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Drug watchdog allocates materials to help hemophilia treatments
BEIJING—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
two 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 |
