請用此 Handle URI 來引用此文件：
http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/98713完整後設資料紀錄
| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 李素華 | zh_TW |
| dc.contributor.advisor | Su-Hua Lee | en |
| dc.contributor.author | 黃兆營 | zh_TW |
| dc.contributor.author | Jow-Ying Huang | en |
| dc.date.accessioned | 2025-08-18T16:12:10Z | - |
| dc.date.available | 2025-08-19 | - |
| dc.date.copyright | 2025-08-18 | - |
| dc.date.issued | 2025 | - |
| dc.date.submitted | 2025-08-11 | - |
| dc.identifier.citation | 生技醫藥產業發展條例（2021），全國法規資料庫。https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=J0040046
[Act for the Development of Biotech and Pharmaceutical Industry (2021), Laws & Regulations Database of The Republic of China (Taiwan). https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=J0040046] 李素華, & 張哲倫 (2023) ，〈藥品專利權期間延長之 立法目的及其落實── 從新近實務爭議談起〉，《月旦法學雜誌》，339卷，頁144-164。https://doi.org/10.53106/1025593133909 [Lee, S., & Chang, R. C. (2023). Patent Term Extension in the Pharmaceutical Sector and the Recent Development in the Judicial Practice in Taiwan. The Taiwan Law Review, 339, 144-164. https://doi.org/10.53106/1025593133909] 陳孟鴻 (2015)，基亞事件對台灣上市 (櫃) 生技公司股價表現之影響，淡江大學財務金融學系碩士在職專班學位論文，頁1-53。 https://doi.org/10.6846/TKU.2015.00406 [Chen, M. (2015). The Impact of Medigen Event on Price Performance of Biotech Stocks in Taiwan. Master’s thesis, Graduate Institute of Banking and Finance (on the job class), Tamkang University, 1-53. https://doi.org/10.6846/TKU.2015.00406] 黃建智 (2019)，從公司治理探討基亞條款對生技醫療相關產業股價之影響，臺中科技大學企業管理系碩士班學位論文，頁1-76。 [Huang, C. (2019). Investigating the Impact of Medigen Clause on the Stock Prices of Biotechnology and Medicine Industries from the Perspective of Corporate Governance. Master’s thesis, Graduate Institute of Business Administration, National Taichung University of Science and Technology, 1-76.] 劉思妤 (2017)，論台灣生技新藥產業之投資人保護制度，臺北醫學大學醫療暨生物科技法律研究所學位論文，頁1-102。 [Liu, S. (2017). On the Investor Protection Regulation for New Drug-developing Biotech Industry in Taiwan. Master’s thesis, Graduate Institute of Health and Biotechnology Law, Taipei Medical University, 1-102.] 劉銘聖 (2017)，新藥解盲失敗對生技股股價的影響，國立成功大學醫企業管理學系碩士在職專班學位論文，頁1-67。 [Liu, M. (2017). The Impact of Unblind Failure of New Drug on Stock Performances of Biotechnology Pharmacy Industry. Master’s thesis, Graduate Institute of Business Administration (on the job class), National Cheng Kung University, 1-67.] 經濟部工業局（2019），《2019生技產業白皮書》，載 於: https://www.biopharm.org.tw/images/2019/Biotechnology-Industry-in-Taiwan-2019.pdf [Industrial Development Bureau, Ministry of Economic Affairs (MOEA). (2019). 2019 Biotechnology White Paper. https://www.biopharm.org.tw/images/2019/Biotechnology-Industry-in-Taiwan-2019.pdf] 經濟部產業發展署（2024），《2024生技產業白皮書》，載 於 : https://www.biopharm.org.tw/images/2024/2024%20Biotechnology%20Industry%20in%20Taiwan.pdf [Industrial Development Administration, Ministry of Economic Affairs (MOEA). (2024). 2024 Biotechnology White Paper. https://www.biopharm.org.tw/images/2024/2024%20Biotechnology%20Industry%20in%20Taiwan.pdf] Campbell, S., Greenwood, M., Prior, S., Shearer, T., Walkem, K., Young, S., ... & Walker, K. (2020). Purposive sampling: complex or simple? Research case examples. Journal of research in Nursing, 25(8), 652-661. https://doi.org/10.1177/1744987120927206 Chen, C. M., Chen, Y. L., Lin, S. M., Wu, H. P., Lin, J. N., Lin, K. H., ... & Chien, D. S. (2024). Effects of high-dose selenium on mortality of sepsis and septic shock patients with severe selenium deficiency in Taiwan. Medical Research Archives, 12(2). https://doi.org/10.18103/mra.v12i2.5044 Chen, L. T., Hitre, E., Lee, W. J., Bai, L. Y., Papaï, Z., Kang, S. Y., ... & Bachet, J. B. (2019). A randomized controlled, open label, adaptive phase III Trial to evaluate safety and efficacy of endoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatment. Annals of Oncology, 30, v321. https://doi.org/10.1093/annonc/mdz247.160 Chen, L. T., Hitre, E., Lee, W. J., Bai, L. Y., Papaï, Z., Kang, S. Y., ... & Bachet, J. B. (2019). A randomized controlled, open label, adaptive phase III Trial to evaluate safety and efficacy of endoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatment. Annals of Oncology, 30, v321. https://doi.org/10.1093/annonc/mdz247.160 Chen, P. J., Lee, P. H., Han, K. H., Fan, J., Cheung, T. T., Hu, R. H., ... & Lai, K. L. (2017). A phase III trial of muparfostat (PI-88) as adjuvant therapy in patients with hepatitis virus related hepatocellular carcinoma (HV-HCC) after resection. Annals of Oncology, 28, v213. Chorniy, A., Bailey, J., Civan, A., & Maloney, M. (2021). Regulatory review time and pharmaceutical research and development. Health Economics, 30(1), 113-128. https://doi.org/10.1002/hec.4180 Coombs, J. E., & Deeds, D. L. (2000). International alliances as sources of capital: Evidence from the biotechnology industry. The journal of high technology management research, 11(2), 235-253. https://doi.org/10.1016/S1047-8310(00)00031-6 DiMasi, J. A., Feldman, L., Seckler, A., & Wilson, A. (2010). Trends in risks associated with new drug development: Success rates for investigational drugs. Clinical Pharmacology & Therapeutics, 87(3), 272–277. https://doi.org/10.1038/clpt.2009.295 Dowden, H., & Munro, J. (2019). Trends in clinical success rates and therapeutic focus. Nature Reviews Drug Discovery, 18(7), 495–496. https://doi.org/10.1038/d41573-019-00074-z Elkin, M. E., & Zhu, X. (2021). Understanding and predicting COVID-19 clinical trial completion vs. cessation. PLoS ONE, 16(7), e0253789. https://doi.org/10.1371/journal.pone.0253789 Elliott, D., Husbands, S., Hamdy, F. C., Holmberg, L., & Donovan, J. L. (2017). Understanding and improving recruitment to randomised controlled trials: qualitative research approaches. European urology, 72(5), 789-798. https://doi.org/10.1016/j.eururo.2017.04.036 Fogel, D. B. (2018). Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemporary Clinical Trials Communications, 11, 156–164. https://doi.org/10.1016/j.conctc.2018.08.001 Galson, S., Austin, C. P., Khandekar, E., Hudson, L. D., DiMasi, J. A., Califf, R., & Wagner, J. A. (2021). The failure to fail smartly. Nature Reviews Drug Discovery, 20(4), 259–260. https://doi.org/10.1038/d41573-020-00167-0 Geletta, S., Follett, L., & Laugerman, M. (2019). Latent Dirichlet allocation in predicting clinical trial terminations. BMC medical informatics and decision making, 19, 1-12. https://doi.org/10.1186/s12911-019-0973-y Getz, K. A., Zuckerman, R., Cropp, A. B., Hindle, A. L., Krauss, R., & Kaitin, K. I. (2011). Measuring the incidence, causes, and repercussions of protocol amendments. Drug information journal: DIJ/Drug Information Association, 45, 265-275. https://doi.org/10.1177/009286151104500307 Gustafsson, J. (2017). Single case studies vs. multiple case studies: A comparative study. Harrison, R. K. (2016). Phase II and phase III failures: 2013–2015. Nature Reviews Drug Discovery, 15(12), 817–818. https://doi.org/10.1038/nrd.2016.184 Hay, M., Thomas, D. W., Craighead, J. L., Economides, C., & Rosenthal, J. (2014). Clinical development success rates for investigational drugs. Nature Biotechnology, 32(1), 40–51. https://doi.org/10.1038/nbt.2786 Hegge, S., Thunecke, M., Krings, M., Ruedin, L., Müller, J. S., & Bünau, P. V., (2020). Predicting Success of Phase III Trials in Oncology. medRxiv. https://doi.org/10.1101/2020.12.15.20248240 Holland, R. (1999). Reflexivity. Human relations, 52(4), 463-484. https://doi.org/10.1177/001872679905200403 Huang, C. S., Yu, A. L., Tseng, L. M., Chow, L. W., Hou, M. F., Hurvitz, S. A., ... & Rugo, H. S. (2016). Randomized phase II/III trial of active immunotherapy with OPT-822/OPT-821 in patients with metastatic breast cancer, Journal of Clinical Oncology, 34 (15). https://doi.org/10.1200/JCO.2016.34.15_suppl.1003 Huang, C. S., Alice, L. Y., Tseng, L. M., Chow, L. W., Hou, M. F., Hurvitz, S. A., ... & Rugo, H. S. (2020). Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 in patients with metastatic breast cancer: phase II randomized, placebo-controlled study. Journal for immunotherapy of cancer, 8(2), e000342. https://doi.org/10.1136/jitc-2019-000342 Hung, J. T., Chen, I. J., Ueng, S. H., Huang, C. S., Chen, S. C., Chen, M. Y., ... & Yu, A. L. (2022). The clinical relevance of humoral immune responses to Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 and expression of Globo H in metastatic breast cancer. Journal for immunotherapy of cancer, 10(6), e004312. https://doi.org/10.1136/jitc-2021-004312 Hwang, T. J. (2013). Stock market returns and clinical trial results of investigational compounds: an event study analysis of large biopharmaceutical companies. PloS one, 8(8), e71966. https://doi.org/10.1371/journal.pone.0071966 Hwang, T. J., Carpenter, D., Lauffenburger, J. C., Wang, B., Franklin, J. M., & Kesselheim, A. S. (2016). Failure of investigational drugs in late-stage clinical development and publication of trial results. JAMA Internal Medicine, 176(12), 1826–1833. https://doi.org/10.1001/jamainternmed.2016.6008 Khandkar, S. H. (2009). Open coding. University of Calgary, 23(2009), 2009. Khunger, M., Rakshit, S., Hernandez, A. V., Pasupuleti, V., Glass, K., Galsky, M. D., & Grivas, P. (2018). Premature clinical trial discontinuation in the era of immune checkpoint inhibitors. The Oncologist, 23(12), 1494–1499. https://doi.org/10.1634/theoncologist.2018-0003 Kim, E., Yang, J., Park, S., & Shin, K. (2023). Factors affecting success of new drug clinical trials. Therapeutic Innovation & Regulatory Science, 57(4), 737–750. https://link.springer.com/article/10.1007/s43441-023-00509-1 Kruizinga, M. D., Stuurman, F. E., Groeneveld, G. J., & Cohen, A. F. (2019). The future of clinical trial design: the transition from hard endpoints to value-based endpoints. Concepts and principles of pharmacology: 100 years of the handbook of experimental pharmacology, 371-397. https://doi.org/10.1007/164_2019_302 Löhr, J. M., Haas, S. L., Bechstein, W. O., Bodoky, G., Cwiertka, K., Fischbach, W., ... & CT4001 Study Group. (2012). Cationic liposomal paclitaxel plus gemcitabine or gemcitabine alone in patients with advanced pancreatic cancer: a randomized controlled phase II trial. Annals of oncology, 23(5), 1214-1222. https://doi.org/10.1093/annonc/mdr379 Manghani, K. (2011). Quality assurance: Importance of systems and standard operating procedures. Perspectives in clinical research, 2(1), 34-37. https://doi.org/10.4103/2229-3485.76288 Rugo, H. S., Chow, L. W., Cortes, J., Fasching, P. A., Hsu, P., Huang, C. S., ... & Xu, B. (2020). Phase III, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of adagloxad simolenin (OBI-822) and OBI-821 treatment in patients with early-stage triple-negative breast cancer (TNBC) at high risk for recurrence, Journal of Clinical Oncology, 38 (15). https://doi.org/10.1200/JCO.2020.38.15_suppl.TPS599 Rugo, H. S., Cortes, J., Barrios, C. H., Cabrera, P., Xu, B., Huang, C. S., ... & Schwab, R. (2022). GLORIA: phase III, open-label study of adagloxad simolenin/OBI-821 in patients with high-risk triple-negative breast cancer. Future Oncology, 18(34), 3801-3813. https://doi.org/10.2217/fon-2022-0812 Rugo, H. S., Cortes, J., Xu, B., Huang, C. S., Kim, S. B., Melisko, M. E., ... & Hsu, P. (2022). A phase 3, randomized, open-label study of the anti-Globo H vaccine adagloxad simolenin/obi-821 in the adjuvant treatment of high-risk, early-stage, Globo H-positive triple-negative breast cancer, Journal of Clinical Oncology, 40 (16). https://doi.org/10.1200/JCO.2022.40.16_suppl.TPS611 Schperberg, A. V., Boichard, A., Tsigelny, I. F., Richard, S. B., & Kurzrock, R. (2020). Machine learning model to predict oncologic outcomes for drugs in randomized clinical trials. International journal of cancer, 147(9), 2537-2549. https://doi.org/10.1002/ijc.33240 Singh, J. A. (2023). Governance of adaptive platform trials. Wellcome Open Research, 8, 141. https://doi.org/10.12688/wellcomeopenres.19058.1 Singh, M., Rocafort, R., Cai, C., Siah, K. W., & Lo, A. W. (2022). The reaction of sponsor stock prices to clinical trial outcomes: An event study analysis. Plos one, 17(9), e0272851. https://doi.org/10.1371/journal.pone.0272851 Snapinn, S., Chen, M. G., Jiang, Q., & Koutsoukos, T. (2006). Assessment of futility in clinical trials. Pharmaceutical Statistics: The Journal of Applied Statistics in the Pharmaceutical Industry, 5(4), 273-281. https://doi.org/10.1002/pst.216 Soni, S., Jain, A., Goyal, V., Narayan, S., Redhu, P., Goyal, P., ... & Talwar, V. (2023). Modified FOLFIRINOX as the first-line chemotherapy in unresectable and metastatic pancreatic adenocarcinoma—a single-center experience in India. Annals of Pancreatic Cancer, 6. Stalmeijer, R. E., Brown, M. E., & O'Brien, B. C. (2024). How to discuss transferability of qualitative research in health professions education. The clinical teacher, 21(6), e13762. https://doi.org/10.1111/tct.13762 Sun, D., Gao, W., Hu, H., & Zhou, S. (2022). Why 90% of clinical drug development fails and how to improve it? Acta Pharmaceutica Sinica B, 12(7), 3049–3062. https://doi.org/10.1016/j.apsb.2022.02.002 Sweetman, E. A., & Doig, G. S. (2011). Failure to report protocol violations in clinical trials: a threat to internal validity? Trials, 12(1), 1-8. https://doi.org/10.1186/1745-6215-12-214 Tang, Q., & Kumar, V. K. (2020). Deep Learning Derived Histopathology Image Score for Increasing Phase 3 Clinical Trial Probability of Success. arXiv preprint arXiv:2011.05406. https://doi.org/10.48550/arXiv.2011.05406 Thomas, D., Chancellor, D., Micklus, A., LaFever, S., Hay, M., Chaudhuri, S., Bowden, R., & Lo, A. W. (2021). Clinical Development Success Rates and Contributing Factors 2011–2020. 1–34. BIO, Informa Pharma Intelligence, and QLS Advisors. Vaismoradi, M., Turunen, H., & Bondas, T. (2013). Content analysis and thematic analysis: Implications for conducting a qualitative descriptive study. Nursing & health sciences, 15(3), 398-405. https://doi.org/10.1111/nhs.12048 Van Norman, G. A. (2019). Phase II trials in drug development and adaptive trial design. JACC: Basic to Translational Science, 4(3), 428–437. https://doi.org/10.1016/j.jacbts.2019.02.005 Vijayananthan, A., & Nawawi, O. (2008). The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomedical imaging and intervention journal, 4(1), e5. Yang, L. (2019). Loss aversion in financial markets. Journal of Mechanism and Institution Design, 4(1), 119-137. https://doi.org/10.22574/jmid.2019.11.005 Yao, J., Hurle, M. R., Nelson, M. R., & Agarwal, P. (2019). Predicting clinically promising therapeutic hypotheses using tensor factorization. BMC bioinformatics, 20, 1-12. https://doi.org/10.1186/s12859-019-2664-1 Zhang, Y., Xu, H., Li, Y., Sun, Y., & Peng, X. (2023). Advances in the treatment of pancreatic cancer with traditional Chinese medicine. Frontiers in Pharmacology, 14, 1089245. https://doi.org/10.3389/fphar.2023.1089245 News, Media Reports and Articles 王詩婷 (2025, Apr. 24)，〈從755元摔到剩42.2元…生技股浩鼎三期解盲失敗 股價跳空急墜創新低〉，《Yahoo財經新聞》，載於: https://tw.stock.yahoo.com/news/%E5%BE%9E755%E5%85%83%E6%91%94%E5%88%B0%E5%89%A9422%E5%85%83%E7%94%9F%E6%8A%80%E8%82%A1%E6%B5%A9%E9%BC%8E%E4%B8%89%E6%9C%9F%E8%A7%A3%E7%9B%B2%E5%A4%B1%E6%95%97-%E8%82%A1%E5%83%B9%E8%B7%B3%E7%A9%BA%E6%80%A5%E5%A2%9C%E5%89%B5%E6%96%B0%E4%BD%8E-025253437.html [Wang, S. (2025, Apr. 24). From NT$ 755 to 42.2 ... Biotech stock OBI Pharma's Phase III trial fails, stock price plummets to a new low. Yahoo Finance. In: https://tw.stock.yahoo.com/news/%E5%BE%9E755%E5%85%83%E6%91%94%E5%88%B0%E5%89%A9422%E5%85%83%E7%94%9F%E6%8A%80%E8%82%A1%E6%B5%A9%E9%BC%8E%E4%B8%89%E6%9C%9F%E8%A7%A3%E7%9B%B2%E5%A4%B1%E6%95%97-%E8%82%A1%E5%83%B9%E8%B7%B3%E7%A9%BA%E6%80%A5%E5%A2%9C%E5%89%B5%E6%96%B0%E4%BD%8E-025253437.html] 李宜儒 (2016, Feb. 22)，〈浩鼎解盲敗在...實驗設計有誤 但臨床療效是成功的〉，《鉅亨網》，載於: https://news.cnyes.com/news/id/290567 [Li, Y. (2016, Feb. 22). OBI Pharma's Unblinding Failed Due to Flawed Trial Design, but Clinical Efficacy Was Achieved. anue. In: https://news.cnyes.com/news/id/290567] 李林璦 (2022, Feb. 9)，〈台睿敗血症新藥三期解盲:結果未達統計學意義〉，《環球生技月刊》，載於: https://news.gbimonthly.com/tw/article/show.php?num=46265 [Li, L. (2022, Feb. 9). TaiRx’s Phase III Unblinding of Sepsis Drug: Results Did Not Reach Statistical Significance. Global Bio & Investment Monthly. In: https://news.gbimonthly.com/tw/article/show.php?num=46265] 李易紓 (2023, Dec. 22)，〈乾眼症新藥解盲失敗，這檔生技股開盤4分鐘熔斷、股價崩跌6成…4個月前才募資30億，下一步怎麼走？〉，《今周刊》，載於: https://www.businesstoday.com.tw/article/category/183016/post/202312220013/ [Li, Y. (2023, Dec. 22). New drug for dry eye disease trial failures, this biotech stock opens with a 4-minute activating a circuit breaker mechanism, stock price collapses by 60%... Raised $3 billion just 4 months ago, what's next? Business Today. In: https://www.businesstoday.com.tw/article/category/183016/post/202312220013/] 何美如. (2015, Aug. 31)，〈個股：浩鼎乳癌新藥明年3月前解盲，下一步拿台灣藥證並啟動全球三期臨床〉，《Yahoo財經新聞》，載於: https://tw.stock.yahoo.com/news/個股-浩鼎乳癌新藥明年3月前解盲-下-步拿台灣藥證並啟動全球三期臨床-010933678.html [He, M. (2015, Aug. 31). Stock Watch: OBI Pharma's Breast Cancer Drug to Undergo Unblinding by March Next Year; Next Steps Include Securing Taiwan Approval and Launching Global Phase III Trial. Yahoo Finance. In: https://tw.stock.yahoo.com/news/個股-浩鼎乳癌新藥明年3月前解盲-下-步拿台灣藥證並啟動全球三期臨床-010933678.html] 全福生物科技. (2025, Jun. 2)，〈全福四項眼科新藥 全力推進臨床試驗〉，載於: http://www.brimbiotech.com/tw/全福四項眼科新藥-全力推進臨床試驗/ [BRIM Biotechnology. (2025, Jun. 2). BRIM Biotechnology Advances Four Ophthalmic Drug Candidates in Clinical Trials. In: http://www.brimbiotech.com/tw/全福四項眼科新藥-全力推進臨床試驗/] 金仁晧. (2016, Apr. 20)，〈浩鼎報告揭密！ 解盲前就可預期「失敗率高」〉，《自由時報》，載於: https://news.ltn.com.tw/news/society/breakingnews/1669966 [Jin, R. (2016, Apr. 20). OBI Pharma Report Revealed: High Failure Rate Was Predictable Even Before Unblinding. Liberty Times Net. In: https://news.ltn.com.tw/news/society/breakingnews/1669966] 林宏達 (2016, Mar. 13)，〈解盲失敗後祭出庫藏股 仍難喚回市場信心 浩鼎四百億市值蒸發的一堂課〉，《今周刊》，載於: https://www.businesstoday.com.tw/article/category/80392/post/201603030027/ [Lin, H. (2016, Mar. 13). Share Buybacks Failed to Restore Investor Confidence After Trial Failure: A Lesson from OBI Pharma’s NT$40 Billion Market Cap Meltdown. Business Today. In: https://www.businesstoday.com.tw/article/category/80392/post/201603030027/] 林彥呈. (2021, Nov. 4)，〈大戶進場了？解盲失利的杏國苦吞連續10根跌停，今日盤中爆量試圖上攻〉，《風傳媒》，載於: https://www.storm.mg/lifestyle/4028764/ [Lin, Y. (2021, Nov. 4). Big investors enter the market? SynCore Biotechnology's trial failures bitter swallowed 10 consecutive stops, intraday burst volume attempt to attack today. Storm Media Group. In: https://www.storm.mg/lifestyle/4028764/] 財訊雙週刊 (2025, May 18) ，〈浩鼎啟示錄》新藥是高風險賽局 OBI-822黯然退場 15年生技夢醒〉，《工商時報》，載於: https://www.ctee.com.tw/news/20250518700011-430504 [Wealth Magazine. (2025, May 18). The OBI Pharma Revelation: New Drug Development as a High-Risk Game — OBI-822 Exits Quietly, Ending a 15-Year Biotech Dream. Commercial Times. In: https://www.ctee.com.tw/news/20250518700011-430504] 夏彌新 (2021, Oct. 30)，〈【專家採訪筆記】60億元研發的反省! 杏國治療胰臟 癌新藥SB05PC 二期「大成功」， 三期卻失敗? (珍藏閱讀)〉，《Genet 觀點》，載於: https://www.genetinfo.com/investment/featured/item/53496.html?start=3 [Xia, M. (2021, Oct. 30). [Expert Interview Notes] A NT$6 Billion R&D Wake-Up Call! SynCore’s Pancreatic Cancer Drug SB05PC Saw 'Great Success' in Phase II but Failed in Phase III? (Featured Reading). Genet Info. In: https://www.genetinfo.com/investment/featured/item/53496.html?start=3] 劉玟妤 (2025, Apr. 24)，〈〈焦點股〉浩鼎乳癌藥OBI-822臨床試驗喊卡 跳空跌停股價創新低〉，《鉅亨網》，載於: https://news.cnyes.com/news/id/5949112 [Liu, W. (2025, Apr. 24).〈Focus Stock〉OBI Pharma Halts Breast Cancer Drug OBI-822 Trial; Stock Plunges to Limit Down and Hits Record Low. anue. In: https://news.cnyes.com/news/id/5949112] 鄭永銘 (2016, Feb. 23) ，〈名家觀點－浩鼎新藥為何失敗〉，《台灣e新聞》，載於: https://www.taiwanenews.com/doc/20160223101.php [Jeng, Y. (2016, Feb. 23). Expert Opinion — Why Did OBI Pharma’s New Drug Fail. Taiwan eNews. In: https://www.taiwanenews.com/doc/20160223101.php] 鄭郁平 (2016, Feb. 23) ，〈台睿敗血症新藥三期解盲未達標 股價重挫「跌到熔斷」〉，《中時新聞網》，載於: https://www.chinatimes.com/realtimenews/20220210001723-260410?chdtv [Zheng, Y. (2022, Feb. 10). TaiRx’s sepsis drug Phase III trial failures; stock plunges to circuit breaker limit. China Times. In: https://www.chinatimes.com/realtimenews/20220210001723-260410?chdtv] 謝金河 (2025, Apr. 30)，〈浩鼎再度解盲失敗！股價「755跌到剩35」…謝金河盤點「股價慘崩」生技公司，嘆：10年一覺生技夢〉，《今周刊》，載於: https://www.businesstoday.com.tw/article/category/183008/post/202504300012/ [Hsieh, C. (2025, Apr. 30). OBI Pharma another trial failures! stock plunges from 755 to just 35 — Hsieh Chin-ho reviews biotech stock collapses, laments a 'Decade-Long Biotech Dream'. Business Today. In: https://www.businesstoday.com.tw/article/category/183008/post/202504300012/] 譚偉晟、段詩潔 (2023, Dec. 27)，〈乾眼症新藥試驗未過關 將重啟三期？ 股價腰斬 拆解全福生技解盲失利下一步〉，《今周刊》，載於: https://www.businesstoday.com.tw/article/category/183015/post/202312270031/ [Tan, W., & Duan, S. (2023, Dec. 27). New dry eye drug trial failures, will restart Phase III? Stock price slashed, dismantling BRIM Biotechnology's next step after trial failures. Business Today. In: https://www.businesstoday.com.tw/article/category/183015/post/202312270031/] Genet 觀點 (2023, Dec. 21) ，〈全福生技 (6885) 公告乾眼症新藥BRM421第一次三期臨床試驗數據解盲之分析結果(12/20日股價73.8元)〉，載於: https://www.genetinfo.com/investment/company-news/item/76141.html [Genet Info. (2023, Dec. 21). BRIM Biotechnology (6885) Announces Analysis Results of First Phase III Trial Unblinding for Dry Eye Drug BRM421 (Stock Price NT$73.8 on Dec. 20). In: https://www.genetinfo.com/investment/company-news/item/76141.html] Appinio. (2023, Oct. 30). What is Comparative Analysis and How to Conduct It? (+ Examples). In: https://www.appinio.com/en/blog/market-research/comparative-analysis Biopharma PEG. (2021, Nov. 18). FDA Approves Besremi (ropeginterferon alfa-2b-njft) for Treating Polycythemia Vera. In: https://www.biochempeg.com/article/228.html CenterWatch. (2024, Jul. 09). Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects. In: https://www.centerwatch.com/clinical-trials/listings/NCT05695781/assessment-of-the-safety-and-efficacy-of-brm421-ophthalmic-solutions-in-dry-eye-subjects?mp=amf&phase=5&state=RI&city=Warwick Chen, T. (2017, Mar. 3). Medigen seeking partners after disappointing trial. Taipei Times. In: https://www.taipeitimes.com/News/biz/archives/2017/03/03/2003666010#:~:text=Fri%2C%20Mar%2003%2C%202017%20page12,and%20toxicity%2C%20the%20company%20said. ClinicalTrials.gov. About ClinicalTrials.gov. In: https://clinicaltrials.gov/about-site/about-ctg (Accessed on Jul. 16, 2025) ClinicalTrials.gov. Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects. In: https://clinicaltrials.gov/study/NCT05695781?term=NCT05695781&rank=1&tab=table (Accessed on Jul. 16, 2025) ClinicalTrials.gov. EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX. In: https://clinicaltrials.gov/study/NCT03126435?term=NCT03126435&rank=1&tab=results (Accessed on Jul. 26, 2025) ClinicalTrials.gov. Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC. In: https://clinicaltrials.gov/study/NCT03562637?term=NCT03562637&rank=1 (Accessed on Jul. 26, 2025) ClinicalTrials.gov. Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects. In: https://clinicaltrials.gov/study/NCT01516307?term=NCT01516307&rank=1 (Accessed on Jul. 26, 2025) Medigen Biotechnology Corp. PI-88 (MUPARFOSTAT). In: https://www.medigen.com.tw/en/clinical-trials/muparfostat-pi-88/ (Accessed on Jun. 26, 2025) OBI Pharma. Globo H. In: https://www.obipharma.com/what-we-do/globo-h/ (Accessed on Jun. 26, 2025) SynCore Bio. EndoTAG®-1. In: https://www.syncorebio.com/en/focus-area/sb05-endotag-1/ (Accessed on Jun. 26, 2025) SynCore Bio. (2020, Aug. 11). SynCore Biotechnology Announces Interim Analysis Results for Novel Pancreatic Cancer Asset, SB05PC (EndoTAG®-1). In: https://www.syncorebio.com/en/syncore-biotechnology-announces-interim-analysis-results-for-novel-pancreatic-cancer-asset-sb05pc-endotag-1/ Taipei Exchange. Introduction of Over-the-Counter Derivatives. In: https://www.tpex.org.tw/en-us/derivative/tpex-derivative/product/otc-derivatives.html (Accessed on Jun. 14, 2025) TaiRx, Inc. Meet TaiRx. In: https://www.trx.com.tw/en/about/ (Accessed on Jun. 26, 2025) Taiwan Clinical Trials. Taiwan Clinical Trials ─ Origin. In: https://www.taiwanclinicaltrials.tw/en/introduction/about (Accessed on Jul. 16, 2025) TaiRx, Inc. Zelnite®. In: https://www.trx.com.tw/portfolio-items/zelnite/ (Accessed on July. 26, 2025) U. S. Food & Drug Administration. (2023, Jun.). E6(R3) GOOD CLINICAL PRACTICE (GCP). In: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp | - |
| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/98713 | - |
| dc.description.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。 | zh_TW |
| dc.description.abstract | 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. | en |
| dc.description.provenance | Submitted by admin ntu (admin@lib.ntu.edu.tw) on 2025-08-18T16:12:10Z No. of bitstreams: 0 | en |
| dc.description.provenance | Made available in DSpace on 2025-08-18T16:12:10Z (GMT). No. of bitstreams: 0 | en |
| dc.description.tableofcontents | 摘要 i
Abstract iii Contents v List of Figures and Tables viii List of Abbreviations ix 1. Introduction 1 1.1 Background and Motivation 1 1.1.1 The Ascendancy of Taiwanese Biopharma Industry (2009–2023) 1 1.1.2 Emergent Challenges and the Specter of Clinical Failure 3 1.2 Significance of the Study 5 1.3 Study Objectives 6 1.4 Scope and Limitations on the Thesis 8 1.5 Thesis Structure 9 2. Literature Review 14 2.1 Global Trends in Trial Success Rates and Determinants of Failure 14 2.2 Qualitative Exploration of Factors Leading to Clinical Trial Failures 16 2.3 The Impact of Clinical Trial Failures on Corporate Valuation 21 2.4 Qualitative Observations of Taiwanese Biopharma Industry Ecosystem and Regulatory Environment 22 2.5 Qualitative Exploration of Clinical Trial Issue Typologies and Early Problem Detection via Public Data Sources 25 2.6 Qualitative Considerations for Inter-Company Comparative Analysis 27 3. Research Methodology 29 3.1 Research Approach and Design 29 3.2 Case Selection Criteria and Sampling Strategy 30 3.3 Data Collection Methods 31 3.4 Data Analysis Strategy 32 3.5 Ethical Considerations 34 4. Case Analyses 36 4.1 OBI Pharma: The Protracted and Convoluted Trajectory of OBI-822 Breast Cancer Vaccine Development and its Subsequent Setbacks 36 4.1.1 Development Context 36 4.1.2 Critical Missteps and Underlying Factors Leading to Trial Failure 40 4.2 Medigen Biotechnology Corp.: Challenges in PI-88 Adjuvant Therapy for Hepatocellular Carcinoma 56 4.2.1 Development Context 56 4.2.2 Critical Missteps and Underlying Factors Leading to Trial Failure 59 4.3 BRIM Biotechnology: The Unfulfilled Promise of BRM421 in Dry Eye Disease Therapy 68 4.3.1 Development Context 68 4.3.2 Critical Missteps and Underlying Factors Leading to Trial Failure 70 4.4 SynCore Biotechnology: Aspirations and Disappointments in SB05 Pancreatic Cancer Therapy 72 4.4.1 Development Context 72 4.4.2 Critical Missteps and Underlying Factors Leading to Trial Failure 74 4.5 TaiRx, Inc.: Setbacks and Reflections on Rexis Sepsis Treatment 82 4.5.1 Development Context 82 4.5.2 Critical Missteps and Underlying Factors Leading to Trial Failure 83 5. Analysis of Predictive Factors: Identifying Qualitative Warning Indicators of Clinical Trial Failures from Public Data Sources 88 5.1 Qualitative Implications of Key Predictive Factors in Publicly Available Data 88 5.1.1 Transparency and Scientific Rigor in Trial Design 88 5.1.2 Execution-Phase Dynamics and Operational Disruptions 90 5.1.3 Sponsor Experience, Financial Resilience, and Communication Ethics 91 5.1.4 Regulatory Interaction and Global Deployment Strategy 92 5.2 The Dynamic Nature of Warning Indicators and Challenges in Interpretation 93 6. Discussion 96 6.1 Interpretation of Findings and Theoretical Reflections 96 6.2 Strategic Implications and Pre-Recommendation Reflections 97 7. Conclusion and Recommendations 99 7.1 Summary of Major Research Findings 99 7.2 Research Recommendations 101 7.2.1 Recommendations for Taiwanese Biopharma Compaines 102 7.2.2 Recommendations for Investors 103 7.2.3 Recommendations for Policymakers 104 7.3 Study Limitations and Future Outlook 105 Bibliography 108 | - |
| dc.language.iso | en | - |
| dc.subject | 生技製藥 | zh_TW |
| dc.subject | 臨床試驗失敗 | zh_TW |
| dc.subject | 公司估值 | zh_TW |
| dc.subject | 公司治理 | zh_TW |
| dc.subject | 新藥開發 | zh_TW |
| dc.subject | 投資人信心 | zh_TW |
| dc.subject | 公開資料 | zh_TW |
| dc.subject | 臺灣 | zh_TW |
| dc.subject | 質化分析 | zh_TW |
| dc.subject | 風險評估 | zh_TW |
| dc.subject | Company Valuation | en |
| dc.subject | Public Data | en |
| dc.subject | Investor Confidence | en |
| dc.subject | Drug Development | en |
| dc.subject | Corporate Governance | en |
| dc.subject | Clinical Trial Failure | en |
| dc.subject | Risk Assessment | en |
| dc.subject | Qualitative Analysis | en |
| dc.subject | Taiwan | en |
| dc.subject | Biopharma | en |
| dc.title | 臨床試驗失誤如何讓臺灣新創療法公司估值陷入低谷 | zh_TW |
| dc.title | Valuation on the Line: How Clinical Missteps Derail Taiwan's Emerging Therapeutic Companies | en |
| dc.type | Thesis | - |
| dc.date.schoolyear | 113-2 | - |
| dc.description.degree | 碩士 | - |
| dc.contributor.oralexamcommittee | 吳全峰;張濱璿 | zh_TW |
| dc.contributor.oralexamcommittee | Chuan-Feng Wu;Pin-Hsuan Chang | en |
| dc.subject.keyword | 生技製藥,臨床試驗失敗,公司估值,公司治理,新藥開發,投資人信心,公開資料,臺灣,質化分析,風險評估, | zh_TW |
| dc.subject.keyword | Biopharma,Clinical Trial Failure,Company Valuation,Corporate Governance,Drug Development,Investor Confidence,Public Data,Taiwan,Qualitative Analysis,Risk Assessment, | en |
| dc.relation.page | 118 | - |
| dc.identifier.doi | 10.6342/NTU202503951 | - |
| dc.rights.note | 未授權 | - |
| dc.date.accepted | 2025-08-13 | - |
| dc.contributor.author-college | 進修推廣學院 | - |
| dc.contributor.author-dept | 事業經營法務碩士在職學位學程 | - |
| dc.date.embargo-lift | N/A | - |
| 顯示於系所單位： | 事業經營法務碩士在職學位學程 | |
文件中的檔案：
| 檔案 | 大小 | 格式 | |
|---|---|---|---|
| ntu-113-2.pdf 未授權公開取用 | 1.76 MB | Adobe PDF |
系統中的文件，除了特別指名其著作權條款之外，均受到著作權保護，並且保留所有的權利。