中国制药企业如何建立创新药物研发体系-药大讲座

file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v1.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v1.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v1.psd中国制药企业如何建立创新药物研发体系file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd中国制药工业现状——增幅超过GDPfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd中国制药工业盈利能力不断增强file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd创新研发是提高医药企业获利能力的唯一途径file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd中国医药产业升级必须走创新研发道路file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd主要跨国大制药公司2007年研发投入排名公司R&D投入(亿USD)占销售收入比率(%)1辉瑞pfizer80.8916.72强生Johnson&Johnson76.8012.63罗氏Roche74.30＞154赛诺菲-安万特Sanofi-Aventis66.2416.25葛兰素-史克GSK66.2114.66阿斯利康AstraZeneca51.6217.57默克Merck49.0020.28拜耳Bayer37.12＞159礼来EliLilly34.8718.710布迈-施贵宝BMS32.8217.011安进Amgen32.6622.112惠氏Wyeth32.5714.513诺华Novartis29.5020.314基因泰克Genetech24.4621.0file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd至2005年全球开发的创新药数量中国在创新药物研究开发领域必须奋起直追！2008年国家科技部启动了重大科技专项“重大新药创制”file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd近5年FDA批准上市新药及全新药品资料来源:SFDANDA（NewDrugApplication）是新药上市申请，在FDA的管理体制下，按照化学分类NDA包括以下几种类型：新分子实体药物；新酯基、新盐或其他非共价衍生物药物；新剂型药物；新复方药物；新制剂配方或新生产商的药物；原已上市但未有NDA申请的药品；由处方药转OTC的药品。新分子实体(NME)的开发难度越来越大!file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd中国医药市场蕴藏着巨大的市场潜力file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd创新药研发——提高企业竞争壁垒file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd先声药业具备了建立以企业为主体创新研发体系的基础条件2007年4月20日先声药业成为中国第一家在美国纽交所上市的化学生物药企业，充分展示了中国民族制药企业的国际形象。经国际权威会计所KPMG审计对投资者公布的财务数据显示：2007年销售收入13.89亿（其中生物药销售达到2.16亿），上缴税收2.01亿，净利润3.01亿。2008年销售收入将达到18.0亿，净利润3.9亿。2007年研发投入6830万，达年销售收入的4.95%，2008年研发投入将达到8000万，2009年预算1亿。“十五”期间自主研发成功创新药恩度，并获准上市，2007年销售达到2.16亿元；现有在研具有自主知识产权的一类创新药物10个具备建立以企业为主体创新药物研发体系的基础条件按照企业发展规划和增长速度，预计2013年销售收入将达到80亿元file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd科研机构高等学校（化学药中试及产业化）生产子公司GMP车间先声药业集团先声药物研究院（生物药中试及产业化）生产子公司GMP车间建立企业创新研发体系的基本思路先声药业技术中心——国家认定企业技术中心/企业博士后科研工作站先声药业有限公司——国家重点高新技术企业国际合作研发file://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Cover_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Section_v2.psdfile://\\IBHKS025\HALFWAY\ArtworkDesignbyHKPresCenter\POWERPOINTTEMPLATE\Earnest\Content_v2.psd设立明确的创新研发中期目标总目标——通过3-5年的建设，建立以先声药业为主体，产学研紧密结合的聚焦