JILIN, China, Jan. 4 /Xinhua-PRNewswire/ -- Global Pharmatech, Inc.
(OTC 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.
(Logo: http://www.prnasia.com/sa/200611101343.JPG )
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 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: zhuojunli@global-pharmatech.com
