BEIJING, June 25, 2012 /PRNewswire-Asia-FirstCall/ --
China Biologic Products, Inc. (NASDAQ: CBPO, "China Biologic" or
the "Company"), a leading fully integrated plasma-based
biopharmaceutical company in China, today announced that its indirectly
owned subsidiary, Shandong Taibang Biological Products Co., Ltd.
("Taibang") has received a manufacturing approval certificate from
the China State Food and Drug Administration ("SFDA") for Human
Coagulation Factor VIII ("FVIII"). With this certificate, the only
approval remaining for Taibang's commercial production of FVIII is
the SFDA's good manufacturing practice ("GMP") certification of the
FVIII production line itself.
Taibang began research for FVIII in 2007 and successfully
developed the technology in 2008. The Company conducted clinical
trials from 2009 to 2010. In June
2010, the Company submitted required materials to Center for
Drug Evaluation for approval to start manufacturing and passed
on-site products verification in January
2011. The Company received official manufacturing approval
certificate on June 21, 2012. FVIII
will be primarily used in the treatment of hemophilia A.
Mr. David Gao, Chairman &
CEO, said, "Receiving SFDA manufacturing approval represents the
culmination of more than five years of work and the first
technological approval of a coagulation factor product developed by
Taibang. With the addition of Factor VIII, we should soon be able
to offer three major categories of blood products: albumin
products, immunoglobulin products and coagulation factor products.
This will further strengthen our competitive position as a leading
plasma-based biopharmaceutical company in China."
"We are very proud to bring FVIII to hemophilia A patients in
China," continued Mr. Gao. "We
believe that Human Coagulation Factor VIII addresses a critically
unmet need of a large patient population and helps ease
under-supply of coagulation products. Although it is not possible
to specify a definitive timeframe in which we will receive GMP
approval, we expect our FVIII production to be inspected by SFDA
and then GMP certified by the end of 2012. Going forward, we intend
to continue to develop and manufacture life-enhancing, effective,
quality-assured products."
About China Biologic Products, Inc.
China Biologic Products, Inc. (Nasdaq: CBPO), is a leading fully
integrated plasma-based biopharmaceutical company in China. The Company's products are used as
critical therapies during medical emergencies and for the
prevention and treatment of life-threatening diseases and
immune-deficiency related diseases. China Biologic is headquartered
in Beijing and manufactures over
20 plasma-based products through its indirect majority-owned
subsidiaries, Shandong Taibang Biological Products Co., Ltd. and
Guiyang Dalin Biologic Technologies Co., Ltd. The Company also has
an equity investment in Xi'an Huitian Blood Products Co., Ltd. The
Company sells its products to hospitals and other healthcare
facilities in China. For
additional information, please see the Company's website
www.chinabiologic.com.
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.
Contact:
China Biologic Products, Inc.
Mr. Ming Yin
Vice President
Phone: +86-10-6598-3099
Email: ir@chinabiologic.com
ICR Inc.
Mr. Rob Koepp
Phone: +86-10-6583-7516 or +1-646-405-5191
E-mail: rob.koepp@icrinc.com
SOURCE China Biologic Products, Inc.