Chinese State Food and Drug Administration Approves Company Facility for Producing Solid Dosage Perindopril
25 Januar 2010 - 2:30PM
PR Newswire (US)
NANTONG, China, Jan. 25 /PRNewswire-Asia-FirstCall/ --
Sinobiopharma, Inc. ("Sinobiopharma" or, the "Company") (OTC:SNBP)
(BULLETIN BOARD: SNBP) is pleased to announce that its production
facility for solid dosage Perindopril has passed the required
Chinese State Food and Drug Administration (SFDA) inspection and is
now approved for production and marketing. Sinobiopharma had
received SFDA approval for its formulation of Perindopril, the
first version of the drug to be developed in China, in April 2009.
SFDA regulations require that drug makers conduct large-scale
production of at least three batches of a newly approved drug in a
Good Manufacturing Practice (GMP) certified production facility.
SFDA officials inspect the production process, the application of
GMP standards, and conducted a full test of randomly picked samples
of the drug. Sinobiopharma successfully met all the requirements
and now has received approval to distribute the drug throughout
China. The Company believes its formulation of Perindopril is the
latest generation worldwide of the product, which is part of a
class of medications known as angiotensin-converting enzyme (ACE)
inhibitors. These medications are used alone or in combination with
other medications to treat high blood pressure. Perindopril allows
blood to flow more smoothly by preventing the production of certain
natural chemicals that constrict blood vessels. Every year, US$3.7
billion is spent on the treatment of hypertension in China.
Sinibiopharma's Perindopril will be marketed under the trade name
YiTai in China. "We believe that YiTai is a first-to-market drug in
China and therefore enjoys the benefit of having a government
sanctioned price premium as well as certain exclusive marketing
rights to hospitals," said Dr. Lequn Lee Huang, CEO of the Company.
"The market for anti-hypertensives in China is huge, but highly
fragmented. Sinobiopharma's YiTai is well positioned to capture
substantial market share quickly." About Sinobiopharma
Sinobiopharma, Inc. is a fully integrated and highly innovative
specialty biopharmaceutical company engaged in the research and
development, manufacture and marketing of biopharmaceutical
products in China, one of the world's fastest growing
pharmaceutical markets. Known as Dong Ying (Jiangsu) Pharmaceutical
Co., Ltd. in China, the Company's current therapeutic focus is on
anesthesia-assisted agents and cardiovascular drugs. FORWARD
LOOKING STATEMENTS This news release may include "forward-looking
statements" regarding Sinobiopharma, Inc., and its subsidiaries,
business and project plans. Such forward looking statements are
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and section 21E of the United States Securities and
Exchange Act of 1934, as amended, and are intended to be covered by
the safe harbor created by such sections. Where Sinobiopharma, Inc.
expresses or implies an expectation or belief as to future events
or results, such expectation or belief is believed to have a
reasonable basis. However, forward-looking statements are subject
to risks, uncertainties and other factors, which could cause actual
results to differ materially from future results expressed,
projected or implied by such forward-looking statements.
Sinobiopharma, Inc. does not undertake any obligation to update any
forward looking statement, except as required under applicable law.
DATASOURCE: Sinobiopharma, Inc. CONTACT: Sinobiopharma, Inc.
Investor Relations, +1-203-987-5632
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