澳門大學碩士研究生論文 Abstract As the second largest manufacturer and main exporter of API (chemical active pharmaceutical ingredient), China is capable to manufacture pharmaceuticals, but less capable at R&D of new drug. For a long time, China has been executed the "me-too" strategy, and 97% of the chemical drugs produced in china are generic drugs. If we want to upgrade the international competition of Chinese pharmaceutical industry, we must discard the purely "me-too" strategy and gradually develop our ability in R&D of new drugs, or we will lose in the new compitition. As far as R&D of new drug is concerned, US is the most powerful country in the world, holding about 60% of worldwide drug patent. Should we clearly clarify its practice and experience essential to its success, it will provide necessary framework and suggestions to improve R&D of new drug and therefore accelerate the healthy and sustainable development of pharmaceutical industry in China. The thesis is devided into three parts. Utilizing the "diamond" system from Nation Competition Theory put forward by Michael Porter, an internationally famous strategy expert, the thesis analyzes the necessary conditions for R&D of new drug in the US, the situations and problems existing in R&D of new drug in China, and strategies of promoting Chinese R&D of new drug, from the aspects of production factors, domestic market situations, development of related industries and sciences, system and strategy of the enterprise vs.the competitors. Key words: china new drug innovation diamond system

澳門大學碩士研究生論文 摘要 中國是一個制藥大國,但不是一個制藥強國,新藥研發能力不強,長期以來, 一直以仿製為主,特別是化學藥,97%都是仿製藥。要提升中國醫藥產業的國際 競爭力,中國必須 棄純粹以仿製為主的產業策略,逐步提升自己的新藥研發能 力,否則中國的醫藥產業將會在新一輪的競爭中處於劣勢。美國是全球新藥研發 能力最強的國家,擁有世界60%左右的藥品專利,如能分析清楚其成功所賴以的 實踐和經驗,將為培養中國的新藥研發能力,促進產業健康、持續發展提供一定 的建議和思路。 本論文分為三部分: 分別運用國際著名戰略專家麥克爾.波特國家競爭理論 的“鑽石體系”為分析框架,從新藥研發生產要素,國內市場環境,相關產業和 學科的發展,企業組織結構、戰略和競爭對手,政府的作用五個角度剖析影響美 國新藥研發能力的各項要素;分析中國新藥研發過程中存在的問題;並提出提升 中國新藥研發能力的戰略措施。 關鍵字:中國 新藥創新 鑽石體系