China's drug authority has decided to allocate raw materials to clotting factor VIII producers to ease a nationwide shortage of the factor, which is a plasma-derived protein and a main treatment for hemophilia.

 

The State Food and Drug Administration (SFDA) said in a notice that the administration has asked four blood products companies based in Shanghai, Shandong, Henan and Guiyang to supply cryoprecipitate to the country's three clotting factor VIII producers as raw materials.

 

In China, three pharmaceutical manufacturers produce clotting factor VIII: Shanghai RAAS Blood Products Co., the Anhui-based Green Cross China Biotheological Co. and Hualan Biological Engineering in Henan Province.

 

Cryoprecipitate is a frozen blood product prepared from plasma.

 

To ensure safety of the products, the administration asked relevant companies to sign agreements to set down supply procedures, prices and transportation means, and submitted relevant documents to local food and drug agencies.

 

According to the SFDA, China has suffered from a shortage of clotting factor VIII in major cities and hospitals since August this year.

 

The total production of factor VIII in 2006 was 48.9 million units, while production so far this year has been only 33.4 million units, and 2 million more units are expected to be on the market by the year end.

 

The SFDA's spokeswoman Yan Jiangying said earlier this week that it indicated "a 32-percent decrease year-on-year."

 

Yan said a shortage of plasma supply is the main cause of the problem, noting that most of factor VIII is extracted from blood plasma.

 

Plasma supply in China dropped by about 50 percent in 2006 from the previous year, said Yan, which in turn led to the lower production of factor VIII by Chinese blood product companies.

 

Hemophilia is a genetic disease. Patients suffer from low levels of plasma clotting factors. They are vulnerable to injuries: once a hemophiliac starts to bleed, there is no way to stop the bleeding except by an injection of the missing clotting factor.

 

(Xinhua News Agency December 16, 2007)