By Fineline Cube 
China’s Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced that it has received the acceptance notice from China’s National Medical Products Administration (NMPA) for the supplemental new drug application (sNDA) of its anti-PD-1 toripalimab (trade name: TUOYI) in combination with disitamab vedotin. This ADC developed by RemeGen Co., Ltd. is indicated for the treatment of HER2-expressing (defined as HER2 immunohistochemistry results of 1+, 2+, or 3+) locally advanced or metastatic urothelial carcinoma (UC). This marks the 13th indication for toripalimab submitted in mainland China.
Clinical Trial Basis
The sNDA is supported by the RC48-C016 study (NCT05302284), a multi-center, randomized, open-label, controlled Phase III clinical trial. The study compared the efficacy and safety of toripalimab in combination with disitamab vedotin versus gemcitabine in combination with cisplatin/carboplatin in systemic-treatment-naive patients with HER2-expressing locally advanced or metastatic UC.
Key Findings
The primary endpoints of progression-free survival (PFS) and overall survival (OS) met the pre-defined efficacy boundary. Results demonstrated that toripalimab in combination with disitamab vedotin significantly improved PFS and OS compared to gemcitabine in combination with cisplatin/carboplatin. The safety profile of toripalimab remained consistent with previous studies, with no new safety signals identified.-Fineline Info & Tech