Recently, Novo Nordisk, a leading global biopharmaceutical company...We announce the official launch of Pertrol Alpha for Injection (trade name: Noyt®) in mainland China. Noyt® is the first and currently the only* approved long-acting recombinant coagulation factor VIII in my country, and has been successfully added to the new version of the National Reimbursement Drug List. The full launch of Noyt® in the mainland China market fills the gap in long-acting treatment for hemophilia A, further improves patient accessibility, and brings Chinese hemophilia A patients into a new stage of treatment.

Hemophilia is an X-linked recessive inherited bleeding disorder, which can be divided into hemophilia A and hemophilia B. Hemophilia A is characterized by a deficiency of clotting factor VIII (FVIII), and patients with this condition account for approximately 80%-85% of all hemophilia cases. It requires lifelong medication, and without timely treatment, it can lead to disability and, in severe cases, even death. With continuous advancements in treatment methods, research shows that an increasing number of patients are hoping for long-acting clotting factors to reduce the frequency of injections.
Professor Sun Jing of Nanfang Hospital, Southern Medical University, stated: "Standard recombinant coagulation factor (SHL-rFVIII) requires frequent infusions, resulting in poor treatment adherence. If used for regular replacement therapy, its trough concentration (the lowest concentration during administration) cannot consistently exceed 1%, leading to a high risk of breakthrough bleeding and disability. Noretex®, through innovative structural modifications, extends the half-life of coagulation factor VIII to 19 hours (1.6 times longer than the standard formulation), reducing the number of intravenous injections by 50%-71%. When used according to the instructions, the trough concentration can be improved to an average of 3%, reducing the patient's injection burden and the risk of joint bleeding. It is particularly suitable for the low-frequency injection and high-activity needs of adolescents, significantly improving treatment adherence."
Since its approval in the United States in 2019, Norexate® has accumulated extensive efficacy and safety data globally for the prevention and treatment of bleeding. The results of the Pathfinder105 multicenter trial in Chinese patients with hemophilia A showed that the median annualized bleeding rate (ABR) of Norexate® was 0.00, with a zero-bleeding rate of 69.4%, and a hemostasis success rate of 94.8% for treating bleeding, providing an efficient and convenient treatment option for Chinese patients with hemophilia A.
Noytec® is indicated for patients aged 12 years and older with hemophilia A (congenital factor VIII deficiency) and can be used for on-demand hemostasis, perioperative management, and routine prophylactic treatment; it is not indicated for von Willebrand disease (vWD). Its reimbursement scope is consistent with that of marketed standard half-life factor VIII, significantly reducing the treatment burden and breaking through the limitations of innovative drugs.The problem of "not being able to afford it".
Zhou Xiaping, Senior Vice President of Novo Nordisk and President of Greater China, said, "The launch and inclusion of NovoMix® in the national medical insurance program is a significant achievement for Novo Nordisk in the field of rare diseases in China. From Noci® and NovoMix® to NovoMix®, Novo Nordisk will continue to provide high-quality solutions for hemophilia patients in China, gradually improve patients' access to medications, continuously improve the patient service system, and contribute to the realization of the 'Healthy China 2030' goal."

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