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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 2-Aug-2023 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).
2. 藥品突破性治療認定要點, (2019).
3. 新藥查驗登記加速核准機制, (2019).
4. 新藥查驗登記精簡審查機制, (2019).
5. 新藥查驗登記審查流程及時間點管控(110年10月). (2021).
6. 新藥查驗登記優先審查機制, (2019).
7. 小兒或少數嚴重疾病藥品審查認定要點, (2019).
8. 經濟部工業局. (2015). 2015生技產業白皮書.
9. 經濟部工業局. (2021). 生技醫藥產業發展條例. Retrieved from https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=J0040046
10. 經濟部工業局. (2022). 2022生技產業白皮書.
11. Porter, M. E. (2019). 競爭策略：產業環境及競爭者分析.
12. 2015智擎公司年報. (2015).
13. 2022智擎公司年報. (2022).


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].
2. 范麗娟. (1994). 深度訪談簡介. 戶外遊憩研究, 7(2), 025-035. https://doi.org/10.6130/JORS.1994.7(2)3
3. 單鴻斌. (2015). 生技產業新藥廠商獲利模式之探討-以某生技公司為例 國立政治大學].
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).
2. (BIO), B. I. O. (2021). Clinical Development Success Rates and Contributing Factors 2011–2020.
3. Ailton Conde, J., Patricia Viveiros de Castro, K., & Edison Fernandes, P. (2010). REFLECTIONS ON BLUE OCEAN STRATEGY: A COMPARISON WITH ANSOFF’S, PORTER’S, AND HAX AND WILDE’S STRATEGIES. Future studies research journal, 2(2), 17-37. https://doi.org/10.7444/future.v2i2.51
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.
6. Biotech’s post-IPO boom: rebounding from a 2022 Low? (2023). https://www.pharmaceutical-technology.com/comment/biotech-post-ipo-boom/
7. Buntz, B. (2022). The top 10 pharma M&A deals of 2022. https://www.drugdiscoverytrends.com/the-top-10-pharma-ma-deals-of-2022/
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
10. http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=
11. https://nccu.primo.exlibrisgroup.com/openurl/886NCCU_INST/886NCCU_INST:886NCCU_INST?url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&genre=article&sid=ProQ:ProQ%3Aabidateline&atitle=Does+drug+licensing+hurt+smaller+firms%3F&title=McClatchy+-+Tribune+Business+News&issn=&date=2007-05-16&volume=&issue=&spage=1&au=By+Sabine+Vollmer&isbn=&jtitle=McClatchy+-+Tribune+Business+News&btitle=&rft_id=info:eric/&rft_id=info:doi/
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
24. http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=
25. https://nccu.primo.exlibrisgroup.com/openurl/886NCCU_INST/886NCCU_INST:886NCCU_INST?url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:book&genre=report&sid=ProQ:ProQ%3Aabiglobal&atitle=&title=Streamlined+Development+Process+for+Certain+New+Drug+Applications+Is+Not+Facilitating+Shorter+Approval+Times%2C+According+to+the+Tufts+Center+for+the+Study+of+Drug+Development&issn=&date=2017-03-01&volume=&issue=&spage=&au=&isbn=&jtitle=&btitle=Streamlined+Development+Process+for+Certain+New+Drug+Applications+Is+Not+Facilitating+Shorter+Approval+Times%2C+According+to+the+Tufts+Center+for+the+Study+of+Drug+Development&rft_id=info:eric/&rft_id=info:doi/
26. Terblanche, N. S. (2008). New pharmaceutical product development: Barriers to overcome and opportunities to exploit. Journal of commercial biotechnology, 14(3), 201-212. https://doi.org/10.1057/jcb.2008.11
27. Weiwei, L. (2021). Analysis of Ansoff Growth Strategy: a Case of Chinese Yunnan Baiyao Company. Industrial Engineering and Innovation Management, 4(2), 1-6.
28. Porter, M. E. (1998). Competitive Strategy: Techniques for Analyzing Industries and Competitors.


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
dc.contributor.advisor 宋 皇 志zh_TW
dc.contributor.author (Authors) 林麗娟zh_TW
dc.contributor.author (Authors) LIN, LI-CHUANen_US
dc.creator (作者) 林麗娟zh_TW
dc.creator (作者) LIN, LI-CHUANen_US
dc.date (日期) 2023en_US
dc.date.accessioned 2-Aug-2023 13:19:12 (UTC+8)-
dc.date.available 2-Aug-2023 13:19:12 (UTC+8)-
dc.date.issued (上傳時間) 2-Aug-2023 13:19:12 (UTC+8)-
dc.identifier (Other Identifiers) G0109932181en_US
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/146370-
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) 109932181zh_TW
dc.description.abstract (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。		zh_TW
dc.description.abstract (摘要) 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.		en_US
dc.description.tableofcontents 封面頁 i
謝辭 ii
中文摘要 iii
英文摘要 iv
目錄 v
表目錄 vi
圖目錄 vii
第一章 緒論 8
第一節 研究背景 8
1.1.1 全球生技產業概況 8
1.1.2 台灣生技產業市場發展概況 10
1.1.3 製藥產業鏈簡介 12
1.1.4 新藥研發上市流程 13
第二節 研究動機 17
1.2.1 台灣新藥研究概況 17
第二章 文獻探討 19
第一節 新藥上市規範 19
第二節 策略分析工具 23
第三章 研究方法 29
第一節 研究架構 29
第二節 研究方法與流程 30
第三節 研究對象 33
3.3.1 智擎生技製藥股份有限公司 33
3.3.2 安基生技新藥股份有限公司 35
第四章 結果 38
第一節 個案分析 38
4.1.1 智擎生技製藥股份有限公司 38
4.1.2 安基生技新藥股份有限公司， 43
第二節 個案比較 47
第五章 結論 52
第一節 研究結論 52
第二節 未來新藥授權及營運策略建議 54
參考文獻 56		zh_TW
dc.format.extent 2702358 bytes-
dc.format.mimetype application/pdf-
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0109932181en_US
dc.subject (關鍵詞) 新藥授權zh_TW
dc.subject (關鍵詞) SWOTzh_TW
dc.subject (關鍵詞) 五力分析zh_TW
dc.subject (關鍵詞) Ansoff 矩陣zh_TW
dc.title (題名) 我國生技新藥研發公司-授權策略分析研究zh_TW
dc.title (題名) Out-licensing Strategic Analysis for Taiwanese Pharmaceutical Companies focusing on development of new drugsen_US
dc.type (資料類型) thesisen_US
dc.relation.reference (參考文獻) 中文部份

1. 藥事法, (2018).
2. 藥品突破性治療認定要點, (2019).
3. 新藥查驗登記加速核准機制, (2019).
4. 新藥查驗登記精簡審查機制, (2019).
5. 新藥查驗登記審查流程及時間點管控(110年10月). (2021).
6. 新藥查驗登記優先審查機制, (2019).
7. 小兒或少數嚴重疾病藥品審查認定要點, (2019).
8. 經濟部工業局. (2015). 2015生技產業白皮書.
9. 經濟部工業局. (2021). 生技醫藥產業發展條例. Retrieved from https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=J0040046
10. 經濟部工業局. (2022). 2022生技產業白皮書.
11. Porter, M. E. (2019). 競爭策略：產業環境及競爭者分析.
12. 2015智擎公司年報. (2015).
13. 2022智擎公司年報. (2022).


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].
2. 范麗娟. (1994). 深度訪談簡介. 戶外遊憩研究, 7(2), 025-035. https://doi.org/10.6130/JORS.1994.7(2)3
3. 單鴻斌. (2015). 生技產業新藥廠商獲利模式之探討-以某生技公司為例 國立政治大學].
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).
2. (BIO), B. I. O. (2021). Clinical Development Success Rates and Contributing Factors 2011–2020.
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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)
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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
24. http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=
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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.		zh_TW