HUNAN LUGU International Medical Apparatus And Instruments Park 中国 · 湖南 · 长沙 · 麓谷国际医疗器械产业园 HUNAN LUGU International Medical Apparatus And Instruments

HUNAN LUGUInternational Medical Apparatus And Instruments Park

中国·湖南·长沙·麓谷国际医疗器械产业园




1 Part 2 The Second Stage

Background and Characteristics

Potential Client

Contents Part 1 The First Stage

Construction Scheme

Construction and Investment Situation

Part 3 The Overall Construction ThoughtTo Establish a Sci-tech and Industrial Base for National Medical Apparatus Industry



Industry Background

In 2011, the market size of domestic medical apparatus and instruments

has achieved 400 billion RMB, of which 70% rely on imports, especially

95% high-end and large-scale equipment rely on imports. So the new

domestic new medical apparatus and instruments market will be over 200

billion during the 12th Five-Year Plan period.

In recent 3 years, the domestic medical apparatus and instruments

industry has maintained over 23% growth per year, far beyond our national

GDP growth. At the same time, it has greatly exceeded the annual growth

of 7% of international medical apparatus and instruments industry .




Industry Background

Due to our late starts and poor starting point, the international market

share of domestic medical apparatus and instruments industry is only 2%,

and the domestic market share is less than 30%. Our main medical products

mainly focuses on the low and high-end medical equipment. Therefore,

most high-end and large-scale equipment rely on imports.

The small and scattered pattern of medical apparatus and instruments

industry is especially damaging for its industry development. In the future,

industry aggregation would become the core power for the medical

equipment development.




Policy Background


(1). In 2011, the State Food and Drug Administration required all medical equipment enterprises to

enforce Good Manufacturing Practice (GMP)

GMP is a set of mandatory standards applicable to the industry, like

pharmaceutical, food etc. It requires enterprises to meet the national

sanitary quality requirements in accordance with relevant state laws and

regulations from raw materials, personnel, facilities and equipment, as well

as the process, packing and shipping, quality control etc. and form a set of

operational practices. The practices is to help enterprises improve business

sanitary conditions, thus to improve timely if any problems were found

during the production process.




Briefly speaking, GMP requires the manufacturing enterprises to

have good production equipment, rational production methods, as

well as perfect quality management and strict detection system to

ensure that the quality of the final product ( including food safety and

hygiene) would conform to the regulations.



Policy Background

(2). The National 12th Five-Year plan has included the bioengineering and pharmaceutical industry in seven strategic emerging industries.

Medical apparatus and instruments is an important foundation of medical and health system construction. It is a foundation with high strategic character, strong industrial promotion and growth. Its strategic position has been paid attention to countries all over the world. It has become a pretty important symbol to measure the level of national science and technology progress and national economy modernization.




Medical apparatus and instruments is a typical high-tech industry, where advanced technology has been intensive applied, different

disciplines are intensive, technology is integrated fully etc. It is not only a particular reflection to the cutting edge of technology level and

technology integration application ability of a nation, but an important engine to drive and lead multidisciplinary technology development .




(3) In December, 2011, Ministry of Science and

Technology published the “Special 12th Five-

Year Plan of Medical Apparatus and

Instruments”. The specialized plan proposes to

establish eight to ten medical apparatus and

instruments industry base of science and

technology in China.


Policy Background



Construction Situation

1.The park will be completed and put into

operation within a year.The park, occupying1250 mu of land (equal to 833,333 square

meters), a total construction area of 1600,000 square meters and with

a total investment of 4.2billion RMB, is constructed by 4 stages. The

first stage is started in June 2012, and covers a construction area of

110,000 square meters. 9 GMP standard factory buildings and 1

worker dormitory has been completed. At the same time, 40

enterprises and research institutions at home and abroad have been

introduced. The first stage of investment has finished already. In

May, 2013, the workshop has put into service and the company has

formally put into production.




2. The First Boosting International Medical Apparatus and Instruments Park

Hunan Lu Gu International Medical Apparatus and Instruments Park is a place

dominated by Changsha National High-tech Industry Development Zone, promoted

by Hunan Food and Drug Administration and relevant department, as well as

constructed by Hunan Lu Gu International Medical Apparatus and Instruments

Park Co., Ltd. It is a modernized industrial park, where production, research and

development of the products, technology transfer, as well as technology incubator,

professional testing, trade show, and industry links etc. can be realized.




Hunan Lu Gu International Medical Apparatus and Instruments Park

gathered a set of medical apparatus and instruments enterprises at home and

abroad to research and develop, produce, operate, and forming industry clusters

through planning and constructing a multi medical apparatus and instruments

park, thus to construct a multi functional industrial platform, to innovate service

operation pattern, also strengthen enterprise hatching and booster an

development. The aim is to establish a national medical apparatus and

instruments industry base of science and technology with five core advantages,

namely, policy, team, hardware, overseas, services to promote the enterprises

development.




The Number of Medical Apparatus and

Instruments Enterprises : 41

Provincial Enterprises: 35

Out-of-Province Enterprises: 5

American Enterprises: 1

The Number of Medical Apparatus and

Instruments Research Institutions: 2

Shanghai Advanced Research Institute, Chinese Academy

of Sciences

Hunan Family Planning Institute, Peripheral Blood Cell

Culture Laboratory

Investment Achievements




1. Policy Advantage

agree to introduce and recommend excellent enterprises in or out of

province to do pioneering work in the park.

exempt regular approval procedure, establish a green passage for

approval and examination; shorten 1/3 of the legal time limit to apply a

park entrance permission in principle.

exempt clinical testing when making a products registration in

accordance with relevant policies and regulations.

Five Core Advantages

A Recommendation

Two Exemptions

Three Simplifications

Save time, save effort



set up a medical apparatus and instruments testing center to offer

relevant testing service; simplify the frequency of permission

examination and supervision inspection.

set up an enterprise service center to undertake GMP authentication,

technology transfer, etc. and other professional services.

simplify park entrance procedures according to changed procedures

when out-of-province enterprises making a park application.




2.Team Advantages

Beijing See with Hi-Tech Investment and Development Co.,Ltd(北京海凭高科 ) has three manufacturing enterprises, four

products selling enterprises, three real estate companies, one construction company, and a consulting company, a property

management company. We have a strong and professional team.

Manufacturing Companies：

Beijing Haiping Yi Bai Medical Apparatus and Instruments Co., Ltd.

Shandong Tian Ren Electronics Co., Ltd.

Changsha Haiping Medical Apparatus and Instruments Co., Ltd.




Products Selling Companies:

Beijing Haiping Century Medical Apparatus and Instruments Co., Ltd.

Beijing Haiping Advanced Medical Apparatus and Instruments Co., Ltd.

Hunan Lu Ding Medical Apparatus and Instruments Co., Ltd.

American Haiping International Trading Co., Ltd.




Main Members of the Team:

Song Guangzheng: president, CEO; 20 years experience in medical apparatus and instruments industry.

Li Juan: executive vice president; a senior professional real estate manager.

Dong Xiaofei: vice president and general manager of American Haiping International trading Co., Ltd.

Ren Dequan: policy advisor; the former deputy director of State Food and Drug Administration, the former

deputy director of State Administrative Bureau of Traditional Chinese Medicine .

Mi Xianqiang: sience and technology advisor, a researcher of Chinese Academy of Sciences, a professor and

the chief expert in Chinese medical apparatus and instruments.

Cheng Genhong: international advisor, tenured professor of University of California-Los Angeles, an expert

in Thousands People Plan of China.



3 、 Hardware Advantages

All buildings are well-designed in accordance with GMP Standards strictly, including 9 workshop with 8 layers, one

worker dormitory with 9 layers. Each workshop covers 5,000-7,000 square meters, and each layer varies from 679 square

meters to 921 square meters. All buildings have independent property rights, and placed in hierarchical pattern. House can

be rent or sold.




4. Overseas Advantages

We have established a professional company in Chicago.

Offices have been found in New York and Los Angles to have medical apparatus and instruments high-tech cooperation and

exchange, and to invite investment for American medical apparatus and instruments enterprises. Preliminary success have

been achieved at present.

In the second half of this year, our company will set up a professional investment company in Europe, with German as the

head to invite investment in Europe.




5. Service Advantages

1.Registration Service 2.Technical Service

3. Standard Clinical Trial Service 4. Financial Service

5. Exhibition Service 6. Biding and Tendering Service

7. Information Service 8. Overseas Market Service




1. Registration Service

Enterprise Registration

GMP Certification Consulting, Production License Registration,

Registration Certificate Renewal, New Products Registration Service.

In order to promote enterprises' development in the park, Hunan Lu Gu International Medical Apparatus And Instruments Park has set up 8 multi functional professional service systems on the basis of offering first class hardware facilities. Specifically including: registration service, standard testing service, technical exchange service, financial service, as well as conference exhibition service, bidding and tendering service, information service and overseas market service etc.

Eight Service Platforms



2. Technical Exchange Service

We will strengthen the introduction of foreign medical apparatus and

instruments brand enterprises and accelerate the introduction and

promotion of the latest international technology through building the

bridge between Chinese and foreign medical apparatus and instruments

industry by monthly communication conference. At the same time, we

will push enterprises to export brand, technology and products through

the incubation and cultivation of national excellent enterprises.




Main Services:

(1) introduce international enterprise

(2) promote international advanced technology exchange and

cooperation

(3) promote the park enterprises to establish overseas branches and

export products and technology

(4) undertake international academic conferences




3. Standard Clinical Testing Service

Main Services:

(1) organize and draft products criteria

(2) undertake factory inspection of medical apparatus and instruments

(3) undertake clinical testing of new products

(4) provide registration testing service of medical apparatus and instruments

(5) organize expert appraising meeting




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发展规划

4. Financial Services

guide the gathering of high quality financial services and form a financial service industry chain, thus to meet park enterprises’ financial demand and decrease financial cost of medium-sized and small enterprises.

park services center has set up a service alliance with bank, VC/PE, petty loan, guarantors, credit organization and other organizations

assist qualified enterprises to apply for government interest subsidy

guide credit cultivation of enterprises in the park and help them to improve financial skills

Bank Cooperation, Financing Lending




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发展规划

Establish a Green Channel for Enterprises to go Public

invite financial securities or relevant department to have a tutoring after getting into the park, and assist the park enterprises to apply for special listed subsidy fund

assist enterprises in the park to hang out New 3 Board, and solve the problem to raise fund by utilizing different capital market.

has built up a channel to market rapidly in American OTCBB Stock Market and Nasdaq Stock Market.




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5. Exhibition Services

Products Exhibition and Exhibition Hallto promote development of enterprises in the park by creating an international medical apparatus and

instruments exhibition hall and network platform to display products and attending international medical apparatus

and instruments exhibition as a group.

Main Services:organize international medical apparatus and instruments exhibition

to have a high-end products display and brand show

release new products

display products networks and multi media




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Medical and Health Conferenceestablish an international conference center with superior environment and multi function and auxiliary facilities, like

hotel, restaurant, entertainment, business center to satisfy enterprises’ demand to high stakes meeting

Main Services:to undertake industry summit and different academic conferences

to undertake relevant conferences hold by industry associations, special organizations and government

to provide conference facility for different enterprises meeting in the park




6. Bidding and Tendering Service


to set up a medical apparatus and instruments bidding and tendering center to provide medical apparatus and instruments bidding and tendering service for enterprises in the park

Main Services： publish medical apparatus and instruments bidding and

tendering

information

provide a great hall for medical apparatus and instruments

bidding and tendering activity

other professional medical apparatus and instruments bidding

and tendering activity



发展规划

7. Information Services


“ a periodical, a newspaper and two websites”

A Helpful Platform

www.happygk.com

Official Website of Hunan Lu Gu Medical Apparatus and Instruments Park

www.lgime.com

An English and Chinese Magazine--- Instruments Window

A mobile phone newspaper---Instruments Mobile Phone Newspaper

Official Website of Beijing See with Hi-Tech Investment and Development Co.,Ltd.



Clinical Testing Cloud Platform

This project opens electronized data management and clinical research cloud data platform by utilizing cutting edge

information technology, like functional unit, template configuration, data quality control, ( 无钥签名数据保全 ) ， mass

storage system and data processing etc.. The aim is to realize the standardization of medical apparatus and instruments

clinical research, and service for those enterprises in the park. The project also provides a supporting platform to set up

mass clinical research data.


Contents:(1) a research about medical apparatus and instruments clinical standardization (includes the standardization of

clinical testing scheme, the standardization of CRF form, the standardization of terms and encoding, the

standardization of data organization after clinical research, and template of statistical approach)

(2) a electronic research about medical apparatus and instruments clinical testing (includes collection of electronized

data,中央随机化流程及监控 , management of clinical testing project.)



Significance:

(1) For those applicants:

the data used to do research tend to be much more reliable. The money has correctly used. The data research is suitable to

the market of products and also the product marketing. And the method of data collection and form is acting on international

convention, which is beneficial to product promotion and transaction.

(2) For the SFDA supervisor:

They are able to bring time monitoring cases into scheduling and quality. So the source data validation （ SDV ） is able to undertake at any time to avoid hasty and inefficiency caused by current field observation.

(3) For the research doctor：

It can avoid inefficiency, mistakes, and additional work caused by filling complicated CRF paper in handwriting.

The first period plans to use molecule diagnosing products as a pilot point. It has won the support from SFD, Hunan Food and

Drug Administration, and Shenzhen Mindray Electronic Medical International Co., Ltd.. In this May, the researcher of Chinese

Academy of Sciences ,Mi Xianqiang, and vice president of Mindray will come to Changsha to confirm the cooperation.


(3) medical apparatus and instruments clinical testing of cloud integration service platform research



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8. Overseas Market Service


A professional company have been established in Chicago.

Offices have been found in New York and Los Angles to have medical apparatus and instruments high-tech cooperation and exchange, and to invite investment for American medical apparatus and instruments enterprises. Preliminary success have been achieved at present.

In the second half of this year, our company will set up a professional investment company in Europe, with German as the head to invite investment in Europe.



1 Part 2 The Second Stage

Potential Client

Contents

Construction Scheme



Construction Scheme

The Second Construction Stage

The second-stage construction land of the park occupies 400mu(equals to 266,667 square meters), a total planned investment of 1.25

billion RMB and with overall floorage of 0.5 million square meters. The main construction includes building GMP standard

workshops of medical apparatus and instruments, international medical apparatus and instruments incubator and accelerator, national

medical apparatus and instruments engineering technical research center, complementary area of international medical apparatus and

instruments logistics distribution center, expert, staff life and business activity. After the project is completed, supporting facilities,

like GMP standard workshops, latest international technology, information, finance, and logistics etc, would be offered to the

registered enterprises. The construction phrase will last 4 years, from 2013 to 2016.

After the project is completed, over 150 enterprises at home and abroad would be attracted to register in the park. More than 10

billion RMB output value would be realized. Taxes per year would reach 1.2 billion RMB. What’s more, not less than 500 mid-

senior talents would be brought in and over 5000 jobs would be provided in manufacture, technical field, trading, as well as logistics

and service industry etc.



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Potential Client

1. Client in Hunan Province

Entrance

There are 470 medical apparatus and instruments manufacturing enterprises and about 1200 marketing enterprises in Hunan Province. 50% of which gathered mainly in Changsha. Over 90% enterprises lack independent property rights manufacturing and marketing place. And most lease place does not conform to the state medical apparatus and instruments GMP request enforced in 2011, which would be a threat to the survival and development of enterprises. Therefore, most provincial enterprises are in badly need of buying GMP standard workshop. But there are only 94,000 square meters GMP standard workshop can be provided in the first stage of construction, namely, about 40 enterprises are allowed to enter into the park. It is still a long way to satisfy enterprises’ demand in the province. 70 enterprises is expected to enter into the park in the second stage.

Common construction

There are 6 influential enterprises in the province has required to have a common construction.



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Potential Client

Out-of-province Client

In accordance with the situation in first stage and established investment channel, more than 20 enterprises are expected to enter into the park in the second stage.

The Hunan Chamber of Commerce in Guangdong Province has organized a group of medical apparatus and instruments manufacturing enterprises in Pearl River Delta to investigate in our park. They showed their intention of entering our park as a group.

After Shenzhen Food and Drug Administration has connected with Hunan Food and Drug Administration, about 30 coastal enterprises would moved into inland. Support in policy, location choosing ands so on are expected.



1

Contents

Part 3 Overall Construction Thought

To Establish a Sci-tech and Industrial Base for National Medical Apparatus Industry



Overall Construction Thought

The whole park should be lead by Changsha High-tech Development Zone, promoted by provincial or municipal food and

drug administration, and operated by Beijing See with Hi-Tech Investment and Development Co.,Ltd.

The planning use land of High-tech Development Zone occupies 1200 mu (equals to 800,000 square meters). The land will

be provided in three stages on the principle of “ connect each area and control the size, supply construction land in

phrases”.

To establish a sci-tech and industrial base for national medical apparatus industry



An Official Reply of High-tech Development Zone to Support the Establishment of National Medical Apparatus and Instruments Industrial Base

In order to carry out and implement The National Plan of Medium and

Long Term Science and Technology Development (2006-2020) and Special

12th Five Plan of Medical Apparatus and Instruments proposed by science

and technology department, and promote the development of Hunan

medical apparatus and instruments industry, our district agree Beijing See

with Hi-Tech Investment and Development Co.,Ltd. to start the second

stage construction of Medical Apparatus and Instruments Park. We have



An Official Reply of High-tech Development Zone to Supporting the Establishment of National Medical Apparatus and Instruments Base

already put the principle of “connecting each area and controlling the size, supplying construction land in phrases” in practice in our bio-medical industry park. Land would be provided according to the project situation. The total planned construction area covers 1200 mu (equal to 800,000 square meters). It is estimates that the supply of land of the first stage in 2013 would be 400 mu to 500 mu (266,667 square meters to 333,3333 square meters). At the same time, our park would strongly support Haiping to establish the industry park as a sci-tech and industrial base for national medical apparatus industry.



湖南麓谷国际医疗器械产业园有限公司HU NAN LUGU Medical International Apparatus And Instruments Park

Project Address ： No.229, Guyuan Road, High-tech Development Zone of Changsha Tel ： 0731——88337689Company Address ： www.happygk.com Official Website of Hunan Lu Gu Medical Apparatus and Instruments Park www.lgime.com

Integration Operators of Medical Apparatus and Instruments Industry

Official Website of Beijing See with Hi-Tech Investment and Development Co.,Ltd.

Documents

HUNAN LUGU International Medical Apparatus And Instruments Park 中国 · 湖南 · 长沙 · 麓谷国际医疗器械产业园 HUNAN LUGU International Medical Apparatus And Instruments