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)