Pharmaceutical Jieankang-B (02617): Gentec® (tengotinib) was included in the CSCO Guidelines for the Diagnosis and Treatment of Biliary Malignancies (2026)

^{Zhitong Finance App News, Yaojie Ankang-B (02617) issued an announcement, and the “Chinese Society of Clinical Oncology (CSCO) Biliary Malignancies Diagnosis and Treatment Guidelines” (hereinafter referred to as the Guidelines) was officially released. The innovative multi-target small molecule kinase inhibitor Jientai® (tengotinib) independently developed by the company was included as a Class II recommendation class 2A for the treatment of advanced biliary tract malignancies.}

Tengotinib was conditionally approved for marketing in China on August 6, 2026 for the treatment of adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have received systemic treatment and FGFR inhibitors and have fibroblast growth factor receptor (FGFR) 2 fusion or rearrangement. Tengotinib is the first drug marketed and approved for this indication in China. It is expected to benefit patients with FGFR mutant cholangiocarcinoma after drug resistance and fill gaps in guidelines for the treatment of advanced biliary tract malignancies. Tengotinib was approved for marketing in just over a month, and it was included in CSCO related diagnosis and treatment guidelines, which fully demonstrates that there are a large number of unmet clinical needs in clinical terminals. The inclusion of this guideline will help clinicians across the country to more comprehensively and thoroughly understand the clinical treatment value of tengotinib, promote the rapid and widespread use of the drug in clinical practice, benefit more patients, and improve patients' survival benefits.

At the same time, data on the efficacy of tengotinib combined with atilizumab in patients with advanced biliary tract tumors who have previously received immunotherapy were also included in the guidelines in the form of “notes”. A key phase IB/II clinical study of tengotinib combined with atilizumab showed efficacy in patients with advanced biliary tract tumors who had previously received immunotherapy, especially in FGFR wild type patients. FGFR wild type patients had an ORR of 27.8%, MDor of 5.7 months, and a DCR of 77.8%, indicating that the immune activation mechanism has the potential to be independent of FGFR mutation status. Clinicians and patients are provided with new treatment options to learn from.

The global cholangiocarcinoma drug market reached 2 billion US dollars in 2024 and is expected to grow to 3.2 billion US dollars in 2027. Of these, about 25.2% of cholangiocarcinoma patients have FGFR variants. According to a research paper published in Cancer Treat Reviews in 2023, cholangiocarcinoma patients develop acquired drug resistance after being treated with FGFR inhibitors. Currently, tengotinib is undergoing a phase III confirmatory clinical study of comparative chemotherapy for patients with cholangiocarcinoma in China; at the same time, the global multi-center registered phase III clinical trial of tengotinib to treat patients with advanced cholangiocarcinoma has completed the enrollment of all subjects.

Tengotinib is an innovative multi-target small-molecule kinase inhibitor targeting FGFR, JAK, VEGFR, and Aurora, developed independently and approved for marketing in China. It exerts anti-tumor effects through precise targeting, lineage remodeling, and immune activation. Currently, tengotinib's first indication for cholangiocarcinoma has been approved for marketing in China, and a number of clinical trials have been carried out globally on solid tumors such as cholangiocarcinoma, prostate cancer, breast cancer, and liver cancer. It was granted “orphan drug certification” and “fast track qualification” for treating cholangiocarcinoma by the US FDA, and “orphan drug certification” for treating biliary tract cancer by the European EMA.