台灣生技新藥產業全球化商業模式-萊特生醫集團為例

Abstract

藥品製造是複雜、耗時、高投資且高風險的過程，而欲將新藥研發成果轉成產品進行銷售則是更加艱辛與耗時。相較於其他生技新藥業者，萊特生醫集團規模屬中小型企業。其核心目標為新藥與新醫療器材開發，而新藥開發主要偏重於植物新藥。綜觀生技新藥產業之運作因子不外乎資金、技術人才及合作夥伴，如何在獲得足夠之資金以滿足新藥開發所需、聘雇適當之技術人才以利新藥開發專案之推動與前端研究單位、原料供應商及臨床試驗單位之合作將為其努力之方向。 萊特生醫集團以「轉譯醫學研究」為核心主軸，在研發鏈之佈局採取與國內（藥技中心、國衛院、藥品查驗中心、工研院生醫中心、台灣大學、陽明大學、交通大學、東海大學等）、國外學術研究單位（Memorial Sloan Kettering Cancer Center、德州 M.D. Anderson Cancer Center、MSKCC、 Stanford University、日本千葉大學、名古屋大學、九州大學等）進行產學合作，其創新技術經評估後技術轉移。當新藥進入臨床試驗後，則與國內試驗單位（三總、北榮、長庚、松德等）進行合作，過程中亦邀請其他合作夥伴（日本雪國舞茸株式會社、Pfizer 、AMAREX Clinical Research 與 Ora, Inc.等）加入。整合各階段業者，創造產業生態鏈。結合國際生技人才及技術，共創產品價值。 新藥產業另一關鍵因素為資金來源，大藥廠因有核心產品收入或新藥授權金之挹注而得以獲得後續研發之資源。但以中小型生技新藥業者而言，主要收益為授權金，而新藥研發之過程長且耗費預算高，在對外授權前主要預算來源將為對外募資所得。萊特生醫集團深知相較於國外資本市場，台灣市場所募資金有限，故在佈局上採取由BioLite Holding 與ABVC分別於NYSE及Nasdaq進行上市。利用全球資金、夥伴進行研發，最終為產品做全球性的佈局。 生技新藥開發產業為資金及技術門檻極高之產業，台灣資本市場相較於國際資本市場為小，在資金充裕度上相較為低。本研究探討全球及台灣生技新藥產業之發展，以了解生技新藥產業之現況。藉由萊特生醫集團發展全球化之事業發展策略，此作為未來台灣生技新藥產業於全球布局之策略參考。

Pharmaceutical manufacturing is a complex, time-consuming, high-investment and high-risk process. It is even more challenging and time-consuming to advance the new drug research and development results to new drug products for marketing. Compared to other new drug biotech companies, Lite Biomedical Group (LBG) is a small and medium-sized enterprise. Its core business is the development of new drugs and innovative medical devices. Furthermore, the new drug development segment mainly emphasizes on botanical drugs. Overall speaking, major operating focuses of the biotech industry are capitals, technical talent and partners: (1) how to get enough funds to meet the new drug development needs; (2) hiring appropriate technical personnel to facilitate the progress of new drug development projects and (3) the cooperation partners , such as front-end research units, the raw material suppliers and the clinical trial units. The core competence of LBG is in the stage of 'translational medical research'. In the new drug development process, LBG collaborates with the academic and research institutions, including domestic partners (such as National Health Research Institute, Medical and Pharmaceutical Industry Technology and Development Center, Industrial Technology Research Institute, National Taiwan University, National Yang-Ming University, National Chiao Tung University, Tunghai University, etc.), and foreign partners (such as Memorial Sloan Kettering Cancer Center, Texas MD Anderson Cancer Center, Stanford University, Japan Chiba University, Nagoya University, Kyushu University, etc.), while their innovative technologies are transferred to LBG after diligent evaluations. At the clinical trial stage, Lite Biomedical Group cooperates with the domestic clinical centers (such as Tri-Services General Hospital, Taipei Veterans General Hospital, Chang Gung Medical Foundation, Taipei City Psychiatric Center, etc.), and other partners (such as Japan Yukiguni Maitake Co., Ltd., Pfizer, AMAREX Clinical Research and Ora, Inc., etc.) LBG aims at Integrating various resources of industries at different stages to create an industrial ecological system which combines international biotechnology talents and advanced technologies to create high product value. One of the key factors in the new drug industry is the source of funds. Large pharmaceutical companies have access to resources to cover subsequent R&D expenses from the core product sales or the out-license income of new drugs. However, in the case of small and medium-sized biotech companies, the main proceeds are out-license incomes. Development of new drugs is long and costly, and the main budget sources will be financed from capital market before the external authorization. LBG understands that compared to major international capital markets, funds raised from the Taiwan market will be limited. That is the reason for LBG's intents to list BioLite Holding in NYSE and to list ABVC in NASDAQ. The intention is to use global funds and partners for research and development, and ultimately for the product to do a global layout. Biotechnology new drug development industry requires high capital and technology threshold. The Taiwan capital market is small and lack of capital adequacy compared to the international capital market. This study examines the status of the new drug biotechnology industry in Taiwan, as compared to the global development. LBG, a Taiwan biotech company focusing on the development of new drugs and innovative medical devices, is illustrated as a case study. LBG's innovative business model, hopefully, will lead an example for Taiwan’s biotech companies who intend to join the global biotech market.