China’s National Medical Products Administration (NMPA) has approved TransThera Sciences’ Yochanra (tinengotinib) for the treatment of adults with advanced, metastatic or unresectable cholangiocarcinoma harbouring FGFR2 fusion or rearrangement who have previously received systemic therapy and an FGFR inhibitor.
The approval, granted on 6 August, makes Yochanra the first drug independently developed in China to address the longstanding global challenge of acquired resistance to FGFR inhibitor therapy in patients with cholangiocarcinoma.
Yochanra is an innovative multi-target small-molecule kinase inhibitor targeting FGFR, VEGFR, JAK and Aurora kinases. According to the company, it exerts antitumor effects through three mechanisms— precision targeting, lineage remodelling and immune activation.
The drug is also being evaluated globally in multiple clinical trials for other solid tumours, including prostate, breast and liver cancers.
The therapy has received Orphan Drug Designation and Fast Track Designation from the US FDA for cholangiocarcinoma, as well as Orphan Drug Designation from the European Medicines Agency (EMA) for biliary tract cancer. In China, it has been included in both the Priority Review and Breakthrough Therapeutic Drugs programmes.
The approval is based on results from a multicenter, open-label, single-arm Phase II trial conducted in China involving 50 patients with advanced cholangiocarcinoma who had previously received chemotherapy and an FGFR inhibitor.
Findings, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, showed an objective response rate (ORR) of 28%, a disease control rate (DCR) of 82%, median progression-free survival (PFS) of 6.0 months, and median overall survival (OS) of 20.7 months. The median duration of response was 8.5 months, while the drug demonstrated a manageable safety and tolerability profile.
According to a 2023 study published in Cancer Treatment Reviews, patients with cholangiocarcinoma commonly develop acquired resistance after treatment with FGFR inhibitors. These patients typically harbour one or more resistance mutations, making drug development in this field particularly challenging. Although several international biotech companies have initiated related research programmes, none have successfully brought a therapy to market.
Currently, neither Chinese nor US treatment guidelines recommend a standard therapy for this patient population, highlighting a significant unmet clinical need.
TransThera said Yochanra’s unique FGFR-binding mode enables it to overcome resistance mutations at multiple sites, with clinical trials demonstrating its ability to effectively address acquired resistance.
The company noted that the approved indication is the first under Yochanra’s multi-indication development strategy. A global registrational Phase III trial in cholangiocarcinoma has completed enrolment, while a confirmatory Phase III study is underway in China. Clinical development is also continuing in prostate, breast and liver cancers.
