TransThera Sciences (Nanjing), Inc., a leading home-grown biopharmaceutical firm based in Nanjing Jiangbei New Area, has received marketing approval from China’s NMPA for Yochanra® (Tinengotinib tablets), its self‑developed Class 1 innovative drug. As the world’s first targeted therapy for patients with FGFR inhibitor-resistant cholangiocarcinoma, Yochanra® fills a long-unmet global clinical gap and delivers new, effective treatment options for patients with advanced, drug-resistant cholangiocarcinoma. The milestone underscores China’s world-class innovation prowess in precision oncology.
Cholangiocarcinoma is a highly aggressive cancer associated with poor patient outcomes and substantial unmet clinical treatment challenges. FGFR inhibitors have long served as the standard targeted therapy for advanced cholangiocarcinoma. However, most patients develop drug resistance following initial treatment. Globally, few effective follow‑up therapies exist, leaving a significant unmet medical need for patients with advanced resistant forms of the disease.
To address this critical clinical gap, TransThera Sciences’ R&D team conducted years of intensive research. Leveraging its in-house small-molecule drug discovery platform, the team systematically investigated key molecular mechanisms behind FGFR resistance. Through persistent research, repeated data validation, and rigorous multi-phase clinical trials, TransThera Sciences overcame major technical bottlenecks to develop Tinengotinib specifically for FGFR inhibitor-resistant cholangiocarcinoma, filling a critical gap within the full‑treatment continuum for advanced cholangiocarcinoma.
Boasting distinct clinical benefits and a first‑in‑class profile, Yochanra® has obtained U.S. FDA Fast Track Designation, U.S. FDA Orphan Drug Designation, and EMA Orphan Drug Designation. As one of the very few innovative drugs of Chinese origin recognized by top regulatory bodies across China, the U.S. and Europe, Yochanra® fully demonstrates the global competitiveness of pharmaceutical innovation rooted in China.
Headquartered in Nanjing Jiangbei New Area, TransThera Sciences focuses on developing high-barrier, high-value oncology drug candidates. Committed to original innovation, the company continuously enhances its in-house R&D system to advance its pipeline and clinical development. Backed by sustained R&D investment and a seasoned core research team, and supported by Jiangbei New Area’s shared research facilities and tailored industrial policies, TransThera Sciences has built integrated capabilities spanning drug discovery, clinical development and commercialization. It has grown into a globally competitive biotech innovator publicly listed on the Hong Kong Stock Exchange.
TransThera Sciences has recently secured marketing approval for two Class 1 innovative drugs in quick succession, reflecting its strong R&D‑to‑commercialization track record and robust pipeline. Moving forward, the company will continue to address unmet clinical needs in oncology, advance original-drug R&D and deliver high‑quality new therapies, while actively engaging in global pharmaceutical collaboration. It aims to bring more high-quality treatment options to cancer patients worldwide and leverage its innovative strengths to build Nanjing Jiangbei New Area into a world-class biomedical innovation hub.
