京都大学 / 新制・課程博士 / 博士(生命科学) / 甲第24044号 / 生博第470号 / 新制||生||63(附属図書館) / 京都大学大学院生命科学研究科統合生命科学専攻 / (主査)教授 河内 孝之, 教授 荒木 崇, 教授 中野 雄司 / 学位規則第4条第1項該当 / Doctor of Philosophy in Life Sciences / Kyoto University / DFAM

京都大学 / 新制・課程博士 / 博士(理学) / 甲第24461号 / 理博第4960号 / 新制||理||1708(附属図書館) / 京都大学大学院理学研究科生物科学専攻 / (主査)講師 嶋田 知生, 教授 松下 智直, 教授 田村 実 / 学位規則第4条第1項該当 / Doctor of Science / Kyoto University / DFAM

在各大藥廠明星藥品專利到期、新藥開發數量銳減的當下，全球首例植物新藥MediGene Veregen™ 的核准上市為製藥產業帶來新的希望，雖然製藥價值鏈與商品化模式已為人所熟知，但針對植物新藥特殊性所架構之商品化模式還是一個全新的議題，為了架構一個適合台灣中小型藥廠的植物新藥開發模式，本研究嘗試以技術層面為根基，從法規面、產品面與產業面深入探討MediGene Veregen™ 關鍵的成功因素，從中獲取值得台灣藥廠參考的經驗，同時考量台灣植物新藥開發的大環境限制因素，包括法規與健保，給予台灣藥廠一些植物新藥商品化策略建議。 本研究之架構以實務觀點出發，首先整理參考文獻以探討植物新藥包含的範圍與藥品開發流程，幫助藥廠了解植物新藥商品化需要具備的條件與資訊；接著針對台灣與美國在植物新藥方面審查上市之法規、流程與審核成果進行研究，結果顯示目前台灣有兩種植物新藥審查系統「中藥新藥」與「植物抽取新藥」，對廠商而言並不如美國單一系統來得便利；再者藉由探討植物新藥的價值鏈結構、法規結構、產品結構與產業結構，試圖架構植物新藥商品化模式；接下來以兩家新藥開發廠商為例進行實際個案研究，一家為成功推出植物新藥商品的德國藥廠MediGene AG，一家為台灣藥廠中天生技/合一生技，主要藉由分析MediGene Veregen™ 商品化過程的關鍵成功因素，比較中天生技/合一生技WH-1商品化模式的異同，探討是否有足以借鏡與改進之處。最後，歸納整理上述的研究做出結論，並且對於台灣藥廠提出策略建議，希望能對於台灣新藥開發公司有實質上的幫助。 / While the star drug patents of each big pharmaceutical company are expired one after another and the quantity of their newly developed drugs sharply declines in these years, MediGene Veregen™, the first botanical new drug in the world, enters the market and therefore brings a new hope for the pharmaceutical industry. Although the value chain and the commercialization model of pharmaceutical industry have been known and researched a lot, the specific construction of commercialization model for botanical drugs is still a brand new subject. In older to construct the model that is suitable for Taiwanese middle and small pharmaceutical companies for the process from development to commercialization of botanical new drugs, this research, based on the technical analysis, attempts to discuss the key success factors of MediGene Veregen™ through analyzing the aspects of the laws, regulations, industry and product itself. With the case study about the environmental limited factors of new drug development in Taiwan, including the laws and regulations as well as the health insurance, this research tries to offer Taiwan pharmaceutical companies some strategic suggestions for the development and commercialization of botanical new drugs. The structure of this research is based on the practical viewpoints. First, we reorganize the reference in order to define the scope of botanical new drugs and the processes of drug development. It can help pharmaceutical companies understand the conditions and information needed for botanical new drug commercialization. Then, our studies focus on the laws and regulations in Taiwan and the United States, as well as the application processes and approvals for botanical new drugs. The results show that there are two evaluation systems in Taiwan for botanical new drug applications. For those pharmaceutical companies, the dual system is not as convenient as the sole evaluation system in the States. Furthermore; based on the discussion on the structure of the value chain, laws, regulations, product and industry, this paper makes an attempt to construct a better commercialization model of botanical new drugs. Next, two pharmaceutical companies are chosen as case study in this paper. One is a German pharmaceutical company, MediGene AG, which launched the first botanical new drug. The other is a Taiwan pharmaceutical company, MicroBio Co., Ltd/Oneness Bio-Tech Co., Ltd. By analyzing the key success factors in the commercialization process of MediGene Veregen™ and comparing its commercialization model with MicroBio Co., Ltd/Oneness Bio-Tech Co. WH-1, we try to get any valuable idea and insight. Finally, our conclusion and strategic suggestions may have solid help for Taiwan botanical new drug pharmaceutical companies.

No description available.

俄羅斯的植物文化與人民的生活作息密不可分，俄羅斯植物因人們的信仰具有靈性，故在民俗活動中具有許多功能。俄羅斯文人將思鄉、戀愛、哀悼等諸多情感投射於植物，賦予植物豐富的美學價值。植物的美學意涵在中國文人墨客的生花妙筆之下，與俄羅斯相比毫不遜色，他們將花卉的意涵昇華至道德思想中，以植物象徵氣節、品格，或是烏托邦式的理想世界，這點是俄羅斯植物文化中罕見的現象。花木表現了各種形式的美，同時蘊含了無法言傳的情感，充分體現了中國人謙抑的民族性。 在俄語學界早已興起以文化背景為研究基礎的語言學說，其中最受人注目的理論便是韋列夏金與科斯托馬羅夫提出的語言國情學。他們提出詞彙背景理論，提倡學習語言應同時著重國情文化知識的涉獵，在當時的學界掀起了不小的旋風。然而隨著時代演變，語言國情學受其視角限制難以前進，在學者們的努力之下，蛻變成為語言文化學（лингвокультурология）。 本論文的中心理論為語言國情學及語言文化學皆看重的文化伴隨意義理論。文化伴隨意義不僅具有雙重性的矛盾現象，在語言對比的層面上，更分為許多類型。藉由分析植物詞語的內部意涵，可探究俄羅斯文化的另一風貌。俄漢植物詞語的對比研究及其翻譯策略一直以來較無系統性的整理與探討，此即本論文之研究緣起。

農作物生長，極易受到氣候如豪雨、颱風、高低溫、寒害、病蟲害等威脅，農民常年使用的農藥、化學肥料等都已被證實，有造成食品安全及水源污染之疑慮，且人口增加、生質燃料的轉作，對糧食供給產生排擠效應。應用溫室設施、水耕栽培技術及 IT 科技，控制植物生長所需光源、溫濕度、養份、病蟲害等環境的「植物工廠」，配合立體及多層架栽培，使農產品能依工業化流程生產及品質管控之新營運模式， 儼然已成為各國解決糧食問題、降低 Food Miles 及碳足跡重要課題。 本研究收集及分析國外植物工廠企業化經營的現況及問題點，運用由外而內(Outside-in)的產業結構分析(亦稱為機會基礎的成長策略)，找尋企業可進入、可獲利的產業機會，從利潤創造公式展開成各種價值動因 ( Value Driver )，把經營重點轉移到營運初期的規劃， 與重點項目評估， 使其能在營運期間的創造價值，進一步與植物工廠運作功能結合， 整理出經營的 9 個價值創造動因，包含單價、單位栽種密度、栽培架層數、栽培面積、年周轉數、平均良率、營運成本、投入成本及使用年限。 找出目前消費者的價值主張， 運用創新、一致、可執行的商業模式來執行及延續，並擬定出企業的策略系統圖 (Strategic Activity System )，經由關鍵的策略活動，執行策略及細部戰術。 / This research aims at the strategic analysis of the business model on the Urban Plant Factory for the future development in Taiwan. The growth of crops is highly vulnerable by climate like heavy rain, typhoon, hot and cold weather, pests etc. Furthermore, the food safety and underground water pollution concerns caused by agricultural pesticides and fertilizers spread. In addition, worldwide population growth and biomass fuels converted create a big pressure to the food supply chain. The " Plant Fatory " uses the greenhouse, hydroponics and IT technology to control light, temperature, humidity, nutrients, pests and disease of the corps growth environment, and the multi-layer cultivation shelf facilities, and the industrial production & quality control technology of new business model to solve the food problem has become an important topic, and solution to reduce foot mils and carbon footprint. In this study, collect and analyse oversea's Urban Plant Factory commerical reports and problems they faced, using the Outside-in strategy of the industrial structure analysis (also known as opportunity-based growth strategy), to find out the company's profitable cut-in opportunities. From the EBIT equation, to develope a variety of value drivers and apply the drivers to the Plant Factory''s management and dialy operation, and focus on the key success factors of the initial business planning and evaluation of the Plant Factory, enabling the value creation during the operationg period. Furthermore, combined with Plant Factory functions and identify nine value creation factors including price, the unit density of planting, cultivation shelf layers, the cultivation total area, annual turnover, annual average yields, operating costs, initial costs and life period. With current proper value proposition, using the innovative, valuable, consistent, executable business model to implement and extend, and develop the Strategic Activity System to find out the key strategic actions to implement the strategy.

No description available.

University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences