17 July 2024 - Shanghai Junshi Biosciences announced that the National Medical Products Administration has accepted for review the supplemental new drug application for toripalimab (Tuoyi) combined with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma.
The supplemental new drug application is based on the HEPATORCH study, a multi-centre, randomised, open-label, active-controlled Phase 3 clinical study aiming to evaluate the efficacy and safety of toripalimab in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma compared to the standard treatment with sorafenib.