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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 June 2012.

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Presentation on theme: "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."— Presentation transcript:

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 Marketing Authorisation市場准入許可
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 Marketing Authorisation市場准入許可 Partner Companies & Purchasing Organizations 合作夥伴公司和採購機構 Chinese Manufacturers 中國製造商 Data资料 Stravencon Ltd. 思泰文康 Payments付款 Payments付款

4 Licensing agreement 授權協議 Agency agreement 代理協議 J/V agreement 合資協議
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 Licensing agreement 授權協議 Products MA held by Stravencon Ltd in EU 産品市場准入證書由思泰文康公司擁有 Products supply- exclusive agreement with Chinese HQ company中國公司通過獨家供貨協議供貨 Agency agreement 代理協議 Products MA held by Chinese legal entity managed by Stravencon産品市場准入證書由中國法人擁有,由思泰文康公司管理 Products supply from Chinese HQ company under management agreement中國公司通過管理協議供貨 J/V agreement 合資協議 Stravencon & Chinese co invest in EU legal entity. MA held by JV 思泰文康和中國建立合資公司,産品市場准入證書由JV公司擁有 Products supply under exclusive agreement with J/V 産品通過通過獨家供貨協議供貨給JV

5 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 Chinese Biotech company 中國生物技術公司 EU Biotech Company 歐洲生物技術公司

6 Technology 技術 Financing 財務和財政
Key issues in the Biotechnology Partnering Model 生物科技夥伴關系模式的關鍵因素 Assessment of technology 技術評估 Modifications of platform science 平台科技的修正 Finding the compatible skills 尋求兼容的技能 Preparing the competitive position 規劃具有競爭性的定位 Technology 技術 Co-development Partner or Investor 合作開發夥伴或投資人 The development plan and true costs 開發計劃和真實成本 Where to do work to minimise time 工作地點選擇,以縮短時間 Allow funds to get this all right 調配資金使運轉正常 Financing 財務和財政

7 Stravencon Board of Directors 思泰文康董事會
Years Industry Name-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 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 Industry Name-姓名 Position-职位 Previous/Current Employers Experience Bruce Murdoch Director of Planning & Avesthagen, Schering-Plough, 40 穆德克 Business Development Pharmacia, AstraZeneca 規劃和業務拓展總監 W.J. Hargan Commercial Director Hospira Healthcare BV, Abbott 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 Industry Name-姓名 Position- 職位 Previous/Current Employers Experience David Bilton Director of Procurement Ice Pharma Group 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 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 法大维(QP) 臨時審計官 SR Pharma David Clapperton QP QA Management Medicines Testing Labs 科大衛(QP) QA管理 CBF and Select Pharma Services Graeme Ladds QP Pharmacovigilance Pharsafer Ltd 藍格木(QP) 藥物監測

10 Outsourced Team –Technical & Regulatory 外協團隊-技術及藥政
Years Industry Name-姓名 Position- 職位 Previous/Current Employers Experience Andy Pickbourne Head of Regulatory & Ice Pharma Group 皮安迪 Documentation 藥政和文件負責人 Archana Khodke Manager of Regulatory Affairs Ice Pharma Group 阿可娜 藥政法規事務經理 Joanna Przysowa Project Manager- Production Ice Pharma Group 周安娜 planning 項目經理-生産計劃 Alex Chu Project Manager-Logistics Ice Pharma Group 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 Finance & Admin財務和行政 Julian Attfield 朱利安 Business Development業務拓展 Bruce Murdoch 穆德克 Country Manager China中華區首席代表 William Wang 王曉立 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 Management QA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
Hospital Segment 醫院産品 Antibiotics& Antifungal 抗生素及抗真菌 Injectable & Oral Oncology注射和口服抗腫瘤藥物 Specialised Cardiology 心髒病專科 Pain control & anesthesia 疼痛控制與麻醉 Support Therapies 支持療法 Biological Therapies 生物療法

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
What are the main factors – positive & negative? 主要的有利因素和不利因素 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。

15 What’s new in the Chinese Pharmaceutical scene? 中國醫藥産業的新氣象
What is driving internal changes? 變化的內因 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 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。 .

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 Private owned - 35% 民營 Foreign funded 29% 外資 State owned - 36% 國有

17 Chinese Pharmaceutical Industry- Transition 中國醫藥行業-轉變
Pharmaceutical companies 醫藥公司 US/EU Approved companies 歐美核可的公司 >6,000 ~3,500 350 2000 2010 2020 <10 ~30 >200

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。 COS’s 278 product approvals 278個産品已被核可 DMF’s 740 product approvals 740個産品已被核可 cGMP certs < 30 sites approved 少于30個場地被核可

19 GMP Changes GMP的變化 State funding support Low Cost base 國家資金方面的支持
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 GMP Changes GMP的變化 Low Cost base 低成本的基礎 API’s in World Mkt 世界市場的原料藥 Market ambition 市場野心 State funding support 國家資金方面的支持

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 Company under discussion 抗癌藥物公司(探討中) New Cephalosporin Plant- final inspection 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 The Injectable Cephalosporins
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
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 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)

25 Shenzhen Plant深圳工廠 Zhijun R& D center & production base in Guanlan
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 Completed in December 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

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

32 Oncology injectable products
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 Oxaliplatin 奧沙利鉑 Docetaxel 多西紫杉醇 Gemcitabine吉西他濱 Irinotecan伊立替康 Doxorubicin阿黴素 Epirubicin表柔比星 Carboplatin卡铂 Oncology injectable products 抗癌注射制剂産品

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 Products 産品 Source 來源 Countries 涵蓋國家 Carboplatin 卡铂 Genepharm Denmark & France Doxorubicin 阿黴素 UK, Ireland & Denmark Epirubicin表柔比星 Irinotecan伊立替康 Orion UK & others Oxaliplatin奧沙利鉑 Dossier only Docetaxel多西紫杉醇 TTY UK, Holland, Sweden Ireland & 9 others Gemcitabine吉西他濱 Spain & Portugal

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 European market value for major oncology injectables 主要抗癌産品的歐洲市場價值 2010 € million (百萬歐元) Evolution Index 指標 DOCETAXEL多西紫杉醇 848,408 101 OXALIPLATIN奥沙利铂 433,844 86 PACLITAXEL紫杉醇 414,269 99 DOXORUBICIN阿黴素 243,052 106 GEMCITABINE吉西他濱 226,539 72 IRINOTECAN伊立替康 225,554 78 EPIRUBICIN表柔比星 112,679 89 CARBOPLATIN卡铂 109,756 88 Source: IMS 2010 data

35 The Oral Oncology products
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 Oncology oral products
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 Capecitabine卡培他濱 Imatinib + other nibs 伊馬替尼+其他替尼 Tacrolimus他克莫司 Exemestane依西美坦 Oncology oral products 口服抗癌産品 Reorder this section to appear after injectables (i.e., chronologically)

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 Stravencon Oral Products口服産品 Product name 産品名稱 Indication 病症 Patent expiry 專利到期 Presentation 規格 Sales -Euros Mil 銷售額 (百萬歐元) Capecitabine 卡培他濱 Colon and Colorectal 2013 150 mg x 60 Tabs 200 Xeloda-Roche Cancer 500 mg x 120 Tabs Exemestane 依西美坦 Breast cancer Expired 25 mg x 30 Tabs 134 Aromasin-Pfizer 25 mg x 90 Tabs Imatinib 伊馬替尼 AML, CLL 2015/2016 60 X 100mg Tabs 775 Glivec -Novartis Pancreatic cancer 30 X 400mg Tacrolimus 他克莫司 Prophylaxis of Organ 1.5 mg x 50 Caps 273 Prograf-Astellas rejection 1 mg x 50 caps 5 mg x 50 caps

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 Rep Office in China Stravencon Ltd in UK
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: F: M:   W: Stravencon Ltd in UK The Landmark 17 Hanover Square, Mayfair London W1S 1HU United Kingdom T: F: M: M: W:


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