臺灣發展幹細胞新藥的可行性 -以國璽公司為例

生技產業已是目前的明星產業，政府正大力推展台灣生技產業發展，中央研究院的基因體中心更是具有研究規模，政府為鼓勵產業發展更是在竹北設立生醫園區、及在南港設立國家生技園區，也由於生技產業的領域相當廣泛，因此再生醫學產業成為近年來大家最為熱烈討論的項目之一；尤其是 2012 年幹細胞研究獲得諾貝爾獎殊榮肯定後，越來越多台灣幹細胞公司不僅儲存幹細胞，也開始從事幹細胞新藥的開發。由於幹細胞新藥與一般新藥開發方式不同，幹細胞新藥是以幹細胞為主要原料，做成細胞製劑進行植入性治療，所以開發方式和規格不同於一般藥物。幹細胞製劑的開發，目前在台灣並沒有任何公司可以成為幹細胞新藥產業的標竿，同時也未有幹細胞新藥在台灣被核准上市。因此，國璽公司發展出屬於自己的研發及營銷模式，希望能夠透過集團所屬公司的資源整合，創造新藥以外的營業收入，使公司可以永續經營。所以本研究使用質化法搭配量化分析方法，藉由分析國璽公司所屬的達文希診所的患者狀況，來探討國璽公司發展新藥的可行性。本研究以國璽公司和達文希診所為研究對象，採用文獻分析法探討幹細胞新藥目前的發展，並運用迴歸分析，針對客戶進行資料分析，發現達文希診所的患者對類細胞治療的需求與意願。因此，本研究結果認為台灣非常具有發展出幹細胞新藥的可行性。

關鍵字

再生醫學；生技產業；幹細胞新藥；迴歸分析法

並列摘要

The biotechnology industry currently is a star industry. The government is vigorously promoting the development of Taiwan’s biotechnology industry. The Genomics Center of the Academia Sinica has a research scale. The government has set up a biomedical park in Zhubei as well as a national biotechnology park in Nangang to encourage the industrial production. Because the field of biotechnology industry is quite wide, the regenerative medicine industry has been heatedly and broadly discussed in recent years, especially following the stem cell research who won the Nobel Prize in 2012. More and more Taiwan stem cell companies not only store stem cells, but also start to develop new stem cell drugs. The new stem cell drugs are developed differently from general new drugs. Stem cell new drugs use stem cells as the main raw material to make cell preparations for implantable treatment, so the development methods and specifications are different from general drugs. For the development of stem cell preparations, few companies in Taiwan have become the benchmark in the new stem cell drug industry, and few new stem cell drugs have been approved for marketing in Taiwan. Therefore, the company Gwoxihas developed its own R&D process and marketing model, hoping to create operating income other than new drugs through the integration of the resources of the group's companies, so that the company can operate sustainably. Therefore, this study uses qualitative methods and quantitative analysis methods to analyze the feasibility of developing new drugs for Gwoxi by analyzing the patient status of DMC Clinic, which belongs to Gwoxi. In this study, Gwoxiand DMCClinic were used as the research objects. The doctrinal analysis was used to explore the current development of new stem cell drugs. The regression analysis was used as the research method for analyzing the data for customers revealing that patients at the DMC Clinic needed and wanted cell-like therapies. Therefore, the results of this study suggest that Taiwan is very feasible to develop new stem cell drugs.