Junshi Biosciences has received approval from China’s National Medical Products Administration (NMPA) for a new indication of toripalimab, expanding the immunotherapy drug’s role in treating advanced Urothelial Carcinoma (UC).

The approval covers toripalimab in combination with disitamab vedotin for patients with HER2-expressing locally advanced or metastatic urothelial carcinoma. HER2 expression in eligible patients is defined through immunohistochemistry testing scores of 1+, 2+ or 3+.

Disitamab vedotin, an antibody-drug conjugate developed independently by RemeGen, is being paired with toripalimab as part of a combination treatment strategy aimed at improving outcomes in patients with advanced disease.

The latest regulatory clearance marks toripalimab’s 13th approved indication in mainland China and further expands Junshi Biosciences’ oncology portfolio.

Urothelial carcinoma ranks among the world’s ten most common cancers and continues to pose a growing health burden in China. According to national cancer estimates, China reported approximately 92,900 new urothelial carcinoma cases and over 40,000 related deaths in 2022.

Toripalimab previously became China’s first approved immunotherapy for non-selective advanced urothelial carcinoma patients in 2021, covering second-line treatment and beyond.

The latest approval is supported by findings from the Phase 3 RC48-C016 clinical study, a multicentre, randomised and controlled trial involving 74 clinical sites across China.

The study compared toripalimab combined with disitamab vedotin against conventional chemotherapy involving gemcitabine paired with cisplatin or carboplatin in patients with HER2-expressing advanced urothelial carcinoma receiving systemic treatment for the first time.

Results demonstrated significant improvements across primary clinical endpoints.

Patients receiving the combination therapy achieved a median progression-free survival of 13.1 months compared with 6.5 months in the chemotherapy arm. Median overall survival also improved substantially, reaching 31.5 months compared with 16.9 months among patients receiving standard chemotherapy.

The treatment combination further showed a stronger objective response rate of 76.1 percent versus 50.2 percent with chemotherapy. Duration of response nearly tripled, reaching 14.6 months compared with 5.6 months in the control group.

Researchers also observed improved safety outcomes in patients receiving the immunotherapy combination.

The RC48-C016 findings were published in The New England Journal of Medicine in October 2025 and were also presented during the Presidential Symposium at the 2025 European Society for Medical Oncology Annual Meeting.

Dr Jianjun Zou, General Manager and Chief Executive Officer of Junshi Biosciences, described the approval as an important milestone for the company and highlighted the value of collaborative research and development efforts.

He said combining two domestically developed therapies created a synergistic treatment approach capable of delivering meaningful improvements in progression-free and overall survival.

Junshi Biosciences indicated that it will continue expanding its immuno-oncology strategy by pursuing next-generation combination therapies and novel oncology targets.

Toripalimab is an anti-PD-1 monoclonal antibody designed to block interactions between the PD-1 receptor and its ligands PD-L1 and PD-L2. The mechanism aims to strengthen the immune system’s ability to recognise and destroy cancer cells.

The therapy has been evaluated globally through more than 40 company-sponsored clinical studies spanning over 15 cancer indications.

Ongoing and completed clinical programmes involving toripalimab include tumour types affecting the lung, nasopharynx, oesophagus, stomach, bladder, breast, liver, kidney and skin.

The approval further strengthens China’s position in oncology drug innovation while providing a new treatment option for patients facing advanced urothelial carcinoma, an area where unmet clinical needs remain significant.