BEIJING, Sept. 19, 2016 /PRNewswire/ -- China
Biologic Products, Inc. (NASDAQ: CBPO, "China Biologic" or the
"Company"), a leading fully integrated plasma-based
biopharmaceutical company in China, today announced that Shandong Taibang
Biological Products Co. Ltd., the Company's majority-owned
subsidiary, recently obtained approval from the China Food and Drug
Administration (the "CFDA") to begin human clinical trials on its
Human Coagulation Factor IX ("FIX") product.
Human Coagulation FIX is intended for use in the therapy of
prevention and control of bleeding in patients who suffer from
inherited FIX deficiency, known as hemophilia B, or acquired
clotting FIX deficiency. The World Federation of Hemophilia
estimates that approximately 80,000 to 120,000 individuals in
China are afflicted with
hemophilia and registered hemophilia B patients represent a small
portion of hemophilia patients due to the poor levels of diagnosis
in China. Currently, there is no
plasma-derived purified FIX product in China. China Biologic initiated its FIX
research program in 2014 and its clinical trial application for FIX
was officially accepted by the CFDA in December 2015. China Biologic plans to commence
clinical trials for the FIX product in 2017 and expects to complete
these trials by 2018.
Mr. David (Xiaoying) Gao,
Chairman and Chief Executive Officer of China Biologic, commented,
"We are proud to become the first domestic Chinese plasma company
to introduce the effective treatment of FIX deficiency to patients
who are routinely treated with fresh frozen plasma when other
treatments are unavailable or unaffordable. Once we commercially
launch the FIX product, we expect that our
prothrombin complex concentrate product, which is used to treat
hemophilia B when affordable FIX product is unavailable,
will play a more critical role in the under-served market for general blood clotting
treatments in China, including
liver disease and surgical bleeding. Our FIX product represents the
fourth coagulation factor product from China Biologic. We continue
our focus on serving the broader needs of coagulation-deficient
hemophilia patients and to further improve plasma fractionation
utilization, which we believe will also contribute to our future
financial performance."
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 different dosage forms of plasma products through its indirect
majority-owned subsidiaries, Shandong Taibang Biological Products
Co., Ltd. and Guizhou Taibang Biological Products Co., Ltd. The
Company also has an equity investment in Xi'an Huitian Blood
Products Co., Ltd. The Company sells its products to hospitals,
distributors 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 "believe," "expect," "are
expected to," or similar expressions, and involve known and unknown
risks and uncertainties. Among other things, the Company's plan
regarding the clinical trials for FIX product, the outlook on the
Company's financial performance driven by FIX product sales and
quotations from management in this news release contain
forward-looking statements. 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, without limitation
potential delay or failure in commencing or completing the clinical
trials for FIX product, potential delay or failure to complete
construction of new collection facilities, potential inability to
pass government inspection and certification process for new
collection facilities, potential inability to achieve the designed
collection capacities at the new collection facilities, potential
inability to achieve the expected operating and financial
performance, 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
Senior Vice President
Phone: +86-10-6598-3099
Email: ir@chinabiologic.com
ICR Inc.
Mr. Bill Zima
Phone: +86-10-6583-7511 or +1-646-405-5191
E-mail: bill.zima@icrinc.com
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SOURCE China Biologic Products, Inc.