherapy, novel therapies have demonstrated significant improvements in terms of survival benefit and tolerability, leading to more diverse and precise treatment options for patients.

The sNDA is based on results from the RC48-C016 study (NCT05302284), a multi-center, randomized, open-label and controlled phase 3 clinical trial, which evaluated the efficacy and safety of toripalimab in combination with disitamab vedotin versus gemcitabine in combination with cisplatin/carboplatin in systemic-treatment-naive patients with HER2 (human epidermal growth factor receptor 2)-expressing locally advanced or metastatic UC. The study was conducted in 74 clinical centers across China with Professor Jun GUO from Beijing Cancer Hospital and Professor Aiping ZHOU from the Cancer Hospital of the Chinese Academy of Medical Sciences as the principal investigators.

In May 2025, the primary endpoints of progression-free survival (“PFS”, based on independent radiographic review) and overall survival (“OS”) of the RC48-C016 study met the pre-defined efficacy boundary. The results showed that in HER2-expressing, locally advanced or metastatic UC, toripalimab in combination with disitamab vedotin as a first-line treatment significantly improved PFS and OS compared to gemcitabine in combination with cisplatin/carboplatin. Toripalimab has a good safety profile that is consistent with previous studies, with no new safety signals identified. Further details will be presented at major international academic conferences.