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思泰文康 - 中國生命科學的貿易和技術平台 Stravencon Limited- Chinese Life Sciences Trade & Technology Platform

思泰文康 - 中國生命科學的貿易和技術平台 Stravencon Limited- Chinese Life Sciences Trade & Technology Platform. June 2012. What is Stravencon? 思泰文康簡介.

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思泰文康 - 中國生命科學的貿易和技術平台 Stravencon Limited- Chinese Life Sciences Trade & Technology Platform

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  1. 思泰文康-中國生命科學的貿易和技術平台Stravencon Limited- Chinese Life Sciences Trade & Technology Platform June 2012

  2. What is Stravencon?思泰文康簡介 • 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 專注于中國和歐盟之間貿易的專業醫療健康産品公司,為希望進入歐盟市場的中國企業提供“一站式”解決方案。 • Provides access to European healthcare markets through:通過如下方式,協助進入歐洲醫療健康産品市場 • Regulatory guidance (GMP auditing/documentation preparation) and European filings to obtain marketing authorizations 藥政法規指導( GMP審計/文件准備)以及在歐盟提交文件以獲得市場准入證書(MA) • Distribution, sales & marketing support through network of partner companies 通過協作網絡進行分銷、銷售和市場營銷支撐 • Builds alliances between European, North American and Chinese firms for 建立歐洲、北美和中國公司的聯盟關系,以進行 • - Toll manufacturing (OEM) 合同生産加工 • - Technology transfer from Europe/US to China 從歐洲和美國技術轉移到中國 • - Product co-development in China 在中國的産品合作開發 • - 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.提供金融咨詢服務,特別是為中國公司在歐洲尋求融資、投資和/或並購歐洲企業提供咨詢服務。

  3. Stravencon Product Trading Platform-China to Europe思泰文康的產品貿易平台-中國到歐洲 • Stravencon obtains marketing authorisations 思泰文康獲得市場准入許可 • Products supplied directly to partner companies and purchasing organisations 產品直接提供給合作夥伴公司和採購機構 • Stravencon manages “closed loop” supply chain 思泰文康管理“閉環”供應鏈 • Manufacturers hold strategic inventory 製造商保有戰略庫存 Products产品 Products产品 Partner Companies & Purchasing Organizations 合作夥伴公司和採購機構 Marketing Authorisation市場准入許可 Chinese Manufacturers 中國製造商 Data资料 Stravencon Ltd. 思泰文康 Payments付款 Payments付款

  4. Stravencon Product Trading Models-China to EU 思泰文康産品貿易模式-從中國出口到歐盟

  5. Chinese Biotech company 中國生物技術公司 The Biotechnology Partnering Model 生物科技夥伴關系模式 Stravencon- Technical /Financial intermediary 思泰文康-技術和財政方面的居間橋梁 ---------------- Gateway to Licensing, Regulatory & Market Information許可證、藥政法規和市場的路徑 Sourceof Funds 融資 EU Biotech Company 歐洲生物技術公司

  6. Key issues in the Biotechnology Partnering Model 生物科技夥伴關系模式的關鍵因素

  7. Stravencon Board of Directors思泰文康董事會 Years IndustryName-姓名 Position- 職位 Previous/Current Employers Experience Douglas B. Andrews Director & CEO Consilient Health Ltd., 34安達格 董事&首席執行官 Schering-Plough Julian Attfield Director & CFO GeneMedix, Sigma-Genosys Ltd. 17朱利安 董事&首席財政官Arthur Andersen (now Deloittes) Veni Harania MBE Non-Exec Director Pharmacist and Pharmacy chain 40 哈維尼 非執行董事 Management

  8. Stravencon Management Team- Commercial operations 思泰文康管理團隊-商務運作 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 規劃和業務拓展總監 W.J. Hargan Commercial Director Hospira Healthcare BV, Abbott 32 哈百裏 商務總監 and Knoll AG Richard Alexander Commercial Operations Teva (IVAX), ratiopharm 20 理查德 Specialty Generics (Hospital Markets and Biosimilars) 商務運作(專科仿制藥) William (Xiaoli) Wang Country Manager Western Australia Trade Office 21 王曉立 China 中華區首席代表

  9. Outsourced Team –Technical & Regulatory 外協團隊-技術及藥政 Years IndustryName-姓名 Position- 職位 Previous/Current Employers Experience David Bilton Director of Procurement Ice Pharma Group 25 畢大偉 and Operations SmithKline Beecham 團體采購及運營總監 Dr Alvaro Espina QP Technical Operations Yerfis, Spyfarma & Ferrer 20奧維羅 博士&QP Chief Auditor Bluefish Pharma 技術團隊首席審計官 David Farrer QP Interim Auditor Ciba Vision, Celltech and 34 法大维(QP) 臨時審計官 SR Pharma David Clapperton QP QA Management Medicines Testing Labs 32科大衛(QP)QA管理 CBF and Select Pharma Services Graeme Ladds QP Pharmacovigilance Pharsafer Ltd 25 藍格木(QP) 藥物監測

  10. Outsourced Team –Technical & Regulatory 外協團隊-技術及藥政 Years IndustryName-姓名 Position- 職位 Previous/Current Employers Experience Andy Pickbourne Head of Regulatory & Ice Pharma Group 20 皮安迪 Documentation 藥政和文件負責人 Archana Khodke Manager of Regulatory Affairs Ice Pharma Group 15 阿可娜 藥政法規事務經理 Joanna Przysowa Project Manager- Production Ice Pharma Group 10 周安娜 planning 項目經理-生産計劃 Alex Chu Project Manager-Logistics Ice Pharma Group 10 褚軍威 項目經理-物流

  11. Stravencon Organigramme思泰文康組織機構圖表 CEO首席執行官 Douglas Andrews 安達格 Operations & Procurement項目及團體采購總監 David Bilton 畢大偉 Country Manager China中華區首席代表 William Wang 王曉立 Finance & Admin財務和行政 Julian Attfield 朱利安 Business Development業務拓展 Bruce Murdoch 穆德克 European Commercial歐盟商務 Bill Hargan 哈百裏 Technical Director技術首席 Dr Alvaro Espina 奧維羅 Regulatory & Tech Doc藥政和文件 Andy Pickbourne皮安迪 QA ManagementQA管理 David Clapperton QP’科大维(QP) Safety & PV 安全和藥物監測 Dr Graeme Ladds藍格木

  12. Stravencon –Therapeutic areas of interest 思泰文康-在治療領域的興趣

  13. The Chinese Pharmaceutical Industry as a Supplier of Generic Medicines to Europe 為歐洲提供仿制藥的中國醫藥行業

  14. Chinese Industry expansion from 2000-2000年以來中國醫藥行業的擴展 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 中國已是全球市場最重要的原料藥供貨商。中國和國際的原料藥法規不久會更加嚴格。 State support for integrated export (i.e., including FDF’s) to regulated markets國家對向藥政法規市場的整合出口(包括制劑)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. 認識到為獲得財務和財務方面的優勢 ,醫藥行業的整合是不可避免的-十年內,3500家企業將變為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的獎懲所驅動,對生産質量和規範的觀念更新正在進行中。 Continuous pressure by Government on improving “external image” which has been badly damaged over recent years with various scandals.來自于政府的改善“外部形象”的壓力。 此 “外部形象”已被近年來的多宗醜聞所嚴重破壞。 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?中國醫藥産業的新氣象 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中國政府和國家藥監局在1995年對産品注冊、臨床試驗要求、 cGMP和進出口法規實施了新法規。到2013年年中,對原料藥生産的更嚴厲的法規將開始實施。 Introduction in 2005 of IP protection and enforcement of Patents on Pharmaceutical products and processes對醫藥産品和生産過程專利的知識産權保護和執法于2005年開始實施。 The Healthcare Stimulus Package of RMB 850 billion ($ 125 billion) between 2009-2011-2009-2011年間的8500億人民幣 (1250億美元)的醫療衛生刺激計劃 The Introduction of 3 National Health Insurance schemes in Oct 2010 to cover 1.23 billion people or 90% of population-2010年10月覆蓋12.3億人口或90%全國人口的3個全國醫療保險方案的實施 The realisation that the “basket of inventions” is running out and “Innovation” will be critical for survival in 21st century意識到“一攬子發明”將枯竭,“創新” 將是在21世紀生存的關鍵 The wealthy middle classes are demanding better products and more intervention in health issues富裕的中産階級需要更好的醫療衛生産品及對健康問題的更多的幹預。 . What is driving internal changes? 變化的內因

  16. Chinese Pharmaceutical Industry中國醫藥産業 State controlled versus Private sector國有控制的企業與民營企業的對比 Source- Datamonitor 2010

  17. Pharmaceutical companies 醫藥公司 US/EU Approved companies 歐美核可的公司 Chinese Pharmaceutical Industry- Transition中國醫藥行業-轉變

  18. Chinese Industry in 2011-2011年的中國醫藥産業 API and FDF sites approved by US FDA or EU authorities. Stringent new regulations on APIs expected by mid-2013 由美國FDA 和歐盟藥政法規當局核可的原料藥和制劑的生産場地。更嚴格的原料藥法規預計將于2013年中期對外公布。

  19. Factors favouring Chinese Companies對中國企業有利的因素 What supports the Opportunities for Chinese Pharmaceutical Industry moving into regulated markets有利于中國制藥企業進入藥政法規市場的各個方面

  20. The Stravencon Portfolio 思泰文康産品組合

  21. Stravencon Products under Development 思泰文康在開發的産品 • Hospital Antibiotics- Series of 4 Cephalosporins under development and 11 MAs under control. 3 supply points confirmed醫院抗生素-4個頭孢系列産品,11個MA。 確定的三個供應點 • Specialized Injectable Oncology products for EU markets from a new greenfield site in Sichuan Province 來自四川省的新建企業的供應歐盟市場的專科抗腫瘤注射劑産品 • Specialized Injectable Oncology products for EU markets. 4 products from US-approved manufacturer in Jiangsu and Shandong Provinces. EU-GMP factory audits conducted 供應歐盟市場的專科抗腫瘤注射劑産品。四個産品來自美國核可的江蘇和山東的生産廠家。 進行了歐盟-GMP工廠審計 • Specialized Oral Oncology products for EU markets. 4 products from an EU-approved manufacturer in Beijing 供應歐盟市場的專科抗腫瘤口服産品。四個産品來自歐盟核可的北京的生産廠家。

  22. Stravencon Partner Network on the mainland of China and Taiwan 思泰文康在大陸和台灣的合作網絡 Oncology Companyunder discussion 抗癌藥物公司(探討中) New Cephalosporin Plant-finalinspection新頭孢工廠(等待最後審計) Injectable Oncology & API manufacturer-ready to sign 抗癌注射制劑和原料藥制造商-准備簽約 Injectable Oncology Manufacturer-ready 抗癌注射制劑制造商 Stravencon Shanghai Office 思泰文康上海辦公室 • New Oncology Manufacturer& JV partner • under construction 新抗癌注射制劑制造商 • & 合資夥伴-在建 Oncology contract signed 抗腫瘤合同已簽 Primary Injectable Ceph Manufacturer for NHS NHS頭孢制劑首要制造商

  23. Stravencon Ltd 思泰文康有限公司 The Injectable Cephalosporins 頭孢類注射制劑

  24. Entry into Injectable Antibiotics Market進入抗生素注射制劑市場 The 4 Cephalosporins are the most widely used in the hospital environment and are considered essential drugs 這四個頭孢菌素品種在醫院裡是最被廣泛使用, 並且是認可的基本藥物 The EU total market value in 2010 is >Euros 150 million 2010年歐盟總市場總價值是超過1.50億歐元 There are limited number of major competitors 只有數量有限的主要競爭者 The prices and volumes of these products are more or less stable in most markets 在大部分的市場,這些産品的價格和數量差不多已穩定 The EU markets are split between Tender and Direct supply 歐盟市場可被劃分為招標和直接供應 Two Chinese suppliers of finished products Shenzhen Zhijun Pharmaceuticals (cGMP-approved) North China Pharmaceuticals (new build) 兩個中國供應商供應頭孢菌素抗生素制劑 深圳致君制藥(cGMP核可) 華北制藥(新建頭孢項目) Stravencon has licensed 4 Cephalosporin antibiotics – 11 Market Authorisations for UK and EU 思泰文康現有四個品種的頭孢菌素抗生素 – 11個規格的英國和歐盟市場准入許可

  25. Completed in December 2006--2006年12月完工 Area: 45,000m2 –面積:45,000平方米 Investment for phase I was 228 million Yuan–一期投資2.28億人民幣 Finished Dosage Form Manufacturer –Sterile injectables 出口歐盟的制劑的生産工廠-無菌注射劑 Shenzhen Plant深圳工廠 Zhijun R& D center & production base in Guanlan 在觀瀾的致君研發中心和生産基地

  26. Shenzhen Zhijun- GMP Certification深圳致君- GMP資質 EU GMP 歐盟GMP

  27. Collaboration with North China Pharmaceutical Group 與華北制藥的合作

  28. Layout of NCPC Hebei, Huamin華北制藥集團華民公司布局圖

  29. Important visitors to NCPC new facility重要客人訪問華藥頭孢新項目 MHRA/UKTI/ Stravencon delegation in front of NCPC Huamin new facility 到訪的英國醫藥産品監管局(MHRA )/英國貿易投資總署(UKTI)/思泰文康代表團在全新的華藥華民基地內合影

  30. Products - Cephalosporin injectables産品-頭孢類抗生素注射劑 An Example of packaging of Cephalosporin range 頭孢類抗生素注射劑包裝樣本

  31. Seacross Pharmaceuticals 海越醫藥 The Injectable Oncology Portfolio 抗癌注射制劑的産品組合

  32. Main Injectable Oncology products 主要抗癌注射制劑産品 Products are being sourced through JV parties and other approved Chinese suppliers産品供應通過合資夥伴和其他認可的中國供應商進行組織

  33. Stravencon Injectable Oncology Portfolio 思泰文康抗腫瘤注射劑産品組合 Product Marketing Authorisation & Dossier acquisition 産品市場准入證書和産品文檔的購入

  34. European market value for major oncology injectables主要抗癌産品的歐洲市場價值 Phase One Oncology Products--European market value 第一階段的抗癌産品- 歐洲市場價值 Source: IMS 2010 data

  35. Stravencon speciality product –Phase 2 思泰文康專科産品 – 第二階段 The Oral Oncology products 口服抗癌産品

  36. Main Oral Oncology products 主要口服抗癌産品 Products are being sourced through approved Chinese suppliers産品供應通過認可的中國供應商來組織

  37. Stravencon Oncology Product List- Phase Two思泰文康抗癌産品列表 - 第二階段 • Oral products- Main indications and EU market size • 口服抗癌産品-主要治療領域和歐洲市場價值

  38. Summary and conclusions 小結和結論 Stravencon excellently placed to benefit from: 思泰文康的精准定位可以從如下方面獲益: Emergence of quality Chinese suppliers of generic finished dosage forms (FDF’s)高品質的中國仿制藥制劑産品供應商的出現 Growing EU Generic Markets as distressed healthcare systems seek greater savings 捉襟見肘的醫療衛生體系尋求開支節約,推動了歐盟仿制藥市場的發展 Already ‘partner of choice’ for some of the most significant Chinese pharmaceutical companies 已經成為一些中國舉足輕重的制藥企業精挑細選後的合作夥伴

  39. Thanks!多謝! 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, Shanghai, P. R of China 上海市淮海路93號大上海時代廣場26樓T: +86 21 51176325 F: +86 21 51179300 M: +86 133 7255 6858   W: www.stravencon.com.cn 

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