Novo Nordisk’s recombinant coagulation factor Ⅷ (turoctocog alfa, trade name: Novoeight) has recently been applied for marketing in China for the treatment of hemophilia A. Chiatai Tianqing previously completed the relevant Phase III clinical trial ahead of Novo Nordisk, however, Novo Nordisk filed the marketing application to the NMPA ahead of Chiatai Tianqing.
As a B-domain truncated recombinant human coagulation factor Ⅷ, turoctocog alfa is used to prevent and treat bleeding in patients with hemophilia A; it is the third-generation recombinant coagulation factor Ⅷ product of Novo Nordisk and uses the latest gene recombination and protein purification techniques; it received FDA’s approval in Oct. 2013.
Turoctocog alfa was evaluated in the Guardian Phase III trials which have been so far the largest clinical pre-registered trial project conducted in hemophilia A patients, involving more than 200 hemophilia A patients. Those Phase III clinical trials conducted by Novo Nordisk included previously treated severe hemophilia A adult and child patients, of which the results proved the prevention and therapeutic effects of turoctocog alpha against bleeding, without inhibitor occurring inside patients.
Global annual sales of Novo Nordisk’s Novoeight and Novoseven are around USD2 billion at present.
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Hemophilia is a group of hemorrhagic diseases with inherited coagulation disorder and belongs to a rare disease, with the common characteristics of active thromboplastin generation disorder, prolonged coagulation time, lifelong slight post-trauma bleeding tendency, and severe patients possibly having "spontaneous" bleeding even without obvious trauma. Hemophilia is generally divided into type A, type B, and type C according to the factor deficiencies, wherein, hemophilia A patients as a result of the deficiency of coagulation factor Ⅷ account for 80%-85% of the total hemophilia patients.
Type | Factor deficient | Patient proportion | Disease characteristic |
Hemophilia A | Coagulation factor Ⅷ |
| It is an X-linked recessive disorder, therefore, the proportion of male patients is far higher than that of female patients: the prevalence in baby boys is around one per five thousand to ten thousand |
Hemophilia B | Coagulation factor Ⅸ | <20% | The proportion of female patients is higher than that of male patients; the prevalence in babies is around one per twenty thousand to thirty-four thousand |
Hemophilia C | Coagulation factor Ⅺ | Very small | Autosomal recessive inherited disorder |
(Source: CNKI)
The inheritance mode of hemophilia is X-linked recessive inheritance and the gene is carried throughout patients’ lives, which still cannot be cured at present. The current therapeutic methods are all replacement therapy, with coagulation factors being the main drugs for hemophilia, wherein, coagulation factor Ⅷ is a kind of glycoprotein with molecular weight reaching over one million and it is dissociated to subunits with molecular weight of about 200,000 under high salt concentration to serve as the cofactor of coagulation factor IXa in the coagulation process and participate in the activ...
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