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Urothelial carcinoma (UC) is one of the ten most common malignant tumors worldwide, with its incidence and mortality rates in China showing a year-on-year upward trend. According to the latest data from the National Cancer Center, there were 92,900 new cases of UC in China in 2022, with over 40,000 deaths[1], posing a serious threat to patients’ lives and health, and representing a significant unmet clinical need.
In 2021, toripalimab was approved for second-line and later treatment of advanced UC, making it China’s first immunotherapy drug approved for a non-selective population indication in advanced UC.
In October 2025, the research findings of RC48-C016 were published in The New England Journal of Medicine (NEJM) and simultaneously presented as an oral report at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting Presidential Symposium (Abstract #LBA7), attracting widespread attention from scholars both domestically and internationally.
Results showed[2] that the primary endpoints of progression-free survival (PFS, based on independent imaging review) and overall survival (OS) achieved “dual positive endpoint results.” Compared with traditional chemotherapy, toripalimab combined with disitamab vedotin as first-line treatment for HER2-expressing advanced UC 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), 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 the objective response rate (ORR) (76.1% vs. 50.2%), and prolonged the median duration of response several-fold (14.6 months vs. 5.6 months). The combination therapy group showed significantly improved safety compared with traditional chemotherapy.
Professor Guo Jun from Peking University Cancer Hospital stated: The breakthrough results of the RC48-C016 study fully confirm that toripalimab combined with disitamab vedotin as first-line treatment for HER2-expressing advanced UC can significantly extend the median OS of patients to 31.5 months, nearly doubling the 16.9 months achieved with traditional chemotherapy, achieving a leapfrog breakthrough in survival benefits. What is even more gratifying is that both drugs in this “immunotherapy + ADC” combination regimen are originally developed in China, not only providing Chinese patients with accessible and affordable high-quality treatment but also establishing a new benchmark for the “Chinese solution” in the global treatment of urothelial carcinoma.
Professor Zhou Aiping from the Cancer Hospital of the Chinese Academy of Medical Sciences stated: The success of the combination therapy of toripalimab and disitamab vedotin lies in its precise coverage of a broader population of beneficiaries. The study confirmed that regardless of patients’ HER2 expression levels (1+ to 3+), cisplatin tolerance status, or tumor location (upper/lower urinary tract), consistent and significant survival benefits were observed, with an objective response rate as high as 76.1%. This approval is an important milestone in the first-line treatment of advanced UC, and we hope that this “chemotherapy-free” precision combination regimen can benefit the vast number of UC patients in China.
Dr. Zou Jianjun, General Manager and CEO of Junshi Biosciences stated: The approval of the thirteenth indication for toripalimab is an important achievement of the company’s open and collaborative R&D strategy, and it further solidifies toripalimab’s leading position in the field of immunotherapy for urological tumors. We are deeply proud to join hands with RemeGen, combining two locally innovative, original drugs to create a “powerful alliance” that provides patients with a high-quality treatment regimen offering dual benefits in PFS and OS. In the future, Junshi Biosciences will continue to deepen its Immuno-Oncology (I-O) 2.0 strategy, constantly exploring better combination treatment regimens and innovative target drugs, fulfilling our commitment to continuous innovation and allowing the fruits of “Chinese wisdom” to benefit doctors and patients worldwide.
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1. This material is intended to convey cutting-edge information and is not intended to promote any product to you, nor should it be used as a guide for clinical medication. |
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2. If you wish to understand specific disease diagnosis and treatment information, please follow the advice and guidance of healthcare professionals. |
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[References] |
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[1] Han B, Zheng R, Zeng H, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent 2024;4:47-53. |
About Toripalimab Injection (Tuoyi®)
Toripalimab injection (Tuoyi®), as the first domestically produced monoclonal antibody targeting PD-1 approved for marketing in China, has received support from the National Major Science and Technology Project and has been honored with the highest national patent award, the “China Patent Gold Award.”
To date, toripalimab has conducted over 40 company-initiated clinical studies covering more than 15 indications globally (including China, the United States, Europe, and Southeast Asia). Ongoing or completed pivotal registration clinical studies are evaluating the safety and efficacy of toripalimab across a range of tumor types, including lung cancer, nasopharyngeal carcinoma, esophageal cancer, gastric cancer, bladder cancer, breast cancer, liver cancer, kidney cancer, and skin cancer.
As of now, toripalimab has been approved for 13 indications in mainland China: [1] For the treatment of unresectable or metastatic melanoma that has failed prior systemic therapy (December 2018); [2] For the treatment of recurrent/metastatic nasopharyngeal carcinoma that has failed second-line or later systemic therapy (February 2021); [3] For the treatment of locally advanced or metastatic urothelial carcinoma that has progressed within 12 months of platinum-containing chemotherapy, including neoadjuvant or adjuvant therapy (April 2021); [4] In combination with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (November 2021); [5] In combination with paclitaxel and cisplatin for the first-line treatment of unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (May 2022); [6] In combination with pemetrexed and platinum for the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer with negative epidermal growth factor receptor (EGFR) gene mutations and negative anaplastic lymphoma kinase (ALK) (September 2022); [7] In combination with chemotherapy for perioperative treatment, followed by monotherapy as adjuvant therapy, for adult patients with resectable stage IIIA-IIIB non-small cell lung cancer (December 2023); [8] In combination with axitinib for the first-line treatment of patients with intermediate/high-risk unresectable or metastatic renal cell carcinoma (April 2024); [9] In combination with etoposide and platinum for the first-line treatment of extensive-stage small cell lung cancer (June 2024); [10] In combination with nab-paclitaxel for the first-line treatment of recurrent or metastatic triple-negative breast cancer with PD-L1 positive (CPS≥1) as assessed by a fully validated test (June 2024); [11] In combination with bevacizumab for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (March 2025); [12] For the first-line treatment of unresectable or metastatic melanoma (April 2025); [13] In combination with disitamab vedotin for the first-line treatment of HER2-expressing urothelial carcinoma (May 2026). In December 2020, toripalimab was first included in the National Reimbursement Drug List (NRDL) through negotiation. Currently, all 12 indications approved before 2026 have been included in the “National Reimbursement Drug List (2025 Edition),” making it the only anti-PD-1 monoclonal antibody drug in the list for the treatment of melanoma, renal cell carcinoma, and triple-negative breast cancer. Three indications of toripalimab for the treatment of advanced nasopharyngeal carcinoma and esophageal squamous cell carcinoma have been approved in Hong Kong, China.
In terms of international expansion, toripalimab has been approved for marketing in countries and regions including the United States, the European Union, India, the United Kingdom, Australia, and Singapore, and is undergoing marketing review in multiple other countries and regions worldwide.
About Junshi Biosciences
Junshi Biosciences (688180.SH, 1877.HK), founded in December 2012, is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies. Leveraging its exceptional capabilities in innovative drug discovery, robust biotechnology R&D, and large-scale production, the company has successfully developed a portfolio of internationally competitive drugs and built a pipeline with a tiered structure, covering therapeutic areas such as malignant tumors, autoimmune diseases, chronic metabolic diseases, and infectious diseases. Its innovation areas encompass cutting-edge directions including monoclonal antibodies, small molecules, antibody-drug conjugates (ADCs), bispecific/multispecific antibodies, fusion proteins, nucleic acid drugs, and vaccines. To date, the company has commercialized five products domestically or internationally, including the PD-1 inhibitor toripalimab (Tuoyi®), which is independently developed by China and approved for marketing in over 40 countries and regions, including China, the United States, and Europe.
With the mission of “providing patients with world-class, trustworthy, and innovative medicines,” Junshi Biosciences is rooted in China and expanding globally. Currently, the company has nearly 3,000 employees worldwide, primarily located in Maryland, USA, and Shanghai, Suzhou, Beijing, and Guangzhou, China.
Official Website: www.junshipharma.com
Official WeChat: Junshi Biosciences