TRANSTHERA-B (02617.HK): Tinengotinib Included in CSCO Guidelines for Biliary Tract Malignancies (2026)
- Tinengotinib was conditionally approved for marketing in China on 6 August 2026 for adult patients with advanced, metastatic or unresectable cholangiocarcinoma who have received prior systemic therapy and FGFR inhibitor therapy and who harbour FGFR2 fusions or rearrangements.
- The pivotal Phase Ib/II trial of tinengotinib combined with atezolizumab in patients with advanced biliary tract tumours previously treated with immunotherapy showed an ORR of 27.8%, an mDOR of 5.7 months and a DCR of 77.8% among FGFR wild-type patients.
- Tinengotinib is undergoing a Phase III confirmatory study against chemotherapy in cholangiocarcinoma patients in China, while its global multicentre registrational Phase III trial has completed enrolment of all subjects.
NewTimeSpace News: On 18 September 2026, TransThera Sciences (Nanjing), Inc. (stock code: 02617) announced that the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Biliary Tract Malignancies have been formally released, with its self-developed innovative multi-target small molecule kinase inhibitor Jeentai® (tinengotinib) included in the guidelines as a Class II recommendation, category 2A, for the treatment of advanced biliary tract malignancies.
Tinengotinib was conditionally approved for marketing in China on 6 August 2026 for adult patients with advanced, metastatic or unresectable cholangiocarcinoma who have received prior systemic therapy and FGFR inhibitor therapy and who harbour FGFR2 fusions or rearrangements, making it the first drug approved for marketing in China for this indication. In addition, efficacy data for tinengotinib in combination with atezolizumab in patients with advanced biliary tract tumours previously treated with immunotherapy were written into the guidelines in the form of a "note"; its pivotal Phase Ib/II trial showed that among FGFR wild-type patients the objective response rate (ORR) reached 27.8%, with a median duration of response (mDOR) of 5.7 months and a disease control rate (DCR) of 77.8%. Tinengotinib is currently undergoing a Phase III confirmatory clinical study in China comparing it with chemotherapy in cholangiocarcinoma patients, while its global multicentre registrational Phase III trial in advanced cholangiocarcinoma has completed enrolment of all subjects.
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