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In a groundbreaking Phase III clinical trial, Rongchang Biology's proprietary ADC drug, Disitamab Vedotin, combined with Toripalimab, has triumphantly achieved the two primary endpoints of progression-free survival (PFS) and overall survival (OS) for the first-line treatment of HER2-positive locally advanced or metastatic urothelial cancer. Conducted across 74 clinical research centers in China, the study enrolled a comprehensive cohort of 484 patients. The findings revealed that, irrespective of HER2 expression levels and prior cisplatin treatment status, the combined therapy demonstrated significant improvements in both PFS and OS when compared to standard chemotherapy, while maintaining a favorable safety profile. Rongchang Biology intends to submit a new drug application for this indication to the National Medical Products Administration at an opportune moment.
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