TRANSTHERA-B (02617) announced that the new drug application for Tinengotinib Tablets has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The drug is intended for treating adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously undergone at least one systemic therapy and FGFR inhibitor treatment. Previously, Tinengotinib Tablets for this indication had been approved for inclusion in the priority review list and breakthrough therapy designation.
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