Part One--Helicobacter Pylori

(H Pylori)(H. Pylori)

ByShenzhen Zhonghe Headway Bio-Sci & Tech

Co., Ltd.,2009.06

Helicobacter Pylori (H. Pylori)

Helicobacter Pylori (H. Pylori)

a spiral-shaped, flagellated, Gram-negative bacterium

inhabiting in gastric mucosa, some adherent to the m cosato the mucosa.

Acid-resistance mechanism, producing , p gurease to catalyze urea hydrolysis to buffering ammonia.g

The discovery of H. Pylori

Discovered by Australians J. Robin Warren and Barry J Marshall in 1982and Barry J. Marshall in 1982.

To prove that H Pylori was a pathogen To prove that H. Pylori was a pathogen, Marshall swallowed these bacteria to cause histological gastritishistological gastritis.

Th di f H P l iThe discovery of H. Pylori

Warren and Marshall were awarded the Nobel Prize in Medicine in 2005 for their work on H. pylori.

H. Pylori: a causative factor for:

chronic gastritis

ti l di peptic ulcer disease

gastric carcinomag

gastric lymphoma

Th ld id l i f iThe worldwide prevalence infection of H. Pyloriy

H. pylori has been found in the stomachs of pyhumans in all parts of the world.

This organism has been shown to infect This organism has been shown to infect more than 50% of the world's population with an incidence up to 80% in developingwith an incidence up to 80% in developing countries.

Transmission of H. Pylori

The transmission of H. Pylori can occur byroutes of:

iatrogenic

fecal-oral

oral oral oral-oral

Detection of H Pylori -- Invasive methodsDetection of H. Pylori Invasive methods

Rapid Urease TestCulture

Hisopathology

Detection of H Pylori Non invasive methodsDetection of H. Pylori -- Non-invasive methods

Stool AntigenSerum Antibody Urea Breath Test

Eradication of H PyloriEradication of H. Pylori

The eradication of H Pylori infection byThe eradication of H. Pylori infection by triple regimens is known to be of proven significant benefit for patients with Hsignificant benefit for patients with H. Pylori-associated peptic diseases.

1、PPI + two antibiotics

2、Bismuth Compound + two antibiotics

Part Two--14C Urea Breath Test14C Urea Breath Test

(14C UBT)

Th hi t f 14C UBTThe history of 14C UBTI 1987 G h d d i i t bl In 1987, Graham succeeded in using stable nuclide 13C to mark urea for the diagnosis of Hp infection based on the characteristicsof Hp infection based on the characteristics of Hp rich in urease.

In 1988, Marshall also gained a satisfactory result using urea [14C] to substitute urearesult using urea [14C] to substitute urea [13C] in the urea [14C] breath test.

The principle of 14C UBTThe principle of C UBT Based on the detection of the enzyme urease,

prod ced b H P loriproduced by H. Pylori Urea labeled with carbon-14 is ingested by the

patientpatient If H. Pylori infection is present, the bacterium’s

urease enzyme breaks down the urea in theurease enzyme breaks down the urea in the stomach

The labeled carbon dioxide (14CO2) is ( 2)subsequently absorbed in the blood and exhaled

Measure the exhaled 14CO2 to determine the i f ti f H P l iinfection of H. Pylori

The principle of 14C UBTThe principle of C UBT

How to conduct a 14C UBTHow to conduct a 14C UBT The test is conducted two hours after meal

or with an empty stomach in the morning

Swallow a 14C Urea capsule with water Swallow a C Urea capsule with water

Sit for 15 minutes

Blow into a breath card for 3-5 minutes

Test the breath card with the analyzer Test the breath card with the analyzer

After 5 minutes, the result will be printed

14The sequence of a 14C UBTTake a 14C Urea capsule with water.

Sit for 15 minutes.

Blow into a breath card for 3-5 minutes until the indicator turns from salmon pink to orangefrom salmon pink to orange.

Test the breath card with the analyzer andwith the analyzer and get the result.

Share the test data via PC connectionPC connection.

Th d t f 14C UBTThe advantages of 14C UBTThe 14C UBT has been recognized as theThe C UBT has been recognized as the “gold standard” for detection of Helicobacter pylori infection combining the advantages of:pylori infection combining the advantages of:

Sensitive (Sensitivity up to 95%) Specific (Excellent specificity of 95%-100%）

Speed (Test completed in 30 minutes)p ( p ) Simple (One-touch operation) Safe (With negligible radiation burden)Sa e ( t eg g b e ad at o bu de )

Why 14C UBT surpasses all other testsWhy 14C UBT surpasses all other tests Non-invasive, free from the trouble of ,

swallowing a tube and cross infection, well tolerated by patientsy p

Easy to operate Telling the active H Pylori infection Telling the active H. Pylori infection Inexpensive An optimum method for monitoring the

therapeutic effect of H. Pylori eradication

Is 14C UBT safe?Is C UBT safe?The answer is absolutely YES!!!y

For patients:

The 14C Urea capsule contains a tiny amount of radioactive material which passes out of theof radioactive material which passes out of the body in a day or so in the urine and breath.

The amount of radioactive exposure from the test is less than you would normally receive in one day from nature.

Is 14C UBT safe?Is 14C UBT safe? For operators: For operators:

The operator has no access to the radioactivity of 14C.

For the environment:14The small doses of 14C from Urea breath tests are

of little significance to the environment and the potential long term impacts from any releases ofpotential long-term impacts from any releases of 14C as a result of these tests are insignificant.

Exemption and approvalExemption and approval

The U.S. Nuclear Regulatory Commission (NRC) exempted the distribution of 14C Urea capsule on Dec. 2, 1997

FDA approval for 14C Urea capsulehttp://www accessdata fda gov/scripts/cder/drugsatfda/indep ,

http://www.nrc.gov/reading-rm/doc-collections/cfr/part032/part032-0021.html

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

国家环境保护总局办公厅国家环境保护 局办公厅

深圳市中核海得威生物科技有限公司：

关于批准C-14尿素呼胶囊用于幽门螺杆菌感染体内诊断放射性豁免管理申请的函

环办函［2002］143号

深圳市中核海得威生物科技有限公司：

你公司《关于C-14尿素胶囊使用的放射性豁免管理申请》收悉。我局已于2002年4月16日在北京召开专家审查会，并于5月11日赴深圳进行生产现场检查，完成了对上述申请的技术审查。

鉴于含有0.75微居的C-14尿素胶囊用于幽门螺杆菌感染体内诊断，对环境、患者和医生，其辐射影响都是非常小的，从辐射防护的角度判断都是安全的；在诊断过程中产生的废物可作为普通废物处理。因此，含有0.75微居的C-14尿素胶囊用于幽门螺杆菌感染体内诊断，无须采取任何辐射防护措施。我局决定批准你公司关于幽门螺杆菌感染体内诊断，无须采取任何辐射防护措施。我局决定批准你公司关于0.75微居的C-14尿素胶囊用于幽门螺杆菌感染体内诊断的放射性豁免管理的申请。

本批准不适用于C-14尿素胶囊用于幽门螺杆菌感染体内诊断之外的任何其他用途。

特此复函。

二00二年五月十七日

主题词：环保 放射性 药品 批准 函 办公厅主题词：环保 放射性 药品 批准 函

抄送：国家药品监督管理局办公厅，广东省环境保护局

国家环境保护总局办公厅 2002年5月20日印发

办公厅

The instructions for 14C UBTThe instructions for 14C UBT Do not take antibiotics or Pepto Bismol within one Do not take antibiotics or Pepto Bismol within one

month of the test

Upper gastrointestinal hemorrhage within 5 days Upper gastrointestinal hemorrhage within 5 days will impact the accuracy of the test

Alth h th di ti d i t l ll Although the radiation dose is extremely small, pregnant women are not suggested to undergo the testtest

Make sure the child who takes this test is able to ll i t t lswallow an intact capsule

14C Urea Breath Test14C Urea Breath Test

In conclusion, 14C Urea Breath Test is a non invasive cost effectiveis a non-invasive, cost-effective, safe and simple method of accurately detecting H. Pylori infection!infection!

Part Three--Come to Headway

The overall view of HeadwayThe overall view of Headway

Welcome to HeadwayWelcome to Headway

About us Shenzhen Zhonghe Headway Bio-Sci &

T h C Ltd t bli h d i 1996

About us

Tech Co., Ltd. was established in 1996.

We are specialized in breath test field. With over one decade’s development, we have consolidated our position as the leader in this industry in Chinathis industry in China.

We are the only company in China that is i iti t l b th 14C Uin a position to supply both 14C Urea Breath Test analyzers and reagents.

Our market situationWe have set up numbers of branches in

Our market situationWe have set up numbers of branches in

China spreading over 33 major cities and provinces and built a nationwideand provinces and built a nationwide sales network.

We’ve occupied the dominant position in domestic breath test reagent market,domestic breath test reagent market, with 100% market share for 14C Urea Breath Test kit.eat est t

Our market situation Our products are widely administered in over

Our market situation Our products are widely administered in over

two thousand large and medium-sized hospitals in China including most first-grade h it lhospitals.

Over 10,000,000 test kits have been consumed by the patients across China.

For the year 2008 round the number of For the year 2008 round, the number of people who undergoes the 14C Urea breath test with our test kits reaches up to 2,100,000.

O d t B th T t A lOur products-Breath Test AnalyzerModel HUBT-20Model HUBT-20Work with our breath card, test the CO2 collected.

Key benefits: Lightweight and compact; One touch operation makes diagnosis easy One-touch operation makes diagnosis easy

and swift; Quick assessment is available in ≤5 minutes;

M β b i i ti h d Measures β-ray by ionization, no harm caused; High accuracy, meets the clinical requirements; Result will be automatically printed; Clock alarm, English menu, troubleshooting tips……

O d t B th T t A lOur products-Breath Test Analyzer

Model HUBT-20AA new generation upgraded fromA new generation upgraded from HUBT-20

Advanced features: Two rooms allows simultaneous

tests, improving test efficiency; Professional software available for Professional software available for

database management; PC connection realizes information

resource sharing;resource sharing;

Our Products-Breath Test Kit

A breath test kit is composed of:composed of:

A 14C Urea capsule+

A breath card

40 kits in a sales package40 kits in a sales package

CertificatesCertificates

ISO Certificate GMP Certificate

CertificatesCertificates

Registration Certificate

O k t P tOur market Prospect With rapid development in the domestic With rapid development in the domestic

market, we are expanding our market territories globallyterritories globally.

Our products have been penetrated in Korea, and now are marching in UAE, Turkey andand now are marching in UAE, Turkey and Iran.

Our aim is to promote the clinical efficiency p yand value for thousands of hospital clients and patients in the world.

Th k !Thanks!

Join our hands in the business for mutual benefits!

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