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

類固醇的困境

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

現有非類固醇藥物(NSAIDs)的瓶頸

Traditional NSAIDs face gastrointestinal, cardiovascular, and renal toxicity limitations — leaving a significant unmet clinical need for a safer, sustainable anti-inflammatory molecule.
未被滿足的臨床需求 Unmet Clinical Need — 安全、長效、可慢性使用的抗發炎解方

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.

非類固醇骨架

不具類固醇核心結構,從根本上規避類固醇相關的全身性副作用風險。

明確化學結構

分子結構清晰,具備標準化生產與品質管控的基礎,符合新藥申報要求。

多機轉抗發炎

作用於多條發炎信號通路,涵蓋NF-κB抑制與促炎細胞因子調節,具備廣譜抗發炎潛力。

平台延伸性

作為API原料藥可授權,亦可作為人類新藥開發的分子基礎,具高度平台延伸潛力。

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

單一分子,結構明確

Reproducibility

標準化生產,品質可控

Regulatory Readiness

符合新藥申報要求

Platform Scalability

從寵物到人類的轉化路徑

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

為何選擇寵物新藥作為第一步?

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.

第一適應症:犬類骨關節炎

犬類骨關節炎(Canine Osteoarthritis)是目前全球寵物骨科最高發病率疾病之一,現有治療方案(主要為NSAIDs)存在明確的肝腎毒性疑慮,市場存在高度未滿足需求。TFA-01在此適應症上的驗證,直接對應人類骨關節炎的臨床需求,形成清晰的轉化邏輯。

Safety & Institutional Validation — Grounded in Scientific Authority

第三方獨立驗證機構

國立屏東科技大學動物疫苗科技研究所。
國立屏東科技大學獸醫學院為台灣頂尖獸醫暨動物科學研究機構,具備完整的動物試驗倫理委員會審查體系及 GLP 標準實驗環境,其出具之安全性數據具備高度國際公信力。 

Validation Scope

Acute Toxicity

評估TFA-01在動物模型中的急性毒性劑量範圍,確認安全治療窗口

Sub-chronic Toxicity

長期給藥安全性評估,涵蓋肝功能、腎功能及血液學指標的系統性監測。

Efficacy Validation

基於標準化犬類關節炎模型,評估抗發炎效果與疼痛行為學改善指標。

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.

關鍵驗證指標

精準定義

標準化疼痛行為學評分(Canine Brief Pain Inventory, CBPI)顯示統計意義上的顯著改善。

發炎指標下降

血清促炎細胞因子(IL-6、TNF-α)水平顯著降低,與作用機轉一致。

安全性指標正常

肝腎功能指標(ALT、BUN、Creatinine)在治療期間維持正常範圍,無顯著毒性信號。

劑量反應關係

確認劑量依賴性療效反應,為後續劑量優化及人類等效劑量推算提供依據。

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.

為何這條路徑更聰明?

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.

路徑的三大風險控制機制

分階段資本投入

每個階段的資本需求與對應的科學里程碑掛鉤,避免過早燃燒高額研發資本。

監管路徑清晰

寵物新藥審查框架成熟,數據轉化至人類IND有明確的科學橋接邏輯。

多元變現選項

API授權、寵物新藥商業化、人類新藥授權,三條並行的價值實現路徑降低單一失敗風險。

Development Pathway — Four Stages of Value Creation

Safety & Standardization

毒理學驗證、GLP標準化、分子結構確認、第三方機構認證

Veterinary New Drug

核心落地階段 — 犬類骨關節炎新藥申請、臨床驗證完成、法規審查推進

API Licensing

原料藥(API)對外授權、技術轉移、國際合作夥伴引入

Human Therapeutics

IND申請、Phase I臨床試驗、人類骨關節炎及慢性發炎適應症開發
★ 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.
寵物新藥臨床數據 → API原料藥授權 → 人類新藥IND申請,三個階段形成遞進的價值創造鏈條,每個節點都具備獨立的商業化潛力。

寵物新藥數據資產

臨床前安全性數據、有效性數據、標準化製程數據,構成平台的科學基礎。

API 原料藥授權

向全球製藥企業授權TFA-01原料藥,提供早期現金流與戰略合作機會。

人類新藥開發

以動物模型數據為橋接,推進IND申請,進入人類骨關節炎與慢性發炎適應症臨床開發。

Market Opportunity — A Convergence of Two High-Growth Sectors

寵物新藥全球抗發炎藥物市場數據資產

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.

寵物醫療市場的快速崛起

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

單一定義分子,區別於傳統植物萃取混合物,具備真正的新藥開發可行性。

Safety Profile

非類固醇骨架從根本上規避最嚴重的長期副作用風險,具備慢性使用的潛力。

Translational Path

從寵物到人類的清晰轉化邏輯,每一步驗證都在降低下一步的開發風險。

Platform Scalability

單一分子,多元適應症,多條商業化路徑,形成可持續的長期價值架構。

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

參與寵物新藥申請及後續平台開發的關鍵融資階段。

API Licensing

與全球製藥企業共同推進TFA-01原料藥的商業化應用。

Co-development

在人類新藥適應症開發上尋求具備臨床資源的戰略合作夥伴。

Next Steps

Request Full Scientific Data Package

Schedule In-depth Technical Briefing

Explore Partnership Framework

Execute NDA & Initiate Due Diligence