臨床試驗失誤如何讓臺灣新創療法公司估值陷入低谷

Abstract

自2022年以來，臺灣生技製藥產業在民間投資、產品出口與創新藥品開發方面展現顯著成長，部分成長動能來自於新藥數量的增加。然而，過去十五年間一連串備受矚目的臨床試驗失敗事件，卻對公司估值造成重大衝擊，干擾商業化進程，並削弱了市場投資信心。為探究其潛在成因與可辨識之預警訊號，本研究採用質化分析方法，選取五家具代表性的臺灣新藥公司—台灣浩鼎、基亞生物科技、全福生技、杏國新藥與台睿生技—進行個案剖析，聚焦2009年至2023年間重大臨床挫敗事件。 本研究結合ClinicalTrials.gov、台灣臨床試驗資訊平台、公司公告、財務報表、媒體報導與法院判決等公開資料來源，深入探討臨床試驗失敗背後的臨床與組織因素。分析結果顯示，試驗設計缺失（如主要終點選擇不當、臨床試驗階段間轉譯驗證薄弱及主要終點變更、不適切的對照設計，與統計設計功效不足）為試驗最主要科學性失敗（治療效果不足）風險來源；此外，風險偏好行為、資本市場壓力與公司治理問題等非科學性因素，亦加劇了臨床試驗失敗的可能性，尤其對於研發管線有限且資源受限的臺灣中小型新藥公司而言更為顯著。 儘管本研究受限於公開資料的深度與完整性，仍指出若干可觀察之潛在風險訊號，包括招募進度延遲、試驗狀態變更、試驗方案頻繁修訂等。透過持續性與情境化的追蹤解讀，此類訊號可作為利害關係人（包括公司經營團隊、投資人與監管機關）早期風險評估與盡職調查的重要參考。 本論文對台灣生技新藥開發體系提供系統性觀察與反思，揭示影響臨床試驗結果的多元因素如何交互作用，並強調成功的新藥開發不僅依賴於科學創新，更需建立嚴謹的試驗設計、提早與國際監管機關對接、擬定審慎的商業策略，以及維持誠實透明的溝通機制。

Taiwan’s biopharma industry has demonstrated notable growth in private investment, export value, and product innovation since 2022, fueled in part by an increasing number of new drug launches. Yet this progress has been marred by a series of high-profile clinical trial failures over the past fifteen years, which have significantly impacted company valuations, disrupted commercialization trajectories, and eroded investor confidence. This thesis investigates the root causes and early warning signs of these clinical missteps through in-depth qualitative analysis of five representative Taiwanese therapeutic companies: OBI Pharma, Medigen Biotechnology Corp., BRIM Biotechnology, SynCore Biotechnology, and TaiRx, Inc. Drawing on publicly accessible data sources—including ClinicalTrials.gov, TaiwanClinicalTrials.tw, corporate disclosures, financial filings, media reports and court judgments—this study examines the clinical and organizational factors underpinning trial failures between 2009 and 2023. The analysis identifies a set of recurrent deficiencies: inadequate endpoint selection, weak translational validation and clinical endpoints switching between trial phases, inappropriate controls, or insufficiently powered statistically sound analytical approaches. In addition, risk-taking behavior, capital market pressures, and inconsistent corporate governance further compounded the risk of failure, particularly for companies with limited pipelines and high single-asset dependency. While constrained by the limitations of public data, the study demonstrates that certain observable patterns—such as recruitment delays, frequent protocol amendments, and shifts in trial status—may serve as qualitative early warning indicators. These findings suggest that proactive and contextual interpretation of such signals can support more informed decision-making by sponsors, investors, and regulators. This thesis contributes to the understanding of Taiwan’s unique biopharma development landscape, highlighting the interplay between scientific, strategic, and systemic factors in determining clinical trial outcomes. It underscores that sustainable success in drug development requires not only scientific innovation but also rigorous trial design, early and global regulatory alignment, prudent strategic planning, and transparent stakeholder communication.