Stravencon Ltd. 思泰文康

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Section Title
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
Confidential
Copyright © Stravencon Limited 2010. All rights reserved.
Confidential
1
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。
Confidential
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Section
TitleProduct Trading Platform-China to Europe
Stravencon
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
Chinese
Manufacturers
Data资料
中國製造商
Payments付款
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Marketing Authorisation
Products产品
市場准入許可
Stravencon Ltd.
思泰文康
Payments付款
Partner
Companies &
Purchasing
Organizations
合作夥伴公司和
採購機構
Confidential
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Section Title Product Trading Models-China to EU
Stravencon
思泰文康産品貿易模式-從中國出口到歐盟
Licensing
agreement
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 supplyexclusive agreement
with Chinese HQ
company中國公司通過
獨家供貨協議供貨
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
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
授權協議
Agency
agreement 代理
協議
J/V agreement
合資協議
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Section
Title
The
Biotechnology
Partnering Model
生物科技夥伴關系模式
Chinese Biotech
company 中國生
物技術公司
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StravenconTechnical
/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
Source
of
Funds
融資
EU Biotech
Company 歐洲
生物技術公司
Confidential
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Section
Title in the Biotechnology Partnering Model
Key
issues
生物科技夥伴關系模式的關鍵因素
Technology
技術
• 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
Financing
財務和財政
• 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
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Section Title Board of Directors 思泰文康董事會
Stravencon
Name-姓名
Position- 職位
Previous/Current Employers
Years Industry
Experience
Douglas B. Andrews Director & CEO
Consilient Health Ltd.,
安達格
董事&首席執行官
Schering-Plough
Julian Attfield
Director & CFO
GeneMedix, Sigma-Genosys Ltd.
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
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Section Title Management Team- Commercial operations
Stravencon
思泰文康管理團隊-商務運作
Name-姓名
Position-职位
Previous/Current Employers
Years Industry
Experience
Bruce Murdoch
Director of Planning &
Avesthagen, Schering-Plough,
穆德克
Business Development
Pharmacia, AstraZeneca
40
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
理查德
Specialty Generics
(Hospital Markets and Biosimilars)
32
20
商務運作(專科仿制藥)
William (Xiaoli) Wang Country Manager
王曉立
Western Australia Trade Office
China
中華區首席代表
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Section TitleTeam –Technical & Regulatory 外協團隊-技術及藥政
Outsourced
Position- 職位
Name-姓名
Previous/Current Employers
David Bilton
Director of Procurement
Ice Pharma Group
畢大偉
and Operations
SmithKline Beecham
Years Industry
Experience
25
團體采購及運營總監
Dr Alvaro Espina QP Technical Operations
奧維羅 博士& QP
Chief Auditor
Yerfis, Spyfarma & Ferrer
Bluefish Pharma
20
Interim Auditor
Ciba Vision, Celltech and
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臨時審計官
SR Pharma
技術團隊首席審計官
David Farrer
QP
法大维(QP)
David Clapperton QP QA Management
科大衛(QP)
QA管理
Graeme Ladds
QP Pharmacovigilance
藍格木(QP)
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Medicines Testing Labs
CBF and Select Pharma Services
Pharsafer Ltd
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25
藥物監測
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Section TitleTeam –Technical & Regulatory 外協團隊-技術及藥政
Outsourced
Name-姓名
Position- 職位
Andy Pickbourne
Head of Regulatory &
皮安迪
Documentation
Previous/Current Employers
Years Industry
Experience
Ice Pharma Group
20
藥政和文件負責人
Archana Khodke
Manager of Regulatory Affairs
阿可娜
藥政法規事務經理
Joanna Przysowa
Project Manager- Production
周安娜
planning
Ice Pharma Group
15
Ice Pharma Group
10
Ice Pharma Group
10
項目經理-生産計劃
Alex Chu
Project Manager-Logistics
褚軍威
項目經理-物流
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Section Title Organigramme 思泰文康組織機構圖表
Stravencon
CEO首席執行官
Douglas Andrews
安達格
Operations &
Procurement
項目及團體采
購總監
Finance &
Admin財務和
行政
Julian Attfield
David Bilton
朱利安
Technical
Director技術首
席
Dr Alvaro Espina
奧維羅
畢大偉
European
Commercial歐
盟商務
Business
Development
業務拓展
Bill Hargan
Bruce Murdoch
哈百裏
穆德克
QA
Management
QA管理
Safety & PV
安全和藥物
監測
Regulatory &
Tech Doc藥政
和文件
David Clapperton
QP’科大维(QP)
Dr Graeme
Ladds藍格木
Andy
Pickbourne皮安
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Country
Manager
China中華區
首席代表
William Wang
王曉立
迪
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Stravencon –Therapeutic areas of interest
思泰文康-在治療領域的興趣
Antibiotics&
Antifungal 抗
生素及抗真
菌
Biological
Therapies 生
物療法
Injectable
& Oral
Oncology注
射和口服抗
腫瘤藥物
Hospital
Segment
醫院産品
Support
Therapies 支
持療法
Specialised
Cardiology
心髒病專科
Pain control
& anesthesia
疼痛控制與
麻醉
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Section Title
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
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Chinese
Industry
Section
Title 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。
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Section
What’s
new inTitle
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 20092011 -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。
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Section Title
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
State
owned 36%
國有
Private
owned 35%
民營
Foreign funded
29%
外資
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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
2000
<10
~3,500
2010
~30
350
2020
>200
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Section
ChineseTitle
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
cGMP
certs
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• 740 product
approvals 740
個産品已被核
可
• < 30 sites
approved
• 少于30個場地
被核可
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Section Title
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
State funding
support
國家資金方面
的支持
Market
ambition
市場野心
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Low Cost
base
低成本的基礎
API’s in
World Mkt
世界市場的
原料藥
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Section Title
The Stravencon Portfolio
思泰文康産品組合
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Section
Title Products under Development
Stravencon
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。
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Stravencon
Section
TitlePartner 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
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Stravencon
Ltd 思泰文康有限公司
Section Title
The Injectable Cephalosporins
頭孢類注射制劑
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Entry into
Injectable Antibiotics Market 進入抗生素注射制劑市場
Section
Title
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)
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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 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
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Shenzhen Zhijun- GMP Certification深圳致君- GMP資質
EU GMP
歐盟GMP
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Collaboration with North China Pharmaceutical Group
與華北制藥的合作
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Layout of NCPC Hebei, Huamin
華北制藥集團華民公司布局圖
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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
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Section Title
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
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Section Title
Seacross
Pharmaceuticals 海越醫藥
The Injectable Oncology Portfolio
抗癌注射制劑的産品組合
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Section
Title
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
Oncology
injectable
products
抗癌注射制剂
産品
• 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
•
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SectionInjectable
Title
Stravencon
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
Genepharm
UK, Ireland & Denmark
Epirubicin表柔比星
Genepharm
UK, Ireland & Denmark
Irinotecan伊立替康
Orion
UK & others
Oxaliplatin奧沙利鉑
Genepharm
Dossier only
Docetaxel多西紫杉醇
TTY
Gemcitabine吉西他濱
TTY
UK, Holland, Sweden
Ireland & 9 others
Spain & Portugal
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Phase
Section
OneTitle
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
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Section
Title
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
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Main Oral
Oncology products 主要口服抗癌産品
Section
Title
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
Oncology oral
products
口服抗癌産品
This is the Title of the Stravencon Documnet
• 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
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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
Indication
産品名稱
病症
Capecitabine
卡培他濱
Colon and Colorectal
Xeloda-Roche
Cancer
Exemestane
依西美坦
Aromasin-Pfizer
Breast cancer
Imatinib
伊馬替尼
Glivec -Novartis
AML, CLL
Pancreatic cancer
Tacrolimus
他克莫司
Prograf-Astellas
Prophylaxis of Organ
rejection
Patent expiry
專利到期
2013
Presentation
規格
Sales -Euros Mil
銷售額 (百萬歐元)
150 mg x 60 Tabs
500 mg x 120 Tabs
200
Expired
25 mg x 30 Tabs
25 mg x 90 Tabs
134
2015/2016
60 X 100mg Tabs
30 X 400mg
775
Expired
1.5 mg x 50 Caps
1 mg x 50 caps
5 mg x 50 caps
273
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Section Title
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
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Thanks! 多謝 !
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
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
Confidential
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