By Fineline Cube 
TransThera Sciences (Nanjing) Inc. (HKG: 2617) announces that Tinengotinib tablets have been included in the List of Products for Priority Review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, for the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma (CCA).
Regulatory Milestone & Drug Profile
| Attribute | Details |
|---|---|
| Company | TransThera Sciences (Nanjing) Inc. (HKG: 2617) |
| Product | Tinengotinib tablets |
| Regulatory Status | Included in CDE Priority Review List (China) |
| Target Indication | Unresectable advanced or metastatic cholangiocarcinoma (post-systemic and FGFR inhibitor therapy) |
| Previous Designation | Breakthrough Therapy Designation (NMPA) for CCA |
| Drug Class | Oral small-molecule kinase inhibitor |
Mechanism of Action & Unique Targeting
Tinengotinib is a multi-kinase inhibitor targeting three key pathways:
- FGFR/VEGFR: Inhibits fibroblast growth factor and vascular endothelial growth factor receptors, blocking tumor angiogenesis and growth signals
- JAK: Suppresses Janus kinase-mediated inflammatory and proliferative signaling
- Aurora kinases: Interferes with mitotic spindle formation, inducing cell cycle arrest
This multi-target approach addresses the heterogeneity of cholangiocarcinoma and may overcome resistance to single-agent FGFR inhibitors.
Market Context & Competitive Landscape
| Market Parameter | Value/Insight |
|---|---|
| Cholangiocarcinoma Incidence (China) | ~60,000 new cases annually; second most common hepatobiliary malignancy |
| Target Population | FGFR inhibitor-refractory patients represent ~30% of advanced CCA cases |
| Current Standard of Care | Limited options after FGFR inhibitor failure; no approved third-line therapies |
| Pipeline Landscape | Tinengotinib is one of three late-stage CCA drugs in China with Breakthrough Therapy status |
| Commercial Potential | Analysts project peak China sales of ¥1.2-1.5 billion (≈ US$170-210 million) if approved |
Strategic Outlook & Development Timeline
- Priority Review Impact: CDE review timeline expected to be reduced from 12-18 months to 6-9 months
- Clinical Data: Based on Phase II data showing objective response rate of 22% and median PFS of 5.8 months in heavily pre-treated FGFR inhibitor-refractory patients
- Global Strategy: TransThera plans to file for FDA Fast Track designation in H1 2026, leveraging China data
- Manufacturing: Commercial-scale production validated; ready for market launch upon approval
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Tinengotinib’s regulatory review timeline, market potential, and clinical development plans. Actual results may differ due to regulatory, competitive, and clinical uncertainties.-Fineline Info & Tech