The list of domestic anti hemophilia drug "coagulation factor" is listed, only 2 domestic and 3 imported

Hemophilia is a group of haemorrhagic diseases caused by the deficiency of hereditary coagulation factors, mainly divided into type A and type B Among them, hemophilia A A is caused by the lack of coagulation factor Ⅷ, the number of patients accounts for about 80% - 85%, and B is lack of coagulation factor IX, the number of patients accounts for about 15% - 20% Hemophilia treatment is very simple, just need to inject "coagulation factor" on time to prevent bleeding, hemophilia patients can be as healthy as normal people So what are the coagulation factors in the domestic market? Which varieties can be made in China? What new drugs are being developed? Today is World Hemophilia Day Let's walk into the world of coagulation factor, the patron saint of hemophilia patients According to the statistics of drug intelligence database, the drugs that have been listed in China for the treatment of hemophilia A at present include human coagulation factor Ⅷ, recombinant human coagulation factor Ⅷ for injection, and recombinant human coagulation factor Ⅶ a for injection; the drugs for the treatment of hemophilia B mainly include recombinant human coagulation factor Ⅸ for injection, recombinant human coagulation factor Ⅶ a for injection, and human prothrombin complex However, at present, there are only two varieties that can be made in China, namely, human coagulation factor Ⅷ and human prothrombin complex Due to the high technical content required for the production of these two drugs, there are few domestic enterprises approved for production The enterprises producing human coagulation factor Ⅷ include Hualan Bioengineering Co., Ltd., green cross biological products, Shanghai Laishi blood products, etc the details are as follows: the enterprises producing human prothrombin complex include Shanghai Laishi blood products, Hualan biological, Shanghai Xinxing medicine, etc the details are as follows: Other drugs, such as recombinant human coagulation factor Ⅷ for injection, recombinant human coagulation factor IX for injection, and recombinant human coagulation factor ⅶ a for injection, can only be imported According to the bidding database of smart drugs, recombinant human coagulation factor Ⅷ for injection has won the bid in 25 regions, with the average price of 1033.75 yuan for 250iu * 1 in 2017; 2135 yuan for 250iu * 1 in 11 regions; and 25ia for injection There is news of winning the bid in the region The average price of 1mg (50K unit) * 1 in 2017 is 5990.73 yuan From this, we can see that the three imported drugs are widely distributed in the market and are expensive Compared with the 2017 average bid price (408.4 yuan) of the specification of human coagulation factor Ⅷ 200 IU * 1, which can be made in China, they are two times or even more than ten times higher According to the statistics of the World Health Organization (who) and the World Hemophilia Federation (WHF), there are about 100000 people suffering from hemophilia in China at present, which increases by 70% every five years In the face of such a severe growth rate of hemophilia patients, we can imagine that the market demand for drugs will increase day by day In terms of the marketing and market situation of related products in China, not only can not meet the demand of patients, but also can not reduce the economic burden of patients Although four of the five varieties mentioned above (except for recombinant human coagulation factor ⅶ a for injection) have been included in the medical insurance, but the medical insurance can also reimburse a small number of costs, most of which are borne by hemophilia patients themselves Fortunately, however, domestic enterprises have never stopped developing hemophilia drugs At present, there are varieties with production approval, such as human coagulation factor Ⅷ and human prothrombin complex, and many enterprises are trying to apply for clinical application or production; only depending on imported varieties, there are also domestic enterprises applying for related new drugs According to the database of drug intelligence registration and acceptance, up to now, CDE has accepted 40 new drug approvals of human coagulation factor Ⅷ, including 31 clinical applications and 9 production applications Of the 9 approvals submitted for production, 6 have been approved, and the remaining 3 approvals are submitted by Boya biology, Shaanxi Kangbao biology and Chengdu Rongsheng pharmaceutical during 2017-2018 The first two enterprises are listed applications, and the latter one has been included in the priority review and approval (see Figure 1 for details) Figure 1 there are 28 new drug approvals of human prothrombin complex accepted by CDE, including 17 clinical applications and 11 production applications Among the 11 approvals submitted for production, Nanyue bio and Shanxi Kangbao bio are the new applicants in 2017 The former is the listing application, and the latter has been included in the priority review and approval varieties (see Figure 2 for details) Figure 2 In addition, of the three imported varieties, only recombinant human coagulation factor Ⅷ for injection has the record of applying for new drugs by domestic enterprises, 9 of which are clinical application Among them, the approval documents of Zhengda Tianqing and Shenzhou cell engineering have been approved for clinical use (see Figure 3 for details) Fig 3 according to the database of Chinese clinical trial of Yaozhi, the clinical study of recombinant human coagulation factor Ⅷ for injection in the treatment of hemophilia A a declared by Shenzhou cell engineering has entered the phase 3 trial (see Fig 4 for details) Figure 4 It is worth mentioning that the recombinant human coagulation factor Ⅷ - Fc fusion protein for injection declared by Kaifeng Pharmaceutical was also accepted by CDE on March 9, 2018 Moreover, because Kaifeng Pharmaceutical was acquired by Furen pharmaceutical in November 2017, the drug was also included in the income bag of Furen pharmaceutical According to the announcement of Fu Ren, the drug is a new class a hemophilia drug, which uses Fc fusion technology to improve the half-life of coagulation factor Ⅷ, and has the potential to provide long-term hemostasis and reduce the frequency of administration.