TRANSTHERA-B - VOLUNTARY ANNOUNCEMENT Enrollment Completed in the Global Multicenter Registrational Phase III Clinical Trial of Tinengotinib Monotherapy for Patients with Advanced Cholangiocarcinoma
TRANSTHERA-B - VOLUNTARY ANNOUNCEMENT
Enrollment Completed in the Global Multicenter Registrational Phase III Clinical Trial of Tinengotinib Monotherapy for Patients with Advanced Cholangiocarcinoma
TransThera Sciences (Nanjing), Inc.
藥捷安康 ( 南京 ) 科技股份有限公司
(A joint stock company incorporated in the People's Republic of China with limited liability)
(Stock Code: 2617)
VOLUNTARY ANNOUNCEMENT
Enrollment Completed in the Global Multicenter Registrational Phase III Clinical Trial of Tinengotinib Monotherapy for Patients with
Advanced Cholangiocarcinoma
This announcement is made by TransThera Sciences (Nanjing), Inc. (the "Company", together with its subsidiaries, the "Group") on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business advancement of the Group.
The board of directors of the Company (the "Board") announced that enrollment for the global multicenter registrational Phase III clinical trial of the Company's core product Tinengotinib (TT-00420) for the treatment of patients with advanced cholangiocarcinoma (CCA) has recently been completed as planned.
This clinical trial is a global multicenter, randomized, controlled Phase III clinical trial designed to evaluate the efficacy and safety of oral Tinengotinib versus Physician's choice in patients with advanced CCA harboring fibroblast growth factor receptor (FGFR) gene aberrations who are refractory or relapsed after chemotherapy and FGFR inhibitor treatment. First patient enrollment for this trial commenced in December 2023, and as of the date of this announcement, the enrollment has completed. The clinical centers for this trial cover the United States, Europe and Asia. This therapy has been granted Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the Food and Drug Administration (FDA), and Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the European Medicines Agency (EMA).
The global market size for CCA therapeutics reached US$2.0 billion in 2024 and is projected to grow to US$3.2 billion by 2027. According to a research paper published in Cancer Treatment Reviews in 2023, approximately 25.2% of CCA patients harbor FGFR alterations, and almost all CCA patients who receive FGFR inhibitor therapy may eventually develop resistance. Tinengotinib is the first and currently the only investigational drug worldwide to enter the application stage for the treatment of CCA patients who are refractory or relapsed after chemotherapy and FGFR inhibitor therapy, and has demonstrated favorable safety and anti-tumor efficacy in multiple clinical trials, holding promise to provide a novel and highly effective clinical treatment option for globally pretreated CCA patients in the late-line setting.
About Tinengotinib
Tinengotinib is an internally discovered, New Drug Application (NDA) stage, multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs/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. Tinengotinib has been included in the List of Products for Priority Review and the List of Breakthrough Therapeutic Drugs by the National Medical Products Administration (NMPA) of China, and granted Orphan Drug Designation (ODD) and Fast Track Designation by the U.S. FDA for the treatment of biliary tract cancer, and Orphan Drug Designation (ODD) by the EMA for the treatment of biliary tract cancer.
Warning under Rule 18A.08(3) of the Listing Rules: There is no assurance that the relevant products will ultimately be successfully developed and marketed by the Company.
By order of the Board
TransThera Sciences (Nanjing), Inc.藥捷安康(南京)科技股份有限公司Dr. Frank Wu
Chairman and Chief Executive Officer
Hong Kong, 1 July, 2026