---
title: China Approves a Bile Duct Cancer Treatment for Patients Whose FGFR Drug Has Stopped Working
description: China's NMPA has approved tinengotinib for bile duct cancer patients whose FGFR inhibitor has stopped working, on a single-arm trial of 50 patients.
author: Darie Nani (Editor-in-Chief)
date: 2026-08-07T10:18:00.073Z
updated: 2026-08-07T10:18:00.085Z
canonical: https://richhealthmagazine.com/article/china-approves-tinengotinib-fgfr-bile-duct-cancer
image: https://cdn.nanimediahouse.com/fgfr-resistance-bile-duct-cancer-116892.webp
categories: Longevity & Science
content_type: News
region: China
publication: Rich Health Magazine
schema_type: Article
---

China's drug regulator has approved a treatment for bile duct cancer patients who had run out of established options: those whose tumours carry an FGFR2 fusion and whose cancer has already stopped responding to an FGFR inhibitor. The National Medical Products Administration cleared tinengotinib, sold as Yochanra, on 6 August 2026. TransThera Sciences (Nanjing) Inc., which developed it, says neither Chinese nor US treatment guidelines carry a high-level recommendation for what to try once that happens.

Bile duct cancer, or cholangiocarcinoma, is a rare cancer that forms in the tubes carrying bile from the liver to the small intestine, according to the US National Cancer Institute. It is usually caught late. Among Americans diagnosed with intrahepatic bile duct cancer between 2012 and 2018, almost 25 in 100 survived five years or more when it was still confined to the bile duct, and almost 5 in 100 once it had spread to other parts of the body.

## The Approval Only Covers Patients Who Have Already Tried an FGFR Inhibitor

It applies to adults with advanced, metastatic or unresectable cholangiocarcinoma whose tumours carry an FGFR2 fusion or rearrangement, and who have already had both chemotherapy and an FGFR inhibitor. Newly diagnosed patients are not covered, nor is anyone yet to try an FGFR inhibitor. TransThera puts the share of cholangiocarcinoma patients carrying an FGFR alteration at around 25.2%. Tinengotinib is a small-molecule kinase inhibitor that targets FGFR alongside VEGFR, JAK and Aurora kinases.

## The Approval Rests on a Single-Arm Trial of Fifty Patients

The NMPA cleared the drug on an open-label Phase II study run at 29 sites, all of them in China, in 50 patients who had each already had at least one course of chemotherapy and one FGFR inhibitor. There was no comparison group. Measured as of 27 December 2025, after a median 12 months of follow-up, 14 of the 50 had a confirmed partial response, an objective response rate of 28.0% by blinded independent central review. Disease was controlled in 82.0% of patients. Responses lasted a median 8.5 months, median progression-free survival was 6.0 months and median overall survival was 20.7 months. The results were presented at the 2026 annual meeting of the American Society of Clinical Oncology.

## The Two FGFR Drugs Already on Sale Treat a Different Group of Patients

Two others are authorised in the European Union for cholangiocarcinoma with an FGFR2 abnormality: pemigatinib, sold as Pemazyre, and futibatinib, sold as Lytgobi. Both are for patients taking an FGFR inhibitor for the first time. Pemigatinib's main study reported tumour shrinkage in around 37% of 108 patients, and [futibatinib's in 42% of 103](https://www.ema.europa.eu/en/medicines/human/EPAR/lytgobi). Neither figure can be set against tinengotinib's 28%, because tinengotinib was tested only in patients for whom one of those drugs had already failed.

## Nobody Outside China Can Be Prescribed the Drug Yet

The NMPA's approval covers China alone. The US Food and Drug Administration has given tinengotinib Fast Track and Orphan Drug designation for cholangiocarcinoma, and the European Medicines Agency has given it Orphan Drug designation for biliary tract cancer, but those designations shape how an application is reviewed rather than allowing a drug to be sold.

TransThera is also running a randomised Phase III study, [FIRST-308](https://clinicaltrials.gov/study/NCT05948475), which compares tinengotinib against a physician's choice of treatment in the same group of patients. Enrolment closed at 200 patients across 87 sites in 13 countries, 19 of them in the United States and four in the United Kingdom, and the study is still running. A second Phase III confirmatory study is under way in China. Memorial Sloan Kettering Cancer Center is separately testing the drug in prostate cancer.

## FAQ

**Q: What are the treatment options for FGFR2 mutations in cholangiocarcinoma?**
In the European Union, pemigatinib (Pemazyre) and futibatinib (Lytgobi) are authorised for cholangiocarcinoma with an FGFR2 abnormality that has progressed after at least one earlier treatment. Tinengotinib is now approved in China for the narrower group whose cancer has already progressed after chemotherapy and an FGFR inhibitor.

**Q: What is an FGFR2 fusion?**
It is a change in which part of the FGFR2 gene joins abnormally to another gene, producing a faulty signal that can drive tumour growth. It is the alteration that FGFR inhibitor drugs are designed to block.

**Q: Is tinengotinib available outside China?**
No. The approval granted on 6 August 2026 covers China only. Its Fast Track and Orphan Drug designations from the US FDA, and its Orphan Drug designation from the EMA, are not permission to sell it. The global Phase III study FIRST-308 has finished enrolling patients at sites including the United States and the United Kingdom.

**Q: What is the newest treatment for cholangiocarcinoma?**
Tinengotinib, sold as Yochanra, approved in China on 6 August 2026 for patients whose tumours carry an FGFR2 fusion or rearrangement and whose cancer has progressed after chemotherapy and an FGFR inhibitor.