China Biologic Receives GMP Certificate for Human Coagulation Factor VIII to Start Commercial Manufacturing This Month
BEIJING, Oct. 24, 2012 /PRNewswire-FirstCall/ — China Biologic Products, Inc. (NASDAQ: CBPO, “China Biologic” or the “Company”), a leading fully integrated plasma-based biopharmaceutical company in China, today announced that its indirectly owned subsidiary, Shandong Taibang Biological Products Co., Ltd. (“Taibang”) has received good manufacturing practice (“GMP”) certification from the China State Food and Drug Administration (“SFDA”) for Human Coagulation Factor VIII (“FVIII”). Taibang earlier received manufacturing approval for FVIII from the SFDA in June 2012. With now both the manufacturing approval and the GMP certificate, Taibang expects start commercial manufacture of FVIII products immediately.
FVIII is widely used in the treatment of hemophilia A. In China, there is a large hemophilia patient population (estimated at 60,000 – 100,000 afflicted with approximately 10,000 patients registered) whose treatment requires lifelong medication. Currently, only three domestic companies produce plasma-based FVIII products. Taibang is in the process to build additional manufacturing line capacity for FVIII in order to mitigate the situation of China’s large under-supply of coagulation products.
Mr. David Gao, Chairman & CEO, said, “We are immensely encouraged by this latest development at Taibang and are proud to now offer the market all three major categories of blood products through the addition of coagulation factor products. To supply FVIII will significantly improve the market penetration of our plasma-based offering and further strengthen our competitive position as one of China’s top plasma-based biopharmaceutical companies.”
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 plasma-based products through its indirect majority-owned subsidiaries, Shandong Taibang Biological Products Co., Ltd. and Guiyang Dalin Biologic Technologies 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 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 “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.
China Biologic Products, Inc.
Mr. Ming Yin
Mr. Rob Koepp
Phone: +86-10-6583-7516 or +1-646-405-5191
SOURCE China Biologic Products, Inc.