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Sanofi announced today that China's National Medical Products Administration has approved Ainocoagulin α for injection (ie, recombinant human coagulation factor IX-Fc fusion protein for injection, trade name: Saijiu Ning®, English trade name Alprolix®) for diagnosis For adults and children with hemophilia B (congenital factor IX deficiency), bleeding control, routine prevention, and perioperative bleeding management
.
As the world's first human recombinant coagulation factor IX Fc fusion protein, Saijiu Ning® significantly prolongs the half-life of coagulation factor and reduces the number of injections for patients.
Urgent clinical need, reduce injection frequency to achieve long-term protection
Hemophilia is a rare recessive inherited bleeding disorder
.
There are about 38,000 hemophilia patients in China, of which 15%-20% are patients with hemophilia B[1]
Sai Jiu Ning ® prolongs the plasma half-life and duration of efficacy of factor IX through Fc fusion technology, which significantly reduces the frequency of administration
.
In routine preventive treatment, the frequency of injections of coagulation factors several times a week has been reduced to an average of once a week
Professor Yang Renchi, Director of the Thrombosis and Hemostasis Diagnosis and Treatment Center of the Hematology Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College, pointed out, “The approval of Sai Jiu Ning® has brought a long-term hemostasis mode for patients with hemophilia B in China
.
It is significantly reducing years of life.
Two multi-center, open phase III 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.
5 to 2.
9 in patients whose treatment was switched to Sejiuling® preventive treatment.
In individualized preventive treatment, Sejiuling® can reduce ABR by 80% or more, more than 1/3 Patients who use Saijiu Ning® for individualized preventive treatment have achieved zero spontaneous bleeding
.
In terms of bleeding control, data show that in 80.
Childhood preventive treatment, effectively reducing the disability rate
More than 90% of bleeding in patients with hemophilia occurs in the joints, often onset in childhood
.
If joints bleed repeatedly for a long time, it may not only cause deformity and disability, but also life-threatening
Professor Wu Runhui, chief physician of the Hematology Oncology Center of Beijing Children's Hospital Affiliated to Capital Medical University, believes that the approval of Saijiu Ning® has enriched the preventive treatment options for patients with hemophilia B, which will help slow the progression of joint disease and improve the quality of life of patients
.
For children with hemophilia, the benefits will be more obvious, because childhood is the golden period of hemophilia treatment, and standard preventive treatment at this time can double the result with half the effort and effectively reduce the disability rate
Dr.
He Enting, President of Sanofi Greater China, said: “As a global leader in the field of rare diseases, Sanofi is proud to extend our innovative product portfolio in China to rare blood diseases
.
Children with friendly diseases bring new treatment options to fill the unmet clinical needs
