The first long-acting coagulation factor VIII Nuwiq上市 in China

Beijing News (Reporter Wang Kala) Recently, Novo Nordisk announced that the injectable Pegetroxin Alpha (brand name: Nuwit) has been officially launched in mainland China. Nuwit is China’s first and currently only approved long-acting recombinant coagulation factor VIII, and has been successfully included in the new national medical insurance catalog. Nuwit is suitable for patients with hemophilia A (congenital factor VIII deficiency) aged 12 and above, and can be used for on-demand hemostasis, perioperative management, and routine prophylactic treatment. Its insurance reimbursement scope is consistent with that of the already marketed standard half-life coagulation factor VIII, significantly reducing treatment burden and solving the problem of “unaffordable” innovative drugs.

Hemophilia is an X-linked recessive hereditary bleeding disorder, which can be divided into hemophilia A and hemophilia B. Hemophilia A is characterized by deficiency of coagulation factor VIII (FⅧ), accounting for about 80%-85% of all hemophilia cases. Patients require lifelong medication; without timely treatment, it can lead to disability, and in severe cases, even threaten life. With continuous advances in treatment methods, studies show that more and more patients hope that long-acting coagulation factors can reduce injection frequency.

Professor Sun Jing from Southern Medical University Southern Hospital stated that standard recombinant coagulation factor (SHL-rFⅧ) has high infusion frequency and poor treatment compliance. When used for regular replacement therapy, its trough concentration (the lowest concentration during dosing) cannot always remain above 1%, leading to a high risk of breakthrough bleeding and disability. Nuwit, through innovative structural modification, extends the half-life of coagulation factor VIII to 19 hours, a 1.6-fold increase over standard preparations, which can reduce the number of intravenous injections by 50%-71%. When used according to the instructions, it can improve trough levels to an average of 3%, reducing injection burden and the risk of joint bleeding, especially suitable for adolescents with low injection frequency and high activity levels, significantly improving treatment compliance.