Gni Group by lethalinterjec

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									                     GNI Group Sees Demand for Synthetic
                          Bone Material Product in China

             Provision of new product, Gu-BangTM, secures stable revenue

Tokyo, October 2, 2006 – GNI Ltd, a leading biopharmaceutical company in Asia, has
announced that its China based affiliate Shanghai Genomics has expanded sales of Gu-
BangTM, a new type of synthetic bone biomaterial, after winning several hospital supply
contracts in Beijing, Shanghai and Guandong province. Shanghai Genomics received a
Product Registration Certificate from the Chinese State Food and Drug Administration
(SFDA) to market Gu-BangTM earlier this year.


The structure and composition of Gu-BangTM closely resembles that of human bone and is
chemically synthesized to form porous, biodegradable and rigid granules. Following
implantation, the porous material provides an inter-connecting microenvironment for host
bone cells to develop during the bone’s healing process. The material’s biocompatibility
means that the implant is gradually reabsorbed and its residual calcium and phosphate is
used in the formation of new bone. This means that Gu-Bang can also act and an ideal
carrier of antibiotics, chemotherapy agents or anti-inflammatory agents for controlled drug
release.


GNI’s Chairman, Chief Executive Officer and founder, Dr. Christopher Savoie, said, “The
ability to manufacture and market Gu-BangTM in China shows that GNI is pressing ahead
with the development of its business in the area of regenerative medicine and is therefore
another significant step forward in the growth and development of GNI’s value chain. The
approval of this product proves that we have an excellent and efficient clinical trial team,
while the initial successes we have had in securing supply contracts is evidence of GNI’s
ability to access China’s double-digit-growth healthcare market of 1.3 billion people. We will
continue to explore possibilities to license and market other similar products in order to build
a strong pipeline in this area”.


Dr. Jun Wu, GNI’s Chief Scientific Officer and co-founder of Shanghai Genomics, said, “The
manufacture of Gu-BangTM utilizes advanced nanotechnology, which is unique in China. This
is GNI and Shanghai Genomics’ first clinically tested product to reach the market. Gu-BangTM
represents an attractive and safe alternative for Chinese patients and, with the increasingly
aging population, bone therapy related products are expected to have considerable growth
prospects. We are continuing to develop Gu-BangTM and to fully explore its potential as a
controlled drug releasing tool for our other drugs that are currently undergoing clinical trials
and we have already begun developing next generation drug-loaded biomaterial”.


Clinical studies:
After obtaining ethical and clinical trials approval, clinical testing of Gu-BangTM was
conducted in three major hospitals in Shanghai, strictly adhering to Good Clinical Practice
(GCP) guidelines set by the Chinese SFDA. All three hospitals are certified as national
clinical trial bases for orthopedic products. The trial was completed in April 2005, and the
results were evaluated by the Chinese SFDA, which approved the manufacturing and
distribution of Gu-BangTM in China on 6 March 2006.
Safety and pharmacological profile:
The basic composition of Gu-BangTM is made up of calcium and phosphate, both materials
that have undergone extensive clinical testing spanning several decades. Using state-of-art
nanotechnology, Gu-BangTM is chemically synthesized to create porous, biodegradable and
rigid granules. The material, which is non-toxic, non-irritant and has excellent biocompatibility,
does not contain proteins, DNA or endotoxins found in allografts, thus avoiding the risk of
abnormal allergic and immunologic reactions following implantation.

Safety and biocompatibility data for Gu-BangTM has been generated based on the
international ISO 10993 standard and American Society for Testing and Materials (ASTM)
guidelines. These include long-term safety and tolerance tests, acute and toxic cellular
toxicity tests, allergic reaction tests and genetic toxicity tests. All pre-clinical studies, as well
as clinical trials have demonstrated the product’s excellent biocompatibility and safety profile.


                                                     *****


For further inquiries
Gavin Anderson & Company                    Tel: 03-5404-0640 (Deborah Hayden, John Short)




                                             Notes to editors

About GNI
Founded in 2001, GNI, a leader in the field of integrated systems pharmacology, is an international
biopharmaceutical company with operations in Japan, China, the U.K. and the U.S. GNI has used ethically
approved methods to successfully map gene regulatory networks via a complex process of reverse-engineering.
Furthermore, GNI has successfully developed the technology required to apply this data to drug development and
discovery, a feat that has not been achieved by any other organization. In June 2005, Shanghai Genomics, which
operates an integrated drug discovery platform combining genetic discovery and drug development, became an
affiliate of GNI. In April 2006, GNI announced an investment in Beijing Continent Pharmaceutical which gives the
company access to manufacturing and distribution in China. For further information, please visit www.gene-
networks.com

								
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