China Biologic Receives SFDA Approval to Begin Clinical Trials for Human Fibrinogen
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.
SOURCE China Biologic Products, Inc.
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