在一般定義上，新藥通常指稱「新發明之成分」，也就是所謂專利藥或品牌藥。值得關注的是，1990年代起，歐美傳統製藥公司將新藥研究開發活動委外，或以合作研發方式與小型專業生技公司或學術機構合作，使得全球製藥產業結構走向專業分工，這些小型專業生技公司專注於新藥探索階段及新藥早期開發階段，例如尋找創新的藥物標的、快速自動化篩選先導化合物、進行臨床前研究，本研究將其定義為「生技新藥研發公司」，傳統製藥公司則有機會購買、引進授權或以併購方式取得其先導化合物、候選藥物進行較晚期開發及臨床試驗，最後通過審核許可上市行銷。 智慧財產權策略，實為企業考量其規模大小、技術水準等因素後，所訂定專利權、商標權、營業秘密、著作權四項法定權利「取得」、「授權」、「訴訟」的指導性原則，擬訂合適有效的智慧財產權策略，將有助於排除喜擅模仿的競爭對手、增加營業外收益，及保護企業受到不當攻擊及榨取。 本研究訪談三家我國生技新藥研發公司，首先初步了解其智慧財產權管理概況，並且以較有系統的方式描述出企業策略、智慧財產權策略的形貌，並對企業策略與智慧財產權策略互動進行整理與分析。 事實上，我國新藥研發公司的目標市場大致相當類似，但企業策略則略有差異，主要受到其切入產業價值鏈位置之影響。在企業策略與智慧財產權策略互動方面，早期布局的卡位申請策略，有助於放眼國際成長性市場；不倚靠單一內部來源取得智慧財產權，更能加速整合互補性資源；積極尋求向外授權、不排除權利共享，能使企業有機會爭取短、中期資金收益，幫助企業建立較為穩定的基礎。

新藥研發為一高風險、高報酬的產業，股票或債券投資人通常不願承擔那麼高的風險。本研究利用類似Mortgage Backed Securities的概念，發行RBO（Research Backed Obligation），募集50億美金的Megafunds，投資在200個藥物上。RBO包含了Senior bond、Junior bond，以及Equity三個tranche。Senior與Junior的利率分別為5%與8%，在4年與6年後到期，Equity不發利息或股利，而是於投資期間結束後，領回基金總額扣除Bond後的價值。 本研究使用2003-2011年共5820個新藥臨床實驗結果，依照藥物型式、對應疾病分為59類，將各種藥物於各階段臨床實驗的成功機率帶入模型。每種藥物模擬5000次。最後得到投資各種藥物時，Senior bond與Junior bond的違約機率與違約時的期望損失，以及Equity報酬率的期望值與標準差。 分析模擬的結果，可得到除了其中三種藥物之外，Senior與Junior bond的違約機率皆分別在5 bp與2.5 %以下。至於Equity的部分，除了其中四種藥物的報酬率較低外，多數藥物年化報酬率的期望值在8-16%間、標準差在14-15.5%間。各藥物的風險並不會差太多，然而各種藥物報酬率的期望值彼此間有所差距。故以RBO投資新藥產業時，仍需注意投資的藥物種類。 / Biomedical innovation has become riskier and more difficult to finance with traditional sources such as private and public equity. Here we propose a financial structure called RBO (Research Backed Obligations) which is similar to Mortgage Backed Securities. In RBO structure, a $5 billion ‘Megafunds’ is financed by issuing Senior bonds, Junior bonds, and Equity. Senior bond and Junior bond tranches yield 5% and 8% annually, due within 4 and 6 years, respectively. Equity tranche does not pay any interest and obtain the residual asset after all debt obligations have been satisfied. ‘Megafunds’ will be invested on the 200 biomedical programs at various development stage to reduce the portfolio’s risk. We use the historical clinical trail data of 5820 new drug programs from 2003 to 2011. These drugs are classified into 59 groups by molecular type and disease area. Success rates of each development stage are imported into our simulation model, 5000 simulations for each drug group. The simulation result included the default rate of the Senior bonds and Junior bonds, loss of the bonds when the bonds default, and the expected value and standard deviation of the Equity return. We show that except for 3 drug groups, the default rate of Senior bond and Junior bond are less than 5 bp and 2.5% respectively for all the drugs. The expected return of Equity are between 8-16% of almost all the drug, although 4 drug groups show poorer performance. The standard deviations are between 14-15.5% for all drug groups. Consequently, almost all the drug groups have similar risks, but the expected return of the Equity tranche of these drug groups are quite different.

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.

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.