BEIJING, June 25, 2012 /PRNewswire-Asia-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 a manufacturing approval certificate from the China State Food and Drug Administration ("SFDA") for Human Coagulation Factor VIII ("FVIII"). With this certificate, the only approval remaining for Taibang's commercial production of FVIII is the SFDA's good manufacturing practice ("GMP") certification of the FVIII production line itself.
Taibang began research for FVIII in 2007 and successfully developed the technology in 2008. The Company conducted clinical trials from 2009 to 2010. In June 2010, the Company submitted required materials to Center for Drug Evaluation for approval to start manufacturing and passed on-site products verification in January 2011. The Company received official manufacturing approval certificate on June 21, 2012. FVIII will be primarily used in the treatment of hemophilia A.
Mr. David Gao, Chairman & CEO, said, "Receiving SFDA manufacturing approval represents the culmination of more than five years of work and the first technological approval of a coagulation factor product developed by Taibang. With the addition of Factor VIII, we should soon be able to offer three major categories of blood products: albumin products, immunoglobulin products and coagulation factor products. This will further strengthen our competitive position as a leading plasma-based biopharmaceutical company in China."
• Alzheimer's Association International Conference (AAIC) 2012 IVIG Offers Long-term Stabilization of Alzheimer's Symptoms No Decline From Baseline in a Subset of Patients at 3 Years Caroline Cassels
July 18, 2012 (Vancouver, British Columbia) — Immunotherapy with intravenous immunoglobulin (IVIG/Gammagard, Baxter) appears to stabilize symptoms of Alzheimer's disease (AD) over the long term, new research shows. Presented here at the Alzheimer's Association International Conference (AAIC) 2012, a small, open-label extension phase 2 trial showed that at 36 months, IVIG slowed the rate of expected cognitive decline in all participants. But the most striking finding was that it stopped decline in a subset of patients who received what proved to be the optimal dose of the immunotherapy for the entire study period. , IVIG is a mixture of IgG antibodies. It is a candidate as a treatment for AD because it contains naturally occurring anti-amyloid antibodies and can alter immune function by reducing the harmful effects of inflammation.