Regorafenib Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Regorafenib 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: 15 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.
Approved
Highest phase
400
Registered trials
531
Result records
7
Matched deals
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 Regorafenib can convert its Small molecule drug profile and BRAF V600E x CRAF x CSF-1R x DDR2 x EphA2 x FGFR1 x FRK x MAPK11 x PDGFRα x PDGFRβ x RET x Tie-2 x TrkA x VEGFR1 x VEGFR2 x VEGFR3 x c-Kit biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Regorafenib (query alias: regorafenib) |
|---|---|
| Modality / target | Small molecule drug; BRAF V600E x CRAF x CSF-1R x DDR2 x EphA2 x FGFR1 x FRK x MAPK11 x PDGFRα x PDGFRβ x RET x Tie-2 x TrkA x VEGFR1 x VEGFR2 x VEGFR3 x c-Kit; BRAF V600E inhibitors, CRAF inhibitors, CSF-1R antagonists |
| Highest global status | Approved |
| Originator | Bayer AG |
| Active developers | Bristol Myers Squibb Co., Bayer AG, Bayer HealthCare Pharmaceuticals, Inc. |
The MCP disease footprint includes Liver Cancer, Hepatocellular Carcinoma, Colorectal Cancer. 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 |
|---|---|---|---|---|
| ChiCTR2600126996 | Phase 3 | Not yet recruiting | 45 | progression-free survival (PFS) |
| ChiCTR2600125457 | Phase 2/3 | Not yet recruiting | 30 | Safety-related observation results such as adverse events. |
| ChiCTR2600126661 | Phase 2 | Not yet recruiting | 40 | Objective Response Rate, ORR |
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
A Phase I/II Study of Regorafenib and Pembrolizumab in Metastatic Colorectal Cancer Patients in 3rd and 4th Line Setting
Phase 1/2; n=73; evaluation: not stated. Reported fields: Number of Patients With Dose Modification Due to Toxicity = 5 Patients ; -; Number of Patients With Dose Modification Due to Toxicity = 2 Patients
A Randomised Phase III Open Label Study of Regorafenib + Nivolumab vs Standard Chemotherapy in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)
Phase 3; n=462; evaluation: not stated. Reported fields: O/S(Median): Hazard Ratio (HR) = 0.88(95% CI, 0.71 - 1.09), P-Value = 0.23; O/S(Median) = 6.28 Months (95% Confidence Interval, 4.80 - 7.36); O/S(Median): Hazard Ratio (HR) = 0.88(95% CI, 0.71 - 1.09), P-Value = 0.23
Apparent diffusion coefficient and kurtosis parameters show early response to anti-angiogenic therapy in patients with colorectal liver metastases
Phase 2; n=20; evaluation: Positive. Reported fields: ADC = 1.035 10^−3 mm^2/s
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
Regorafenib addresses Liver Cancer, Hepatocellular Carcinoma, Colorectal Cancer. 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: 7 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 |
|---|---|---|---|
| 2025-03-06 | 拜耳医药授予亿帆医药拜万戈和多吉美在中国的独家市场推广权益 | Approved | Financial terms not disclosed |
| 2025-02-07 | Chong Kun Dang to exclusively distribute and sell Bayer's Nexavar and Stivarga | Approved | Financial terms not disclosed |
| 2019-12-18 | Arcus Biosciences, in Collaboration with Genentech, Announces Two Randomized Clinical Studies to Advance AB928, a Dual Adenosine Receptor Antagonist, into Novel Combinations for Colorectal and Pancreatic Cancers | 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
The milestone feed surfaced a patent-application signal described as “RET gene fusions and uses thereof”.
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 15 July 2026. Counts and status fields may change as source records update.
