Yochanra® approved in China as world-first for FGFR inhibitor-resistant cancer

TransThera Sciences has announced the approval of Yochanra^® (tinengotinib) by China’s National Medical Products Administration (NMPA) for adults with advanced, metastatic or unresectable cholangiocarcinoma harbouring an FGFR2 fusion or rearrangement, who have received prior systemic treatment and FGFR inhibitor therapy.

Yochanra^® is a multi-target kinase inhibitor targeting FGFR/VEGFR, JAK and Aurora kinases. According to TransThera, its “unique FGFR-binding mode” enables it to overcome resistance mutations at multiple sites while maintaining high binding activity.

[The approval] reflects growing efforts to address acquired resistance and meet an unmet need for patients with limited treatment options.”

The approval makes Yochanra^® the first drug specifically developed to address resistance to FGFR inhibitors to enter the global market. It reflects growing efforts to address acquired resistance and meet an unmet need for patients with limited treatment options.

This marketing approval was supported by results from the Phase II FIRST-08 study, which were presented at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO).

At data cut-off, the study reported an objective response rate of 28.0% and a disease control rate of 82.0%. Median duration of response was 8.5 months, while median progression-free survival was 6.0 months and median overall survival was 20.7 months.

In addition to cholangiocarcinoma, Yochanra^® is currently being investigated across multiple other indications, including prostate cancer, breast cancer and liver cancer, as part of a broader development programme. It has also received Orphan Drug designation for biliary tract cancer from the European Medicines Agency (EMA), and Fast Track and Orphan Drug designations for cholangiocarcinoma from the US Food and Drug Administration (FDA).

Enrollment has now been completed for the Phase III FIRST-308 study, which will provide additional clinical evidence for Yochanra^® globally and confirmatory evidence for its use in China. The results could provide further support for the drug’s regulatory development in other markets.