Tinengotinib Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Tinengotinib Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.
Decision date: 24 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.
Executive recommendation: GO
Decision memo
Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.
The central underwriting question is whether Tinengotinib can convert its Small molecule drug profile and Aurora A x Aurora B x CSF-1R x FGFR1 x FGFR2 x FGFR3 x JAK1 x JAK2 x VEGFR biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Tinengotinib (query alias: Tinengotinib) |
|---|---|
| Modality / target | Small molecule drug; Aurora A x Aurora B x CSF-1R x FGFR1 x FGFR2 x FGFR3 x JAK1 x JAK2 x VEGFR; Aurora A inhibitors, Aurora B inhibitors, CSF-1R antagonists |
| Highest global status | NDA/BLA |
| Originator | TransThera Sciences (Nanjing), Inc. |
| Active developers | TransThera Sciences (Nanjing), Inc., WUXI APPTEC, INC |
The MCP disease footprint includes Advanced Bile Duct Carcinoma, Carcinoma bile duct non-resectable, Metastatic Cholangiocarcinoma. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT07328919 | Phase 3 | Not yet recruiting | 138 | PFS by BICR |
| CTR20262772 | Phase 2 | 进行中 （尚未招募） | 182 | Not disclosed |
| NCT07498478 | Phase 2 | Recruiting | 94 | Part A: safety evaluation parameters |
The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.
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3. Clinical readouts: what is known
Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial
Phase 2; n=55; evaluation: Positive. Reported fields: Adverse Event: Grade 3 treatment-related adverse events = Grade 3 treatment-related adverse events included hypertension in 17 (31%) of 55 patients, palmar-plantar erythrodysesthesia syndrome in seven (13%) patients, and stomatitis in six (11%) patients.
81MO - Survival and safety of tinengotinib in pooled patients with advanced, fibroblast growth factor receptor (FGFR) inhibitor refractory/relapsed cholangiocarcinoma (CCA)
Phase 1/2; n=109; evaluation: Positive. Reported fields: -; TRAE(Grade 3) = 59.0 Pts ; -
拓展投资小分子：康方启动肝癌联合疗法临床
Not Applicable; n=43; evaluation: Positive. Reported fields: mPFS = 6.0 month
These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.
4. Market and competitive position
Tinengotinib addresses Advanced Bile Duct Carcinoma, Carcinoma bile duct non-resectable, Metastatic Cholangiocarcinoma. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.
The strongest market-validation signal in this screen is partner behavior: 1 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.
5. Transaction precedent and economics
| Date | Transaction | Phase at deal | Disclosed economics |
|---|---|---|---|
| 2021-05-26 | TransThera will assess the combination of TT-00420 and Roche's atezolizumab as a treatment for GI tract cancers in China. | Approved | Financial terms not disclosed |
Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.
6. IP and freedom-to-operate screen
No asset-specific patent-application milestone appeared in the returned milestone slice. That absence is not a freedom-to-operate conclusion; a dedicated family, claim, ownership, expiry, and legal-status search remains mandatory before signing.
The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.
7. Principal risks and diligence gates
- Therapeutic index across KRAS/BRAF mutation subgroups
- On-target toxicity and adaptive MAPK resistance
- Lack of matched efficacy results in the current MCP result set
Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.
8. Final go/no-go memorandum
GO
Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.
Required pre-signing gates: reproduce key efficacy analyses; complete an indication-specific safety review; run a full patent-family and freedom-to-operate search; model risk-adjusted economics by territory; and reconcile all rights, sublicenses and encumbrances.
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Data provenance: PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP; accessed 24 July 2026. Counts and status fields may change as source records update.
