Jan 27 2010
Sinobiopharma, Inc.
("Sinobiopharma" or, the "Company") (OTC 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."
SOURCE Sinobiopharma, Inc.