China's RemeGen has announced its antibody-drug conjugate (ADC) disitamab vedotin, combined with toripalimab, met both progression-free survival (PFS) and overall survival (OS) endpoints in a Phase III trial (RC48-C016) for HER2-expressing advanced urothelial carcinoma. The study, involving 484 patients across 74 Chinese centres, demonstrated statistically significant clinical benefits regardless of cisplatin eligibility or HER2 expression levels, with manageable side effects. Lead investigator Professor Jun Guo from Peking University Cancer Hospital hailed the "HER2-ADC + immunotherapy" approach as a global treatment paradigm shift. RemeGen plans to submit a new drug application to China’s regulatory authority, with detailed data to be presented at an international conference. The results position disitamab vedotin, China’s first self-developed ADC, as a potential frontline therapy reshaping global standards for bladder cancer care.