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| Title: | 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 |
| Authors: | 林麗娟
LIN, LI-CHUAN |
| Contributors: | 宋 皇 志
林麗娟
LIN, LI-CHUAN |
| Keywords: | 新藥授權
SWOT
五力分析
Ansoff 矩陣 |
| Date: | 2023 |
| Issue Date: | 2023-08-02 13:19:12 (UTC+8) |
| Abstract: | 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. |
| Reference: | 中文部份
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英文部份
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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
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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.
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| Description: | 碩士
國立政治大學
經營管理碩士學程(EMBA)
109932181 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0109932181 |
| Data Type: | thesis |
| Appears in Collections: | [經營管理碩士學程EMBA] 學位論文
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