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On April 23, Sanofi announced that its Ainocoagulin alpha for injection (trade name: Saijiu Ning) has been approved by the National Medical Products Administration (NMPA) of China for the diagnosis of adult and child hemophilia B Patients' bleeding control, routine prevention, and perioperative bleeding management.
In China, Saijiu Ning is one of the second batch of overseas new drugs that are urgently needed for clinical use.
The press release pointed out that this approval made the drug the first long-acting recombinant factor IX approved in China.
Hemophilia is a rare recessive inherited bleeding disorder.
Patients with hemophilia B are at risk of severe bleeding throughout their lives due to the lack or low activity of coagulation factor IX in the body.
As the world’s first recombinant coagulation factor IXFc fusion protein (rFIXFc for short), Sai Jiu Ning prolongs the plasma half-life and curative effect duration of factor IX through Fc fusion technology, and reduces the frequency of injections of coagulation factor several times a week on conventional preventive treatment to On average, once a week.
Two multi-center, open phase 3 clinical studies (B-LONG and Kids B-LONG) and an extended study (B-YOND) showed that: in terms of preventing bleeding, from receiving traditional recombinant IX factor (rFIX) every week to prevent The annualized bleeding rate (ABR) decreased from 5.
In addition, Saijiu Ning is used in childhood preventive treatment, which can effectively reduce the disability rate.
