BEIJING, Oct. 9. 2017 /PRNewswire/ -- China Biologic
Products Holdings, 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. ("Shandong Taibang"), the Company's
majority-owned subsidiary, has received approval from the China
Food and Drug Administration (the "CFDA") for commercial
manufacturing of human fibrinogen ("Fibrinogen") at its facility in
Shandong Province. The Company
expects that Shandong Taibang will receive the good manufacturing
practice certificate issued by CFDA within a month and commence
commercial production immediately thereafter, and expects the first
batch of products to be released to market by the end of 2017.
Human fibrinogen is mainly used to treat (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. China
Biologic began pre-clinical research for Fibrinogen in 2008 and
received approval to begin Phase III clinical trials for Fibrinogen
in 2012. The CFDA completed on-site inspection of Shandong
Taibang's production facility in late 2016 and completed on-site
clinical data inspection at various hospitals that carried out the
phase III clinical trials during the second quarter of 2017.
Mr. David (Xiaoying) Gao,
Chairman and Chief Executive Officer of China Biologic, commented,
"We are very excited to receive this long-awaited approval from the
CFDA to launch our Fibrinogen production. Fibrinogen products have
been in short supply in China over
the last several years with prices experiencing significant
increases since the NDRC lifted price-ceiling controls in early
2015. We believe our newly launched Fibrinogen products with our
applied patent manufacturing process will address under-supplied
market conditions and offer premium quality treatment to congenital
fibrinogen deficiency and acquired fibrinogen deficiency patients.
We expect to see meaningful profit contribution from Fibrinogen in
2018 and are confident our Fibrinogen products will solidify our
leadership in the China
coagulation market and unlock significant market growth potential
over the long term."
About China Biologic Products Holdings, Inc.
China Biologic Products Holdings, 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 subsidiary, Shandong Taibang Biological Products
Co., Ltd. and its wholly owned subsidiary, 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
Holdings, 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 "intend,"
"believe," "expect," "are expected to," "will," or similar
expressions, and involve known and unknown risks and uncertainties.
Among other things, the Company's plans regarding the production
and sale of human fibrinogen products and the management's
quotations 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 to obtain the good manufacturing
practice certificate from the CFDA, potential inability to achieve
the expected production capacities, potential change in market
demand for human fibrinogen and other plasma products, 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 Holdings, 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
View original
content:http://www.prnewswire.com/news-releases/china-biologic-receives-approval-for-commercial-manufacturing-of-human-fibrinogen-300533030.html
SOURCE China Biologic Products Holdings, Inc.