Section Title
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
Confidential
Copyright © Stravencon Limited 2010. All rights reserved.
Confidential
1
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。
Confidential
2
Section Title Product Trading Platform-China to Europe
Stravencon
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
Chinese
Manufacturers
中国制造商
Marketing Authorisation
市场准入许可
Data资料
Payments付款
This is the Title of the Stravencon Documnet
Stravencon Ltd.
思泰文康
Partner
Companies &
Purchasing
Organizations
Payments付款 合作伙伴公司和
采购机构
Products产品
Confidential
3
Section
Title Product Trading Models-China to EU
Stravencon
思泰文康产品贸易模式-从中国出口到欧盟
Licensing
agreement 授权
协议
Products MA held by
Stravencon Ltd in EU 产品
市场准入证书由思泰文康公
司拥有
Products supply- exclusive
agreement with Chinese
HQ company中国公司通过
独家供货协议供货
Agency
Products MA held by
Products supply from
agreement 代理
Chinese legal entity
Chinese HQ company
managed by Stravencon产
under management
品市场准入证书由中国法人
agreement中国公司通过管
拥有，由思泰文康公司管理
理协议供货
协议
J/V agreement
合资协议
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Stravencon & Chinese co
invest in EU legal entity.
MA held hereS和中国建立
合资公司，产品市场准入证
书由JV公司拥有
Products supply under
exclusive agreement with
J/V 产品通过通过独家供货
协议供货给JV
Confidential
4
Section
Title
The
Biotechnology
Partnering Model
生物科技伙伴关系模式
Chinese Biotech
company中国生
物技术公司
This is the Title of the Stravencon Documnet
StravenconTechnical
/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
Source
of
Funds
融资
EU Biotech
Company
欧洲生物技术公
司
Confidential
5
Section
Title in the Biotechnology Partnering Model
Key
issues
生物科技伙伴关系模式的关键因素
• Assessment of technology 技术评估
Technology
• Modifications of platform science 平台
科技的修正
技术
• Finding the compatible skills 寻求兼容
的技能
• Preparing the competitive position 规划
Financing
财务和财政
具有竞争性的定位
• Co-development Partner or Investor 合
作开发伙伴或投资人
• The development plan and true costs
开发计划和真实成本
• Where to do work to minimise time 工作
地点选择，以缩短时间
• Allow funds to get this all right 调配资金
使运转正常
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Section Title Board of Directors 思泰文康董事会
Stravencon
Name-姓名
Position-职位
Previous/Current Employers
Years Industry
Experience
Douglas B. Andrews Director & CEO
Consilient Health Ltd.,
安达格
董事&首席执行官
Schering-Plough
Julian Attfield
Director & CFO
GeneMedix, Sigma-Genosys Ltd.
朱利安
董事&首席财政官
Arthur Andersen (now Deloittes)
Veni Harania MBE
Non-Exec Director
Pharmacist and Pharmacy chain
哈维尼
非执行董事
Management
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34
Confidential
17
40
7
Section Title Management Team- Commercial operations
Stravencon
思泰文康管理团队-商务运作
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
规划和业务拓展总监
W.J. Hargan
Commercial Director
Hospira Healthcare BV, Abbott
哈百里
商务总监
and Knoll AG
Richard Alexander
Commercial Operations
Teva (IVAX), ratiopharm
理查德
Specialty Generics
(Hospital Markets and Biosimilars)
32
20
商务运作(专科仿制药)
William (Xiaoli) Wang Country Manager
王晓立
Western Australia Trade Office
China
中华区首席代表
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21
Section TitleTeam –Technical & Regulatory外协团队-技术及药政
Outsourced
Name
Position
Previous/Current Employers
David Bilton
Director of Procurement
Ice Pharma Group
毕大伟
and Operations
SmithKline Beecham
Years Industry
Experience
25
团体采购及运营总监
Dr Alvaro Espina QP Technical Operations
奥维罗 博士& QP
Chief Auditor
Yerfis, Spyfarma & Ferrer
Bluefish Pharma
20
Interim Auditor
Ciba Vision, Celltech and
34
临时审计官
SR Pharma
技术团队首席审计官
David Farrer
QP
法大维（QP）
David Clapperton QP QA Management
科大卫（QP）
QA管理
Graeme Ladds
QP Pharmacovigilance
蓝格木（QP）
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Medicines Testing Labs
CBF and Select Pharma Services
Pharsafer Ltd
32
25
药物监测
Confidential
9
Section TitleTeam –Technical & Regulatory外协团队-技术及药政
Outsourced
Name-姓名
Position-职位
Andy Pickbourne
Head of Regulatory &
皮安迪
Documentation
Previous/Current Employers
Years Industry
Experience
Ice Pharma Group
20
药政和文件负责人
Archana Khodke
Manager of Regulatory Affairs
阿可娜
药政法规事务经理
Joanna Przysowa
Project Manager- Production
周安娜
planning
Ice Pharma Group
15
Ice Pharma Group
10
Ice Pharma Group
10
项目经理-生产计划
Alex Chu
Project Manager-Logistics
褚军威
项目经理-物流
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Section Title Organigramme 思泰文康组织机构图表
Stravencon
CEO首席执行官
Douglas Andrews
安达格
Finance &
Admin财务和
行政
European
Commercial欧
盟商务
Business
Development
业务拓展
Julian Attfield
Operations &
Procurement
团体采购及运
作总监
Bill Hargan
Bruce Murdoch
朱利安
David Bilton
哈百里
穆德克
Country
Manager
China中华区
首席代表
William Wang
王晓立
毕大伟
Technical
Director技术首
席
Dr Alvaro Espina
奥维罗
QA
Management
QA管理
Safety & PV
安全和药物
检测
Regulatory &
Tech Doc药政
和文件
David Clapperton
QP’科大维（QP）
Dr Graeme
Ladds蓝格木
Andy
Pickbourne皮安
This is the Title of the Stravencon Documnet
迪
Confidential
11
Stravencon –Therapeutic areas of interest
思泰文康-在治疗领域的兴趣
Antibiotics&
Antifungal 抗
生素及抗真
菌
Biological
Therapies 生
物疗法
Hospital
Segment
Injectable
& Oral
Oncology注
射和口服抗
肿瘤药物
医院产品
Support
Therapies 支
持疗法
Specialised
Cardiology
心脏病专科
Pain control
& anesthesia
疼痛控制与
麻醉
Confidential
12
Section Title
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
This is the Title of the Stravencon Documnet
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Section
Title expansion from 2000-2000年以来中国医药行业的扩张
Chinese
Industry
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。
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Section
What’s
new inTitle
the Chinese Pharmaceutical scene? 中国医药产业的新气象
What is driving internal changes? 变化的内因
 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 20092011 -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。
.
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Section Title
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
Private
owned 35%
State
owned 36%
国有
民营
Foreign funded
29%
外资
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Chinese Pharmaceutical Industry- Transition 中国医药行业-转变
Pharmaceutical companies
医药公司
US/EU Approved companies
欧美核可的公司
>6,000
2000
<10
~3,500
2010
~30
350
2020
>200
Confidential
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Section
ChineseTitle
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。
COS’s
• 278 product
approvals
• 278个产品已被
核可
DMF’s
• 740 product
approvals 740
个产品已被核
可
• < 30 sites
approved
cGMP
certs
This is the Title of the Stravencon Documnet
• 少于30个场地
被核可
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18
Section Title
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
GMP
Changes
GMP的变化
State funding
support
国家资金方面
的支持
Market
ambition
市场野心
This is the Title of the Stravencon Documnet
Low Cost
base
低成本的基础
API’s in
World Mkt
世界市场的
原料药
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Section Title
The Stravencon Portfolio
思泰文康产品组合
This is the Title of the Stravencon Documnet
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Section
Title Products under Development
Stravencon
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。
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Stravencon
Section
TitlePartner Network on the mainland of China and Taiwan
思泰文康在大陆和台湾的合作网络
Oncology Company under
discussion
抗癌药物公司(探讨中)
New Cephalosporin
Plant- final inspection 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
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Stravencon
Ltd 思泰文康有限公司
Section Title
The Injectable Cephalosporins
头孢类注射制剂
This is the Title of the Stravencon Documnet
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Entry into
Injectable Antibiotics Market 进入抗生素注射制剂市场
Section
Title
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
 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）
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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
 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
Confidential
25
Shenzhen Zhijun- GMP Certification 深圳致君- GMP资质
EU GMP
欧盟GMP
Confidential
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Collaboration with North China Pharmaceutical Group
与华北制药的合作
Confidential
27
Layout of NCPC Hebei, Huamin
华北制药集团华民公司布局图
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28
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
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Section Title
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
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Section Title
Seacross
Pharmaceuticals 海越医药
The Injectable Oncology Portfolio
抗癌注射制剂的产品组合
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Section
Title
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
Oncology
injectable
products
抗癌注射制剂
産品
• Oxaliplatin 奥沙利铂
• Docetaxel 多西紫杉醇
• Gemcitabine吉西他滨
• Irinotecan伊立替康
• Doxorubicin阿霉素
• Epirubicin表柔比星
• Carboplatin卡铂
•
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Section Title
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
Products 产品
Source 来源
Countries 涵盖国家
Carboplatin 卡铂
Genepharm
Denmark & France
Doxorubicin 阿霉素
Genepharm
UK, Ireland & Denmark
Epirubicin表柔比星
Genepharm
UK, Ireland & Denmark
Irinotecan伊立替康
Orion
UK & others
Oxaliplatin奥沙利铂
Genepharm
Dossier only
Docetaxel多西紫杉醇
TTY
Gemcitabine吉西他滨
TTY
UK, Holland, Sweden
Ireland & 9 others
Spain & Portugal
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Phase
Section
OneTitle
Oncology Products--European market value
第一阶段的抗癌产品- 欧洲市场价值
European market value for major oncology injectables
主要抗癌产品的欧洲市场价值
2010
€ million
(百万欧元)
Evolution Index
指标
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阿霉素
243,052
106
GEMCITABINE吉西他滨
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
思泰文康专科产品 – 第二阶段
The Oral Oncology products
口服抗癌产品
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Main Oral
Oncology products主要口服抗癌产品
Section
Title
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
Oncology oral
products
口服抗癌产品
• Capecitabine卡培他滨
• Imatinib + other nibs
• 伊马替尼+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
Stravencon Oral Products口服产品
Product name
Indication
产品名称
病症
Capecitabine
卡培他滨
Colon and Colorectal
Xeloda-Roche
Cancer
Exemestane
依西美坦
Aromasin-Pfizer
Breast cancer
Imatinib
伊马替尼
Glivec -Novartis
AML, CLL
Pancreatic cancer
Tacrolimus
他克莫司
Prograf-Astellas
Prophylaxis of Organ
rejection
Patent expiry
专利到期
2013
Presentation
规格
Sales -Euros Mil
销售額 （百万欧元）
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
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Section Title
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
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Thanks! 多谢！
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
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
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