Junshi Biosciences' Subcutaneous Toripalimab Application Accepted by China's NMPA for Bladder Cancer

Junshi Biosciences (1877.HK) said China's National Medical Products Administration has accepted a supplemental new drug application for subcutaneous toripalimab combined with disitamab vedotin as a first-line treatment for HER2-expressed locally advanced or metastatic urothelial carcinoma. The filing covers tumors with HER2 expression of 1+, 2+, or 3+ by immunohistochemistry. Acceptance places the application under regulatory review and does not indicate approval. The subcutaneous formulation (JS001sc) is designed for administration under the skin rather than intravenous infusion. Junshi said a Phase 3 trial of JS001sc plus chemotherapy in first-line non-squamous non-small cell lung cancer met its primary endpoint in November 2025, and data presented at the European Lung Cancer Congress in March 2026 showed non-inferior drug exposure with comparable efficacy and safety. Applications for JS001sc covering all 13 approved intravenous toripalimab indications have now been accepted by the NMPA, the company said. The stock last traded at HKD 15.92, down 0.87%, within a 52-week range of HKD 15.25 to HKD 30.80.