疫苗大会文稿.pptx

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1、Global Vaccine Leaders 世界疫苗的竞争格局世界疫苗的竞争格局The top 5 players accounting for around 80%of the total market 全球前五大疫苗企业占了全球疫苗市场的80%2005,3 out of the world top 10 pharmas involved in vaccine business2010,9 out of the world top10 pharmas involved in vaccine business2005年，世界十大制药企业只有三家有疫苗；目前十家里九家有疫苗产业2005百特澳洲

2、英联邦血液实验室凯龙惠氏Sanofi Pasteur (2008.07,$546M)赛诺菲巴斯德Novartis 诺华(2006,$5.5B)AstraZeneca 阿斯利康(2007.06,$15.6B)博尔纳Crucell 科伯纳(2005.12.8,$450M)Pfizer 辉瑞(2009.10.15,$68B)Johnson&Johnson 强生(2009.09,EU302M=18%stock)苏威Abbott 雅培(2010.02,EU4.5B)Merck 默沙东(2009.9.3 Flu vaccine)默沙东葛兰素史克赛诺菲巴斯德第1页/共20页Major Vaccines in

3、 Development 全球现处临床开发阶段的主要疫苗全球现处临床开发阶段的主要疫苗2Infectious Diseases 传染病传染病Manufacturer 生产厂家生产厂家Vaccine疫苗名称疫苗名称Development临床开发阶段临床开发阶段Notes 备注备注Travelers diarrhea 旅行者腹泻IntercellN/APhase IITuberculosis 结核菌GSKN/APhase IIIntercellN/APhase IWith Sanofi-AventisRSV 呼吸道合胞病毒MedImmuneMotavizumabPhase IIIHIV/AIDS

4、艾滋病病毒NovavaxN/APreclinicalSanofi-AventisN/APhase IIIHSV-2 2型单纯疱疹病毒GSKSimplirixPhase IIIFormally HerpevacDengue fever 登革热病毒GSKN/APhase IIWest Nile virus 西尼罗河脑炎病毒Sanofi-AventisChimeriVax-WN02Phase IIMalaria 疟疾GSKRTS,SPhase IIIGSKMosquirixPhase IIEBV 艾普斯登-巴尔病毒GSKN/APhase IIFrom MedImmuneTyphoid 伤寒菌Norv

5、atisN/APreclinicalWith Wellcome TrustCMV 细胞巨大型病毒GSKN/APhase IStaph.aureus 金黄色葡萄球菌MerckV710Phase II With Intercell“Nice Shot-Why vaccines are pharmas Next Big Thing.”By Megan Scudellari,The Scientist 2009 24:32 第2页/共20页Domestic Vaccine Market 中国疫苗市场中国疫苗市场Worlds largest population;17 million newborn b

6、abies each year.世界1/4人口；每年的一千五到七百万新生儿。The largest vaccine manufacturer by dose;the fourth largest vaccine market.世界上最大的疫苗生产国；世界第四大疫苗市场.Over 30 manufacturers producing 40 vaccines against over 20 diseases共有疫苗生产企业30多家，可以生产预防20多种传染病的40多种疫苗The growth rate for the past has been 15%,exceeding 5 billion RM

7、B on 2009.中国的疫苗市场过去几年的增速大约是15%,2009年超过RMB￥50亿元，The best selling vaccines(by sales)are Rabies and Influenza vaccines.以狂犬病疫苗和流感疫苗销售最高。The growth rate for next few years over 20%,reaching 8 billion RMB by 2012.未来几年的增速有望达到25%；到2012年，市场的容量将达到RMB￥80亿元。Only 1/25th of the world vaccine market.占全球疫苗市场的25-30分

8、之一 3第3页/共20页Room for Growth:Vaccine Supply vs.Demand 成长空间：成长空间：中国疫苗产能中国疫苗产能For many vaccines,current domestic production capabilities cant meet demand.Most production processes need a major upgrade.中国许多疫苗品种的产能严重不足，生产技术急需提升4第4页/共20页Room for Growth:Process Improvement Needed成长空间：国内疫苗需要提升的生产工艺成长空间：国内疫苗

9、需要提升的生产工艺5Areas need future improvement生产工艺需要提升的疫苗领域生产工艺需要提升的疫苗领域Large scale production technologies for mammalian cells and several viral vaccines病毒型疫苗及其宿主细胞的大规模培养技术，包括流感裂解疫苗，轮状病毒疫苗和水痘疫苗Effective yeast expression platform and HPV vaccine酵母高效表达平台，及酵母表达的HPV疫苗Effective insect expression platform and H

10、PV vaccine昆虫细胞高效表达平台，及昆虫细胞HPV疫苗Recombinant vaccine development各种新型基因工程构建的亚单位疫苗Large scale production and process upgrade for several vaccines newly added to the National Immunization Plan扩大免疫计划疫苗的规模化生产和升级换代，包括脊髓灰质炎疫苗；无细胞百白破疫苗；麻腮风三联减毒活疫苗；甲肝疫苗Scale-up production and QC techniques for Pneumococcal 23-v

11、alent polysaccharide vaccine23价肺炎疫苗的规模化生产和质控关键技术Highly efficient expression and purification of carrier proteins for conjugate vaccines 结合疫苗载体蛋白的高效表达技术和分离纯化技术Conjugate vaccine technologies,including activation of polysaccharide,conjugation,purification,QC,and evaluation of conjugation efficiency,etc

12、.细菌多糖蛋白结合疫苗技术，包括多糖活化，结合条件和纯化条件的优化；质量分析标准的研究；疫苗结合效果的评估。涉及疫苗包括肺炎，流脑，Hib，伤寒，副伤寒，痢疾，及大肠杆菌疫苗第5页/共20页Pros and Cons of Chinese R&D Environment中国疫苗研发环境的优缺点比较中国疫苗研发环境的优缺点比较6Pros优点Affordable HR cost(1/7 of USA HR cost)容易负担的人力资源 Strong government supports on land and infrastructure强大的政府支持力度High quality hardwar

13、e(GMP plant,instrument)高质量的硬件系统Good working ethics优良的职业道德Strong wills to learn new technologies强烈的求知欲望Vaccine R&D budget can be relatively high(10-20%)疫苗研发投入比例相对较高第6页/共20页Pros and Cons of Chinese R&D Environment中国疫苗研发环境的优缺点比较中国疫苗研发环境的优缺点比较7Cons缺点Expensive instruments(150%of listed prices)偏贵的进口设备Long

14、 waiting period for any imported goods(2-3 months)对进口物品漫长的等待时间Frugal attitude towards consumables can be costly对消耗品的节约可能适得其反Softwares(SOP,training,compliance)need improvement软件部分需要改进Not often with R&D mind-sets,lack of innovative thinking无研发和创新思维习惯Leadership&VC are mostly looking for short-term retu

15、rn领导和VC多数只重短期效益Cant often take“its not working”for an R&D result通常难接受研发不利的结果Non-R&D functions can negatively impact R&D outcome非研发部门可以影响研发全局IT security management close to non-existing 信息安全意识和管理几乎为零第7页/共20页8R&D Strategy of A Typical Vaccine Manufacturer 国内私营疫苗企业的研发策略国内私营疫苗企业的研发策略Most products have b

16、een developed through collaborations or tech transfer新产品开发主要采用联合开发或转让的方式Basic research activities are often carriedout by academic collaborators基础研究由科研机构完成R&D team takes over each project at pilot stage,often with established process研发团队在中试阶段进入R&D R&D Tech Transfer and Tech Transfer and Process Adap

17、tationProcess AdaptationThis way,the R&D team can focus itslimited resources mostly on industrialization研发团队集中有限力量进行产业化研究第8页/共20页Success Example：Recombinant HEV Vaccine 成功范例：基因工程戊肝疫苗成功范例：基因工程戊肝疫苗9Seroprevalence data suggest that a third of the worlds population has been infected with the hepatitis E

18、 virus.Currently there is no HEV vaccine.血清学数据表面全球有三分之一人口曾感染过戊型肝炎病毒。国内外尚无疫苗。Through a long term collaboration among Dr.Ning-Shao Xia at National Institute of Diagnostics and Vaccine Development in Infectious Diseases,Beijing Wantai Biological Pharmacy,and Xiamen Innovax Biotech,a major breakthrough

19、has been made in HEV vaccine development.The vaccine,HEV 239,has just passed a Phase III efficacy trial with 97356 participants,and is on SFDAs fast approval track.The results were published in Lancet 2010.由厦门大学国家传染病诊断试剂与疫苗工程技术研究中心夏宁邵博士、北京养生堂万泰生物药业股份有限公司、厦门万泰沧海生物技术有限公司等单位联合研制的戊型肝炎疫苗取得重大突破，由97356人参加的

20、三期临床研究证实戊肝疫苗安全有效，等待药监部门批准后即可迅速上市。相关研究成果近日在柳叶刀发表。Four international patents on the vaccine have been granted.迄今已取得4项国内外授权发明专利，是我国少见的高度原创性生物药物之一。Zhu,F-C,et al.2010.Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults:a large-scale,randomised,double-blind placebo-controlled,phase

21、3 trial.The Lancet,376(9744):895-902,第9页/共20页401(K)Management vs.China Vaccine R&D Strategy 类比退休基金管理和中国疫苗研发策略类比退休基金管理和中国疫苗研发策略10第10页/共20页11Innovation Drives Growth 创新刺激增长创新刺激增长Simcere R&D Strategy:Increasing focus on innovation先声研发策略：逐渐增加对创新的药和候选物的重视20052005200620062007200720082008第11页/共20页1212Simce

22、re Snapshot先声药业集团简介 A NYSE company,with highest standard of corporate compliance and transparency About 3000 sales reps and 1,500 distributors,covering over 3,000 hospitals and 70,000 retail pharmacies 8 GMP facilities supporting small molecule and biologics manufacturing China-leading R&D capabilit

23、ies 中国领先的研发能力12第12页/共20页A Leader in Chinas Pharmaceutical Industry中国医药业的领袖中国医药业的领袖CAGR=33%Ranking(排行):#21 in Net Profit in China healthcare industry*中国医疗业总利润排名第21名#7 among the Top 20 most competitive public listed healthcare companies in China中国最具竞争力的前20家医疗业上市企业中排第7名*2009 Chinese Medical Statistical

24、 Yearbook by Ministry of Industry and Information Technology of PRCRevenue(M,RMB)13第13页/共20页Differentiated Products with Market Leadership in Oncology and CNS差别性产差别性产品和聚焦医疗领域品和聚焦医疗领域14Therapeutic AreaTherapeutic AreaBrand NameBrand NameProductProductOncologyEnduProprietary recombinant human endostat

25、in injection,NSCLCJiebaishuNedaplatin injectionSinofuan5FU sustained release implantNeuroscienceBicun/YidashengEdaravone injection,ischemic strokeCardiovascularXintaLevamlodipine besylate tablets,hypertensionShufutanGeneric rotuvasatin tablets,hyperlipidemiaInfectious DiseaseAnxinBiapenem injection,

26、bacterial infectionZanamivirZanamivir inhalation powder,influenzaInflammationYingtaiqingDiclofenac sodium delayed release capsules,arthritis painQiangkeEtanercept,Ankylosing Spondylitis 第14页/共20页15Simcere Biologics Capabilities先声生物制先声生物制品品Biopharmaceuticals100%Simcere R&D Center35%52.5%Shanghai Celg

27、en Bio-Pharmaceutical Co.Ltd.上海赛金生物制药 Jiangsu Yanshen Biological Technology Stock Co.Ltd.江苏延申生物Humanized Rabbit MAbsCo-development with Epitomics on humanized RabMab antibody therapeutics for multiple tumorsVaccine ResearchEtanerceptDrug to treat auto-immune diseases.Completed clinical trials and aw

28、aiting SFDA approvalVaccinesManufacturer of Influenza vaccine(to be marketed on 2011)R&D pipeline with Hep A and Rabies vaccine candidates,etcInstitute of Biologics Research 生物制品所Department of Vaccine Research 疫苗研究部Shandong Simcere Medgenn Bio-Pharmaceutical Co.Ltd.山东先声麦得津生物制药Endu(Endostatin)Innovat

29、ive anti-cancer drug with sales of RMB124m in 2009Platforms平台 MAbs单克隆抗体Mammalian cells哺乳细胞表达Pilot under construction 中试在建New-type vaccine research planned新型疫苗研究在计划中Platforms平台 MAbs单克隆抗体Mammalian cells哺乳细胞表达Pilot&GMP 中试和GMP生产Platforms平台 Egg-based split vaccineCell-based inactivated vaccine 鸡胚裂解疫苗和细胞灭

30、活疫苗Pilot&GMP 中试和GMP生产Platforms平台 Recombinant protein重组蛋白E.coli Expression大肠杆菌表达Yeast Expression 酵母表达Pilot&GMP 中试和GMP生产第15页/共20页16New Vaccine Facilities and Products 新厂新厂址和产品址和产品Build on a 19.5 acres land.占地130亩.R&D pilot plant has been used to develop Rabies vaccine based on a bioreactor technology.

31、目前研发中试车间已经用于生物反应器狂犬疫苗的开发Hep A and Flu vaccine facilities,Fill&Finish,as well as new QC lab,will be completed this year甲肝、流感、分包装车间和新的QC实验室于今年完工第16页/共20页Simcere Vaccine Strategy先声疫苗战略先声疫苗战略Enter Chinese vaccine market through acquisition of Jiangsu Yanshen通过兼并疫苗企业进入中国疫苗市场Ensure progress of the current

32、 product pipelines in Jiangsu Yanshen确保目前江苏延申生物的产品线的进程Establish Vaccine Research Department in Simcere R&D Center,with both upstream discovery and downstream development capabilities,as well as a rich pipeline balancing short-,mid-,and long-term goals在先声研发中心成立先声疫苗研究部，建立上游发现和下游攻关相结合的、短中长相匹配的、管线丰富的研发体

33、系Seek technology transfer and in-license opportunities for established vaccine processes and products to enrich Simcere current product portfolio寻找机会，对成熟的工艺和产品进行技术转让或项目引进以丰富先声疫苗产品Seek collaboration opportunities for clinical-and/or pre-clinical stage vaccine candidates both internationally and domes

34、tically寻求对处于临床和临产前阶段的疫苗候选物的合作机会，放眼国际也关注国内17第17页/共20页Simcere Vaccine Strategy先声疫苗战略先声疫苗战略Enter Chinese vaccine market through acquisition of Jiangsu Yanshen通过兼并疫苗企业进入中国疫苗市场Ensure progress of the current product pipelines in Jiangsu Yanshen确保目前江苏延申生物的产品线的进程Establish Vaccine Research Department in Simc

35、ere R&D Center,with both upstream discovery and downstream development capabilities,as well as a rich pipeline balancing short-,mid-,and long-term goals在先声研发中心成立先声疫苗研究部，建立上游发现和下游攻关相结合的、短中长相匹配的、管线丰富的研发体系Seek technology transfer and in-license opportunities for established vaccine processes and produc

36、ts to enrich Simcere current product portfolio寻找机会，对成熟的工艺和产品进行技术转让或项目引进以丰富先声疫苗产品Seek collaboration opportunities for clinical-and/or pre-clinical stage vaccine candidates both internationally and domestically寻求对处于临床和临产前阶段的疫苗候选物的合作机会，放眼国际也关注国内18Simcere is the partner of choice for a number of multina

37、tional companies先声是各大跨国企业的首选合作伙伴第18页/共20页Continuous Improvement不断改进不断改进We know we are not there yet.But we are fully committed to continuously improve ourselves.And we welcome all the helps and collaboration opportunities to reach this goal.我们知道离目标还有差距，但我们承诺不断地改进自己.我们欢迎所有能够帮助我们实现这个目标的合作伙伴和机遇。19China Vaccine ManufacturersGlobal VaccineLeaders第19页/共20页4/20/202320感谢您的观看！第20页/共20页