TransThera Sciences (Nanjing) Inc. announced that its new drug application for Tinengotinib tablets has been accepted by the Center for Drug Evaluation of the National Medical Products Administration in China. The application pertains to the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma who have received at least one prior systemic treatment and FGFR inhibitor treatment. Tinengotinib tablets have previously been included in lists for priority review and breakthrough therapy designation for this indication.
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