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China's drug regulator has accepted a new application for a subcutaneous version of toripalimab paired with disitamab vedotin as a first-line treatment for HER2-expressing advanced bladder cancer. The move follows the May 2026 approval of the intravenous combo, which dramatically outperformed chemotherapy in a phase 3 trial. This marks a significant step toward a more convenient delivery option for patients.
China's National Medical Products Administration (NMPA) has accepted a supplemental new drug application for a subcutaneous formulation of toripalimab combined with disitamab vedotin as a first-line treatment for patients with HER2-expressing locally advanced or metastatic urothelial carcinoma (bladder cancer). The application covers tumors with HER2 immunohistochemistry scores of 1+, 2+, or 3+, and completes the NMPA's acceptance of subcutaneous toripalimab applications across all 13 of its approved indications in China.
The intravenous version of this combination was approved in China in May 2026, based on the phase 3 RC48-C016 trial, which enrolled 484 previously untreated patients and compared the toripalimab–disitamab vedotin combo against standard platinum-based chemotherapy. Support for the subcutaneous formulation comes from a separate phase 3 NSCLC study, which confirmed that the under-the-skin version delivers drug exposure equivalent to the IV form, with similar efficacy and safety.
By the Numbers
Why it matters: This combination significantly outperforms chemotherapy across survival and response outcomes, while also carrying a notably better safety profile. A subcutaneous option could further improve patient convenience and treatment adherence — a meaningful quality-of-life benefit for those managing advanced bladder cancer.
