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思泰文康 - 中国生命科学的贸易和技术平台 Stravencon Limited- Chinese Life Sciences Trade & Technology Platform

思泰文康 - 中国生命科学的贸易和技术平台 Stravencon Limited- Chinese Life Sciences Trade & Technology Platform. June 2012. What is Stravencon? 思泰文康简介.

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思泰文康 - 中国生命科学的贸易和技术平台 Stravencon Limited- Chinese Life Sciences Trade & Technology Platform

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  1. 思泰文康-中国生命科学的贸易和技术平台Stravencon Limited- Chinese Life Sciences Trade & Technology Platform June 2012

  2. What is Stravencon?思泰文康简介 • Specialized healthcare product company focussed on trade between China and Europe. It operates as a “one stop shop” for Chinese companies wishing to access European markets 专注于中国和欧盟之间贸易的专业医疗健康产品公司,为希望进入欧盟市场的中国企业提供“一站式”解决方案。 • Provides access to European healthcare markets through: 通过如下方式,协助进入欧洲医疗健康产品市场 • Regulatory guidance (GMP auditing/documentation preparation) and European filings to obtain marketing authorizations 药政法规指导( GMP审计/文件准备)以及在欧盟提交文件以获得市场准入证书(MA) • Distribution, sales & marketing support through network of partner companies 通过协作网络进行分销、销售和市场营销支撑 • Builds alliances between European, North American and Chinese firms for 建立欧洲、北美和中国公司的联盟关系,以进行 • - Toll manufacturing (OEM) 合同生产加工 • - Technology transfer from Europe/US to China 从欧洲和美国进行技术转移到中国 • - Product co-development in China 在中国的产品合作开发 • - Biotechnology 生物科技 • Provides financial advisory services, particularly for Chinese pharmaceutical companies seeking to raise capital, invest and/or acquire assets in Europe. 提供金融咨询服务,特别是为中国公司在欧洲寻求融资、投资和/或并购欧洲企业提供咨询服务。

  3. Stravencon Product Trading Platform-China to Europe思泰文康的产品贸易平台-中国到欧洲 • Stravencon obtains marketing authorisations 思泰文康获得市场准入许可 • Products supplied directly to partner companies and purchasing organisations 产品直接提供给合作伙伴公司和采购机构 • Stravencon manages “closed loop” supply chain 思泰文康管理“闭环”供应链 • Manufacturers hold strategic inventory 制造商保有战略库存 Products产品 Products产品 Partner Companies & Purchasing Organizations 合作伙伴公司和采购机构 Marketing Authorisation市场准入许可 Chinese Manufacturers 中国制造商 Data资料 Stravencon Ltd. 思泰文康 Payments付款 Payments付款

  4. Stravencon Product Trading Models-China to EU 思泰文康产品贸易模式-从中国出口到欧盟

  5. Chinese Biotech company中国生物技术公司 The Biotechnology Partnering Model 生物科技伙伴关系模式 Stravencon- Technical /Financial intermediary 思泰文康-技术和财政方面的居间桥梁 ---------------- Gateway to Licensing, Regulatory & Market Information 许可证、药政法规和市场的路径 Sourceof Funds融资 EU Biotech Company 欧洲生物技术公司

  6. Key issues in the Biotechnology Partnering Model 生物科技伙伴关系模式的关键因素

  7. Stravencon Board of Directors 思泰文康董事会 Years IndustryName-姓名 Position-职位 Previous/Current Employers Experience Douglas B. Andrews Director & CEO Consilient Health Ltd., 34安达格 董事&首席执行官Schering-Plough Julian Attfield Director & CFO GeneMedix, Sigma-Genosys Ltd. 17朱利安 董事&首席财政官Arthur Andersen (now Deloittes) Veni Harania MBE Non-Exec Director Pharmacist and Pharmacy chain 40 哈维尼非执行董事 Management

  8. Stravencon Management Team- Commercial operations 思泰文康管理团队-商务运作 Years IndustryName-姓名 Position-职位 Previous/Current Employers Experience Bruce Murdoch Director of Planning & Avesthagen, Schering-Plough, 40穆德克 Business DevelopmentPharmacia, AstraZeneca 规划和业务拓展总监 W.J. Hargan Commercial Director Hospira Healthcare BV, Abbott 32 哈百里 商务总监 and Knoll AG Richard Alexander Commercial Operations Teva (IVAX), ratiopharm 20 理查德 Specialty Generics (Hospital Markets and Biosimilars) 商务运作(专科仿制药) William (Xiaoli) Wang Country Manager Western Australia Trade Office 21 王晓立 China 中华区首席代表

  9. Outsourced Team –Technical & Regulatory外协团队-技术及药政 Years IndustryName Position Previous/Current Employers Experience David Bilton Director of Procurement Ice Pharma Group 25 毕大伟 and Operations SmithKline Beecham 团体采购及运营总监 Dr Alvaro Espina QP Technical Operations Yerfis, Spyfarma & Ferrer 20奥维罗 博士&QP Chief Auditor Bluefish Pharma 技术团队首席审计官 David Farrer QP Interim Auditor Ciba Vision, Celltech and 34 法大维(QP) 临时审计官 SR Pharma David Clapperton QP QA Management Medicines Testing Labs 32科大卫(QP) QA管理 CBF and Select Pharma Services Graeme Ladds QP Pharmacovigilance Pharsafer Ltd 25 蓝格木(QP) 药物监测

  10. Outsourced Team –Technical & Regulatory外协团队-技术及药政 Years IndustryName-姓名 Position-职位 Previous/Current Employers Experience Andy Pickbourne Head of Regulatory & Ice Pharma Group 20 皮安迪 Documentation 药政和文件负责人 Archana Khodke Manager of Regulatory Affairs Ice Pharma Group 15 阿可娜 药政法规事务经理 Joanna Przysowa Project Manager- Production Ice Pharma Group 10 周安娜 planning 项目经理-生产计划 Alex Chu Project Manager-Logistics Ice Pharma Group 10 褚军威 项目经理-物流

  11. Stravencon Organigramme 思泰文康组织机构图表 CEO首席执行官 Douglas Andrews 安达格 Country Manager China中华区首席代表 William Wang 王晓立 Finance & Admin财务和行政 Julian Attfield 朱利安 Operations & Procurement团体采购及运作总监 David Bilton 毕大伟 Business Development业务拓展 Bruce Murdoch 穆德克 European Commercial欧盟商务 Bill Hargan 哈百里 Technical Director技术首席 Dr Alvaro Espina 奥维罗 Regulatory & Tech Doc药政和文件 Andy Pickbourne皮安迪 QA ManagementQA管理 David Clapperton QP’科大维(QP) Safety & PV 安全和药物检测 Dr Graeme Ladds蓝格木

  12. Stravencon –Therapeutic areas of interest思泰文康-在治疗领域的兴趣

  13. The Chinese Pharmaceutical Industry as a Supplier of Generic Medicines to Europe 为欧洲提供仿制药的中国医药行业

  14. Chinese Industry expansion from 2000-2000年以来中国医药行业的扩张 China is already the leading supplier of pharmaceutical active ingredients (API’s) to the global market. Chinese and international regulation of API’s will soon become more rigourous中国已是全球市场最重要的原料药供货商。中国和国际的原料药法规不久会更加严格。 State support for integrated export (i.e., including FDF’s) to regulated markets 国家对向药政法规市场的整合出口(包括制剂)的支持 There is a realization that pharmaceutical industry consolidation is inevitable in order to gain financial strength – The 3,500 will become 350 within 10 years.认识到为获得财务和财务方面的优势,医药行业的整合是不可避免的-十年内,3500家企业将变为350家。 A major “change of mindset” regarding production quality and discipline is underway, driven by SFDA with incentives and penalties. Also supported by presence of US FDA and EMA offices. 由SFDA的奖惩所驱动,对生产质量和规范的主要的观念更新正在进行中。 Continuous pressure by Government on improving “external image” which has been badly damaged over recent years with various scandals. 来自于政府的改善“外部形象”的压力。 此 “外部形象”已被近年来的多宗丑闻所严重破坏。 What are the main factors – positive & negative? 主要的有利因素和不利因素

  15. What’s new in the Chinese Pharmaceutical scene? 中国医药产业的新气象 Since 1995, the Chinese Government and SFDA have introduced new regulations on Product Registration, Clinical Trials requirements, cGMP , Import & export regulations. By mid-2013 stricter regulations will be in place regarding the manufacturing of APIs in Chinese factories 中国政府和国家药监局在1995年对产品注册、临床试验要求、 cGMP和进出口法规实施了新法规。到2013年年中,对原料药生产的更严厉的法规将开始实施。 Introduction in 2005 of IP protection and enforcement of Patents on Pharmaceutical products and processes 对医药产品和生产过程专利的知识产权保护和执法于2005年开始实施。 The Healthcare Stimulus Package of RMB 850 billion ($ 125 billion) between 2009-2011-2009-2011年间的8500亿人民币 (1250亿美元)的医疗卫生刺激计划 The Introduction of 3 National Health Insurance schemes in Oct 2010 to cover 1.23 billion people or 90% of population-2010年10月覆盖12.3亿人口或90%全国人口的3个全国医疗保险方案 的实施 The realisation that the “basket of inventions” is running out and “Innovation” will be critical for survival in 21st century 意识到“一揽子发明”将枯竭,“创新” 将是在21世纪生存的关键 The wealthy middle classes are demanding better products and more intervention in health issues 富裕的中产阶级需要更好的医疗卫生产品及对健康问题的更多的干预。 . What is driving internal changes? 变化的内因

  16. Chinese Pharmaceutical Industry 中国医药产业 State controlled versus Private sector 国有控制的企业与民营企业的对比 Source- Datamonitor 2010

  17. Pharmaceutical companies 医药公司 US/EU Approved companies 欧美核可的公司 Chinese Pharmaceutical Industry- Transition 中国医药行业-转变

  18. Chinese Industry in 2011-2011年的中国医药产业 API and FDF sites approved by US FDA or EU authorities. Stringent new regulations on APIs expected by mid-2013 由美国FDA 和欧盟药政法规当局核可的原料药和制剂的生产场地。更严格的原料药法规预计将于2013年中期对外公布。

  19. Factors favouring Chinese Companies 对中国企业有利的因素 What supports the Opportunities for Chinese Pharmaceutical Industry moving into regulated markets 有利于中国制药企业进入药政法规市场的各个方面

  20. The Stravencon Portfolio 思泰文康产品组合

  21. Stravencon Products under Development 思泰文康在开发的产品 • Hospital Antibiotics- Series of 4 Cephalosporins under development and 11 MAs under control. 3 supply points confirmed 医院抗生素-4个头孢系列产品,11个MA。确定的三个供应点 • Specialized Injectable Oncology products for EU markets from a new greenfield site in Sichuan Province 来自四川省的新建企业的供应欧盟市场的专科抗肿瘤注射剂产品 • Specialized Injectable Oncology products for EU markets. 4 products from US-approved manufacturer in Jiangsu and Shandong Provinces. EU-GMP factory audits conducted供应欧盟市场的专科抗肿瘤注射剂产品。四个产品来自美国核可的江苏和山东的生产厂家。进行了欧盟-GMP工厂审计 • Specialized Oral Oncology products for EU markets. 4 products from an EU-approved manufacturer in Beijing供应欧盟市场的专科抗肿瘤口服产品。四个产品来自欧盟核可的北京的生产厂家。

  22. Stravencon Partner Network on the mainland of China and Taiwan 思泰文康在大陆和台湾的合作网络 Oncology Companyunder discussion 抗癌药物公司(探讨中) New Cephalosporin Plant-finalinspection 新头孢工厂(等待最后审计) Injectable Oncology & API manufacturer-ready to sign 抗癌注射制剂和原料药制造商-准备签约 Injectable Oncology Manufacturer-ready 抗癌注射制剂制造商 Stravencon Shanghai Office 思泰文康上海办公室 • New Oncology Manufacturer& JV partner • under construction 新抗癌注射制剂制造商 • & 合资伙伴-在建 Oncology contract signed 抗肿瘤合同已签 Primary Injectable Ceph Manufacturer for NHS NHS头孢制剂首要制造商

  23. Stravencon Ltd 思泰文康有限公司 The Injectable Cephalosporins 头孢类注射制剂

  24. Entry into Injectable Antibiotics Market 进入抗生素注射制剂市场 The 4 Cephalosporins are the most widely used in the hospital environment and are considered essential drugs 这四个头孢菌素品种在医院裡是最被广泛使用, 并且是认可的基本药物 The EU total market value in 2010 is >Euros 150 million 2010年欧盟总市场总价值是超过1.50亿欧元 There are limited number of major competitors 只有数量有限的主要竞争者 The prices and volumes of these products are more or less stable in most markets 在大部分的市场,这些产品的价格和数量差不多已稳定 The EU markets are split between Tender and Direct supply 欧盟市场可被划分为招标和直接供应 Two Chinese suppliers of finished products Shenzhen Zhijun Pharmaceuticals (cGMP-approved) North China Pharmaceuticals (new build) 两个中国供应商供应头孢菌素抗生素制剂 深圳致君制药(cGMP核可) 华北制药(新建头孢项目) Stravencon has licensed 4 Cephalosporin antibiotics – 11 Market Authorisations for UK and EU 思泰文康现有四个品种的头孢菌素抗生素 – 11个规格的英国和欧盟市场准入许可

  25. Completed in December 2006--2006年12月完工 Area: 45,000m2 –面积:45,000平方米 Investment for phase I was 228 million Yuan–一期投资2.28亿人民币 Finished Dosage Form Manufacturer –Sterile injectables 出口欧盟的制剂的生产工厂-无菌注射剂 Shenzhen Plant深圳工厂 Zhijun R& D center & production base in Guanlan 在观澜的致君研发中心和生产基地

  26. Shenzhen Zhijun- GMP Certification 深圳致君- GMP资质 EU GMP 欧盟GMP

  27. Collaboration with North China Pharmaceutical Group 与华北制药的合作

  28. Layout of NCPC Hebei, Huamin华北制药集团华民公司布局图

  29. Important visitors to NCPC new facility 重要客人访问华药头孢新项目 MHRA/UKTI/ Stravencon delegation in front of NCPC Huamin new facility 到访的英国医药产品监管局(MHRA )/英国贸易投资总署(UKTI)/思泰文康代表团在全新的华药华民基地内合影

  30. Products - Cephalosporin injectables 产品-头孢类抗生素注射剂 An Example of packaging of Cephalosporin range 头孢类抗生素注射剂包装样本

  31. Seacross Pharmaceuticals 海越医药 The Injectable Oncology Portfolio 抗癌注射制剂的产品组合

  32. Main Injectable Oncology products主要抗癌注射制剂产品 Products are being sourced through JV parties and other approved Chinese suppliers 产品供应通过合资伙伴和其他认可的中国供应商进行组织

  33. Stravencon Injectable Oncology Portfolio思泰文康抗肿瘤注射剂产品组合 Product Marketing Authorisation & Dossier acquisition 产品市场准入证书和产品文档的购入

  34. European market value for major oncology injectables主要抗癌产品的欧洲市场价值 Phase One Oncology Products--European market value 第一阶段的抗癌产品- 欧洲市场价值 Source: IMS 2010 data

  35. Stravencon speciality product –Phase 2 思泰文康专科产品 – 第二阶段 The Oral Oncology products 口服抗癌产品

  36. Main Oral Oncology products主要口服抗癌产品 Products are being sourced through approved Chinese suppliers 产品供应通过认可的中国供应商来组织

  37. Stravencon Oncology Product List- Phase Two思泰文康抗癌产品列表 - 第二阶段 • Oral products- Main indications and EU market size • 口服抗癌产品-主要治疗领域和欧洲市场价值

  38. Summary and conclusions 小结和结论 Stravencon excellently placed to benefit from: 思泰文康的精准定位可以从如下方面获益: Emergence of quality Chinese suppliers of generic finished dosage forms (FDF’s)高品质的中国仿制药制剂产品供应商的出现 Growing EU Generic Markets as distressed healthcare systems seek greater savings 捉襟见肘的医疗卫生体系寻求开支节约,推动了欧盟仿制药市场的发展 Already ‘partner of choice’ for some of the most significant Chinese pharmaceutical companies 已经成为一些中国举足轻重的制药企业精挑细选后的合作伙伴

  39. Thanks!多谢! Stravencon Ltd in UK The Landmark 17 Hanover Square, Mayfair London W1S 1HU United Kingdom T: +44 20 7518 0378 F: +44 20 7518 0302 M: +44 788 182 0416 M: +86 133 5711 6495 W: www.stravencon.com Stravencon Rep Office in China Level 26, Shanghai Times Square, No.93 Huaihai Rd, Puxi 上海市淮海路93号大上海时代广场26楼T: +86 21 51176325 F: +86 21 51179300 M: +86 133 7255 6858   W: www.stravencon.com.cn 

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