Atorvastatin/Fimasartan Drug Asset Due Diligence Report 2026

This Atorvastatin/Fimasartan 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: 23 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

1264

Registered trials

284

Result records

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 Atorvastatin/Fimasartan can convert its Small molecule drug profile and AT1R x HMGCR biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Atorvastatin/Fimasartan (query alias: Atorvastatin/Fimasartan)
Modality / target	Small molecule drug; AT1R x HMGCR; AT1R antagonists, HMG-CoA reductase inhibitors
Highest global status	Approved
Originator	Boryung Corp.
Active developers	Boryung Corp.

The MCP disease footprint includes Dyslipidemias, Hypertension. 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
NCT07685938	Phase 2	Not yet recruiting	60	Percent difference in the radiation (RT)-induced reduction of myocardial perfusion
CTR20262683	Phase 1	进行中（尚未招募）	40	Not disclosed
NCT07717788	Not Applicable	Completed	65	change in bone mineral density (lumbar spine and hip)

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.

Reproduce the asset-to-trial workflow with PatSnap MCP

3. Clinical readouts: what is known

Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes

Phase 3; n=31; evaluation: not stated. Reported fields: -; -; Prevalence of eCD = 2 Participants

Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

Early Phase 1; n=5; evaluation: not stated. Reported fields: -; Number of Participants With Treatment-related Adverse Events = 0 Participants ; -

The role of early ezetimibe combination with atorvastatin in patients with atherosclerotic cardiovascular disease

Phase 4; n=137; evaluation: Positive. Reported fields: AE = 58.5 % ; AE = 85.0 %

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

Atorvastatin/Fimasartan addresses Dyslipidemias, Hypertension. 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: 4 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
2021-03-31	Astellas and Viatris will jointly promote Lipitor tablets to treat hypercholesterolemia in Japan.	Approved	Financial terms not disclosed
2011-09-02	Sanofi signs deal with Pfizer to sell generic Lipitor	Approved	Financial terms not disclosed
2000-01-01	Warner-Lambert Company and Astellas Announce co-development for Lipitor	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