On December 18, 2025 TransThera Sciences Nanjing, Inc. (the "TransThera") reported that the new drug application for Tinengotinib tablets has been accepted by the Center for Drug Evaluation ("CDE")of the National Medical Products Administration ("NMPA") of the PRC. It is intended for the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma (CCA) who have received at least one prior systemic treatment and FGFR inhibitor treatment. Previously, Tinengotinib tablets have been included in the List of Products for Priority Review and the List of Breakthrough Therapy Designation for this indication.
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About Tinengotinib
Tinengotinib is an internally discovered, NDA stage, multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials conducted globally have revealed the potential of tinengotinib to be efficacious in various solid tumors, such as cholangiocarcinoma, prostate cancer, breast cancer, and liver cancer. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the European Medicines Agency (EMA), the Priority Review and Approval Procedure and the Breakthrough Therapy Designation (BTD) by the National Medical Products Administration (NMPA) in China for the treatment of CCA.
(Press release, TransThera Biosciences, DEC 18, 2025, View Source [SID1234661542])