本文以台灣上市、上櫃及興櫃的生技製藥公司為主要研究對象，探討通過美國食品藥物管理局(FDA)各階段的審核對於股票異常報酬的影響，採用事件研究法加以檢測。本研究透過「台灣經濟日報」蒐集生技製藥公司通過審核之新聞宣告資訊，實證結果發現企業通過FDA審核新聞宣告，對於股價有正向且顯著的累積異常報酬，顯示投資人對於新藥能否成功上市的重視。而在FDA審核新藥的漫長階段中，又以中間的人體第一階段、第二階段和第三階段試驗以及通過查廠的階段有較高的累積正向異常報酬，大於前段的申請階段以及後段的藥品核准階段，其中以第三階段試驗有最高的累積正向異常報酬。因為投資人了解藥品審核有需花大量的資金、時間以及高失敗率的特性，因此會在較有把握的時期進行投資。另外，台灣政府於2007年7月4日頒布的「生技新藥產業發展條例」，提供研究與發展和創投減稅的優惠，這兩部分對於台灣剛起步的生技製藥產業是相當重要的環節。本研究係將各新聞事件按照FDA審核的六大階段予以分類，並設計迴歸模型加以檢測。研究結果發現研究與發展費用越高，股價會隨之增高，產生正向的異常報酬；創投的部分對於公司雖然是不可或缺的資金來源，但因為投資人行為會產生負向的異常報酬。

This study uses event study to examine the relation between the approvals of FDA and abnormal returns for listed, OTC and emerging biotech companies in Taiwan. Our research finds that there are positive and significant cumulated abnormal returns due to the FDA approval news announcement by collecting news from Taiwan Economic Journal. It shows that whether the drugs are approved or not matters for investors. As for the long period of verification, the middle stages, including the phase 1 testing, phase 2 testing, phase 3 testing and facility inspection, have higher positive cumulated abnormal returns than IND application and drug approval stages. Phase 3 testing is the highest among them. It implies that the investors are more willing to invest in the periods that have more chances to have positive abnormal returns due to the high fail rate of drug verification. Moreover, the government in Taiwan enacts “The Development of Biotech and New Pharmaceuticals Industry Act” on July 4, 2007, providing tax reduction for R&D and VCs. They are crucial for the development of biotech industries in Taiwan. This research classifies all the news events by six stages of FDA approvals and contains a regression model. The result shows that the higher R&D expense the company is willing to spend, the higher stock price it will have, generating positive abnormal returns. When it comes to VC, even though they are an indispensable source of capital, it will generate negative abnormal returns because of investors’ behavior.

Chinese Literature:
1.The Ministry of Economy Affairs, R.O.C., (2007) “The Development of Biotech and New Pharmaceuticals Industry Act”, Article 5, Article 8
行政院經濟部(2007) 生技新藥產業發展條例 第5條、第8條
2.Huang, M.L. and Young, H.H., (2008) , “The Development of Biotech and New Pharmaceuticals Industry Act is passed. Chi-Huey Wong sees 55 trillion biotech industries”
楊瑪利、黃漢華(2008) 生技新藥產業發展條例相關獎勵辦法通過 翁啟惠領軍搶攻55兆生技:遠見雜誌

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