再生醫學（Regenerative medicine）已是近年全球重視度很高的領域，近年因Covid-19肆虐全球，群眾對於生醫保健觀念意識抬頭，其中幹細胞製劑新藥運用幹細胞特有的增值與分化特性，對身體受損的器官或組織進行汰舊換新，讓細胞再生、器官修復及治病的效果，世界各國也因此對再生醫學越來越重視，再生醫學已成為世界潮流趨勢並迅速蓬勃發展。
製藥產業研發階段需要經過動物實驗、人體試驗一期、二期、三期成功後才能上市並獲得收益，其中在研發過程中承擔著高度開發失敗的風險，除此之外，更需要高昂的研發費用，雖開發新藥所需資金相當龐大，且所需耗費的研發時間很長，但若新藥開發成功，所產生的的附加價值極高，這也是世界各國積極投入的原因。
本論文主要是探討與研究:幹細胞製劑產業如何在高研發成本、高風險、研發耗時長的艱困條件下，使用開放式創新的商業模式讓企業走出活路。
本研究運用個案研究的方法，透過相關文獻探討及與次級資料的蒐集，以開放式創新商業模式的開放核心作為應用，同時合併使用商業模式九宮格模型建構出企業、內外部結合的創新價值，提出企業降低成本與提升營收的策略規劃方向，再進行資料彙整、歸納及分析整合出G個案公司透過開放式創新商業模式締造的價值，最後結論並提出關鍵的建議。

Regenerative medicine has become one of the fields of global attention in recent years. In recent years, due to the ravaging pandemic of Covid-19 around the world, the public's awareness of biomedical health care has risen. Among them, stem cell preparations take advantange of the unique proliferation and differentiation characteristics of stem cells. The replacement of old tissues with new ones has the effect of cell regeneration, organ repair and disease treatment. Therefore, countries around the world pay more and more attention to regenerative medicine. Regenerative medicine has become a rapidly developing trend all around the world.
In the R&D stage of the pharmaceutical industry, it is necessary to go through the animal experiments and human trials phases Ⅰ、Ⅱ、Ⅲ before it can get the license and gain profits. In the R&D process, it bears a high risk of development failure and also requires expensive Cost .Once the new drugs are successfully developed, the value generated is extremely high. That is why countries around the world actively invest in it although it required quite large funds to develop new drugs and spend lots of time.
This paper mainly discusses and researches: how the stem cell preparation industry use the open innovation business model to make the enterprise survive under the difficult conditions of high R&D cost ,high risk and long R&D time.
This research is based on the method of case study through the discussion of relevant literature and the collection of secondary data with the application of the open core of the open innovation business model . Combining the nine-square model of the business model to construct the innovative value of the combination of internal and external enterprises. Propose strategic for the company reducing costs and increasinf revenue . In this study, the case study is based on G company and provide deep analysis about open innovation strategies of this company, and concluded with key suggestions.

中文部分
1.亞歷山大．奧斯瓦爾德等，2012，尤傳莉譯，獲利世代（Business Model Generation），早安財經文化有限公司。
2.經濟部工業局，2021年，中華民國2022生計醫藥產業簡介。
3.經濟部工業局，2021年，2021生技產業白皮書。
4.朱柔若譯，2000，社會研究方法:質化與量化取向，揚智出版社
5.謝英哲、張元杰、王建航、李孟哲，2018，「龐貝氏症的新藥開發:中國合成橡膠公司的管理實踐」，中山管理評論，26卷4期:719~744。
英文部分
1.Alliance for Regnerative Medicine（2021）,Regenerative Medicine : Disrupting The Status Quo,p.7-12.
2.Chesbrough,H.W.,2003,Open Innovation:The new imperative for creating and profiting from technology.Boston:Harvard Business School Prss.
3.Chesbrough,H.W.,2007,Why companies should have open business models.MIT Sloan Management Review,48(2),22-28.
4.Nature Reviews Drug Discovery,2010,How to improve R&D productivity:the pharmaceautical industry’s grand challenge.
5.Research and Markets,2022,Outlook on the AI-based drug discovery global market to 2035.
6.Stabell,C.B.,& Fjeldstads,R.D.,1998,Configuring value for competitiveadvantage:on chain,shops,& networks,Strategic Management Journal,19,413-437.

網路文獻
1.The News Lens關鍵評論，2018，從實驗到上市，一款藥物的開發可以耗費多少青春與成本？。檢至
https://www.thenewslens.com/article/95507（2022.5.15）
2.工研院IEK產業情報網，2010，Nature Reviews Drug Discovery。檢至https://ieknet.iek.org.tw/（2022.5.15）