TransThera completes late-stage trial enrollment for Tinengotinib cancer drug

The Chinese biotech said the enrollment marks a key milestone for its advancing bile duct cancer treatment

By Teri Yu 

Clinical-stage biotech firm TransThera Sciences (Nanjing) Inc. (2617.HK) said it has completed patient enrollment for a global late-stage trial of its experimental cancer drug Tinengotinib, marking a key milestone for the therapy targeting a hard-to-treat form of bile duct cancer.

The Phase Three trial spans more than 100 clinical sites across the U.S., Europe and other regions, and is evaluating Tinengotinib in patients with advanced cholangiocarcinoma (CCA) who have stopped responding to existing targeted therapies known as fibroblast growth factor receptor (FGFR) inhibitors.

CCA, a major form of bile duct cancer, is a rare but aggressive cancer with limited treatment options, particularly in later stages. Patients who develop resistance to FGFR inhibitors currently lack widely accepted standard treatments, highlighting a significant medical need.

TransThera said Tinengotinib is the only investigational drug to date showing activity in FGFR inhibitor–resistant patients and, if successful, could be the first approved therapy in a niche but clinically important segment.

The drug’s progress also reflects advances in a technically challenging field. Several global biotech companies, including U.S.-based Relay Therapeutics (RLAY.US), have explored but later abandoned similar approaches, underscoring the difficulty of overcoming FGFR resistance.

In China, TransThera said its new drug application (NDA) has been accepted by the country’s drug regulator and is approaching a potential decision. Beyond bile duct cancer, the drug is also being studied in prostate cancer and breast cancer, and has shown potential to reverse resistance to respective hormonal therapies, suggesting broader applicability across tumor types.

Founded in 2014, TransThera is a relatively small biotech company with just over 100 employees. The company has drawn attention for its focus on global clinical development, with other core programs advancing through trials primarily in the U.S.

This early focus on overseas clinical development reflects the company’s globalization strategy. By aligning with global regulatory standards and leveraging mature clinical trial systems from early in the development phase, the company is positioning its treatments for potential multi-region approvals.

TransThera’s global orientation is reflected in founder and Chairman Dr. Frank Wu, whose international drug development experience shapes its strategy. In 2025, TransThera further reinforced its international footprint through a collaboration valued at up to $880 million with U.S.-based Neurocrine Biosciences (NBIX.US) to develop treatments targeting the NLRP3 inflammasome, a pathway linked to inflammatory diseases.

Results from the Phase Three study are expected to be released after sufficient patient follow-up, which will determine whether the drug can move toward regulatory approval in multiple regions.

Listed as a pre-revenue biotech company in Hong Kong a year ago, TransThera develops targeted therapies for cancers expressing genetic mutations and drug resistance, an area of growing interest in oncology with significant unmet clinical needs. While the company remains at an early stage in terms of commercialization, its differentiated pipeline and globally oriented development strategy may help it to stand out in an increasingly crowded biotech landscape.

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