TRANSTHERA-B (02617): Jienntai (tinengotinib) included in the CSCO Guidelines for the Diagnosis and Treatment of Biliary Tract Malignancies (2026)

TRANSTHERA-B (02617) announced that the "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Biliary Tract Malignancies" (hereinafter referred to as the Guidelines) has been officially released, and Jienntai (tinengotinib), an innovative multi-target small molecule kinase inhibitor independently developed by the Company, has been included in the Guidelines as a Class II recommendation, Category 2A for the treatment of advanced biliary tract malignancies. Tinengotinib was granted conditional approval for marketing in China on August 6, 2026, for the treatment of adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received systemic therapy and FGFR inhibitor therapy and who harbor fibroblast growth factor receptor (FGFR) 2 fusion or rearrangement. Tinengotinib is the first drug approved for marketing in China for this indication, and is expected to benefit patients with FGFR-mutant cholangiocarcinoma after resistance, filling the guideline gap in the treatment of advanced biliary tract malignancies. Just over one month after its approval for marketing, tinengotinib has been included in the relevant CSCO diagnosis and treatment guidelines, fully reflecting the substantial unmet clinical needs at the clinical front line. This inclusion in the Guidelines will help clinicians nationwide to more comprehensively and deeply recognize the clinical therapeutic value of tinengotinib, promote faster and broader clinical application of the drug, benefit more patients, and improve patient survival benefits. Meanwhile, the efficacy data of tinengotinib in combination with atezolizumab for the treatment of patients with advanced biliary tract tumors who have previously received immunotherapy has also been written into the Guidelines in the form of a "note." A key Phase Ib/II clinical trial of tinengotinib in combination with atezolizumab showed that efficacy was observed in patients with advanced biliary tract tumors who had previously received immunotherapy, especially in FGFR wild-type patients, with an ORR of 27.8%, an mDOR of 5.7 months, and a DCR of 77.8% in FGFR wild-type patients, suggesting that its immune activation mechanism has the potential to be independent of FGFR mutation status. This provides clinicians and patients with a new treatment option for reference. The global cholangiocarcinoma drug market was valued at USD 2 billion in 2024 and is expected to grow to USD 3.2 billion by 2027, with approximately 25.2% of cholangiocarcinoma patients exhibiting FGFR alterations. According to a research paper published in Cancer Treat Reviews in 2023, cholangiocarcinoma patients develop acquired resistance after treatment with FGFR inhibitors. Currently, tinengotinib is conducting a Phase III confirmatory clinical study in China comparing it with chemotherapy for cholangiocarcinoma patients; meanwhile, the global multicenter registrational Phase III clinical trial of tinengotinib for the treatment of advanced cholangiocarcinoma patients has completed enrollment of all subjects. Tinengotinib is an independently developed, China-approved innovative multi-target small molecule kinase inhibitor targeting FGFR, JAK, VEGFR, and Aurora, which exerts antitumor effects through precise targeting, lineage remodeling, and immune activation. Currently, tinengotinib's first indication, cholangiocarcinoma, has been approved for marketing in China, and multiple clinical trials have been conducted globally for solid tumors including cholangiocarcinoma, prostate cancer, breast cancer, and liver cancer. It has been granted "Orphan Drug Designation" and "Fast Track Designation" for the treatment of cholangiocarcinoma by the U.S. FDA, and "Orphan Drug Designation" for the treatment of biliary tract cancer by the European EMA.