China Biologic Products set to make clotting aid post CFDA inspection
PCC is a combination of blood clotting factors II, VII, IX and X prepared from human blood plasma and used to reduce bleeding in patients, including those suffering from congenital diseases such as hemophilia.
In China, only two companies manufacture the product – Shanghai RAAS Blood Products and Hualan Bio – but Beijing-headquartered firm China Biologics Products said it expected to soon receive approval for its human PCC, which is produced at its Shandoing Taibang facility.
“Our PCC facility in Shandong has been inspected by the CFDA, and we expect to receive the CFDA manufacture approval in October or early the last quarter of 2014,” Ming Yin, Senior Vice President, said during a conference call Sunday (transcript here).
Yin also said that despite competition in China, only very small quantities of PCC products have been available to the domestic market – around 260,000 vials – and as such an upcoming approval would “deliver meaningful contributions” to the firm’s financials in 2015.
For the second quarter, total sales stood at $60m (€45m) compared to $54m in the same period 2013, and was attributed to increases in plasma-based products and placenta polypeptide products.
The firm’s topseller is its human albumin product which contributed 34% to total revenues, though this percentage fell from 43% in the second quarter 2013 due to the deflation of inventory out of its Guizhou Taibang plant, as most of the newly produced albumin products were still awaiting government approval production resumed in March.
Human albumin is used as to transport hormones, fatty acids, and other compounds and is often used to replace lost fluid and help restore blood volume in patients. As well as local companies, China Biologic Products faces competition from international albumin prodcuers including Baxter and CSL.