Biohit intensifies its business activities in China
BIOHIT OYJ STOCK EXCHANGE RELEASE 2 AUGUST 2005
Biohit intensifies its business activities in China
In order to meet the demand of Biohit products in China and
some other Asian countries in an efficient and economic manner,
Biohit Oyj is currently preparing to begin the assembly and
manufacture of pipettors, diagnostics products and other
products in China in 2006. This will also involve local
sourcing of materials and services. These preparations are
speeded up by the fact that the Chinese authorities recently
approved Biohits GastroPanel tests, an approval which has been
awaited for several years (Biohit Stock Exchange Release, July
29th 2005). Another factor speeding up the preparations is the
great need and growing demand for GastroPanel, other Biohit
products and functional entities consisting of all Biohit
products (analysis systems), particularly in China.
Biohit has had a Representative Office in Shanghai since 2003,
which has mainly been working with the local Regulatory
Authorities and coordinating scientific cooperation and
participation in congresses. In July 2003, Biohit Oyj and
Shanghai 2nd Medical University Renji Hospital made an
agreement, allowing Biohit to use the expertise and facilities
of this institute specialising in gastroenterological diseases
for the demonstration of GastroPanel tests and the analysis
system as well as for training and marketing activities. From
the end of 2005, Biohit will also begin local marketing of its
products in cooperation with Biohit importers and distributors.
Biohits pipettors are imported and marketed by Shanghai Kehua
Bioengineering Co., Ltd.; Shanghai Huijing Biotech Co., Ltd.;
and Beijing GenoSys Tech-Trading Co., Ltd. Furthermore, Biohit
recently made a distribution contract for GastroPanel tests
with Da An Gene Co., Ltd., owned by the Sun Yat-sen (Zhongshan)
University.
So far, there are two diagnostics companies listed on the stock
exchange in China: Shanghai Kehua Bioengineering and Da An Gene
Co., Ltd. Kehua, the largest diagnostics company in China, has
been marketing Biohit pipettors in the Chinese market since
2004, as well as marketing mechanical Proline pipettors it has
assembled from components supplied by Biohit. Biohits
distribution agreement with Da An Gene was only made recently.
Biohit diagnostics & GastroPanel
In the diagnostics business, Biohit focuses on the research,
development, production, and marketing of products for the
screening, prevention, and diagnosis of diseases of the
gastrointestinal tract. The companys diagnostic products
include the GastroPanel examination performed on a blood sample
(biomarkers: Pepsinogen-I, Pepsinogen-II, Gastrin-17, and
Helicobacter antibodies), e.g. for the diagnosis of upper
abdominal complaints (dyspepsia), as well as biopsy specimen
quick tests for the diagnosis of lactose intolerance and
Helicobacter pylori infection. The companys diagnostic tests
are combined with liquid handling products, instruments and
related software (such as GastroSoft) to provide comprehensive
analysing systems for research and clinical diagnostics.
(www.biohit.com / Diagnostics / Products / GastroPanel /
GastroSoft)
Biohits diagnostics comply with EU standards and regulations,
allowing EU-wide marketing and distribution of all its
diagnostics products. In addition to the recently granted
marketing authorisation for China, GastroPanel has also been
cleared for marketing in India, Canada and Russia. The
GastroPanel tests for pepsinogen I and II are still being
evaluated by the US Food and Drug Administration (FDA). In
Japan, the clinical research data required for a similar
approval is currently being collected.
A total of 23 evaluations (with approximately 17,000 patients)
and clinical research utilising GastroPanel have been
conducted, and another 35 studies comprising 35,000 patients
are still ongoing in Europe, North America and Asia.
(for results, see articles: www.biohit.com / Diagnostics /
Literature).
In the light of current research data, the GastroPanel
examination promotes evidence-based medicine as follows:
1) In the diagnosis and treatment of functional and organic
dyspepsia, Helicobacter pylori infection, atrophic gastritis
and the associated risks (gastric cancer, peptic ulcer and
vitamin B12 deficiency).
2) In monitoring the success of treatment for Helicobacter
pylori infection and atrophic gastritis.
3) In monitoring the status of mildly symptomatic or often
asymptomatic atrophic gastritis and the related risks,
associated with Helicobacter pylori infections and autoimmune
disease. Monitoring the incidence of atrophic gastritis and a
possible increase or decrease in its severity promotes
targeted, safe treatment and decreases the costs and adverse
effects of medication. If the patient has not been diagnosed
with peptic ulcer disease, the Helicobacter pylori infection
only needs to be treated if the patient is developing atrophic
gastritis or the patient and doctor agree on eradication
treatment for other reasons (e.g., close relatives have been
diagnosed with gastric cancer; in some cases the Helicobacter
pylori infection may lead to a risk of gastric cancer and
peptic ulcer not associated with atrophic gastritis).
4) In assessing the risk of gastroesophageal reflux disease.
In Western countries, 20-40% of the population suffer from
dyspeptic problems (upper abdominal complaints and pain). Over
50% of the global population (e.g., in Russia, China and many
other Asian countries 60-90%) has Helicobacter pylori
infection. Almost 50% of this population will develop atrophic
gastritis and related risks (gastric cancer, peptic ulcer and
vitamin B12 deficiency). The prevalence of gastroesophageal
reflux disease is over 20% in Western countries, with almost
50% occasionally suffering from symptoms of the disease.
GastroPanel in China
Biohit participated in an international congress and exhibition
for gastroenterologists in Shanghai from July 7th to 9th 2005,
with lectures on GastroPanel and related diseases. Additionally
Biohit and Da An Gene showcased Biohit products at a joint
exhibition stand. During this event, Biohit agreed e.g. on
scientific cooperation with Professor Sung (The Chinese
University of Hong Kong) and Professor Hu (Sun Yat-sen
University, Guangzhou) and their teams. These teams seek to
find new biomarkers that would allow the reliable diagnosis of
gastric cancer and the associated risks together with the
biomarkers of GastroPanel. A further objective of the study
comprising 1200 patients is to verify the benefits of
GastroPanel in the diagnosis of gastric cancer.
GastroPanel has been utilised in two different population
studies in China, both of which proved the suitability of
GastroPanel for screening the risk of gastric cancer. A study
by Professor Yuan-Yuan and his team (The First Affiliated
Hospital of China Medical University, Shen Yang) studied 7996
people. They were able to detect and compile a group of
patients with atrophic gastritis at risk of gastric cancer.
6.9% of these patients were later diagnosed with cancer, while
the corresponding figure in similar risk groups (not examined
with GastroPanel) was 2.1%. The results of this study allow us
to estimate that a combination of GastroPanel followed by
gastroscopy and biopsy specimen examination to confirm the
diagnosis of precancerous lesions and early gastric cancer and
combined with subsequent surgical treatment, could decrease
gastric cancer mortality by at least 25%.
On the basis of the Finnish Setti study of 23,000 male smokers
aged 50-65 years, it has been estimated that GastroPanel
screening for atrophic gastritis and the related risk of
gastric cancer and precancerous lesions could prevent 200300
gastric cancer deaths annually among persons aged over 50 in
Finland. In Finland, gastric cancer is decreasing and less than
1000 new cases are diagnosed annually. On the other hand, the
population-adjusted incidence of gastric cancer in e.g. Japan,
China and Russia is considerably higher than in Finland.
In China, gastric cancer is one of the most common types of
cancer and the most commonly fatal one. Although the number of
gastric cancer cases is decreasing e.g. in Finland, the global
number of new gastric cancer cases is increasing in line with
the increase of the average lifespan. Gastric cancer, as well
as vitamin B12 deficiency and the associated risks (dementia,
depression, polyneuropathies, cardiac attacks, and strokes
etc.), mainly affect the elderly population new cases appear
more as the population ages. In China, this means that both the
need for healthcare capacity and healthcare costs increase at
an accelerating speed.
The most common gastric cancer is thought to arise from a
series of changes within the gastric mucosa progressing from
atrophic gastritis to intestinal metaplasia and dysplasia to
gastric cancer (adenocarcinoma). Atrophic gastritis may heal as
a result of Helicobacter pylori eradication, which is thus
strongly recommended in atrophic gastritis. On the other hand,
and despite the eradication treatment, intestinal metaplasia
may progress into cancer. It is not clear, either, that
Helicobacter eradication would always result in the healing of
atrophic gastritis and the elimination of the cancer risk
associated with it. Consequently, the diagnosis and treatment
of Helicobacter pylori infection alone (i.e., the test-and-
treat method), without the diagnosis or monitoring of atrophic
gastritis and the related risks (gastric cancer, peptic ulcer
disease and vitamin B12 deficiency), does not present a safe
and ethical treatment method for dyspepsia, Helicobacter pylori
infection and the associated gastric cancer or precancerous
lesions.
This serious medical problem can be solved simply and
economically by using the GastroPanel examination rather than
a test for Helicobacter pylori as the diagnostic test of
choice in the test-and-treat method. The new research results
will probably pave the way for such evidence-based-medicine in
China, too.
Biohit Oyj
Osmo Suovaniemi
President & CEO
Further information: Osmo Suovaniemi, President & CEO
Tel: 09-773 861
GSM: +358-40-745 5605
Email: osmo.suovaniemi@biohit.com
http://www.biohit.com
Distribution: Helsinki Exchanges
Financial Supervisory Authority
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