BEIJING, March 23, 2012 /PRNewswire-Asia-FirstCall/ --
China Biologic Products, Inc. (NASDAQ: CBPO, "China Biologic" or
the "Company"), one of the leading plasma-based biopharmaceutical
companies in the People's Republic of
China, today announced that its indirectly owned subsidiary,
Shandong Taibang Biological Products Co., Ltd. ("Taibang"),
recently received approval from the China State Food and Drug
Administration ("SFDA") to begin clinical trials for its human
fibrinogen to be used to treat congenital fibrinogen deficiency and
acquired fibrinogen deficiency.Under Chinese regulations, the
Company can begin with the phase III clinical trials, which
includes the efficacy study, since phases I and II are not required
for this product.
Mr. Chao Ming (Colin) Zhao, China
Biologic's President & Chief Executive Officer, said, "We are
very pleased to receive the SFDA's approval to enter clinical
trials for our human fibrinogen product. Our human fibrinogen is
made using our internally developed new manufacturing process,
which improves product quality, compared with currently available
products in the Chinese market. The new process also increases
plasma utilization and production efficiency. We plan to secure a
patent for our manufacturing invention. We believe this new product
also will advance our plasma protein development pipeline. The
phase III clinical trials are expected to last about two years,
after which we will begin commercial production and sales, assuming
the clinical trials prove that the product provides the safe and
effective treatments we expect."
The Company began pre-clinical research in 2008 for its human
fibrinogen, including its production process development and
pharmaceutical research. In 2009, it completed pre-clinical
inactivated virus research and validation work related to the
product's development. In 2010, the Company conducted the pilot
study for human fibrinogen and in mid-2010 submitted its
application to the SFDA for approval to start human clinical trials
for its human fibrinogen.
About human fibrinogen
The Company's human fibrinogen product that is entering its
clinical trials is a heat-treated, lyophilized fibrinogen powder
made using plasma from healthy humans. Human fibrinogen is
indicated for the treatment of (a) congenital fibrinogen reduction
or deficiency and (b) acquired fibrinogen deficiency associated
with serious liver damage, cirrhosis, disseminated intravascular
coagulation, or coagulation disorder resulting from the lack of
fibrinogen related to postpartum hemorrhage, major surgery, trauma,
or acute bleeding.
About China Biologic Products, Inc.
China Biologic Products, Inc., through its indirect
majority-owned subsidiaries, Shandong Taibang Biological Products
Co., Ltd. and Guiyang Dalin Biologic Technologies Co., Ltd. and its
equity investment in Xi'an Huitian Blood Products Co., Ltd., is one
of the leading plasma-based biopharmaceutical companies in
China.
China Biologic is a fully integrated biologic products company
with plasma collection, production and manufacturing, research and
development, and commercial operations. The Company's plasma-based
biopharmaceutical products are irreplaceable during medical
emergencies and are used for the prevention and treatment of
various diseases. The Company sells its products to hospitals and
other healthcare facilities in China. Please see the Company's website
www.chinabiologic.com for additional information.
Safe harbor statement
This news release may contain certain "forward-looking
statements" relating to the business of China Biologic Products,
Inc. and its subsidiaries. All statements, other than statements of
historical fact included herein, are "forward-looking statements."
These forward-looking statements are often identified by the use of
forward-looking terminology such as "believes," "expects," or
similar expressions, and involve known and unknown risks and
uncertainties. Although the Company believes that the expectations
reflected in these forward-looking statements are reasonable, they
involve assumptions, risks, and uncertainties, and these
expectations may prove to be incorrect. Investors should not place
undue reliance on these forward-looking statements, which speak
only as of the date of this news release. The Company's actual
results could differ materially from those anticipated in these
forward-looking statements as a result of a variety of factors,
including its potential inability to achieve the expected operating
and financial performance in 2012, potential inability to find
alternative sources of plasma, potential inability to increase
production at permitted sites, potential inability to mitigate the
financial consequences of a temporarily reduced raw plasma supply
through cost cutting or other efficiencies, and potential
additional regulatory restrictions on its operations and those
additional risks and uncertainties discussed in the Company's
periodic reports that are filed with the Securities and Exchange
Commission and available on its website (http://www.sec.gov). All
forward-looking statements attributable to the Company or persons
acting on its behalf are expressly qualified in their entirety by
these factors. Other than as required under the securities laws,
the Company does not assume a duty to update these forward-looking
statements.
Company Contact
Mr. Y. Tristan Kuo
Chief Financial Officer
China Biologic Products, Inc.
Telephone: +86 1065983188
Email: ir@chinabiologic.com
www.chinabiologic.com
SOURCE China Biologic Products, Inc.