生技藥品開發技術成功商業化策略探討-以生技中心為例

Analysis on Successful Commercialization Strategy of Biopharmaceuticals Development -- Development Center for Biotechnology as an Example

蔡巧彥(Chiao-Yen Tsai)

指導教授 ： 郭佳瑋

國立臺灣大學/進修推廣學院/生物科技管理碩士在職學位學程/碩士(2021年)

https://doi.org/10.6342/NTU202103858

摘要

生技藥品開發從業者要如何在高資金燃燒率(burning rate)及開發期長的產業環境下，追求成長甚至是存活，常是經營管理者，心中晝夜思考的策略難題。因此在這個必須比氣長的產業環境中，如何多方取得營運資金、節省研發支出，以及如何將所開發的技術成功商品化的營運策略更顯重要。
生技藥品開發業者，除了選擇爭取政府補助、於資本市場募資以外，隨著國內生技藥品產業的技術逐漸成熟，透過提供委託服務、技術授權交易與成立新創衍生公司等方式，是近年來常被運用的商業手段。尤其在2016年浩鼎OBI-822三期臨床試驗解盲失敗後，國內生技產業發展經歷募資不易的低潮下，如何成功從賣方的觀點來促成技術交易，達到技術活化目的，更被產業所重視。近來隨著數件國內研發之生技新藥於國外成功上市，及成功國際授權案例產出之際，可見到台灣生技產業過去的努力，正透過授權交易出現成長的曙光。
由於過去國內生技藥品產業規模小，其商業模式常被統括在整體醫藥產業中探討，即使生技藥品開發產業的高商業風險和與各種組織的相互依賴性，使得商業模式設計已成為提高公司穩定發展和盈利能力的關鍵要素，但目前對生技藥品產業商業模式設計與技術商業化的研究卻很有限。
國內生技藥品產業發展，從無到有，前期需要的產品開發關鍵平台技術，有許多項關鍵設施及技術，是由經濟部補助之財團法人生物技術開發中心所建立，作為國內生技藥品開發產業先行者，為了活化已開發技術，促進產業發展，近幾年生技中心透過技術成果商業化，已成功將生技中心多項科專成果移轉產業運用。故本研究選定生物技術開發中心之共四件科專技術成果商業化運用實績，包括抗單純皰疹病毒治療性單株抗體技轉聯生藥公司、LT平台及其衍生產品技轉昱厚生技公司、「CGMP生技藥品先導工廠」衍生成立台康生技公司，以及「生技藥品檢驗中心」衍生成立啓弘生技公司，對承接技術個案廠商進行訪談與質化研究分析，探討以技轉授權或成立衍生公司為目的之生技藥品成功商業化策略。
本研究結論指出三點生技中心成功將生技藥品開發技術商業化之核心概念：(1)技術標的選擇與技術整合是首要：發展符合市場需要的前沿技術與智財佈局是技術授權交易成功的要件，而衍生公司要能順利，還必須整合技術與團隊，而組織文化營造與變革管理是法人成立衍生公司的重要挑戰；(2)技術交易模式趨向開放、多元與互利：國內生技藥品開發產業規模，不若國際大廠，面對高風險的生技產品開發之路，趨向開放創新與多元的商業模式，並採取共創雙贏的態度，可以增加交易成功的機會與未來的收益；(3)合宜的商業化交易時機：適當的產品或技術成熟度，有利於吸引交易對象，選擇主客觀條件適當的交易時機，能夠促成交易的成功。本研究結果除可提供我國在生技藥品開發領域技術商業化的數種常見態樣的瞭解外，對於法人成功技術商業化的策略與邏輯思維，可提供推動生技藥品技術產業化的法人與產業技術開發者營運策略擬定之參考。

關鍵字

生技藥品 ； 技術商業化 ； 技術移轉 ； 衍生公司 ； 開放式創新

並列摘要

In the past, the discussion of the small-scale the business model in domestic biopharmaceutical area usually included in whole pharmaceutical industry. As considering the high commercial risks and the dependence of various organizations in the biotechnology drug industry, the business model design has became a key element to improve the growth and profitability of company. However, it is still limited research and growth of the business model design and technology commercialization in the biopharmaceutical industry currently.
The failure unblind result of the OBI-822 Phase III clinical trial caused a huge impact on Taiwan's biopharmaceutical industry in 2016, especially from capital market perspective. The domestic biotechnology industry has experienced a low tide of fundraising. Therefore, it becomes more important for whole industry successfully to promote technology transaction from seller’s point of view and to activate technology application.
The institute of Development Center for Biotechnology (as shown DCB) has played an important role as a pioneer in the process of developing Taiwan's biopharmaceutical industry from scratch. In this study, there are four biotechnology cases selected from DCB which have been commercialized, including the technology transfer of herpes simplex virus therapeutic monoclonal antibody technology transfer UBI Asia/UBP, the technology transfer of LT platform and its derivative products to Advagene, the case of DCB " CGMP Biopharmaceutical Pilot Plant" spins off into EirGenix, and the case of DCB " Testing Facility for Biological Safety (TFBS) " spins off into TFBS Bioscience. It is exploring the successful commercialization strategies of biologics development technologies by using technology transfer or spin-off companies by conducting interviews to do qualitative research and analysis.
The conclusion of the study points out three core concepts of DCB’s successful commercialization cases of biotechnology drug business. First of all is the selection of technology targets and technology integration: the most important qualifications to develop technology licensing transactions successfully which are the cutting-edge technologies and the layout of intellectual wealth to meet market needs. Become a successful spin-off company, it must need to integrate technology and team work. However, to create company own culture and to reform management is great challenge to build a spin-off company from non-profit organization. Secondary, the models of technology trading tend to be open, diversified and mutually beneficial: not like international giant business, the scales of domestic biopharmaceutical industry are small and facing the high-risk business running. tending to open and innovative business models and cooperation, and adopting a co-creating win-win attitude, which can increase the chances of successful transactions and future benefits. Towards an open and innovative business model and cooperation, and adopting a co-creating win-win strategies, which can increase the chances of successful transactions and profit in the future. Finally, appropriate commercial transaction timing: Appropriate product or technology maturity is conducive to attracting trading partners. Under an appropriate circumstance for both can improve the success opportunity of the transaction. Theseresults can provide an understanding of several aspects of technology commercialization in the field of biotechnology drug industry in Taiwan.
The strategy and logical thinking of successful technology commercialization cases can provide as references for non-profit organization and technology developer of biopharmaceuticals to develop their own business models.

並列關鍵字

biopharmaceutical ； commercialize ； technology transfer ； spin-off ； open innovation

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