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    Title: 運用資產鑑價模型取得新藥開發授權之研究 -以首智生醫科技公司投資案為例
    Research on Obtaining New Drug Development License by Adopting Asset Valuation Model – A Case Study of Preferred Smart Biomedical Technology Co., Ltd
    Authors: 謝東瑾
    Hsieh, Tung-Chin
    Contributors: 巫立宇
    馮震宇

    Wu, Lei-Yu
    Fong, Jerry G.

    謝東瑾
    Hsieh, Tung-Chin
    Keywords: 外部創新成長策略
    授權商業策略
    資產鑑價模型
    External growth strategy
    Licensing Business Strategy
    Asset Valuation Model
    Date: 2024
    Issue Date: 2024-05-02 10:30:03 (UTC+8)
    Abstract: 生技醫藥產業是一個智慧專利技術與資金需求龐大的高壁壘障礙性產業,因與人類的生命健康息息相關,需要於高度品質監控系統下通過各國主管機關審查通過後才可上市,所以生技製藥業一直是全球化產業結構供應鏈的典範。
    新藥研發在全球化及嚴格法規制定規則,符合政府機構對高度品質監管下,其投入成本逐年攀升,為能讓該產業能順利運營,多元化商業策略如購併與併購、資產授權或合資研發、聯盟合作等等外部創新模型已成為新藥研發公司創造產品價值的關鍵要素。本論文依據所研究分析論點,希望能提供一些有效資訊讓相關台灣新藥公司可以參考之,並一起鼓勵台灣相關新藥研發廠商能善加利用外部創新的商業模式,來提高藥物開發技術層次及新藥研發能力,進而設立高障礙藥物供應鏈系統的產業定位競爭優勢。
    有鑑於此,本論文認為台灣生技產業若能透過新商業模式趨勢如採用授權商業策略將上下游資源整合並作最佳化利用,將可開啟創新企業的成長空間。故本論文以實際發生的個案探討為主,採用個案的經驗分析,將筆者實際參與商業授權策略的成果,藉由公開揭露的商業資源與交易資訊所提供可量化的數據之分析,探討是如何獲得技術與商業知識而達到企業成長力;其次,討論個案商業策略(如授權商業合約)對企業營運機制若產生正面影響,將可做為多數為中小企業、且為資本額較小的台灣製藥業參酌,進而可供台灣生醫企業在企業成長的每個階段,欲達成資源投入極大化及發揮有效作為之策略目標時,作為各生醫企業擬定營運成長策略目標資源整合之參考。
    The Industry characteristics of biotech pharmaceuticals are highly technology within barriers to entry and capital-intensive needs. Because of closely related to human healthcare, it required a higher-level quality control system to be approved into the market. Therefore, the biotech pharmaceutical industry has always played a globalization supplier system.
    Higher development costs for new drugs at recent era, external innovation business strategies such as mergers and acquisitions, collaborative R&D, and licensing have become the key for those start-up drug development companies to create smart and differential valuation. Based on the findings from our paper, we could provide some better points to which now suffered by new drug development or trapped in the milestone of operation. Also, within sharing our experience to encourage the developers of Taiwan’s new drug built the right business models using utilize external innovation tool to improve development technology and capabilities, and establish a high-barrier value chain to position your competitive advantage.
    Therefore, this study mainly focuses on the real case study, the results which actually participated in the commercial licensing strategy to discuss how to obtain through what you should have and really prepared well. Learn to maximize and effectively allocate your resources at every stage when the growth strategy of Corporation met and done.
    Reference: 一、中文文獻
    1. 汪嘉林 (2011)。我國生技製藥產業創新演化的回顧與前瞻。科學發展,457,146-150。
    2. 張珮娟(2010),智慧資本與企業績效之關聯性研究-以台灣生技產業為例,國立中正大學會計與資訊科技研究所碩士論文。
    3. 李元志等(2009),製藥公司智慧資本管理研究,經濟部,跨領域研發成果產業化國際高階人才培訓計畫。
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    6. 楊延超著,知識產權資本化,法律出版社,2008年8月,頁269-275。
    7. 劉正斌(2015)。國內藥廠面對不同法規市場邁向國際化之探討。東海大學企業管理學系高階企業經營碩士在職專班碩士論文,台中市。
    8. 歐進士, 李翠琴, 卓佳慶, & 林惠美. (2016). 製藥廠顧客利潤之決定因素: 個案分析. 臺大管理論叢, 26(3), 93-117.
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    12. 蕭佩珍. (2020). [2020 年全球生技製藥產業趨勢與展望]-工研院專題演講活動報導. 證券服務, (678), 92-94.
    13. 經濟部2023 生技產業白皮書 (2023 年版)。中華民國: 經濟部工業局。
    14. 2023 生物技術與醫藥產業簡介 (2023 年版)。中華民國: 經濟部生技醫藥產業發展推動小組。
    15. 伍忠賢著,公司鑑價,三民書局,民國91年8月版。
    16. 林佩璇(2000)。個案研究及其在教育研究上的應用。載於中正大學主編,質的教育研究方法,頁 239-262。

    二、英文文獻
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    2. Almeida, P., Song, J., & Grant, R. M. (2002). Are firms superior to alliances and markets? An empirical test of cross-border knowledge building. Organization science, 13(2), 147-161.
    3. Booz, & Allen & Hamilton. (1982). New products management for the 1980s. Booz, Allen & Hamilton.
    4. Damodaran, A. (2001). The dark side of valuation: valuing old tech, new tech, and new economy companies. FT Press.
    5. D'aveni, R. A., & Gunther, R. E. (1994). Hypercompetitive rivalries. Free Press.
    6. Dierks, R. M. L., Bruyère, O., & Reginster, J. Y. (2018). Critical analysis of valuation and strategical orientation of merger and acquisition deals in the pharmaceutical industry. Expert review of pharmacoeconomics & outcomes research, 18(2), 147-160.
    7. Grant, R. M. (2002). Contemporary Strategy Analysis: Concept, Techniques, Aplicattions. Mssachusetts: Blackwell.
    8. National Institute for Health and Care Excellence (NICE), PMG6: The guidelines manual. RegMed 2019 Vol. 105 10
    9. Wang, L., Plump, A., & Ringel, M. (2015). Racing to define pharmaceutical R&D external innovation models. Drug discovery today, 20(3), 361-370.
    10. Baruch Lev, B.(2001), Intangibles: management, measurement, and reporting, Washington DC, Brookings Institution Press.
    11. Michael J. Mard, James R. Hitchner, Steven D. Hyden.(2007), Valuation for Financial Reporting: Fair Value Measurements and Reporting, Intangible Assets, Goodwill and Impairment (2ed)。
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    15. David Connell(2005), “Secrets” of the world’s largest seed capital fund: How the United States Government uses its small business innovation research (SBIR) programme and procurement budgets to support small technology firms.
    16. Lash, A.(2010), In the Midst of a Shakeout, Biotech VCs Must Embrace New Partners, New Math, Start-Up, Sept 2010.
    17. Petersson, S., Mårdström, V., Fornell, A., Westergård, V., Larsson, G., and Barrehag, L. (2012), Accelerating success: a study of seed accelerators and their defining characteristics.
    18. Ansoff, H. I. (1957). Strategies for diversification. Harvard business review, 35(5), 113-124.
    19. Rautiainen, T (2001) Critical Success Factors in Biopharmaceutical Business – A Comparison Between Finnish and Californian Businesses. Technology Review 113:1-21.
    20. Cooper, R. G., Kleinschmidt, E.J. (2007) Winning Businesses in Product Development: The Critical Success Factors. Research Technology Management 50 (3): 52-66.
    三、相關網站
    1. 新藥研發模式白皮2016 https://www2.deloitte.com/content/dam/Deloitte/tw/Documents/life-sciences-health-care/tw-2016drug-development-rd.pdf (檢索時間2023.10)
    2. 全球生技製藥趨勢: 新藥授權價值提升 https://www.pwc.tw/zh/publications/bio-insights/pdf/bio-insights-2206.pdf (檢索時間2023.10)
    3. 產業價值鏈資訊平台https://ic.tpex.org.tw/introduce.php?ic=C100&stk_code=(檢索時間2022.11)
    4. 經理人 https://www.managertoday.com.tw/articles/view/65047?utm_source=copyshare (檢索時間2023.10)
    5. 財團法人台灣經濟科技發展研究院https://www.tedr.org.tw/page/about/index.aspx?kind=48&gad_source=1&gclid=CjwKCAjw17qvBhBrEiwA1rU9w_tZuiX-8IrxptV4OMplePo9PXCIZ0hrgrgsCJsQq237uvONlTajsBoCCoQQAvD_BwE (檢索時間2023.10)
    6. 聖島國際專利商標聯合事務所
    https://www.saint-island.com.tw/report/data/IPR_201008.htm (檢索時間2023.10)
    7. 中華管理評論國際學報http://cmr.ba.ouhk.edu.hk/cmr/webjournal/v11n2/CMR149C06.pdf (檢索時間2022.09)
    8. 亞律國際專利商標聯合事務所 (亞律智權雙月刊) https://www.alipo.com.tw/zh-tw/news.php?act=list&cid=5 (檢索時間2023.10)
    9. 財團法人國家實驗研究院科技政策研究與資訊中心https://www.narlabs.org.tw/tw/xmdoc/cont?XsmSId=0I148615590003759624 (檢索時間2023.11)
    10. Visual Capitalist (檢索時間2023.11)
    11. PharmExec.com https://www.pharmexec.com/view/2023-pharm-exec-top-50-companies (檢索時間2023.11)
    12. Evaluate.com https://www.evaluate.com/(檢索時間2023.11)
    13. 哈佛商業評論全球繁體中文版https://www.hbrtaiwan.com/article/19853/when-licensing-new-tech-is-better-than-building-it-in-house (檢索時間2023.11)
    14. 骨關節炎治療產業概述 https://www-mordorintelligence-com.translate.goog/zh-CN/industry-reports/osteoarthritis-treatment-market? (檢索時間2023.11)
    15. IQVIA官網 https://www.iqvia.com/ (檢索時間2023.10)
    16. 資誠會計師事務所官網https://www.pwc.tw/zh.html (檢索時間2023.11)
    17. Gogo partners夥伴行銷設計有限公司https://blog.gogopartners.com/%E4%BA%94%E5%8A%9B%E5%88%86%E6%9E%90
    (檢索時間2021.01)
    18. 衛生福利部官網 https://www.mohw.gov.tw/mp-1.html (檢索時間2023.11)
    19. 衛生福利部食品藥物管理署 https://www.mohw.gov.tw/mp-1.html (檢索時間2023.11)
    20. 社團法人國家生技醫療產業策進會https://ibmi.taiwan-healthcare.org/news_detail.php?REFDOCTYPID=&REFDOCID=0pkbl1kadiubpt9u (檢索時間2023.11)
    21. Kim, J.S. (2017, April 14). New drug to be found outside rather than in R&D center’NRDO Bio-venture to be emerged one after another. http://eng.dt.co.kr/contents.html?article_no=20170414104632000287
    (last visited: 2023/10/1)
    22. 台灣生技製藥產業與資本市場的實與虛。http://www.yucc.org.tw/news/domestic/20160224-1 (檢索時間2023.11)
    23. 新藥與疫苗研究開發上市流程
    file:///C:/Users/user/Downloads/1050407-%E8%A1%9B%E7%92%B0-%E6%96%B0%E8%97%A5%E8%88%87%E7%96%AB%E8%8B%97%E7%A0%94%E7%A9%B6(%E8%A1%9B%E7%A6%8F%E9%83%A8)_0054278001%20(2).pdf (檢索時間2023.12)
    Description: 碩士
    國立政治大學
    經營管理碩士學程(EMBA)
    107932183
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0107932183
    Data Type: thesis
    Appears in Collections:[經營管理碩士學程EMBA] 學位論文

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