TransThera Sciences (Nanjing), Inc. (HKG: 2617) announced that China’s National Medical Products Administration (NMPA) formally accepted its New Drug Application (NDA) for tinengotinib tablets for the treatment of advanced, metastatic, or unresectable cholangiocarcinoma (CCA) in adult patients who progressed after at least one systemic therapy and an FGFR inhibitor. The drug previously received Breakthrough Therapy Designation and Priority Review from NMPA.
Regulatory Milestone
Item
Details
NDA Acceptance Date
19 Dec 2025
Agency
NMPA (China)
Product
Tinengotinib tablets
Indication
Advanced, metastatic, or unresectable cholangiocarcinoma post-systemic therapy and FGFR inhibitor
Multi-kinase inhibitor targeting FGFR/VEGFR, JAK, and Aurora kinases
Broad spectrum vs. selective FGFR inhibitors
Administration
Oral tablets (patient-convenient)
Differentiated from IV therapies
Indication Focus
Cholangiocarcinoma post-FGFR inhibitor
Addresses high-unmet-need population
Development Status
NDA accepted (Phase III completed)
Near-term commercialization potential
Innovation
First multi-kinase inhibitor targeting FGFR/VEGFR/JAK/Aurora for CCA
Novel combination of targets
Market Opportunity
Metric
Value
Context
China CCA Incidence
~12,000-15,000 new cases annually
Rare but aggressive malignancy
FGFR-Altered CCA
10-15% of CCA patients have FGFR2 fusions/mutations
Eligible for FGFR inhibitors
Post-FGFR Inhibitor Market
¥500-800 million (≈ US$70-112M)
High unmet need after progression
Tinengotinib Peak Sales
¥300-500 million (≈ US$42-70M) by 2030
40-50% share of post-FGFR CCA segment
Competitive Landscape
Limited options; no approved therapy post-FGFR inhibitor
First potential therapy in this setting
Strategic Implications
For TransThera: NDA acceptance validates Phase III success; Breakthrough/Priority designations enable expedited review; first‑in‑class multi‑kinase approach creates competitive moat; potential for global expansion based on China data.
For Patients:Oral therapy offers convenience vs. IV options; multi‑target inhibition may overcome resistance to FGFR‑only inhibitors; addresses critical unmet need in post‑FGFR CCA population.
For Market: Demonstrates China’s capability in rare oncology drug development; FGFR inhibitor sequencing becomes new paradigm; tinengotinib could set standard for post‑FGFR therapy.
Forward‑Looking Statements This brief contains forward‑looking statements regarding tinengotinib’s regulatory review timeline, market penetration, and competitive positioning. Actual results may differ due to NMPA feedback, clinical risks, or competitive responses.-Fineline Info & Tech
By Fineline Cube 