TRANSTHERA-B’s Tinengotinib Secures Class 2A Spot in 2026 CSCO Biliary Tract Cancer Guidelines

TRANSTHERA-B (TransThera Sciences [Nanjing], Inc.) announced that YOCHANRA (tinengotinib), its self-developed multi-target small-molecule kinase inhibitor, has been incorporated into the 2026 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Biliary Tract Cancers. The drug is listed as a Class II, Level 2A recommendation for adults with unresectable advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 fusion or rearrangement who have previously received systemic therapy and an FGFR inhibitor.

Tinengotinib gained conditional marketing approval in China on 6 August 2026, becoming the country’s first therapy specifically approved for this CCA subgroup. Its rapid inclusion—just over one month post-approval—underscores the substantial unmet clinical need for treatments addressing FGFR-altered CCA.

The guidelines also reference Phase Ib/II data on tinengotinib combined with atezolizumab for patients with advanced biliary tract tumors pre-treated with immunotherapy. In FGFR wild-type patients, the regimen achieved an objective response rate of 27.8 %, a median duration of response of 5.7 months, and a disease control rate of 77.8 %, suggesting an immune-activation mechanism that may extend benefit beyond FGFR-mutated populations.

Market potential is significant: the global CCA drug market reached USD 2.00 billion in 2024 and is projected to rise to USD 3.20 billion by 2027, with roughly 25.2 % of patients exhibiting FGFR alterations. Tinengotinib is currently under evaluation in a Phase III confirmatory trial in China and a global multicenter Phase III study that has completed enrollment.

Beyond China, tinengotinib holds U.S. FDA Orphan Drug and Fast Track designations for CCA and an EMA Orphan Drug designation for biliary tract cancers, reinforcing its international development trajectory.

Management emphasises that, while the drug’s inclusion in the CSCO guidelines enhances clinician awareness and could accelerate adoption, ongoing clinical and regulatory milestones remain critical for full commercial rollout.