Allist's Jetientai (tengotinib) included in CSCO diagnosis and treatment guidelines
核心洞察
Allist's multi-target kinase inhibitor tengotinib (搜索) has been included in the CSCO biliary tract malignancy guidelines as a Category 2A recommendation for advanced disease.
Tengotinib (搜索) received conditional approval in China on August 6, 2026 for FGFR2 (搜索) fusion or rearrangement-positive cholangiocarcinoma (搜索) after prior systemic and FGFR inhibitor therapy.
Data from a Phase Ib/II trial of tivantinib plus atezolizumab in previously immunotherapy-treated biliary tract tumors were added to the guidelines as an annotation.
The Chinese Society of Clinical Oncology (搜索) has released its Guidelines for the Diagnosis and Treatment of Biliary Tract Malignancies (搜索), and Allist's tengotinib (搜索) (Jietai) has been included as a Category 2A recommendation for the treatment of advanced biliary tract malignancies. Tengotinib is a multi-target small-molecule kinase inhibitor developed by the company that targets FGFR, JAK, VEGFR and Aurora kinases.
Tengotinib (搜索) received conditional marketing approval in China on August 6, 2026 for adult patients with advanced, metastatic or unresectable cholangiocarcinoma (搜索) who have previously received systemic therapy and an FGFR inhibitor and whose tumors harbor FGFR2 (搜索) fusions or rearrangements. It is the first approved therapeutic agent in China for this indication. The FDA has granted tengotinib Orphan Drug Designation and Fast Track Designation for cholangiocarcinoma, and the EMA has granted Orphan Drug Designation for biliary tract cancers. Trials are ongoing in cholangiocarcinoma, prostate cancer, breast cancer and hepatocellular carcinoma.
The guidelines also carry an annotation for tivantinib plus atezolizumab in patients with advanced biliary tract tumors previously treated with immunotherapy. In the pivotal Phase Ib/II trial, the subgroup with wild-type FGFR showed an objective response rate of 27.8%, a median duration of response of 5.7 months and a disease control rate of 77.8%. Tivantinib is being evaluated in a Phase III confirmatory trial in China against chemotherapy in cholangiocarcinoma (搜索), and the global registrational Phase III trial in advanced cholangiocarcinoma has completed enrollment.