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題名 臨床試驗結果對台灣生技新藥公司價值的影響
The Impact of Clinical Trial Result of Pharmaceutical Company’s Valuation
作者 李姵瑩
Lee, Pei Ying
貢獻者 陳嬿如<br>翁嘉祥
Chen, Yenn-Ru<br>Weng, Chia-Hsiang
李姵瑩
Lee, Pei Ying
關鍵詞 新藥臨床試驗結果
異常報酬
New drug
abnormal return
Clinical Trial
日期 2025
上傳時間 4-Aug-2025 13:06:09 (UTC+8)
摘要 台灣生技新藥產業在政策與資本市場支持下快速成長，成為亞洲新藥研發重鎮。本研究以六家台灣上市櫃新藥公司（全福生技、康霈生技、智擎生技、圓祥生技、藥華藥、中裕新藥）為研究對象，運用事件研究法，分析 2015 至2025 年間臨床試驗結果公告對公司股價的影響。研究發現，臨床試驗成功與國際藥證核准等重大事件，普遍帶來顯著正向異常報酬（AR）；反之，臨床試驗失敗則導致劇烈負向異常報酬。市場反應強度受試驗階段、公司知名度、資訊揭露品質及新聞提前洩漏等因素影響，其中三期臨床試驗成功及藥證核准對股價的正向影響尤為明顯。 研究結論顯示，臨床試驗階段越高（如三期相較於二期），市場預期異常報酬可能更高，但實際異常報酬不一定隨階段提升而遞增，顯示仍有其他因素（如市場預期、公司知名度、國際藥證取得等）影響報酬幅度。特別是美國FDA 核准等國際藥證新聞，對市場異常報酬的正向影響最為顯著。臨床試驗成功新聞對台灣新藥公司普遍產生正向異常報酬，反映台灣市場對利多資訊有快速且強烈的反應；臨床試驗失敗新聞則會造成顯著負向異常報酬，顯示市場對失敗資訊反應過度，股價波動劇烈。此外，若存在新聞外洩現象，臨床試驗結果在正式公告前的 CAR 已顯著上升，正式公告時反應有限或甚至反向，反映市場對資訊流通的敏感度與效率。最終，新藥國際藥證核准的消息帶來較高的正向異常報酬，二期事件波動大，三期與核准事件則趨於穩定正向。
The Taiwanese biotechnology and new drug industry has experienced rapid growth under supportive policies and capital market development, positioning itself as a key hub for new drug R&D in Asia. This study focuses on six listed Taiwanese pharmaceutical companies (BRIM Biotechnology, CBLB, PharmaEngine, Yuan Hsiang Biotech, PharmaEssentia, and TaiMed Biologics), employing the event study methodology to analyze the impact of clinical trial result announcements on stock prices from 2015 to 2025. The results indicate that positive clinical trial outcomes and international regulatory approvals generally lead to significant positive abnormal returns (AR), while trial failures result in substantial negative abnormal returns. The magnitude of market reactions is influenced by the clinical trial phase, company visibility, disclosure quality, and potential information leakage. Notably, Phase III clinical trial successes and international approvals provide the most pronounced positive effects on stock prices. The study concludes that while higher clinical trial phases (such as Phase III compared to Phase II) may lead to greater expected abnormal returns, actual abnormal returns do not always increase with phase progression, as other factors—including market expectations, company reputation, and international regulatory milestones—also play significant roles. Specifically, news of U.S. FDA and other international regulatory approvals has the most significant positive impact on abnormal returns. Positive clinical trial news generally results in strong positive abnormal returns, reflecting the Taiwanese market’s rapid and intense response to favorable information; conversely, negative clinical trial news triggers sharp negative abnormal returns, indicating an overreaction to failure and heightened stock price volatility. Additionally, if information leakage occurs, cumulative abnormal returns (CAR) may rise significantly before the official announcement, resulting in limited or even reversed market reactions upon announcement, highlighting the market’s sensitivity and efficiency in processing information flow. Ultimately, approval events generate the most significant positive abnormal returns, with Phase II events showing greater volatility, while Phase III and approval events tend to be more stable and positive.
參考文獻 【1】Wang, J. C., & Chen, M. H. (2019). Policy impacts on Taiwan’s biotech industry. Journal of Policy Modeling, 41(3), 453–467. 【2】Ministry of Economic Affairs. (2024). Taiwan biotech industry report 2024. Ministry of Economic Affairs. 【3】Lin, C. Y., & Huang, T. H. (2021). R&D challenges in Taiwan’s biotech industry. Technology Analysis & Strategic Management, 33(6), 712–725. 【4】Kim, H., & Park, S. (2023). Biotech industry trends in Asia: Challenges and opportunities. Journal of Asian Business Studies, 17(1), 89–104. 【5】Chen, C. H., & Lee, H. W. (2020). Biotech industry development in Taiwan: Policy and performance. Asia Pacific Journal of Management, 37(4), 1123–1145. 【6】DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20–33. 【7】MoneyDJ. (2021). 中裕新藥 Trogarzo 試驗成功股價大漲. https://www.moneydj.com 【8】Anue 鉅亨. (2023). 藥華藥 Ropeginterferon alfa-2b 試驗進展. https://www.cnyes.com 【9】Kothari, S. P., & Warner, J. B. (2007). Econometrics of event studies. In B. E. Eckbo (Ed.), Handbook of corporate finance: Empirical corporate finance (pp. 3–36). Elsevier. 【10】Fama, E. F. (1970). Efficient capital markets: A review of theory and empirical work. Journal of Finance, 25(2), 383–417. 【11】Bhagat, S., & Umesh, Z. (1997). The impact of information leakage on stock returns: Evidence from earnings announcements. Journal of Business Finance & Accounting, 24(7–8), 1037–1056. 【12】Xu, J., & Wang, L. (2018). Market reactions to clinical trial outcomes in the biotech industry. Financial Analysts Journal, 74(4), 88–102. 【13】Sharma, A., & Lacey, N. (2004). Linking product development outcomes to market valuation of the firm: The case of the U.S. pharmaceutical industry. Journal of Product Innovation Management, 21(5), 297–308. 【14】Ahern, K. R. (2017). Information networks: Evidence from illegal insider trading tips. Journal of Financial Economics, 125(1), 26–47. 【15】Fama, E. F., Fisher, L., Jensen, M. C., & Roll, R. (1969). The adjustment of stock prices to new information. International Economic Review, 10(1), 1–21. 【16】MacKinlay, A. C. (1997). Event studies in economics and finance. Journal of Economic Literature, 35(1), 13–39. 【17】Rothenstein, J. M., Tomlinson, G., & Tannock, I. F. (2011). Company stock prices before and after public announcements related to oncology drugs. Journal of the National Cancer Institute, 103(20), 1507–1512. 【18】Brown, S. J., & Warner, J. B. (1985). Using daily stock returns: The case of event studies. Journal of Financial Economics, 14(1), 3–31. 【19】Damodaran, A. (2012). Valuation: Measuring and managing the value of companies (5th ed.). Wiley. 【20】Golec, J., & Vernon, J. A. (2007). Financial risk of the biotech industry versus the pharmaceutical industry. Applied Health Economics and Health Policy, 5(3), 155–165. 【21】Ball, R., & Brown, P. (1968). An empirical evaluation of accounting income numbers. Journal of Accounting Research, 6(2), 159–178. 【22】Chen, Y. T., & Lee, C. F. (2021). Stock price reactions to clinical trial outcomes: Evidence from Taiwan biotech firms. Journal of Financial Studies, 29(2), 45–67. 【23】MoneyDJ. (2024). 順藥 ST-101 試驗進展公告. https://www.moneydj.com 【24】Anue 鉅亨. (2022). 智擎生技 PEP02 試驗進展公告. https://www.cnyes.com
描述 碩士
國立政治大學
經營管理碩士學程(EMBA)
112932158
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0112932158
資料類型 thesis
dc.contributor.advisor 陳嬿如<br>翁嘉祥zh_TW
dc.contributor.advisor Chen, Yenn-Ru<br>Weng, Chia-Hsiangen_US
dc.contributor.author (Authors) 李姵瑩zh_TW
dc.contributor.author (Authors) Lee, Pei Yingen_US
dc.creator (作者) 李姵瑩zh_TW
dc.creator (作者) Lee, Pei Yingen_US
dc.date (日期) 2025en_US
dc.date.accessioned 4-Aug-2025 13:06:09 (UTC+8)-
dc.date.available 4-Aug-2025 13:06:09 (UTC+8)-
dc.date.issued (上傳時間) 4-Aug-2025 13:06:09 (UTC+8)-
dc.identifier (Other Identifiers) G0112932158en_US
dc.identifier.uri (URI) https://nccur.lib.nccu.edu.tw/handle/140.119/158354-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 經營管理碩士學程(EMBA)zh_TW
dc.description (描述) 112932158zh_TW
dc.description.abstract (摘要) 台灣生技新藥產業在政策與資本市場支持下快速成長，成為亞洲新藥研發重鎮。本研究以六家台灣上市櫃新藥公司（全福生技、康霈生技、智擎生技、圓祥生技、藥華藥、中裕新藥）為研究對象，運用事件研究法，分析 2015 至2025 年間臨床試驗結果公告對公司股價的影響。研究發現，臨床試驗成功與國際藥證核准等重大事件，普遍帶來顯著正向異常報酬（AR）；反之，臨床試驗失敗則導致劇烈負向異常報酬。市場反應強度受試驗階段、公司知名度、資訊揭露品質及新聞提前洩漏等因素影響，其中三期臨床試驗成功及藥證核准對股價的正向影響尤為明顯。 研究結論顯示，臨床試驗階段越高（如三期相較於二期），市場預期異常報酬可能更高，但實際異常報酬不一定隨階段提升而遞增，顯示仍有其他因素（如市場預期、公司知名度、國際藥證取得等）影響報酬幅度。特別是美國FDA 核准等國際藥證新聞，對市場異常報酬的正向影響最為顯著。臨床試驗成功新聞對台灣新藥公司普遍產生正向異常報酬，反映台灣市場對利多資訊有快速且強烈的反應；臨床試驗失敗新聞則會造成顯著負向異常報酬，顯示市場對失敗資訊反應過度，股價波動劇烈。此外，若存在新聞外洩現象，臨床試驗結果在正式公告前的 CAR 已顯著上升，正式公告時反應有限或甚至反向，反映市場對資訊流通的敏感度與效率。最終，新藥國際藥證核准的消息帶來較高的正向異常報酬，二期事件波動大，三期與核准事件則趨於穩定正向。zh_TW
dc.description.abstract (摘要) The Taiwanese biotechnology and new drug industry has experienced rapid growth under supportive policies and capital market development, positioning itself as a key hub for new drug R&D in Asia. This study focuses on six listed Taiwanese pharmaceutical companies (BRIM Biotechnology, CBLB, PharmaEngine, Yuan Hsiang Biotech, PharmaEssentia, and TaiMed Biologics), employing the event study methodology to analyze the impact of clinical trial result announcements on stock prices from 2015 to 2025. The results indicate that positive clinical trial outcomes and international regulatory approvals generally lead to significant positive abnormal returns (AR), while trial failures result in substantial negative abnormal returns. The magnitude of market reactions is influenced by the clinical trial phase, company visibility, disclosure quality, and potential information leakage. Notably, Phase III clinical trial successes and international approvals provide the most pronounced positive effects on stock prices. The study concludes that while higher clinical trial phases (such as Phase III compared to Phase II) may lead to greater expected abnormal returns, actual abnormal returns do not always increase with phase progression, as other factors—including market expectations, company reputation, and international regulatory milestones—also play significant roles. Specifically, news of U.S. FDA and other international regulatory approvals has the most significant positive impact on abnormal returns. Positive clinical trial news generally results in strong positive abnormal returns, reflecting the Taiwanese market’s rapid and intense response to favorable information; conversely, negative clinical trial news triggers sharp negative abnormal returns, indicating an overreaction to failure and heightened stock price volatility. Additionally, if information leakage occurs, cumulative abnormal returns (CAR) may rise significantly before the official announcement, resulting in limited or even reversed market reactions upon announcement, highlighting the market’s sensitivity and efficiency in processing information flow. Ultimately, approval events generate the most significant positive abnormal returns, with Phase II events showing greater volatility, while Phase III and approval events tend to be more stable and positive.en_US
dc.description.tableofcontents 第一章 緒論 1 第一節 研究背景與動機 1 第二節 研究目的 2 第二章 理論及文獻探討 3 第一節 台灣生技新藥產業概況 3 第二節 臨床試驗與市場反應 4 第三節 事件研究與異常報酬 4 第四節 公司價值與大盤比較 5 第三章 研究方法 6 第一節 研究假說 6 第二節 樣本與資料來源 6 第三節 事件研究法與分析模型 7 第四節 名詞定義 7 第四章 實證分析 8 第一節 選定新藥公司簡介 8 第二節 六家新藥公司臨床試驗新聞對股價的影響 14 第三節 綜合比較 24 第五章 結論與建議 27 第一節 研究結論 27 第二節 管理與投資意涵 29 第三節 研究限制與未來建議 29 參考文獻 30zh_TW
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0112932158en_US
dc.subject (關鍵詞) 新藥臨床試驗結果zh_TW
dc.subject (關鍵詞) 異常報酬zh_TW
dc.subject (關鍵詞) New drugen_US
dc.subject (關鍵詞) abnormal returnen_US
dc.subject (關鍵詞) Clinical Trialen_US
dc.title (題名) 臨床試驗結果對台灣生技新藥公司價值的影響zh_TW
dc.title (題名) The Impact of Clinical Trial Result of Pharmaceutical Company’s Valuationen_US
dc.type (資料類型) thesisen_US
dc.relation.reference (參考文獻) 【1】Wang, J. C., & Chen, M. H. (2019). Policy impacts on Taiwan’s biotech industry. Journal of Policy Modeling, 41(3), 453–467. 【2】Ministry of Economic Affairs. (2024). Taiwan biotech industry report 2024. Ministry of Economic Affairs. 【3】Lin, C. Y., & Huang, T. H. (2021). R&D challenges in Taiwan’s biotech industry. Technology Analysis & Strategic Management, 33(6), 712–725. 【4】Kim, H., & Park, S. (2023). Biotech industry trends in Asia: Challenges and opportunities. Journal of Asian Business Studies, 17(1), 89–104. 【5】Chen, C. H., & Lee, H. W. (2020). Biotech industry development in Taiwan: Policy and performance. Asia Pacific Journal of Management, 37(4), 1123–1145. 【6】DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20–33. 【7】MoneyDJ. (2021). 中裕新藥 Trogarzo 試驗成功股價大漲. https://www.moneydj.com 【8】Anue 鉅亨. (2023). 藥華藥 Ropeginterferon alfa-2b 試驗進展. https://www.cnyes.com 【9】Kothari, S. P., & Warner, J. B. (2007). Econometrics of event studies. In B. E. Eckbo (Ed.), Handbook of corporate finance: Empirical corporate finance (pp. 3–36). Elsevier. 【10】Fama, E. F. (1970). Efficient capital markets: A review of theory and empirical work. Journal of Finance, 25(2), 383–417. 【11】Bhagat, S., & Umesh, Z. (1997). The impact of information leakage on stock returns: Evidence from earnings announcements. Journal of Business Finance & Accounting, 24(7–8), 1037–1056. 【12】Xu, J., & Wang, L. (2018). Market reactions to clinical trial outcomes in the biotech industry. Financial Analysts Journal, 74(4), 88–102. 【13】Sharma, A., & Lacey, N. (2004). Linking product development outcomes to market valuation of the firm: The case of the U.S. pharmaceutical industry. Journal of Product Innovation Management, 21(5), 297–308. 【14】Ahern, K. R. (2017). Information networks: Evidence from illegal insider trading tips. Journal of Financial Economics, 125(1), 26–47. 【15】Fama, E. F., Fisher, L., Jensen, M. C., & Roll, R. (1969). The adjustment of stock prices to new information. International Economic Review, 10(1), 1–21. 【16】MacKinlay, A. C. (1997). Event studies in economics and finance. Journal of Economic Literature, 35(1), 13–39. 【17】Rothenstein, J. M., Tomlinson, G., & Tannock, I. F. (2011). Company stock prices before and after public announcements related to oncology drugs. Journal of the National Cancer Institute, 103(20), 1507–1512. 【18】Brown, S. J., & Warner, J. B. (1985). Using daily stock returns: The case of event studies. Journal of Financial Economics, 14(1), 3–31. 【19】Damodaran, A. (2012). Valuation: Measuring and managing the value of companies (5th ed.). Wiley. 【20】Golec, J., & Vernon, J. A. (2007). Financial risk of the biotech industry versus the pharmaceutical industry. Applied Health Economics and Health Policy, 5(3), 155–165. 【21】Ball, R., & Brown, P. (1968). An empirical evaluation of accounting income numbers. Journal of Accounting Research, 6(2), 159–178. 【22】Chen, Y. T., & Lee, C. F. (2021). Stock price reactions to clinical trial outcomes: Evidence from Taiwan biotech firms. Journal of Financial Studies, 29(2), 45–67. 【23】MoneyDJ. (2024). 順藥 ST-101 試驗進展公告. https://www.moneydj.com 【24】Anue 鉅亨. (2022). 智擎生技 PEP02 試驗進展公告. https://www.cnyes.comzh_TW