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The Rare Disease Treatment Drug, Emeraldimumab, Was Approved For Marketing
Dec 05, 2018

Hemophilia A is a recessive hereditary hemorrhagic disease caused by X-linked clotting factor VIII deficiency and abnormal blood coagulation. The patient's blood does not coagulate normally and is prone to uncontrolled and frequent persistent or spontaneous bleeding. Developed by Roche, Ameselizumab is a recombinant humanized, bispecific monoclonal antibody that replaces the cofactor activity of activated factor VIII and promotes the activation of FX by FIXa, which in turn leads to thrombin. The production is significantly increased to achieve hemostasis in the bleeding site of patients with FVIII dysfunction or hemophilia A who are completely deficient in FVIII. As a clinically urgently needed variety, Lemeximumab injection is included in the priority review process to expedite the review and approval. In view of the clinical efficacy of this product is clear, the risk is controllable, the tolerance is good, the drug delivery is easy to follow, and there is no clear difference in efficacy and safety between patients of different races. On November 30, the State Drug Administration approved This product is imported for routine preventive treatment of hemophilia A patients with congenital factor VIII deficiency (congenital factor VIII deficiency) to prevent bleeding or reduce the frequency of bleeding.


In accordance with the spirit of the Central Committee of the Communist Party of China and the State Council on deepening the reform of the drug review and approval system, the State Drug Administration continues to speed up the importation of new drugs listed overseas in China, for the treatment of rare diseases and for the prevention and treatment of serious life-threatening diseases. Optimize the review process, simplify the listing requirements, and ensure that Chinese patients have already used new drugs listed overseas

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