在學術領域之中，其過去對於新藥產業的研究大多集中於「新藥發展策略」、「產業環境分析」與「智慧財產權策略」等領域，而探討新藥研發各階段之團隊組成與運作模式的研究仍然極少。 本研究以個案訪談法為主要研究方式，深入探討兩家台灣新藥研發公司（包括基亞生技、台灣微脂體），並以『新藥研發流程』與『技術知識特質』兩個構面來探索其對於『新藥研發專案團隊運作』之影響。 所得到的初步研究發現包括： 1. 新藥研發專案各階段中，技術知識路徑相依程度與技術知識系統複雜程度呈現負相關，當路徑相依程度越高時，系統複雜程度則越低。 2. 新藥研發專案隨著階段的推進，專案團隊的組成與結構也會隨之產生變化，臨床前與臨床試驗皆有不同的團隊組成與結構。 3. 技術知識系統複雜程度會影響新藥研發團隊組成的異質/多元程度：技術知識系統複雜程度越高，其團隊組成的異質/多元程度越高。 4. 技術知識路徑相依程度會影響團隊採取何種團隊運作策略：（1）路徑相依程度愈「高」或是愈「低」，專案團隊會傾向採取「自行發展」的團隊運作模式；（2）路徑相依程度為「中」時，專案團隊會傾向採取先執行「初步研發」活動之後，再與外部廠商進行「合作研發」。 5. 技術知識路徑相依程度會影響新藥研發專案各階段的團隊類型：（1）技術知識路徑相依程度愈低，專案團隊會傾向採用「重量級」、「自主型」的團隊運作模式；（2）技術知識路徑相依程度愈高會傾向採用「功能型」、「輕量級」的團隊運作模式。 6. 技術知識內隱化程度愈高，該專案在團隊運作上愈容易將外部成員視為內部團隊，甚至在團隊組成上直接將外部成員納入內部團隊之中。 7. 在臨床試驗階段，試驗主持人的過往經驗為成功關鍵之一。 8. 新藥研發廠商若擁有先導研發的能力，可以減短研發時程與成本。 / Most of previous the studies on pharmaceutical industry have been focused on the development strategy, environmental analysis and intellectual property. Very few of them emphasize the stage of new drug development concerning the project team management. This study uses technological knowledge characteristics (path dependence, complexity, and explicitness) and drug development process (drug discovery, non-clinical, pre-clinical, and clinical ) to explore the effect upon project team management. The result of this study： 1. In every stage of new drug development, the path dependence and the complexity of technological knowledge have significantly negative correlation. 2. When the new drug development project evolves into the clinical stage, the structure of project team will be different. 3. The complexity of technological knowledge can affect the composition of team members. If the complexity of technological knowledge is higher, the complexity of members is higher. 4. The path dependence of technological knowledge can affect the development strategy. If the path dependence is higher or lower, the team members prefer “inner development”. If the path dependence is medium degree, the team members prefer “primary inner development” and then “cooperative research and development”. 5. The path dependence of technological knowledge can affect the team structure. If the path dependence is higher, the enterprise prefers “Heavyweight team structure” or “Autonomous team structure”. If the path dependence is lower, the enterprise prefers “Lightweight team structure” or “Functional team structure”. 6. If the explicitness of technological knowledge is higher, the enterprise intends to recruit team member from outside. 7. In clinical stage, the practice investigator can be key person of the success. 8. If the enterprise has the ability of “primary inner development”, the time and the cost of the new drug development can be reduced.

有鑑於生物科技成為科技趨勢，以及其創造出的龐大價值，近年來台灣也開始大力推動生技產業的發展。產業是企業的組合，企業的成長與否正是驅動產業生態變化的主要原因。本研究主要探討台灣生技藥物研發公司的創業過程，希望透過研究成果對台灣生技公司的發展有所貢獻。 　　本研究的研究架構以Timmons Model做為主軸，以機會、資源、團隊做為主要的研究構面，先對個案公司進行靜態的研究構面探討，然後分析其發展的動態平衡過程。 / Because biotechnology sets a trend and creates great value, Taiwan government tries to develop his own biotechnology industry. However, an industry will bloom if most of companies related to the industry are operated well. The objective of this study is to observe and analyze the entrepreneurial process of biomedical R&D companies in Taiwan. 　　The research bases on Timmons Model that was developed by Timmons for analyzing an entrepreneurial process of a company and consists of three driving forces, opportunity, resource, and team. Every entrepreneurial process of companies in the thesis is observed first according to the three driving forces. Then it is analyzed by using the idea of constant balancing.

全民健康保險制度在台灣開辦以來已經快二十年了，在全民都有保險、給付的範圍從基礎到複雜的醫療照護完整、合約醫療機構相當普遍、就醫的方便性等，得到大多數台灣民眾的肯定。 但全民健保這一路實施下來卻為台灣帶來的龐大國家赤字。健保局針對於每年五千餘億的健保費用其中的藥品費用(為第二大支出，占了其中的25%)多次長期進行多種的藥費及藥價管控措施，低廉的新藥核價加上每兩年的藥價調查後的藥價調降，國外藥廠除了要配合健保的藥價政策外，還需要面對醫療機構對於現有藥品再降價的要求。長久下來，藥廠利潤逐年下降影響甚劇。 其中以今年七月所要實施二代健保中「藥品三同」對於原開發藥廠藥衝擊最大。衛生署所實施的三同政策，即是針對健保給付超過15年的藥品，實施「同成分」、「同品質」、「同價格」，調整為同價格。此一政策倘若實施，原開發藥廠利潤嚴重下降，可能會導致會放棄台灣市場，民眾只剩下國產學名藥可以選擇。再者，三同政策最大的瑕疵，在於只單方面考慮健保給付的藥價，卻忽略了藥廠製藥成本，此舉明顯不顧成本不同卻硬性規定價格，明顯違反市場機制，也違反健保精神。 專利藥到期的原開發藥藥廠要如何因應以縮小品質及價格的爭端，只著眼於一昧砍藥價來填補健保財務虧損，不仔細思考同成分就一定同品質的問題而將藥品砍至同一價格的健保署藥物品質認定及給付標準。 本研究探討之研究問題包括: 1)在台灣健保逐年調降藥價的政策下藥品三同政策前，原開發藥廠在台的經營模式為何,2)在政府政策培育下的學名藥如何日益茁壯來影響專利藥到期的原開發藥廠市場活動，3)藥品三同政策實施後對專利藥到期的原開發藥廠的衝擊4)主要獲利的專利藥品皆到期的台灣武田藥品公司未來的經營模式從主要價值活動面該如何調整因應。 本研究以Afuah A.(2004)經營模式架構，先從過去健保政策下原開發藥廠的營運模式做說明，再以目前健保政策環境因素的變化，如何影響個案公司的市場行銷活動，而活動又如何影響公司的資源、定位及成本。 本研究發現「藥品三同」對台廠學名藥因具有較佳的成本競爭優勢，對原開發藥廠產生威脅，但因原料的不穩定性讓病患、處方醫師無法信任。所以原開發藥廠除了監督政府長期對學名藥廠品質加以把關、用訴訟延緩學名藥的上市外、另外一方面併購國內學名藥廠，以配合醫療院所對於低價高品質藥品的需求。最後，專利藥到期的原開發藥廠從健保政策中與學名藥廠價格競爭獲得利潤，就必須改變營運模式，首要的就是降低成本。如何從採購及製造方面有效降低成本著手，進一步調整有形、無形資產投入、人員配置培養與組織等策略資源，以及定價、市場區隔等定位修正，是原開發藥廠需要深入思考的問題。 / National Health Insurance (NHI) program has been implemented in Taiwan for almost 20 years. It has earned recognition for the compulsory enrollment for all residents in Taiwan, the benefits covered from basic to complicated medical care, the prevalence of contract medical facility and the convenience of going to doctors. NHI, however, has caused fiscal deficit for the past few years. Drug cost, among the over 500,000,000,000 NTD health insurance fee, is the second largest expenditure, which takes up 25 percent of health insurance fee. Therefore, Bureau of National Health Insurance has taken measures to manage and control drug cost and drug price multiple times for a long period. Foreign pharmaceuticals have cooperated on the low-priced pricing for new drugs and have lowered drug price after drug price evaluation every two year. However, there is still demand from medical institution for lowering drug price. The profit is therefore significantly affected in the long run. Among the impacts, the significant one for research-based pharmaceutical companies is “three sameness of drug” in the 2nd generation NHI, which will be implemented in this coming July. This three sameness policy is to adjust those drugs which are covered by NHI for over 15 years and are of the same ingredients and quality to the same price. If this policy is put into practice, the profit of research-based pharmaceutical companies would plunge, which may result in their leave of Taiwan market. The domestic generic drugs, as a result, would be the only choice for the general public. Moreover, the major flaw of this three sameness policy is that it merely considers the drug price NHI covers, not the costs of pharmaceutical companies. That the drug price is set inflexibly without taking costs difference into consideration is against not only market mechanism but also the essence of NHI. The questions this study aimed to investigate were: 1. What have been the operating models of research-based pharmaceutical companies in Taiwan in the circumstances of drug price drop year by year before “three sameness policy”? 2. How have the government-sponsored generic drugs affected the market activities of drug patent expiration of research-based pharmaceutical companies? 3. What have been the impacts of “three sameness policy” on drug patent expiration of research-based pharmaceutical companies? 4. How should the operating model of Takeda Pharmaceuticals Taiwan, Ltd. adapt to, from the aspect of primary value activities, the condition of drug patent expiration of its profitable drugs? Based on the framework of operating model by Afuah A.(2004), this study began with the operating model of research-based pharmaceutical companies in former NHI policy. It then elaborated on how changes of the present NHI policy have influenced the marketing activities of the case company and how these activities have influenced the company’s resources, position and costs. This study reveals that “three sameness policies” is favorable for Taiwanese generic manufacturers for their costs competition. However, the instability of raw materials could not gain the trust of patients and doctors. Therefore, in order to cooperate on the demand for low-price and high-quality drug, researched-based pharmaceutical companies supervise the government’s check on the quality of generic manufacturers, employ litigation to suspend the launch of generic drugs or merge domestic generic manufacturers. If research-based pharmaceutical companies with drug patent expiration would like to compete with generic manufacturers and make a profit in NHI policy, they would have to change their operating model. How to reduce costs of purchase and manufacture and go further to adjust the input of physical and intangible assets, strengthen professional training of personnel and organization and modify strategies for pricing and market segmentation are the main issues worth considering.

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.