The top drug authority is set to approve imports of a hemophilia treatment to help make up for a shortfall that has deprived some patients of the medication they need.
The recombinant-clotting factor produced by the German pharmaceutical company Bayer Healthcare will be on the market soon, according to an announcement on the State Food and Drug Administration (SFDA) website.
"This does not mean that we are easing the two-decade ban on imported blood and plasma-derived products of all kinds," SFDA spokeswoman Yan Jiangying said Wednesday.
The authorities imposed the ban in 1986, in response to a case of HIV infection caused by imported factor VIII that was detected around 1983.
The German-made treatment does not fall into the category of products that are subject to the embargo because it is not made from human plasma, said Yin Hongzhang, a division director with the SFDA's department of drug registration.
However, the recombinant-clotting factor has the same medical effect as plasma-derived factor VIII. It is widely used to treat hemophiliacs in China.
Many clinicians believe such treatments pose little risk of transmitting an infectious disease.
Larry Zhang, regional head for Asia Pacific of Bayer Healthcare, said the treatment would be made available at a lower price in China than in other countries because of the financial difficulties that many patients here face and the lack of a comprehensive health insurance scheme.
Recombinant-clotting factor will cost no more than 5 yuan (65 cents) in China, Zhang said. The average international price is 30 yuan.
A unit of factor VIII currently costs more than 1 yuan in China. In case of a hemorrhage, 1,000 units are required to stop a potentially fatal bout of bleeding.
Chu Yuguang, a Beijing-based hemophiliac and the director of the Hemophilia Home of China, a volunteer group of more than 3,000 patients, applauded the plan to import recombinant-clotting factor, describing it as a timely measure by the government.
"However, many patients cannot even afford locally made factor VIII, let alone the much more expensive import," Chu said.
In another development, recombinant-clotting factor donated by Bayer Healthcare, enough for roughly 650 patients, is on its way from the US to China and should arrive at six Chinese hospitals next week, Zhang said.
最高药品管理当局批准进口治疗血友病治疗药物,帮助解决药品不足,避免一些病人无药可治.
根据国家食品药品监督管理局网站上发表的声明, 德国拜尔医药保健有限公司生产的重组凝血因子不久将要上市.
星期三,SFDA新闻发言人颜江瑛说:"这并不意味着我们放宽了二十年来所禁止的血液和血浆来源的所有药品的要求"
大约在1983年,在进口药物VIII因子中检测出HIV病毒,并造成1例感染,对此,SFDA在
1986年强行禁止该类药物进口.
国家食品药品监督管理局,药品注册司药品注册司部门主任尹红章说,德国制造的药物并非来自人源血浆,因此不在此禁止进口药物之列.
然而,重组凝血因子与血浆源性因子VIII具有相同的作用,在中国广泛应用于治疗血友病.
许多临床医师认为这种治疗方法被感染的几率很小.
拜耳保健有限公司亚太地区主管拉里·张说, 在中国可以实行比其他国家较低的定价因为经济困难,许多病人缺少广泛的健康保险计划.
张说,在中国重组凝血因子花费不会超过5元人民币(65美分).而国际平均水平则是30元人民币.
中国目前1单位VIII因子花费超过1元.对于血友病患者要阻断1次潜在的致命流血需要1000单位.
北京血友病患者楚宇光,中国血友病之家主任,拥有超过3000名友病患者,极力支持进口重组凝血因子的计划,形容它是政府作出的及时的措施.
楚说,然而,许多病人尚不能支付国产 VIII因子,更不用说价格更贵的进口药.
张说,在另一项发展中,由拜耳保健有限公司捐赠,足够650名患者使用的重组凝血因子,正从美国运往中国,将于下周送往六家医院.
