TransThera sets out Phase II tinengotinib data in The Lancet

5 December 2025

Chinese biotech TransThera has reported new Phase II data showing its experimental kinase inhibitor tinengotinib delivered durable responses in patients with cholangiocarcinoma who had progressed after earlier FGFR-targeted therapies.

The findings, published in The Lancet Gastroenterology and Hepatology, highlight rising interest in next-generation agents for a rare but challenging cancer. Lead author Dr Milind Javle said tinengotinib “demonstrated durable responses and meaningful clinical benefit,” adding that results support a Phase III registration trial.

Tinengotinib, designed to block FGFR and compensatory resistance pathways, sits in a growing field shaped by Pemazyre (pemigatinib) and Lytgobi (futibatinib), which are widely used but limited by modest durability and frequent resistance. Analysts expect strong demand for new approaches as FGFR-driven cancers expand as a therapeutic category.

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