Objective： In the age of knowledge economy, multi-national companies have raised larger influence than ever in globalization. With the evolvement of the competition situation of pharmaceutical industry globally, pharmaceutical MNCs are facing the dilemma of not knowing which kind of pipeline will maximize their benefits. This study aims to explore the developing potential of global medical market by therapeutic categories, identify the association between pharmaceutical MNCs’ R&D and commercial performance, disclose the optimal structure of drug development pipeline and further to reveal the relationship between patent protection and product launch of MNCs in China, thus to raise their specific globalization strategies of R&D and market launch. Methods： In the globalization study, the sample is composed of 16 therapeutic areas and Top 50 drug firms in the world in 2009, drug count in 7 R&D periods are collected(Source: IMS Health Knowledge Link Database). Cluster analysis with Pearson correlation measuring pipeline similarity is conducted on the sampled therapeutic areas and companies. One-way ANOVA with firm sales as dependent variable is run after companies are clustered. The pipeline concentration ratio was measured by Herfindahl-Hirschman Index (HHI). Spearman’s correlation test between HHI and firm sales is run. In the localization study, all companies in Drugs & Biotechnology Industry categories in Forbes 2008 Top 500 are sampled, the data includes amount of patent application(PA), import drug approval(IDA) and local drug approval(LDA) of sampled companies in China from 1992 to 2009, multi-variable statistical analysis is conducted, localization degree (LD=IDA/(IDA+ LDA)) is established. Results： Entering therapeutic categories of anti-cancer, anti-infection and nervous system drugs with high market growth potential in beneficial to companies’ constant development. Pipeline concentration ratio correlates negatively with sampled MNCs’ sales. According to pipeline similarity, sampled firms are divided into three clusters. Type I Firms have highest sales of 19,076 million USD, compared to Type II and Type III firms. There are significant correlations between PA, IDL, and LDA of MNCs in China. PA is correlated to 2-year lag to 7-year lag of IDL, and is correlated to 4-year lag of IDL most significantly. Most pharmaceutical MNCs’ LD maintains a relatively low standard. Conclusion： Efficient R&D resource allocation has become the crucial factor affecting pharmaceutical MNCs’ global competition. R&D structure is significantly associated with corporate performance in pharmaceutical sector. Pipeline dispersion, raising quantity and quality of drug candidates thus balancing early-stage risk versus long-term rewards in drug development programs could yield high commercial performance. High patent application input in China could increase MNCs’ market share by multi-varieties and multi-specifications launch. They apply for Chinese patents in advance of 4 years on average when exporting drugs to China. MNCs mainly execute product trade strategies instead of localization investment and technology introduction in Chinese medical market. Key words： Multi-national pharmaceutical company, R&D, market launch, globalization, localization

在知識經濟時代，跨國公司對經濟全球化進程具有舉足輕重的影響。隨著世 界藥業競爭格局的演變，跨國製藥企業面臨著不知道哪一種藥物開發管線能夠最 大化商業效益的難題。本研究旨在探索全球藥品市場各治療類別的發展潛力，揭 示跨國製藥企業藥物研發與經營績效的内在联系及其药物開發管线的最優結構， 發掘跨國製藥企業在華產品市場投放與專利保護的內在聯繫。以期為跨國製藥企 業提升全球與中國的研發与市場投放效率提供策略規劃。 全球化研究以 IMS Health 公司 Knowledge Link 數據庫為數據源，獲取 2009 年全球藥品市場 16 個治療領域及前 50 位跨國製藥企業處於 7 個藥品開發階段的 藥品數量，分別對治療類別和樣本企業進行聚類分析，對聚類後樣本企業的銷售 額進行單因素方差分析。利用赫芬達爾—赫希曼指數衡量樣本企業管線的集中 度，將企業的管線集中度與銷售收入進行斯皮爾曼秩相關分析。本土化研究以福 布斯 2008 全球 500 強中 Drugs & Biotechnology Industry 類別中的上市醫藥公 司為樣本，收集 1992 年至 2009 年樣本企業在華的專利申請量（PA），進口藥品 註冊證量（IDL）以及藥品批准文號量（LDA），進行多變量統計分析，并建立跨 國製藥企業在華本土化程度的評價指標體系：本地化程度（LD）=LDA /（IDL+ LDA）。 進入抗腫瘤，抗感染，神經系統藥物等市場成長潛力高的治療領域，有利於 跨國藥企持續的市場發展。樣本企業管線集中度與銷售收入負相關，且根據藥品 開發管線結構的相似性可聚集為三類，I 型公司的營銷收入平均為 190.76 億美 元，顯著的高於 II 和 III 型公司。跨國藥企在華的專利申請量與藥品註冊品種 顯著性正相關，與 2 年滯後到 7 年滯後的進口藥品註冊證數量顯著性正相關，且 與 4 年滯後的進口藥品註冊證量的相關係數最大。多數的跨國藥企在華的投資本 土化程度處於較低水平。 注重研發資源的重點投放是跨國藥企全球化競爭的根本途徑。跨國製藥企業 藥物研發結構與經營績效存在密切的聯繫。藥物開發管線的分佈離散化，注重提 升在研藥物的數量和質量以取得藥品開發項目中早期風險與長期回報的平衡能 夠為跨國藥企產出更高的經營績效。優勢的專利申請投入可以促使跨國藥企通過 多品種多規格的藥品投放提升在華的市場份額。跨國藥企趨向於在對藥品申請中國專利后平均 4 年左右後獲得進口藥品上市許可。跨國藥企在中國醫藥市場採取 產品貿易為主、產業投資和技術引進為輔的市場投放模式， 關鍵字：跨國製藥企業，新藥研發，市場投放，全球化，本土化