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▎ WuXi AppTec content team editor April 23, according to the official website of China National Medical Products Administration (NMPA), Sanofi (Sanofi) company's injection of Ainocoagulin α (ie recombinant human coagulation factor IX-Fc for injection) The fusion protein, trade name: Saijiu Ning®, English trade name Alprolix®) was officially approved for marketing applications, used for bleeding control, routine prevention, and perioperative bleeding management in adults and children with hemophilia B.
Screenshot source: NMPA official website about hemophilia Hemophilia (hemophilia) is a rare recessive inherited bleeding disorder.
There are about 38,000 patients in China, mainly males, and female patients are extremely rare.
Hemophilia can be divided into two types: hemophilia A (HA) and hemophilia B (HB).
Hemophilia A is a deficiency of coagulation factor Ⅷ (FⅧ), and hemophilia B is a deficiency of coagulation factor Ⅸ (FⅨ).
Among all hemophilia patients, hemophilia A accounts for 80%-85%, and hemophilia B accounts for 15%-20%.
The clinical manifestations of hemophilia A and hemophilia B are similar.
They are mainly bleeding in joints, muscles and deep tissues, but also in internal organs such as the gastrointestinal tract and central nervous system.
If bleeding is repeated, failure to treat in time can lead to joint deformities or pseudo-tumor formation, and severe cases can be life-threatening.
According to the activity level of coagulation factors, hemophilia can be divided into mild, intermediate and severe.
The clinical classification of hemophilia A and hemophilia B (screenshot source: Reference [1]) To learn more about rare disease related knowledge and research progress, please click to visit the rare disease think tank applet About Saijiu Ning® Type B Patients with hemophilia face the risk of severe bleeding throughout their lives due to the lack or low activity of coagulation factor IX in the body.
In the past, in order to keep the coagulation factor IX in the body of hemophilia B patients at a certain level, it was necessary to infuse the coagulation factor once a day.
This poses a great challenge to patient compliance and prognosis.
Therefore, there is an urgent need for clinical treatments that can reduce the frequency of injections and improve patient compliance.
According to Sanofi’s press release, as the world’s first recombinant coagulation factor IX Fc fusion protein (rFIXFc for short), Sai Jiu Ning® significantly prolongs the half-life of the coagulation factor and the duration of the effect.
The coagulation factor is used several times a week for routine preventive treatment.
The frequency of injections was reduced to an average of once a week.
The drug is especially suitable for preventive treatment of children, promotes the recovery of target joints, and can bring comprehensive and long-lasting hemostatic protection for patients with hemophilia B.
Two Phase 3 clinical studies (B-LONG and Kids B-LONG) and an extended study (B-YOND) showed that: in terms of preventing bleeding, the traditional recombinant factor IX (rFIX) preventive treatment was switched from weekly to Sai Jiu In patients undergoing prophylactic treatment, the annualized bleeding rate (ABR) decreased from 5.
5 to 2.
9.
In the individualized preventive treatment, Saijiuning® can reduce the annualized bleeding rate by 80% or more, more than 1/3 Patients who have undergone individualized preventive treatment with Jiu Ning® have achieved zero spontaneous bleeding; in terms of bleeding control, data shows that in 80.
8% of major operations, only a single injection of Sai Jiu Ning® can maintain hemostasis.
In addition, Saijiu Ning® is used in childhood preventive treatment, which can effectively reduce 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.
Therefore, prevention and treatment of hemophilia patients in childhood is particularly important.
The Kids B-LONG study shows that in the preventive treatment of Saijiu Ning®, the annualized spontaneous blood rate of children of different age groups, including joints, is zero.
Image source: 123RF 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 that "The approval of Saijiu Ning® has brought a long-term hemostasis model for Chinese patients with hemophilia B.
It can significantly reduce the annual bleeding rate while reducing the frequency of patient injections, and its annual factor consumption is half of the current non-long-acting recombinant factors on the market, which can further save medical resources and reduce patients and families caused by frequent injections.
burden.
"Professor Wu Runhui, chief physician of the Hematology Oncology Center of Beijing Children's Hospital, Capital Medical University, said: "The approval of Saijiu Ning® has enriched the prevention and 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.
"Recommended reading The third-generation EGFR-TKI lung cancer targeted drug Ivesa® was approved, and the charity aid project was launched at the same time.
China was approved for listing! A new drug for multiple sclerosis is finally here, and icatibant acetate has been widely used worldwide! China Nearly 30,000 patients with hereditary angioedema usher in a new era of acute treatment drugs! China's first gastrointestinal stromal tumor precision treatment drug approved for precision treatment of lung cancer, China's first RET inhibitor pratinib approved reference materials [1] Guidelines for the diagnosis and treatment of rare diseases (2019 edition) [2] To reduce the disability rate of children with hemophilia, the first long-acting recombinant blood coagulation nine-factor Saijiu Ning® was approved.
Retrieved Apr 25, 2021, from https:/ /www.
sanofi.
cn/-/media/Project/One-Sanofi-Web/Websites/Asia-Pacific/Sanofi-CN/Home/media/press-release-center/Press-Release-2021/20210423.
pdf?la =zh Note: This article aims to introduce the progress of medical and health research, not to recommend treatment plans.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
Screenshot source: NMPA official website about hemophilia Hemophilia (hemophilia) is a rare recessive inherited bleeding disorder.
There are about 38,000 patients in China, mainly males, and female patients are extremely rare.
Hemophilia can be divided into two types: hemophilia A (HA) and hemophilia B (HB).
Hemophilia A is a deficiency of coagulation factor Ⅷ (FⅧ), and hemophilia B is a deficiency of coagulation factor Ⅸ (FⅨ).
Among all hemophilia patients, hemophilia A accounts for 80%-85%, and hemophilia B accounts for 15%-20%.
The clinical manifestations of hemophilia A and hemophilia B are similar.
They are mainly bleeding in joints, muscles and deep tissues, but also in internal organs such as the gastrointestinal tract and central nervous system.
If bleeding is repeated, failure to treat in time can lead to joint deformities or pseudo-tumor formation, and severe cases can be life-threatening.
According to the activity level of coagulation factors, hemophilia can be divided into mild, intermediate and severe.
The clinical classification of hemophilia A and hemophilia B (screenshot source: Reference [1]) To learn more about rare disease related knowledge and research progress, please click to visit the rare disease think tank applet About Saijiu Ning® Type B Patients with hemophilia face the risk of severe bleeding throughout their lives due to the lack or low activity of coagulation factor IX in the body.
In the past, in order to keep the coagulation factor IX in the body of hemophilia B patients at a certain level, it was necessary to infuse the coagulation factor once a day.
This poses a great challenge to patient compliance and prognosis.
Therefore, there is an urgent need for clinical treatments that can reduce the frequency of injections and improve patient compliance.
According to Sanofi’s press release, as the world’s first recombinant coagulation factor IX Fc fusion protein (rFIXFc for short), Sai Jiu Ning® significantly prolongs the half-life of the coagulation factor and the duration of the effect.
The coagulation factor is used several times a week for routine preventive treatment.
The frequency of injections was reduced to an average of once a week.
The drug is especially suitable for preventive treatment of children, promotes the recovery of target joints, and can bring comprehensive and long-lasting hemostatic protection for patients with hemophilia B.
Two Phase 3 clinical studies (B-LONG and Kids B-LONG) and an extended study (B-YOND) showed that: in terms of preventing bleeding, the traditional recombinant factor IX (rFIX) preventive treatment was switched from weekly to Sai Jiu In patients undergoing prophylactic treatment, the annualized bleeding rate (ABR) decreased from 5.
5 to 2.
9.
In the individualized preventive treatment, Saijiuning® can reduce the annualized bleeding rate by 80% or more, more than 1/3 Patients who have undergone individualized preventive treatment with Jiu Ning® have achieved zero spontaneous bleeding; in terms of bleeding control, data shows that in 80.
8% of major operations, only a single injection of Sai Jiu Ning® can maintain hemostasis.
In addition, Saijiu Ning® is used in childhood preventive treatment, which can effectively reduce 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.
Therefore, prevention and treatment of hemophilia patients in childhood is particularly important.
The Kids B-LONG study shows that in the preventive treatment of Saijiu Ning®, the annualized spontaneous blood rate of children of different age groups, including joints, is zero.
Image source: 123RF 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 that "The approval of Saijiu Ning® has brought a long-term hemostasis model for Chinese patients with hemophilia B.
It can significantly reduce the annual bleeding rate while reducing the frequency of patient injections, and its annual factor consumption is half of the current non-long-acting recombinant factors on the market, which can further save medical resources and reduce patients and families caused by frequent injections.
burden.
"Professor Wu Runhui, chief physician of the Hematology Oncology Center of Beijing Children's Hospital, Capital Medical University, said: "The approval of Saijiu Ning® has enriched the prevention and 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.
"Recommended reading The third-generation EGFR-TKI lung cancer targeted drug Ivesa® was approved, and the charity aid project was launched at the same time.
China was approved for listing! A new drug for multiple sclerosis is finally here, and icatibant acetate has been widely used worldwide! China Nearly 30,000 patients with hereditary angioedema usher in a new era of acute treatment drugs! China's first gastrointestinal stromal tumor precision treatment drug approved for precision treatment of lung cancer, China's first RET inhibitor pratinib approved reference materials [1] Guidelines for the diagnosis and treatment of rare diseases (2019 edition) [2] To reduce the disability rate of children with hemophilia, the first long-acting recombinant blood coagulation nine-factor Saijiu Ning® was approved.
Retrieved Apr 25, 2021, from https:/ /www.
sanofi.
cn/-/media/Project/One-Sanofi-Web/Websites/Asia-Pacific/Sanofi-CN/Home/media/press-release-center/Press-Release-2021/20210423.
pdf?la =zh Note: This article aims to introduce the progress of medical and health research, not to recommend treatment plans.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
