SHANGHAI, China, May 21, 2026 — 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 new drug application (NDA) for toripalimab in combination with disitamab vedotin for patients with HER2-expressing (which is defined as achieving a score of 1+, 2+ or 3+ in HER2 immunohistochemistry test), locally advanced or metastatic urothelial carcinoma (UC) was approved by the National Medical Products Administration (NMPA). Disitimab vedotin is an antibody drug conjugate independently developed by RemeGen Co., Ltd. With this latest approval, toripalimab injection now has 13 approved indications in the Chinese Mainland.
UC is among the top ten most prevalent malignant tumors in the world, and in China, its incidence and mortality rates continue rising. 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 exceeded 40,000. UC is a serious threat to the life and health of patients, and there are huge unmet clinical needs.
In 2021, toripalimab injection 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.
The approval of this new indication is based on results from the RC48-C016 study (NCT05302284). The study is 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 (which is defined as HER2 IHC 1+, 2+ or 3+) 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 October 2025, the study results of RC48-C016 were published in The New England Journal of Medicine (NEJM), and shared in an oral presentation at the Presidential Symposium of the 2025 European Society for Medical Oncology (ESMO) annual meeting (#LBA7).
The results were positive for both primary endpoints, progression free survival (“PFS”, assessed by blinded independent review) and overall survival (“OS”). Compared with traditional chemotherapy, toripalimab in combination with disitamab vedotin for the first-line treatment of HER2-expressing advanced UC more than doubled the median PFS [13.1 months vs. 6.5 months, hazard ratio (HR)=0.36, 95%CI: 0.28-0.46; p<0.0001], as well as the median OS (31.5 months vs. 16.9 months, HR=0.54, 95%CI: 0.41-0.73; p<0.0001). The objective response rate (ORR) greatly increased (76.1% vs. 50.2%) and the medium duration of response (DoR) almost tripled in comparison (14.6 months vs. 5.6 months). The combination therapy group also demonstrated significant improvements in safety compared to the chemotherapy group.
Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “The approval of toripalimab’s 13th indication is a huge milestone for us all, and sheds light on the importance of our open collaboration R&D strategy. In urologic oncology immunotherapy, toripalimab continues to be a driving force and this approval deepens its impact across the immunotherapy landscape. We are immensely proud to partner with RemeGen. Together, we were able to combine two locally-developed innovations to create a powerful synergistic treatment that significantly improves both PFS and OS. Moving forward, Junshi Biosciences will expand on our Immuno-Oncology (I-O) 2.0 strategy, pursuing the next generation of combination therapies and novel target drugs to fulfill our commitment to enduring innovation, ensuring China’s innovation benefits global patients.”