New Chinese Policy to Benefit Global Pharmatech
04 Janvier 2007 - 4:00PM
PR Newswire (US)
JILIN, China, Jan. 4 /Xinhua-PRNewswire/ -- Global Pharmatech, Inc.
(OTC:GBLP.OB) (BULLETIN BOARD: GBLP.OB) a company that develops,
manufactures and markets proprietary botanical drugs and dietary
supplements, announced that the Chinese State Food and Drug
Administration (SFDA), has recently issued a new policy on the
preclinical development of new drug products. This policy will
force Chinese drug companies to use only GLP ("Good Laboratory
Practice")-certified labs to conduct pre-clinical trials. Currently
there are only 22 GLP-certified labs located in China and Global
Pharmatech owns one of them. As now required by the SFDA, all
pivotal pharmacology and toxicology studies for preclinical
development of "new drugs" must be conducted in GLP- certified
laboratories. A "new drug" is defined by the SFDA as any chemical,
biological and botanical drug product which will be registered to
the SFDA as a drug product after January 1, 2007. Preclinical
evaluation is a necessary step for the development of all new
drugs. Preclinical evaluation of a new drug involves a series of
pharmacology and toxicology experiments which can be very costly
for a pharmaceutical company. As of the end of November 2006, only
twenty-two preclinical facilities had been inspected and recognized
as GLP certified laboratories by the SFDA. Jilin Tian Yao Drug
Safety Evaluation Co., Ltd. ("JDE"), a 99.5% owned indirect
subsidiary of GBLP is one of these laboratories and one of only two
privately owned GLP laboratories certified by the Chinese
authorities. GBLP owns its interest in JDE through its wholly-
owned subsidiary, Natural Pharmatech, Inc. JDE was established in
2003 and became a GLP certified laboratory through a series of SFDA
inspection and evaluation procedures. Currently, JDE has the
capacity to perform almost all types of toxicology studies for new
drug evaluation, including toxicology studies in rodents or
non-rodents, reproductive toxicology studies, mutagenicity studies,
carcinogenicity studies, immunotoxicity studies. JDE is also able
to conduct safety pharmacology and local irritation studies. During
the past few years, JDE has been providing its services to various
domestic and international pharmaceutical companies, including its
involvement in pivotal toxicology studies for more than thirty new
drug products. Ms. Lianqin Qu, Chairwoman and CEO commented: "We
are extremely pleased to see this new policy issued by the SFDA. We
believe that it is an important step to bring Chinese regulatory
requirements of preclinical development up to international
standards. As one of the few GLP-certified labs currently operating
in China, we believe that the implementation of this new policy
will give us more opportunities to participate in the development
of new drug products in China." About Global Pharmatech Global
Pharmatech, through its subsidiaries, develops, manufactures and
markets proprietary drugs that are based on Traditional Chinese
Medicine using modern facilities and advanced R&D technologies.
The company offers a full range of start-to-finish biotech
services, from research and testing to manufacture and sale of
liquid and solid dose products. The Company employs unique
proprietary extraction methods and also licenses patents and
technologies for botanical/biological drug products. Global
Pharmatech's operations are currently based in the People's
Republic of China with sales distribution centers in China,
Malaysia, Singapore and Indonesia. For more information, please
visit http://www.global-pharmatech.com/ Safe Harbor Statement under
the Private Securities Litigation Reform Act of 1995 This news
release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. These statements are based upon our current
expectations and speak only as of the date hereof. Our actual
results may differ materially and adversely from those expressed in
any forward-looking statements as a result of various factors and
uncertainties, including our ability to successfully develop and
commercialize products, competitive products in our key markets,
changes in consumer demand for our products, legislative,
regulatory and competitive developments and general economic
conditions. Our SEC filings discuss some of the important risk
factors that may affect our business, results of operations and
financial condition. We undertake no obligation to revise or update
publicly any forward-looking statements for any reason. For more
information, please contact: Zhuojun Li Investor Relations Global
Pharmatech, Inc. Tel: +1-905-787-8225 Email: DATASOURCE: Global
Pharmatech, Inc. CONTACT: Zhuojun Li, Investor Relations, Global
Pharmatech, Inc., +1-905-787-8225, Web site:
http://www.global-pharmatech.com/
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