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    Title: 韓國KOTEC評估方法探討 - 以台灣新藥研發公司為例
    A Study on South Korea's KOTEC Evaluation Method - Taiwan New Drug Development Companies as Examples
    Authors: 吳書帆
    Contributors: 陳桂恒
    吳書帆
    Keywords: 新藥研發公司
    融資順位理論
    台灣中小企業信用保證基金
    藥物重新定位
    韓國技術信用保證基金
    new drug development company
    pecking order theory
    Taiwan SMEG
    drug repositioning
    KOTEC
    Date: 2014
    Issue Date: 2014-12-01 14:19:03 (UTC+8)
    Abstract: 生技產業為我國未來六大明星產業之一,除政府成立生技創投基金,民間企業也陸續加入這波生技投資行列,如永豐餘集團旗下的上智生技創投,與潤泰集團旗下的鑽石生技投資。以籌資來源而言,又分為借款融資關係(負債端)的外部資金,以及股東投資關係(權益端)的自有資金兩種,對於公司經營各有優缺點,亦應取得平衡。唯目前多數為權益端的資金投入,尤其以該產業中風險最高的新藥研發公司為例,仍普遍高達95%以上的股東權益比率。顯示其籌資來源有限,且難以吸引負債端的投資者參與。而這樣的資金來源比例,除不符合企業融資順位理論於公司成長階段的籌資策略與負債權益比率,權益端資金多以短期獲得高利潤為目的,以資金性質亦不適合占資產達95%以上之比例。

    以目前負債端籌資管道,新藥研發公司多數利用台灣中小企業信用保證基金直保部或經濟部促進產業創新或研究發展貸款計畫專案申請,唯融資額度上限遠不足以支付藥物開發費用,且非一般負債端直接經由銀行評估取得融資之方式。綜觀國際業態,單一全新藥物開發至上市平均需約USD8億元(約NTD240億元)不等,而台灣公司的研發策略多數為分段發展或老藥新用(藥物重新定位)策略,但仍有高度資金需求。唯銀行、負債端投資者普遍缺乏投入該產業的意願,主要顧慮為具冗長的產品研發週期業態、高度不確定性的產品上市審查、長期臨床試驗伴隨的高額成本。此外,對於資金專注研發之新藥研發公司,亦面臨擔保品不足之問題。而實務上,負債端資金提供者如銀行,對於複雜的生技領域與新藥研發公司業態不甚了解,為降低融資意願的另一主因。

    故本研究旨在建立一套適用於新藥研發公司之一般性價值評估方式,解決此雙方認知差異問題,以增加更多元的籌資管道。其中,本文參考其他國家評估方法,選擇其中針對技術型公司、發展久遠的韓國技術信用保證基金KOTEC評估模式,導入台灣微脂體、基亞生物科技、賽德醫藥科技3間新藥研發公司個案作一評估。並於最後研究結論,經由分析比較個案公司間歷年經營狀況,得出公司整體與個別質、量性指標項目量化的相對分數,以台灣微脂體分數157分最高,基亞生技次之。本研究亦參考個案評估狀況,得出該類公司較佳的一般性經營策略結論,發現公司創立早期可先以開發週期短、風險較低的老藥新用開發以代替副業產生短期營收的效用,同時累積本業開發經驗,待時機成熟再轉入全新藥物開發為一攻守兼具的經營模式,以供新藥研發公司參考。此外,本研究屬於探索性研究,僅於評估新藥研發公司分數階段,尚未轉換為公司融資評等。該部分尚待具一定案源量後,以統計模型將評估分數與還款違約率關聯性做一分析,方能計算融資評等。而建立內部評等模型、資訊系統對台灣銀行規模而言,為一額外高昂成本,亦建議可效法韓國由政府主導為可行方式之一。
    The biotechnology industry is one of the six future stars of the industries in Taiwan. The government established Biotechnology Venture Capital (BVC), and the more and more private companies joined the procession of biotech investments, such as the two famous biotech funds, Taiwan Global BioFund (TGB) and Diamond BioFund Inc.. According to sources of funding, we can divided them into two groups: one is the loan of external funds (liability side), and the other is the shareholder investment of internal funds (equity side), both of them have different advantages and disadvantages for the company, and the company should strike a balance between these advantages and disadvantages. However, the majority of the funds are invested from the equity side, especially the new drug development companies, which are the highest risk types in the industry, and most of their equity ratio is higher than 95 %. This information indicates the limited sources of funding, and the difficulty to attract liability side’s investors to participate. That proportion of funding sources doesn’t comply with the company’s financing strategy and debt to equity ratio in the growth stage of the enterprise life cycle in the pecking order theory, and equity side’s funds are not suitable for accounting for more than 95% of assets in balance sheet because most of them want to get high profits in the short-term.

    Currently, major new drug development companies usually apply for loans from the Direct Guarantee Dept. of the Small & Medium Enterprise Credit Guarantee Fund of Taiwan (Taiwan SMEG) or the Promote Industrial Innovation or R&D Loan Program of Industrial Development Bureau in Taiwan, but the amount of loan is insufficient to cover the costs for the new drug development, and this method is not a general way to obtain liability side’s financing from the bank’s direct evaluation. In the international situation, the progress from development to sale of a single new drug spends about US $800 million (about NT $24 billion) on average. Despite Taiwan's R&D strategies only cover the sectional development progress or the policy of the new usage of old drugs (drug repositioning), there is still a high degree of capital requirement. However, in the present, banks and other liability side’s investors still lack the will to invest in the new drug development companies. These investors concern about several major problems, including the lengthy product development cycle, high uncertainty of the product examination and approval, the high cost of long-term clinical trials in this industry. In addition, these companies are also faced with the problem of lacking collateral, because they invest much money in new drug R&D. On the other hand, liability side’s investors, such as banks, don’t understand the complex field of new drug development companies' business models, and this situation becomes another reason for reducing the financing will.

    Therefore, we should establish a general evaluation method applicable to new drug development companies, to solve the problem of cognitive differences between liability side’s investors and the borrowers, and expand the funding sources of these companies. This article refers to the actual evaluation method in other countries, chooses the most suitable and well developed evaluation model --- Korea Technology Finance Corporation (KOTEC)’s evaluation method for the technology-based company, and utilizes the method to evaluate three cases of the new drug development companies in Taiwan, including Taiwan Liposome Co., Medigen Biotechnology Crop., and CytoPharm, Inc.. In conclusion of the study, by analyzing and comparing the three companies’ operating situations in recent years, we can get relative quantified scores from the companies’ overall and individual qualitative, quantitative indicators, and the result is that Taiwan Liposome Co. gets the highest score, 157 points, then Medigen Biotechnology Crop. gets the middle one. This study also refers the case situations, to find a better general business strategy for such companies. We find that new drug development company in the early stage can focus on new usage development of old drugs ,which has advantages of short development cycle and lower risk, to replace the sideline that generates short-term revenue, and accumulate the experience of drug development. When the time is ripe, it can transfer to new drug development. This way is the general suggestion of both offensive and defensive business model for new drug development companies. In addition, this study is an exploratory research, which only focuses on the evaluation stage, and has not converted the result into a corporate financing credit rating. To calculate financing credit ratings, we require a lot of historical cases data to establish a statistical analysis model, and link evaluation scores with repayment default rates. The establishment of an internal rating model or information system incurs high additional costs for the size of the banks in Taiwan, so the recommended one of the possible ways is that we can follow the example led by the South Korea Government.
    第一章 緒論 1
    第一節 研究動機與目的 1
    第二節 研究方法 4
    第三節 研究架構 6
    第四節 資料來源 7
    第五節 研究限制 8
    第二章 文獻回顧 9
    第一節 生技產業介紹 9
    壹、 生技產業範疇 9
    貳、 製藥產業市場概況 17
    參、 製藥產業分類與特性 28
    第二節 新藥研發成本與風險分析 33
    壹、 美國研發成本與風險分析 34
    貳、 台灣研發成本與風險分析 42
    第三節 融資需求分析與評估方式 44
    壹、 各國銀行、信保機構法人融資評估模式介紹 48
    貳、 無形資產鑑價指標 69
    第四節 本章小結 78
    第三章 研究方法 79
    第一節 研究架構 79
    第二節 研究方法 81
    第三節 資料蒐集 84
    壹、 研究對象的選擇 84
    貳、 資料來源 85
    第四節 研究限制 86
    第五節 本章小結 87
    第四章 個案研究 88
    第一節 台灣微脂體個案 88
    壹、 公司介紹 88
    貳、 負責人能力(指標) 90
    參、 技術能力(指標) 95
    肆、 市場性(指標) 101
    伍、 商業價值與盈利能力(指標) 104
    第二節 基亞生物科技個案 106
    壹、 公司介紹 106
    貳、 負責人能力(指標) 108
    參、 技術能力(指標) 114
    肆、 市場性(指標) 119
    伍、 商業價值與盈利能力(指標) 125
    第三節 賽德醫藥科技個案 129
    壹、 公司介紹 129
    貳、 負責人能力(指標) 132
    參、 技術能力(指標) 138
    肆、 市場性(指標) 141
    伍、 商業價值與盈利能力 143
    第四節 本章小結 145
    第五章 結論探討 151
    第一節 個案評估結果探討 151
    第二節 優良的新藥研發公司策略 160
    第六章 研究建議 164
    參考文獻 169
    Reference: 一、中文部分
    論文
    任建翔 (2007)。我國信用保證對智慧財產權融資之研究。淡江大學管理科學研究所企業經營碩士在職專班碩士論文。

    江政倫 (2011)。台灣新藥研發公司多角化策略分析:從知識管理程序觀點。國立政治大學科技管理研究所碩士論文。

    吳佳穎 (2006)。智慧財產權與中小企業融資信用保證-以中韓兩國為例。實踐大學企業管理研究所碩士論文。

    周芳君 (2011)。從全球疫苗產業趨勢探討我國預防接種的政策發展。國立政治大學科技管理研究所碩士論文。

    洪嘉鴻 (2009)。生技製藥智慧資本與研發管理對策-以台灣新創製藥公司為例。國立政治大學智慧財產研究所碩士論文。

    張朝龍 (2000)。生物技術專利權保護程度於進入模式的影響性探討。國立東華大學國際企業研究所碩士論文。

    期刊
    王漢民、曹秀惠 (2006)。企業選擇負債融資工具影響因素之探討。經濟與管理論叢, 2(1), 53-70。

    侍安宇、黃博怡、沈中華、梁連文 (2010)。美國SBA與CRA在中小企業融資市場的角色。 中小企業發展季刊,(17),81-117。

    張延軍、王靜波、郭劍非 (2010)。美國孤兒藥法案及其對新藥研發的影響。中國藥物經濟學,(1),27-34。


    書籍
    汪嘉林等人 (2013)。2013生技產業白皮書。臺北市:經濟部工業局。

    吳萬益 (2011)。企業研究方法(四版)。台灣:華泰文化。

    黃俊英 (2010)。企業研究方法(四版)。台灣:東華書局。

    羅敏菁 (2011)。生技投資聖經:看懂台灣生技股的第一本書。台灣:旗標出版股份有限公司。

    饒秀珍 (2014)。生醫新視野:生技產業投資停看聽。台灣:財信出版有限公司。

    報告
    行政院科技顧問組 (2013)。「臺灣生技產業起飛行動方案」行動計畫。臺北市:行政院科顧組。

    行政院科技顧問組 (2009)。「台灣生技起飛鑽石行動方案」行動計畫。臺北市:行政院科顧組。

    任建翔 (2009)。信用保證與生技產業融資。臺北市:財團法人中小企業信用保證基金。

    汪萱蕙 (2013)。2014年我國生物技術產業分析。臺北市:台灣經濟研究院。

    汪萱蕙 (2013)。2014年我國西藥及生技製藥產業分析。臺北市:台灣經濟研究院。

    吳品頤等人 (2013)。2013生技技術產業年鑑。臺北市:經濟部生物技術開發中心。

    姜瑞貞 (2012)。我國與韓國信用保證機制之比較。臺北市:國家發展基金會。

    劉依蓁 (2013)。2014台灣生技醫藥產業分析報告。臺北市:台灣經濟研究院。

    法案
    日本中小企業基本法 (1963)。


    二、英文部分
    期刊
    Aggarwal, S. (2014). What’s fueling the biotech engine—2012 to 2013. Nature Biotechnology, 32(1) : 32-39.

    Aggarwal, S. (2012). What’s fueling the biotech engine—2011 to 2012. Nature Biotechnology, 30: 1191-1197.

    Aggarwal, S. (2011). What’s fueling the biotech engine—2010 to 2011. Nature Biotechnology, 29: 1083-1089.

    Ashburn,T.T.& Thor,K.B. (2004). Drug repositioning: identifying and developing new uses for existing drugs. Nature Reviews Drug Discovery, 3: 675.

    DiMasi, J.A., & Grabowski, H.G. (2007). The Cost of Biopharmaceutical R&D: Is Biotech Different? Managerial and Decision Economics, 28: 469-479.

    Hunn, P. (1971). Bank Credit in the 1970's— New Realities and Old Verities. The Journal of Commercial banking Lending, 53(10) : 29-34.

    Meekings, K.N., Williams, C.S., & Arrowsmith, J.E.(2012). Orphan drug development: an economically viable strategy for biopharma R&D. Drug Discov Today, 17(13-14): 660-664.

    Yin, W. (2009). R&D policy, agency costs and innovation in personalized medicine. Journal of Health Economics, 28(5): 950-962.

    書籍
    Cooper, D.R., & Schindler, P.S. (2013). Business Research Methods(12th ed). NY:McGraw-Hill Education.

    European Commission (1996). Biotechnology R&D in Europe:National Files. Brussel: European Commission.

    Iacobucci, D., & Churchill, G.A. (2009). Marketing Research: Methodological Foundations(10th ed). MA:Cengage Learning.

    National Science and Technology Council (1995). Biotechnology for the 21st Century: New Horizons. U.S.:National Science and Technology Council.

    Yin, R.K. (2013). Case Study Research: Design and Methods(5th ed.). CA:SAGE Publications.


    報告
    Ernst & Young (2007). Beyond Borders:Global Biotechnology Report 2007. Bahamas :EYGM Limited.

    Golding, D. (2012). SME Support Overseas – Learning from International Peer Reviews. Brussels: European Commission.

    IMS Institute for Healthcare Informatics (2013). The Global Use of Medicines: Outlook through 2017. NJ: IMS Institute.

    Kaddar, M. (2012). Global Vaccine Market Features and Trends. Geneva: World Health Organization.

    Park, H.C. (2012). Supporting innovative SMEs in Korea. Report presented at the meeting of INNO Partnering Forum, Stockholm, SE.

    法案
    Canadian Environmental Protection Act, §2, CA. (1999).

    Framework act on small and medium enterprises, KR. (1966).

    網站資料
    Biotechnology Industry Organization (2009). BIO Asks Congress To Help Small Businesses Find New Sources of Capital in Wake of Financial Downturn. Retrieved September 9, 2014, from http://www.reuters.com/article/2009/10/14/idUS171438+14-Oct-2009+BW20091014
    Description: 碩士
    國立政治大學
    科技管理與智慧財產研究所
    98361014
    103
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0983610144
    Data Type: thesis
    Appears in Collections:[科技管理與智慧財產研究所] 學位論文

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