BEIJING, October 17, 2014 /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 the Company has received approval from the China Food and Drug Administration (the “CFDA”) for commercial manufacturing of human prothrombin complex concentrate (“PCC”) at its Shandong Taibang facility. The CFDA inspected Shandong Taibang’s new coagulation factor production facility for Good Manufacturing Practices (“GMP”) compliance in June 2013 and is expected to issue the GMP certificate before early December. The Company expects to commence commercial production of PCC at its Shandong Taibang facility immediately upon the receipt of the GMP certificate.
PCC is used for the prophylaxis and treatment of congenital and acquired clotting factor II, factor VII, factor IX or factor X deficiencies, including those caused by hemophilia and other liver diseases. Other indications for PCC include anticoagulant reversal and vitamin K deficiency. The Company has already received CFDA approval to commercially manufacture PCC at its Guizhou Taibang facility and expects to commence commercial production in early 2015.
Mr. David (Xiaoying) Gao, Chairman and Chief Executive Officer of China Biologic, commented, “We are delighted to receive approval from the CFDA to launch PCC production. With production underway at both our Shandong Taibang and Guizhou Taibang facilities, we are confident that we will be able to meet the growing market demand for PCC. We anticipate that the added production will contribute to our 2015 financial performance as we continue to reinforce our industry leadership.”
About China Biologic Products, Inc.
China Biologic is a leading 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 dosages of plasma-based 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 and inoculation centers, as well as distributors, 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 “is expected to,” “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 2014, 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.
China Biologic Products, Inc.
Mr. Ming Yin
Senior Vice President
Mr. Bill Zima
Phone: +86-10-6583-7511 or +1-646-405-5191