China’s NMPA accepted the application for Disitamab vedotin plus subcutaneous Toripalimab for HER2-expressing Urothelial carcinoma

CAR-T Digest - August 2020

Weekly Digest - October 2026

28 October 2026: China’s NMPA accepted the application for Disitamab vedotin plus subcutaneous Toripalimab for HER2-expressing Urothelial carcinoma

Junshi Biosciences’ supplemental new drug application for subcutaneous Toripalimab in combination with Disitamab vedotin has been accepted by China’s NMPA for first-line treatment of locally advanced or metastatic HER2-expressing urothelial carcinoma (IHC 1+, 2+, or 3+), extending the regulatory pathway for this ADC-immunotherapy regimen
The application advances the combination of Disitamab vedotin, a HER2-directed ADC, with anti-PD-1 immunotherapy toward a more convenient first-line treatment option for advanced UC. The regulatory filing covers patients across HER2 expression levels, potentially broadening the population eligible for this ADC-based combination approach
The application addresses an important need in locally advanced or metastatic UC, where outcomes remain poor and additional first-line treatment options are needed. Combining a HER2-directed ADC with PD-1 inhibition offers a strategy to integrate targeted cytotoxic activity and immune checkpoint blockade across a broad HER2-expressing patient population
Disitamab vedotin is a HER2-targeted ADC developed by RemeGen, comprising a HER2-directed antibody conjugated to the microtubule-inhibiting payload monomethyl auristatin E. By delivering cytotoxic payloads to HER2-expressing tumor cells, the ADC provides targeted antitumor activity, while Toripalimab blocks PD-1 to enhance antitumor immune responses
Strategically, the filing highlights the continued advancement of Disitamab vedotin-based combination regimens in first-line urothelial cancer and the growing role of HER2-directed ADCs beyond later-line treatment. For Junshi Biosciences, the application also expands the potential use of Toripalimab through a subcutaneous formulation designed to improve administration convenience, while reinforcing the importance of ADC-immunotherapy combinations in the evolving UC treatment landscape