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    题名: 新藥研發公司之商業模式與授權策略:以微脂體新藥研發為多重個案研究
    Business Models and Licensing Strategies of New Drug Development Companies: Multiple Case Studies of Liposomal Drug Development
    作者: 莊家銘
    贡献者: 鄭至甫
    莊家銘
    关键词: 微脂體
    新劑型新藥
    授權策略
    商業模式
    新藥研發
    Liposome
    New drug in new formulation
    Licensing strategy
    Business model
    New drug development
    日期: 2024
    上传时间: 2024-08-05 12:41:32 (UTC+8)
    摘要: 在現代生技藥物開發領域中,利用微脂體平臺作為藥物載體平台來提升藥物療效和安全性已成為一個重要的研發趨勢。本研究採多重個案研究法,針對三間專注於發展微脂體新藥的台灣生技公司的授權案例進行探討,目的在於分析此三個案公司在激烈競爭的生技市場中獲得成功的關鍵因素。
    三家公司在商業模式上均以新藥研發為核心,利用微脂體平臺開發新劑型新藥。然而,它們在所選擇的疾病治療領域、商業談判策略和臨床試驗結果卻存在顯著差異,進而導致各自的授權案例規模及對象差異。例如,公司A專攻癌症領域,憑藉其抗癌藥品在全球市場的成功上市和授權,獲得可觀的收益;公司B則主攻疼痛管理、眼疾和癌症等領域,其針對關節炎疼痛治療的新藥獲得美國藥廠高達6.7億美元的授權合約;公司C則專注於開發治療罕見疾病肺高壓新藥,與美國藥廠簽訂最高可達2.25億美元的授權協議。
    通過對這三家公司授權案例的比較分析,本研究提出了一些建議供台灣其他新藥公司參考,包括:1)可以專注於尋找特定治療領域的利基市場;2)適時與外部資源合作,以加速新藥的研發和上市;3)在商業談判中應考慮多方因素,如開發成本、市場潛力和競爭局勢等,以期達成更有利的授權條件。總的來說,本研究希望能為台灣生技製藥企業在新藥開發和授權策略方面提供有價值的啟示。
    In the modern biotechnology-based drug development field, the use of liposome platforms to enhance drug efficacy and safety has become an important research and development trend. This study conducts an in-depth investigation of three Taiwanese biotechnology companies that focus on developing liposome-based new drugs, with the aim of analyzing the key factors behind the success of three companies in the highly competitive biotech market.
    The three companies all have a business model centered on new drug development, utilizing the liposome platform to develop drugs in new formulations. However, they differ significantly in the targe therapeutic areas, commercialization strategies, and clinical trial results, which have influenced the effectiveness of their respective licensing outcomes. For example, Company A specializes in the cancer field and has successfully licensed and commercialized its drug globally, generating significant revenue; Company B focuses on pain management, ophthalmology, and oncology, and has secured a licensing contract worth up to $670 million with the US pharmaceutical company for its drug; Company C concentrates on developing a treatment for the rare disease pulmonary hypertension, and has signed a licensing agreement with the US company with a potential value of up to $225 million.
    Through comparative analysis of the licensing cases of these three companies, this study proposes several recommendations for other Taiwanese new drug companies to consider: 1) focus on finding niche markets in specific treatment areas; 2) collaborate with external resources in a timely manner to accelerate new drug development and commercialization; 3) consider multiple factors in business negotiations, such as development costs, market potential, and competitive landscape, to achieve more favorable licensing terms. Overall, this study aims to provide valuable insights for Taiwanese biotechnology and pharmaceutical enterprises in their new drug development and licensing strategies.
    參考文獻: Osterwalder, A., & Pigneur, Y. (2010). Business Model Generation. John Wiley & Sons Singapore Pte.
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    林金榮. (2022). 生醫產業授權大不同 - 新藥授權應注意事項. In: 資誠聯合會計師事務所.
    徐玉君. (2019). 新藥授權從單一到多途徑: 國際市場群雄環繞 如何殺出一條血路?. 先探投資周刊. http://weekly.invest.com.tw/001.asp?artNo=2029-12-01&OC=open
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    產業名錄:智擎生技製藥股份有限公司. 環球生技多媒體股份有限公司. https://news.gbimonthly.com/tw/invest/show2.php?num=86
    智擎生技製藥股份有限公司. MoneyDJ. https://www.moneydj.com/kmdj/wiki/wikiviewer.aspx?keyid=4d231153-6d7c-4edd-91e9-1dade2125729
    智擎生技製藥股份有限公司. (2022). 智擎生技製藥股份有限公司 111年度年報. 智擎生技製藥股份有限公司.
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    藥事法, (2018). https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0030001
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    謝柏宏. (2024). 智擎「安能得」獲歐盟藥品管理局 EMA 核准並在德國上市. 經濟日報. https://udn.com/news/story/7241/7961374
    描述: 碩士
    國立政治大學
    經營管理碩士學程(EMBA)
    111932163
    資料來源: http://thesis.lib.nccu.edu.tw/record/#G0111932163
    数据类型: thesis
    显示于类别:[經營管理碩士學程EMBA] 學位論文

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