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    題名: 我國生技新藥研發公司-授權策略分析研究
    Out-licensing Strategic Analysis for Taiwanese Pharmaceutical Companies focusing on development of new drugs
    作者: 林麗娟
    LIN, LI-CHUAN
    貢獻者: 宋 皇 志
    林麗娟
    LIN, LI-CHUAN
    關鍵詞: 新藥授權
    SWOT
    五力分析
    Ansoff 矩陣
    日期: 2023
    上傳時間: 2023-08-02 13:19:12 (UTC+8)
    摘要: 自COVID-19疫情蔓延以來，國內外對生技醫療之需求持續增加，台灣沉寂多年之生技醫療產業也迎來了一波投資榮景，加上近兩年來台灣新藥研發公司陸續傳出捷報，成功取得新藥國際授權且其授權金額屢創新高。針對台灣新藥研發公司，從成功取得授權之新藥公司中選取兩間公司作為研究對象，選擇分析之個案公司為智擎公司及安基公司。
    本研究藉由深度訪談，輔以SWOT、五力分析及Ansoff 矩陣等分析方法，從研發選題、專利佈局考量及授權決策，到國際臨床試驗與各國法規路徑及銷售規劃深入探討，分析其成功之關鍵因素，經由綜合分析後發現，兩家個案公司新藥授權成功之關鍵為: 選擇利基市場切入增加成功機率，擅用505(b2)新劑型新藥及孤兒藥法令之保障縮短藥品上市時間，長期合作關係緊密之供應商，選擇關鍵互助型之授權合作夥伴，掌握授權合約談判局勢，控制風險以維持自身優勢使授權利益最大化。
    根據綜合分析以上個案公司授權成功之關鍵因素及目前台灣生技產業現況，建議未來台灣新藥研發公司授權及營運策略: 1)擴展藥品使用族群 2)增加研發產品線 3)強化人才留任 4)加強外部網絡連結 5) 提升公司核心技術能力，擴大產品線使藥品授權佈局更完整，或採取策略聯盟共同開發模式，加速收益實現及強化獲利模式使公司能永續成長。
    The demand for biotechnology and medical industry continues to increase both domestically and internationally since COVID-19 pandemic. Taiwan`s biotechnology and medical industry, which has remained silent for many years, is now experiencing a wave of investment prosperity. In the past two years, Taiwanese pharmaceutical research companies have been continuously announcing good news, successfully obtaining international out-licensing for new drugs and achieving high record in upfront payment, milestone payment and royalty. Two of these successful pharmaceutical companies from Taiwan have been selected as research subjects.
    The analysis aims of this study is to explore the key success factors and, through comprehensive analysis, it has been found that the key factors for the successful licensing of new drugs by the two case companies are as follows:
     Choosing niche markets to increase the probability of success.
     Leveraging the protection provided by the 505(b)(2) regulatory pathway for new dosage forms and orphan drug act to expedite the time to market.
     Establishing long-term cooperative relationships with reliable suppliers.
     Selecting key collaborative licensing partners who can provide mutual assistance
     Mastering the negotiation dynamics of licensing agreements to control risks and maximize licensing benefits.
    By controlling these factors, the companies are able to maintain their competitive advantage and maximize the benefits from licensing.Based on the comprehensive analysis of the key success factors for out-licensing and the current situation of the biotechnology medical industry in Taiwan, the following recommendations are suggested for future out-licensing and operational strategies for Taiwanese pharmaceutical research companies:
    1. Expand the target patient population for drug utilization
    2. Increase the product pipeline
    3. Strengthen talent retention to retain skilled professionals
    4. Enhance external networking and collaborations
    5. Improve the company`s core technological capabilities
    Through expanding the product pipeline to achieve a more comprehensive drug out-licensing portfolio. Alternatively, consider adopting a strategic alliance or joint development model to accelerate revenue realization and strengthen the profitability model for sustainable growth.
    By implementing these recommendations, Taiwanese pharmaceutical research companies can enhance their competitiveness, broaden their market presence, and achieve sustainable growth in the industry.
    參考文獻: 中文部份

    1. 藥事法, (2018).
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    博碩士學位論文

    1. 洪錫娟. 台灣發展醫藥研發服務產業之探討--以臨床試驗部分為例 國立政治大學].
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    4. 蔡如茵. (2019). 台灣生技產業專利授權模式分析 國立政治大學].


    英文部份
    1. 21 CFR 314.50 (Content and format of an NDA).
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    4. Avenue Therapeutics Enters into a Transformational License Agreement with AnnJi Pharmaceutical to Develop and Commercialize AJ201, a. F.-i.-C. C. A. f. t. T. o. S. a. B. M. A. (2023). Avenue acquires rights to AJ201 for SBMA in certain countries https://ir.avenuetx.com/news-events/press-releases/detail/65/avenue-therapeutics-enters-into-a-transformational-license
    5. Benzaghta, M. A., Elwalda, A., Mousa, M. M., Erkan, I., & Rahman, M. (2021). SWOT analysis applications: An integrative literature review. In: Digital Commons @ University of South Florida.
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    8. By Sabine, V. (2007, 05/16/
    9. 2007 May 16). Does drug licensing hurt smaller firms? McClatchy - Tribune Business News, 1. https://proxyone.lib.nccu.edu.tw/login?url=https://www.proquest.com/wire-feeds/does-drug-licensing-hurt-smaller-firms/docview/462369910/se-2?accountid=10067
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    12. Gui, P., & Mei, Y. L. (2013). Study on Bio-Pharmaceutical Industry Development Route and Strategy. Applied Mechanics and Materials, 365-366, 1350-1354. https://doi.org/10.4028/www.scientific.net/AMM.365-366.1350
    13. Hernberg-Ståhl, E., & Reljanović, M. (2013). Orphan drugs : understanding the rare disease market and its dynamics / E. Hernberg-Ståhl and M. Reljanović. Woodhead Pub.
    14. Kim, H. R. (2012). Openness and strategic aggressiveness as R&D management capabilities in the context of bio-pharmaceutical industry. Alliant International University.
    15. Lolic, M. (2017). FDA NDA Review Timeline. In. FDA.
    16. Meekings, K. N., Williams, C. S. M., & Arrowsmith, J. E. (2012). Orphan drug development: an economically viable strategy for biopharma R&D. Drug discovery today, 17(13-14), 660-664. https://doi.org/10.1016/j.drudis.2012.02.005
    17. Merrill, J. (2022). The Next Big Patent Cliff Is Coming, And Time Is Running Out To Pad The Fall. https://scrip.pharmaintelligence.informa.com/SC146175/The-Next-Big-Patent-Cliff-Is-Coming-And-Time-Is-Running-Out-To-Pad-The-Fall
    18. Molloy, P. L., & Johnson, L. W. (2016). Biotechnology, a strategic planning orphan: Towards an effective strategy framework for biotechnology firms. Journal of commercial biotechnology, 22(3), 118-125. https://doi.org/10.5912/jcb748
    19. Ormanidhi, O., & Stringa, O. (2008). Porter`s Model of Generic Competitive Strategies. Business economics (Cleveland, Ohio), 43(3), 55-64. https://doi.org/10.2145/nabe20080305 (Business Economics)
    20. Pharma, E. (2022). World Preview 2022 Report https://www.evaluate.com/thought-leadership/pharma/world-preview-2022-report
    21. Salminen, W. F., Wiles, M. E., & Stevens, R. E. (2019). Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway. Drug discovery today, 24(1), 46-56. https://doi.org/10.1016/j.drudis.2018.07.005
    22. Sean. (2023). The Process and Costs of Drug Development. https://ftloscience.com/process-costs-drug-development/
    23. Streamlined Development Process for Certain New Drug Applications Is Not Facilitating Shorter Approval Times, According to the Tufts Center for the Study of Drug Development. (2017). https://proxyone.lib.nccu.edu.tw/login?url=https://www.proquest.com/reports/streamlined-development-process-certain-new-drug/docview/1875352230/se-2?accountid=10067
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    網際網路

    1. 智擎生技製藥股份有限公司網站. http://www.pharmaengine.com/tw/index
    2. 安索夫矩陣(Ansoff Matrix). (2015). https://wiki.mbalib.com/zh-tw/%E5%AE%89%E7%B4%A2%E5%A4%AB%E7%9F%A9%E9%98%B5
    3. 安基生技新藥股份有限公司網站. https://www.ajpharm.com/zh/product-pipeline-%e7%94%a2%e5%93%81%e9%80%b2%e7%a8%8b/
    4. 吳培安. (2022). 智擎一線胰腺癌組合療法OS勝出標準組合療法將送美國sNDA申請. 環球生技.
    5. 李林璦. (2023). 黃文英領軍安基罕病First-in-Class新藥2.5億美元授權國際藥廠Avenue. 環球生技.
    6. 產業價值鏈資訊平台. https://ic-test.tpex.org.tw/introduce.php?ic=C100
    7. 郭文生. (2022). 轉型成功，安基靠皮膚與罕病新藥異軍突起. 理財周刊.
    描述: 碩士
    國立政治大學
    經營管理碩士學程(EMBA)
    109932181
    資料來源: http://thesis.lib.nccu.edu.tw/record/#G0109932181
    資料類型: thesis
    顯示於類別:[經營管理碩士學程EMBA] 學位論文

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