China Biologic Receives SFDA Approval For Clinical Trial Of Human Coagulation Factor VIII

Main Category: Blood / Hematology
Also Included In: Clinical Trials / Drug Trials
Article Date: 20 Sep 2008 - 1:00 PDT

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China Biologic Products, Inc. (OTC Bulletin Board: CBPO) ("China Biologic" or the "Company"), one of the leading plasma-based pharmaceutical companies in the People's Republic of China ("PRC"), announced that the Company received approval from the PRC State Food and Drug Administration (the "SFDA") to commence clinical trial of its new Human Coagulation Factor VIII product ("FVIII"), a coagulation treatment for hemophilia and mass hemorrhaging.

As one of four suppliers of Cryoprecipitate in China, China Biologic has been engaged in a contract to supply Cryoprecipitate to Green Cross China for use in the production of FVIII. With its own supply of Cryoprecipitate and its continued research and development of FVIII, the Company has obtained approval to commence clinical trial for 200 IU and 300 IU per dose of FVIII.

China Biologic has commenced preparations for the clinical study and expects to receive results by mid-2009. If the clinical study is successful, management expects to get SFDA's approval for production to launch the product at the beginning of 2010.

"We are pleased that our continued focus on research and development has led us to receive approval from the SFDA for clinical trial of FVIII," said Mr. Chao Ming Zhao, the Company's CEO. "The approval represents a significant milestone on diversifying our product portfolio. In addition, we believe our ability to produce Cryoprecipitate from clinical extra plasma - plasma that would have been discarded previously - will yield a higher gross profit margin in the production of FVIII."

About China Biologic Products, Inc.

Through its indirect majority-owned subsidiary, Shandong Taibang Biological Products Co. Ltd., China Biologic Products, Inc. (the "Company"), is principally engaged in the research, development, production and manufacturing and sale of plasma-based biopharmaceutical products to hospitals and other health care facilities in China. The Company's human albumin products are mainly used to increase blood volume and its immunoglobulin products are used for the treatment and prevention of diseases.

Safe Harbor Statement

This release may contain certain "forward-looking statements" relating to the business of China Biologic Products, Inc. and its subsidiary companies. All statements, other than statements of historical fact included herein are "forward-looking statements," including statements regarding: the significance of SFDA approval for FVIII clinical trials; the ability of the Company to continue production of Cryoprecipitate from clinical extra plasma and its effect on future profit margins; the ability of the Company to achieve its commercial objectives; the business strategy, plans and objectives of the Company and its subsidiaries; and any other statements of non-historical information. These forward-looking statements are often identified by the use of forward-looking terminology such as "believes," "expects" or similar expressions, involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do 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 press 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 those 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.
http://www.chinabiologic.com