News Center | 2026-07-02 11:23:00
Ennovation Ventures Portfolio | The global multicenter registered phase III clinical trial of TransThera's core product, Tegotinib monotherapy, for the treatment of advanced cholangiocarcinoma patients has been completed and enrolled
Nanjing, China, and Gaithersburg, Maryland, USA | July 2, 2026 – TransThera Sciences (Nanjing), Inc.("TransThera," "the Company") announced that the global multicenter registration Phase III clinical trial for its core product Tinengotinib (TT-00420) in the treatment of advanced cholangiocarcinoma patients has recently completed the planned subject enrollment.
This clinical trial is a global multicenter, randomized controlled Phase III study designed to evaluate the efficacy and safety of oral tefinostat compared to investigator-selected therapy in patients with advanced cholangiocarcinoma harboring fibroblast growth factor receptor (FGFR) gene abnormalities who are refractory or relapsed after chemotherapy and FGFR inhibitor treatment. The first subject was enrolled in December 2023, and enrollment has been completed as of the date of this announcement. The clinical centers for this trial include regions such as the United States, Europe, and Asia. This therapy has received the "Orphan Drug Designation" (ODD) and "Fast Track Designation" from the FDA, as well as the orphan drug designation (ODD) for the treatment of biliary tract cancer from the European EMA.
The global market size for cholangiocarcinoma drugs is projected to reach $2 billion in 2024 and is expected to grow to $3.2 billion by 2027. According to a 2023 research paper published in *Cancer Treatment Reviews*, approximately 25.2% of cholangiocarcinoma patients exhibit FGFR mutations, and nearly all such patients may eventually develop resistance after FGFR inhibitor treatment. Trametinib is the world's first and currently the only investigational drug in the late-stage approval process for treating refractory or recurrent cholangiocarcinoma patients following chemotherapy and FGFR inhibitor therapy. It has demonstrated favorable safety and antitumor efficacy in multiple clinical trials, offering a novel and highly effective clinical treatment option for advanced cholangiocarcinoma patients globally.
Tengolotinib is an innovative multi-target small molecule kinase inhibitor that is independently developed and in the stage of new drug application. It exerts anti-tumor effects by targeting tumor cells and improving the tumor microenvironment. At present, Tiengotini has carried out a number of clinical trials worldwide for solid tumors such as bile duct cancer, prostate cancer, breast cancer, liver cancer, etc., and has obtained the "Orphan Drug Design" (ODD) and "Fast Track Design" granted by the US FDA for the treatment of bile duct cancer, the "Orphan Drug Design" (ODD) granted by the European EMA for the treatment of bile duct cancer, and the Chinese NMPA for approval to be included in the list of priority review varieties and breakthrough treatment varieties.
TransThera is a biopharmaceutical company that is clinically oriented and focused on discovering and developing innovative small molecule therapies for tumors, inflammation, and cardiovascular metabolic diseases. With further in-depth research on translational medicine and drug design, we aim to develop strategically significant first of its kind or best candidate drugs to meet urgent clinical needs worldwide!
