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I 摘要 乳腺癌是严重威胁女性健康的恶性肿瘤。根据国际癌症研究署(IARC)网络 数据库 GLOBOCAN 的统计,乳腺癌是全球范围内女性发病率最高(25%)的癌症, 就癌症相关死亡而言,乳腺癌是全球女性第一位(15%)的死亡原因。在中国,2013 年我国乳腺癌 DALY 为 166.6 万人/年,占全球 12.7%,较 1990 年增加 56.7%,其 中 DALY 率峰值年龄是 50~59 岁,伤残损失寿命年占 DALY 比重的全国水平为 8.7%(分省份该数值范围为 8.l%~9.0%)。其重要原因一方面是自然环境的恶化及 女性生活压力的增加,另一方面是抗癌药物少、疗效低、价格高,多数药物依靠 进口。JT 药业公司正是在这一背景下提出伊沙匹隆研发、生产项目。这一项目的 可行性是本报告研究探讨的主题。本文以 JT 药业公司伊沙匹隆项目为背景,利用 项目管理方法中关于可行性研究的理论与方法,对项目的技术方案的确定、财务 和经济、环境影响及产品的市场前景进行了分析与评估,对项目的可行性进行了 综合分析和客观评价,为 JT 药业公司的项目实施提供了理论支持。报告主要分析 了以下内容, 一、概述了项目可行性研究理论起源及在国内发展运用情况,分析了伊沙匹 隆的临床优势及在国内外生产方法、现状及发展趋势,为伊沙匹隆项目提供了相 关市场数据支持,并提出本文研究主要目标、研究方法和研究内容; 二、描述了伊沙匹隆项目的主要内容和企业概况,通过对目前我国药品研发、 生产企业存在问题的分析,提出了该项目的必要性和优势条件,并给出了项目投 资估算和资金使用的主要数据; 三、系统分析了 JT 药业公司伊沙匹隆项目建设方案的相关内容,主要为市场 分析、技术分析、环境保护分析等项目关键内容,为项目投资提供了科学客观的 依据; 四、从风险管理和经济评价的角度,对项目可行性方案进行项目风险管理和 风险分析及财务效益评价,使之能够客观、准确、详实的反映伊沙匹隆项目的实 际情况。 药物的研发和生产已经成为当今制药产业中极为重要的组成部分,而抗癌药 物的研发和生产更是该领域中的重点投资方向。本文不仅为 JT 药业公司伊沙匹隆 项目投资提供了依据,同时也通过对该项目的研究,为药物自主研发、生产类企 业制定发展规划和投资计划提供了可以借鉴的基本模式。摘要 II 关键词,投资项目,项目管理,可行性研究,技术可行性,经济可行性,环境影 响评价ABSTRACT III ABSTRACT Breast cancer is a serious malignant tumor that threatens women's health. According to GLOBOCAN, a network database of the International Agency for Research on Cancer (IARC), breast cancer is the highest incidence of cancer in women worldwide (25%), and in the case of cancer-related deaths, breast cancer is the leading cause of death among women worldwide (15%). In China, DALY of breast cancer in China was 1.666 million people / year in 2013, accounting for 12.7% of the world, 56.7% more than in 1990. The peak DALY age was 50-59 years old, and the national level of years lived with disability accounting for the proportion of DALY is 8.7% (The numerical range of the province is 8.l% ~ 9.0%). On the one hand, the significant cause is the deterioration of the natural environment and the increase of the pressure on women’s daily lives; on the other hand, it is caused by the lack of anticancer drugs, with low curative effect but high prices, and mostly rely on import. It is in this context that JT Pharmaceutical Company proposed the R&D, production project of ixabepilone. The feasibility of this project is the theme of this thesis. Based on the ixabepilone project of JT Pharmaceutical Company, this thesis takes advantage of the theory and method of feasibility study in project management methods to analyze and evaluate the project construction conditions, technical solutions, process parameters, finance and economy, environmental impact and market prospect. To provide JT Pharmaceutical Company project implementation with a theoretical support, this thesis conducts a comprehensive analysis and objective evaluation of the feasibility of the project, mainly in the following four aspects: Firstly, it summarizes the origin of the project feasibility study theory and its application in China, and put forward the main objectives of this study, research methods and contents. Providing relevant clinical and industrial data support for the ixabepilone project, it analyzes the clinical advantages, production methods at home and abroad, current situation and development trend of ixabepilone. Secondly, it describes the background and business profile of ixabepilone project. Through the analysis of the existing problems in Chinese pharmaceutical R & D and manufacturing enterprises, it put forward the necessity and advantages of the project, with the main data for project investment estimation and fund-raising.ABSTRACT IV Thirdly, to provide a scientific and objective basis for project investment, it systematically analyzes the construction plan of the JT Pharmaceutical Company’s ixabepilone project, which is mainly composed of key elements such as market analysis, technical analysis and environmental protection analysis. Fourthly, from the perspective of risk management and economic evaluation, it conducts project risk management and analysis, financial benefit evaluation on the feasibility plan to objectively and accurately reflect the actual conditions of the project. Nowadays, R & D and production of drugs has become an extremely important part of the pharmaceutical industry. Furthermore, the development and production of anticancer drugs is the focus of investment in this area. This thesis not only provides the basis for the investment of JT Pharmaceutical Company's Ixabepilone project, but also a basic model that can be drawn upon for the independent R & D and manufacturing pharmaceutical enterprises to formulate the development plan and investment plan through the research on this project. Keywords:Investment Project, Project Management, Feasibility Study, Technical Feasibility, Economic Feasibility, Environmental ImpactAssessment目录 V 目录 第一章 绪论.....................................................................................................................1 1.1 项目研究的背景与意义......................................................................................1 1.1.1 理论背景...................................................................................................1 1.1.2 项目背景...................................................................................................3 1.1.3 研究的意义和价值...................................................................................4 1.2 可行性研究的必要性..........................................................................................4 1.3 可行性研究的目标和内容..................................................................................5 1.4 可行性研究的方法..............................................................................................5 1.5 可行性研究的基本原则......................................................................................6 第二章 抗癌药物伊沙匹隆项目概况.............................................................................8 2.1 药物合成方法的创新、研发及生产背景介绍..................................................8 2.1.1 药物合成方法创新的相关基本概念.......................................................8 2.1.2 相关产业概述...........................................................................................8 2.2 抗癌药物伊沙匹隆概况......................................................................................9 2.3 项目的 SWOT 分析..........................................................................................11 2.3.1 SWOT 分析法的含义..............................................................................11 2.3.2 伊沙匹隆项目的 SWOT 分析................................................................12 2.4 申报平台构建的关键要素分析........................................................................12 2.4.1 我国药物申报政策的历史沿革.............................................................12 2.4.2 药品评审、注册管理部门的变迁.........................................................13 2.4.3 当前药品注册制度调整对企业申报药品的影响.................................14 2.4.4 当前政策下 JT 药业的申报平台关键要素...........................................15 2.5 生产平台构建的关键要素分析........................................................................16 2.5.1 基本原则.................................................................................................16 2.5.2 生产平台搭建过程中的要素.................................................................17 第三章 通过全合成方法生产伊沙匹隆的任务分解及工艺路线...............................19 3.1 全合成方法生产抗癌药物伊沙匹隆过程的任务分解....................................19 3.1.1 全合成方法生产伊沙匹隆项目的总体目标.........................................19 3.1.2 工作分解结构 WBS(Work Breakdown Structure).................................20 3.1.3 全合成方法生产伊沙匹隆项目的工作分解.........................................22目录 VI 3.2 全合成伊沙匹隆工艺路线................................................................................25 3.3 研发平台构建的关键要素分析........................................................................26 第四章 通过全合成方法生产伊沙匹隆的技术可行性分析.......................................29 4.1 技术基础............................................................................................................29 4.2 技术研究过程分析............................................................................................30 4.2.1 JT 药业首席科学家关于伊沙匹隆的技术研究过程.............................30 4.2.2 JT 药业研发团队研究过程.....................................................................31 4.3 技术特点及意义................................................................................................34 第五章 通过全合成方法生产伊沙匹隆的市场需求分析...........................................36 5.1 抗癌药物及抗乳腺癌药物的市场需求分析....................................................36 5.2 伊沙匹隆市场分析............................................................................................38 5.3 伊沙匹隆在国内定价预测................................................................................39 第六章 JT 药业公司伊沙匹隆项目经济评价及风险分析..........................................40 6.1 财务评价............................................................................................................40 6.1.1 投资和成本估算.....................................................................................40 6.1.2 资金流和经济评价.................................................................................43 6.1.3 敏感性分析.............................................................................................46 6.2 环境影响评价....................................................................................................47 6.2.1 环境影响评价的内容.............................................................................47 6.2.2 环境影响评价的作用.............................................................................48 6.2.3 研发过程的环境影响评价.....................................................................48 6.2.4 生产过程的环境影响评价.....................................................................49 6.3 风险分析............................................................................................................51 第七章 总结...................................................................................................................53 7.1 报告研究的主要结论........................................................................................53 7.2 未来的研究方向................................................................................................53 致谢.................................................................................................................................55