Next-Generation Non-Steroidal Anti-Inflammatory New Drug Molecular Platform

We are not selling a product.

We are advancing a validated pathway — one grounded in molecular science, clinical discipline, and a long-term vision for human health.

This is not the story of a single product. It is the beginning of a molecular platform — built on validated science, clinical evidence, and a disciplined de-risked development strategy designed for long-term value creation.

The Fundamental Limitation of Current Anti-Inflammatory Solutions

Unmet Challenges in Corticosteroid Treatment

Corticosteroids remain effective for acute inflammation but carry systemic risks that render long-term use clinically unacceptable.

Challenges and Unmet Needs of Current NSAID Therapies

Traditional NSAIDs face gastrointestinal, cardiovascular, and renal toxicity limitations — leaving a significant unmet clinical need for a safer, sustainable anti-inflammatory molecule.

Unmet Clinical Need: A Safe, Long-Acting, and Chronic-Use Anti-Inflammatory Solution

A New Anti-Inflammatory Molecule — TFA-01

TFA-01(Antcin A)

TFA-01 (Antcin A) is a structurally defined triterpenoid derived from Antrodia cinnamomea — the foundational molecule of our non-steroidal anti-inflammatory platform.

Non-Steroidal Molecular Structure

Unlike corticosteroids, TFA-01 does not possess a steroidal core structure, thereby fundamentally reducing the risk of steroid-related systemic side effects.

Clearly Defined Chemical Structure

Its well-defined molecular structure enables standardized manufacturing and robust quality control, supporting regulatory compliance and new drug development requirements.

Multi-Mechanistic Anti-Inflammatory Effects

Acts on multiple inflammatory signaling pathways, including NF-κB inhibition and pro-inflammatory cytokine modulation, demonstrating broad-spectrum anti-inflammatory potential.

Platform Versatility

TFA-01 can be commercialized through API licensing while also serving as a foundational molecule for human therapeutics development, demonstrating substantial platform scalability and expansion potential.

One Molecule. One Pathway. Precision from the ground up.

TFA-01 is not a botanical extract — it is a chemically defined single molecule. This distinction is fundamental: it enables reproducible manufacturing, regulatory-grade validation, and a clear translational pathway from veterinary to human medicine.

Precision

Single Molecule with a Well-Defined Structure

Reproducibility

Standardized Manufacturing, Controlled Quality

Regulatory Readiness

Aligned with New Drug Regulatory Requirements

Platform Scalability

Translational Pathway from Veterinary to Human Therapeutics

Pet Drug as First Application — The Platform's Entry Point

Why Start with Veterinary Drug Development?

Veterinary drug development offers a faster regulatory pathway, lower trial complexity, and reduced capital intensity — making it the ideal validation gateway before advancing to human therapeutics.
The pet drug is not the destination — it is the proof-of-concept that de-risks the entire platform.

First Indication: Canine Osteoarthritis

Canine osteoarthritis (OA) is one of the most prevalent orthopedic diseases in companion animals worldwide. Current treatment options, primarily non-steroidal anti-inflammatory drugs (NSAIDs), are associated with well-recognized concerns regarding hepatic and renal toxicity, highlighting a significant unmet medical need in the market.

Validation of TFA-01 in this indication directly addresses clinical challenges that parallel those of human osteoarthritis, establishing a clear and compelling translational pathway from veterinary to human therapeutics.

Safety & Institutional Validation — Grounded in Scientific Authority

Independent Third-Party Validation

National Pingtung University of Science and Technology (NPUST)

The College of Veterinary Medicine at National Pingtung University of Science and Technology (NPUST) is a premier veterinary and animal science research institution in Taiwan. Supported by a rigorous IACUC oversight system and GLP-standard research facilities, the institution provides high-quality safety data with strong scientific credibility and international acceptance.

Validation Scope

Acute Toxicity

Evaluate the acute toxicity profile of TFA-01 in animal models and establish its therapeutic window to support safe dose selection.

Sub-chronic Toxicity

Assessment of long-term safety following chronic administration, with comprehensive monitoring of hepatic function, renal function, and hematological parameters.

Efficacy Validation

Using a standardized canine osteoarthritis model, the anti-inflammatory efficacy of TFA-01 and its impact on pain-related behavioral outcomes were evaluated.

Standardized Clinical Validation — Evidence from a Canine Arthritis Model

Canine Osteoarthritis Model

The canine OA model is internationally recognized as a high-fidelity translational model, with strong anatomical and pathophysiological relevance to human osteoarthritis.
Canine model data directly supports the scientific rationale for human IND filings.

Key Validation Endpoints

Improvement in Pain Scores

Standardized pain behavior assessments using the Canine Brief Pain Inventory (CBPI) demonstrated statistically significant improvements.

Reduction in Inflammatory Markers

Serum levels of pro-inflammatory cytokines, including IL-6 and TNF-α, were significantly reduced, consistent with the proposed mechanism of action.

Normal Safety Parameters

Liver and kidney function markers, including ALT, BUN, and creatinine, remained within normal ranges throughout the treatment period, with no significant signs of toxicity observed.

Dose–Response Relationship

Confirmed a dose-dependent therapeutic response, providing a scientific basis for subsequent dose optimization and human equivalent dose (HED) estimation.

A Disciplined, De-risked Development Pathway

In pharmaceutical development, risk management is the foundation of capital efficiency. Our platform is architectured from inception with a de-risking logic: each stage generates the scientific evidence, regulatory credibility, and valuation foundation needed for the next.

Why This Is the Smarter Development Path?

Traditional human drug development carries enormous upfront risk. Our strategy leverages veterinary validation as a lower-cost, faster proof-of-concept before unlocking the full human therapeutic value.

Three Key Risk Mitigation Strategies

Phased Capital Deployment

Capital deployment is aligned with defined scientific milestones at each development stage, reducing the need for substantial upfront R&D expenditures.

Clear Regulatory Pathway

A mature regulatory framework for veterinary therapeutics supports the generation of data that can be scientifically bridged to human IND development through a well-defined translational pathway.

Multiple Monetization Pathways

Three parallel value-realization pathways—API out-licensing, veterinary drug commercialization, and human therapeutics licensing—diversify revenue opportunities and reduce the risk associated with a single development pathway.

Development Pathway — Four Stages of Value Creation

Safety & Standardization

Toxicology Validation, GLP Standardization, Molecular Structure Confirmation, and Independent Third-Party Certification

Veterinary New Drug

Core Execution Phase — Canine Osteoarthritis Drug Application, Clinical Validation Completed, and Regulatory Review Advancement

API Licensing

API Out-Licensing, Technology Transfer, and Strategic Partner Acquisition

Human Therapeutics

IND Submission, Phase I Clinical Development, and Expansion into Human Osteoarthritis and Chronic Inflammatory Indications

★ Step 2 represents the pivotal validation milestone that unlocks the full value of the molecular platform.

From Application to Platform — Expanding the Value Architecture

Platform Thinking

TFA-01 is not merely a drug candidate — it is the foundation of a molecular platform. Each data point generated in the veterinary context simultaneously builds the asset base for higher-value human therapeutic applications.

Veterinary clinical data → API out-licensing → Human IND submission

This progressive value-creation chain enables value realization at multiple stages, with each milestone offering independent commercialization potential while reducing overall development risk.

Veterinary Therapeutics Data Assets

Comprehensive preclinical safety, efficacy, and standardized manufacturing datasets establish the scientific foundation of the platform.

Active Pharmaceutical Ingredient (API) Licensing

Out-licensing TFA-01 as an Active Pharmaceutical Ingredient (API) to pharmaceutical companies worldwide, generating early-stage cash flow while establishing strategic collaboration opportunities.

Human Therapeutics Development

Animal model data serve as a translational bridge to support IND submission and advance clinical development in human osteoarthritis and chronic inflammatory indications.

Market Opportunity — A Convergence of Two High-Growth Sectors

Global Anti-Inflammatory Drug Market

The global NSAIDs market exceeds USD 20 billion, with aging demographics driving sustained demand for safer, long-term anti-inflammatory solutions — a gap TFA-01 is positioned to address.

The Rapid Expansion of the Pet Healthcare Market

The global pet healthcare market exceeds USD 30 billion with CAGR over 6%. Safety concerns with existing veterinary NSAIDs create a direct market entry opportunity for TFA-01.

A New Paradigm for Anti-Inflammatory Medicine

We stand at an inflection point in anti-inflammatory medicine. TFA-01 represents not an incremental improvement, but a fundamentally new molecular approach — non-steroidal, multi-mechanistic, chemically defined, and systematically de-risked.

Molecular Precision

As a single, well-characterized molecule, TFA-01 differs fundamentally from conventional botanical extract mixtures and offers a viable pathway for modern drug development.

Safety Profile

By virtue of its non-steroidal architecture, TFA-01 has the potential to mitigate the most significant long-term safety concerns associated with corticosteroids, making it well suited for chronic therapeutic use.

Translational Path

A well-defined translational pathway from veterinary to human therapeutics, with each validation milestone systematically reducing the risk of subsequent development stages.

Platform Scalability

One molecule, multiple indications, and multiple commercialization pathways form a scalable and sustainable long-term value creation platform.

We are already in motion.

This is not a concept awaiting initiation. Safety validation is complete. Clinical models have been established. Third-party institutional endorsement is secured. We are already in motion — and we are inviting strategic partners to join at this critical inflection point.

Safety Validation Complete

Clinical Model Established

Third-party Institutional Validation

Veterinary NDA in Progress

Learn More — Connect with Our Team

Talk to us

We welcome in-depth conversations with pharmaceutical R&D institutions, strategic investors, and development partners interested in veterinary drug collaboration, API licensing, and human therapeutic co-development.

Partnership Opportunities

Strategic Investment

Join a pivotal financing round that will advance veterinary drug registration and accelerate the development of the broader platform.

API Licensing

Partner with leading global pharmaceutical companies to accelerate the commercial application of TFA-01 as an Active Pharmaceutical Ingredient (API).

Co-development

Seek strategic partners with strong clinical development resources to accelerate the development of human therapeutic indications.

Next Steps

Request Full Scientific Data Package

Schedule In-depth Technical Briefing

Explore Partnership Framework

Execute NDA & Initiate Due Diligence