China Biologic Receives SFDA Approval for Clinical Trial of Human Coagulation Factor VIII
September 17 2008 - 8:00AM
PR Newswire (US)
TAIAN CITY, Shandong, China, Sept. 17 /Xinhua-PRNewswire-FirstCall/
-- China Biologic Products, Inc. (OTC:CBPO) (BULLETIN BOARD: CBPO)
("China Biologic" or the "Company"), one of the leading
plasma-based pharmaceutical companies in the People's Republic of
China ("PRC"), today announced that the Company received approval
from the PRC State Food and Drug Administration (the "SFDA") to
commence clinical trial of its new Human Coagulation Factor VIII
product ("FVIII"), a coagulation treatment for hemophilia and mass
hemorrhaging. As one of four suppliers of Cryoprecipitate in China,
China Biologic has been engaged in a contract to supply
Cryoprecipitate to Green Cross China for use in the production of
FVIII. With its own supply of Cryoprecipitate and its continued
research and development of FVIII, the Company has obtained
approval to commence clinical trial for 200 IU and 300 IU per dose
of FVIII. China Biologic has commenced preparations for the
clinical study and expects to receive results by mid-2009. If the
clinical study is successful, management expects to get SFDA's
approval for production to launch the product at the beginning of
2010. "We are pleased that our continued focus on research and
development has led us to receive approval from the SFDA for
clinical trial of FVIII," said Mr. Chao Ming Zhao, the Company's
CEO. "The approval represents a significant milestone on
diversifying our product portfolio. In addition, we believe our
ability to produce Cryoprecipitate from clinical extra plasma -
plasma that would have been discarded previously - will yield a
higher gross profit margin in the production of FVIII." About China
Biologic Products, Inc. Through its indirect majority-owned
subsidiary, Shandong Taibang Biological Products Co. Ltd., China
Biologic Products, Inc. (the "Company"), is principally engaged in
the research, development, production and manufacturing and sale of
plasma-based biopharmaceutical products to hospitals and other
health care facilities in China. The Company's human albumin
products are mainly used to increase blood volume and its
immunoglobulin products are used for the treatment and prevention
of diseases. Safe Harbor Statement This release may contain certain
"forward-looking statements" relating to the business of China
Biologic Products, Inc. and its subsidiary companies. All
statements, other than statements of historical fact included
herein are "forward-looking statements," including statements
regarding: the significance of SFDA approval for FVIII clinical
trials; the ability of the Company to continue production of
Cryoprecipitate from clinical extra plasma and its effect on future
profit margins; the ability of the Company to achieve its
commercial objectives; the business strategy, plans and objectives
of the Company and its subsidiaries; and any other statements of
non-historical information. These forward-looking statements are
often identified by the use of forward-looking terminology such as
"believes," "expects" or similar expressions, involve known and
unknown risks and uncertainties. Although the Company believes that
the expectations reflected in these forward-looking statements are
reasonable, they do 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 press 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 those 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. For more information, please contact: Company Contact:
Mr. Y. Tristan Kuo CFO China Biologic Products, Inc. Tel: +86-538-
6202206 Email: Web: http://www.chinabiologic.com/ Investor
Relations Contact: Mr. Crocker Coulson President CCG Investor
Relations Tel: +1-646-213-1915 (NY office) Email: Web:
http://www.ccgir.com/ DATASOURCE: China Biologic Products, Inc.
CONTACT: Company Contact: Mr. Y. Tristan Kuo, CFO of China Biologic
Products, Inc., +86-538- 6202206, or ; or Investor Relations
Contact: Mr. Crocker Coulson, President of CCG Investor Relations,
+1-646-213-1915 (NY office), or Web site:
http://www.chinabiologic.com/
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