China Regulator Accepts Junshi’s Supplemental NDA for Subcutaneous Toripalimab Combination

Overview

• Junshi announced that the China National Medical Products Administration has accepted a supplemental new drug application for its subcutaneous toripalimab (JS001sc) used with disitamab vedotin for first‑line HER2‑expressing advanced or metastatic urothelial carcinoma and said NDAs covering all 13 intravenous toripalimab indications are under review.
• The company cites a randomized Phase 3 trial showing JS001sc achieved non‑inferior drug exposure and comparable efficacy and safety to the intravenous formulation, which Junshi says underpins the regulatory submissions.
• Junshi frames JS001sc as the first domestically developed anti‑PD‑1 subcutaneous formulation to reach the NDA stage in China with the aim of reducing long infusion times and improving convenience for immunotherapy patients.
• NMPA acceptance indicates formal filing and the start of regulatory review but does not equal approval, and regulators may request additional data before any marketing or label expansion is permitted.
• Toripalimab is already approved in more than 50 countries, and Junshi’s push to pair the subcutaneous PD‑1 drug with targeted therapy for HER2‑expressing tumors signals a strategy to expand patient access and tailor treatment to biomarkers.