药物基本信息
通用名：人凝血因子Ⅷ
临床用途：用于血浆凝血因子Ⅷ(FⅧ)缺乏的甲型血友病治疗
市场需求
FⅧ是治疗血友病的救命药，临床急需的药。但其出自血浆，所以该类产品产量受原料血浆的限制，血浆来源的有限势必会限制FⅧ的供应，导致有些患者得不到及时有效的治疗；另外，血浆来源的FⅧ存在较高的免疫原性和病毒污染的潜在风险，我国曾有由于输送FⅧ而导致人类免疫缺陷病毒（HIV）感染的报道。
所以，基因重组型凝血因子的开发早已是趋势，和传统的血浆中提取的凝血因子相比避免了血浆杂蛋白和病毒污染。
由于凝血因子结构较为复杂，开发及制备难度较高，成本和工艺都不是一般的国内公司能够达到。因此重组型凝血因子由进口产品占据。目前国内获得批文上市的凝血因子均由血浆制取，国内的企业目前只能生产冻干人凝血因子VIII，生产上已经落后国外产品。
The basic information of drug
Common name: FVIII
Clinical use: treatment of hemophilia lacking of plasma coagulation factor Ⅷ (FⅧ)
Market demand
FⅧ is the drug used to hemophilia life-saving and urgently needed in clinical. But it is from the plasma. So the production of it is limited by plasma. The source of plasma limits the supply of FⅧ, resulting in some patients are not timely and effective treated; In addition, the FⅧ which is from plasma has a high potential risk of immunogenicity and virus contamination. In my country, there has been a report that someone gets human immunodeficiency virus (HIV) infection due to the transport of FⅧ.
Therefore, the development of recombinant gene coagulation factor has long been a trend, and it avoids the plasma albumin and virus contamination comparing with traditionally extracting the coagulation factor from plasma.
Because the structure of coagulation factor is more complex, the development and preparation of it are high difficulty, and the cost and technology of it are not achieved by ordinary domestic companies. So the market of recombinant type coagulation factor is occupied by imported products. At present, domestic approved listed blood coagulation factors are made by the plasma. Domestic enterprises can only produce freeze-dried human factor VIII, and it has been fallen behind the foreign products.
