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Hemophilia is a rare disease.
Patients will experience frequent and repeated bleeding, which can cause permanent damage to the joints, disability and other serious consequences
.
At present, in clinical practice, coagulation factor Ⅷ (FⅧ) is mainly used for on-demand or preventive replacement therapy to reduce bleeding events.
However, coagulation factor prophylaxis requires frequent intravenous injections to maintain blood concentration and faces many risks
.
The non-coagulation factor drug iimerizumab has the advantages of significantly lowering the risk of bleeding, long half-life, low injection frequency, and convenient administration.
It brings continuous protection to hemophilia families, helps patients get rid of the shackles of wheelchairs, and meets colorful The future
.
Recently, Iimerizumab was officially approved for the routine preventive treatment of adult and pediatric patients with hemophilia A (congenital FVIII deficiency) without FⅧ inhibitors, which means that Iimerizumab has become the current China The first and currently the only conventional preventive drug for hemophilia A with or without FⅧ inhibitors in the body at the same time, providing hemophilia patients with a more flexible and effective treatment plan and reducing the burden of disease.
.
Localized management, homogenized diagnosis and treatment, hemophilia center construction accelerates standardized diagnosis and treatment of hemophilia In 2012, the Ministry of Health of the People's Republic of China proposed the establishment of a hierarchical diagnosis and treatment system for hemophilia
.
The construction of the hemophilia center aims at achieving hierarchical diagnosis and treatment or three-level management, and is divided into a hemophilia diagnosis and treatment center, a hemophilia treatment center, and a hemophilia comprehensive management center
.
It is hoped that the overall level of diagnosis and treatment of hemophilia in various regions will be improved to achieve the goal of localized management and homogeneous diagnosis and treatment
.
Professor Yang Renchi introduced that more than 180 hospitals in China have entered data on the registration platform of the National Hemophilia Case Information Management Center.
Among them, 30 hospitals have passed the data review, and 16 hospitals have passed the on-site assessment and been awarded licenses.
.
There is still room for further improvement in the construction of hemophilia centers.
It is hoped that more domestic centers can meet the assessment criteria and become hemophilia diagnosis and treatment centers, treatment centers, and comprehensive management centers
.
The construction of the hemophilia center plays a key role in the promotion of standardized diagnosis and treatment of hemophilia
.
Medical institutions at all levels should actively establish hemophilia centers, carry out information registration and reporting of hemophilia cases, and provide standardized diagnosis and treatment guidance for patients with hemophilia; publicize the advantages of hemophilia prevention and treatment in many ways, Actively carry out preventive treatment among patients with friendly diseases, and reduce critical bleeding through preventive treatments, and reduce the risk of patients' disability; it is also necessary to strengthen the education of hemophilia and improve the compliance of hemophilia patients
.
For patients with hemophilia, the availability of drugs still needs to be improved
.
The construction of the blood disease treatment center has improved the accessibility of medicines, so that patients with hemophilia can better understand how to conduct family treatment, self-support, and daily management
.
Since non-coagulation factor products were not yet on the market at the time of the establishment and evaluation of the hemophilia center construction standards, the drug demand standards of the hemophilia center evaluation system did not include non-coagulation factor drugs
.
However, the application of non-coagulation factor drugs represented by iimerizumab can help improve the level of diagnosis and treatment in hemophilia centers, and the inclusion of national medical insurance can help improve the availability of drugs for hemophilia
.
Replacement therapy for hemophilia is at risk, and better treatment drugs are urgently needed.
Hemophilia is a rare inherited coagulopathy disease
.
Patients with hemophilia may cause spontaneous or traumatic bleeding due to FⅧ deficiency
.
The most common bleeding sites include joints, muscles, and soft tissues.
Severe intracranial bleeding can be life-threatening
.
It is gratifying that through effective preventive treatment, it has become a reality for children with hemophilia to live like normal children
.
At present, the treatment of hemophilia is still based on preventive treatment and on-demand treatment
.
Preventive treatment is through regular injection of coagulation factors for replacement therapy, so that the coagulation factors in the plasma can be maintained at a certain level for a long time, which can effectively reduce the bleeding rate and disability rate
.
The preventive treatment of blood diseases includes primary prevention, secondary prevention and tertiary prevention
.
A large number of clinical trials have confirmed that the effect of primary prevention is very good, and it can avoid important organ bleeding, joint bleeding and teratogenicity.
It has been widely adopted at home and abroad
.
For children with hemophilia, long-term standardized preventive treatment can achieve the goal of zero bleeding, let the children return to normal life, and improve the quality of life
.
FⅧ currently used for replacement therapy mainly includes plasma-derived FⅧ and recombinant FⅧ
.
The half-life of these drugs is relatively short.
In acute bleeding or other preventive treatments, frequent intravenous injections are required, causing pain and inconvenience to patients, and may face the risk of viral infection and inhibitor production in clinical applications
.
Effectiveness and safety are both important, and the prophylactic treatment of imicelizumab makes "zero bleeding" possible.
For patients with hemophilia, choosing drugs with good efficacy and safety can better control bleeding and reduce life-threatening Of adverse health events occurred
.
The non-coagulation factor drug iimerizumab is the most interesting new drug for hemophilia in recent years.
It can be injected subcutaneously.
It has the advantages of convenient administration, long half-life, easy storage, and few adverse reactions.
It is suitable for patients with or without prevention and treatment of hemophilia a patients with inhibitors
.
Immexizumab can not only avoid the production of inhibitors, but also solve the problem of frequent injections and high costs of similar drugs
.
Eimexizumab is a drug with an innovative mechanism of action, leading the prevention and treatment of childhood hemophilia into the era of zero-treatment bleeding
.
Eimexizumab is a humanized bispecific monoclonal antibody with a half-life of 4-5 weeks.
By simulating the cofactor function of FⅧ and bridging FⅨa and FⅩ at the same time, FⅨa activates FⅩ without FⅧ , To restore the natural coagulation pathway and reduce the number of bleeding in patients with hemophilia
.
In addition, because Immexizumab has no FⅧ similar structure, it will not produce anti-FⅧ antibodies, which reduces side effects and improves the safety of preventive treatment
.
The results of the HAVEN3 and HAVEN4 studies showed that for patients with hemophilia with or without FⅧ inhibitors, compared with patients who did not receive preventive treatment, patients who received eimerizumab prophylaxis reduced bleeding events by 96%-97% , 56.
1% had no bleeding events, and 90.
2% had bleeding events ≤3 times
.
Both studies have demonstrated the better efficacy and safety of imitizumab
.
The HAVEN5 study also explored the efficacy and safety of iimerizumab in hemophilia patients with or without FⅧ inhibitors
.
Compared with patients with hemophilia who did not receive preventive treatment, the annualized bleeding rate of patients receiving imitolizumab preventive treatment was reduced by 96%, and the annualized bleeding rate of patients with different dosage regimens was 1.
0, and the zero bleeding rate reached 55.
6%
.
On May 7, 2021, Iimerizumab was formally approved by the National Medical Products Administration (NMPA) of China for use in patients with severe hemophilia A without FⅧ inhibitors (congenital FⅧ deficiency, FⅧ<1 %) Routine preventive treatment for adults and children to prevent bleeding or reduce the frequency of bleeding episodes
.
The approval of the new indications provides a safe, effective and convenient option for the prevention and treatment of blood disease patients, which has far-reaching significance
.
As an innovative drug for routine preventive treatment that can be used for both adult and pediatric patients, Eimexizumab greatly simplifies the treatment process while significantly reducing the risk of bleeding
.
The administration method of subcutaneous injection once a week solves the problem of intravenous accessibility and compliance of hemophilia patients, especially children, and provides more flexible and effective treatment options for children with hemophilia, so that more patients Children can return to school and grow up healthily
.
Professor Yang Renchi said that both hemophiliac doctors and patients expect that Immexizumab can enter the medical insurance as soon as possible, reduce the disease burden of patients, and allow more hemophilia patients to benefit from it
.
Summary The current diagnosis and treatment of hemophilia is still facing certain difficulties.
However, non-coagulation factor drugs represented by iimerizumab can improve the treatment route and injection frequency, in terms of the time and cost of treatment, the convenience of treatment, and the ease of treatment.
Sexuality greatly reduces the impact of hemophilia on patients’ work, study, and life, improves the efficacy of hemophilia prevention and treatment, and at the same time brings better quality of life to patients, and the approval of new indications is more hemophilia The treatment of the disease brought another breakthrough
.
I look forward to further improving the standardized diagnosis and treatment of hemophilia in the future, bringing clinical benefits to more hemophilia patients, getting rid of the heavy burden of treatment, improving the quality of life, and living a normal life
.
The little research that everyone is doing, come and move your little finger! ↓↓↓Poke "Read the original", we will make progress together
Patients will experience frequent and repeated bleeding, which can cause permanent damage to the joints, disability and other serious consequences
.
At present, in clinical practice, coagulation factor Ⅷ (FⅧ) is mainly used for on-demand or preventive replacement therapy to reduce bleeding events.
However, coagulation factor prophylaxis requires frequent intravenous injections to maintain blood concentration and faces many risks
.
The non-coagulation factor drug iimerizumab has the advantages of significantly lowering the risk of bleeding, long half-life, low injection frequency, and convenient administration.
It brings continuous protection to hemophilia families, helps patients get rid of the shackles of wheelchairs, and meets colorful The future
.
Recently, Iimerizumab was officially approved for the routine preventive treatment of adult and pediatric patients with hemophilia A (congenital FVIII deficiency) without FⅧ inhibitors, which means that Iimerizumab has become the current China The first and currently the only conventional preventive drug for hemophilia A with or without FⅧ inhibitors in the body at the same time, providing hemophilia patients with a more flexible and effective treatment plan and reducing the burden of disease.
.
Localized management, homogenized diagnosis and treatment, hemophilia center construction accelerates standardized diagnosis and treatment of hemophilia In 2012, the Ministry of Health of the People's Republic of China proposed the establishment of a hierarchical diagnosis and treatment system for hemophilia
.
The construction of the hemophilia center aims at achieving hierarchical diagnosis and treatment or three-level management, and is divided into a hemophilia diagnosis and treatment center, a hemophilia treatment center, and a hemophilia comprehensive management center
.
It is hoped that the overall level of diagnosis and treatment of hemophilia in various regions will be improved to achieve the goal of localized management and homogeneous diagnosis and treatment
.
Professor Yang Renchi introduced that more than 180 hospitals in China have entered data on the registration platform of the National Hemophilia Case Information Management Center.
Among them, 30 hospitals have passed the data review, and 16 hospitals have passed the on-site assessment and been awarded licenses.
.
There is still room for further improvement in the construction of hemophilia centers.
It is hoped that more domestic centers can meet the assessment criteria and become hemophilia diagnosis and treatment centers, treatment centers, and comprehensive management centers
.
The construction of the hemophilia center plays a key role in the promotion of standardized diagnosis and treatment of hemophilia
.
Medical institutions at all levels should actively establish hemophilia centers, carry out information registration and reporting of hemophilia cases, and provide standardized diagnosis and treatment guidance for patients with hemophilia; publicize the advantages of hemophilia prevention and treatment in many ways, Actively carry out preventive treatment among patients with friendly diseases, and reduce critical bleeding through preventive treatments, and reduce the risk of patients' disability; it is also necessary to strengthen the education of hemophilia and improve the compliance of hemophilia patients
.
For patients with hemophilia, the availability of drugs still needs to be improved
.
The construction of the blood disease treatment center has improved the accessibility of medicines, so that patients with hemophilia can better understand how to conduct family treatment, self-support, and daily management
.
Since non-coagulation factor products were not yet on the market at the time of the establishment and evaluation of the hemophilia center construction standards, the drug demand standards of the hemophilia center evaluation system did not include non-coagulation factor drugs
.
However, the application of non-coagulation factor drugs represented by iimerizumab can help improve the level of diagnosis and treatment in hemophilia centers, and the inclusion of national medical insurance can help improve the availability of drugs for hemophilia
.
Replacement therapy for hemophilia is at risk, and better treatment drugs are urgently needed.
Hemophilia is a rare inherited coagulopathy disease
.
Patients with hemophilia may cause spontaneous or traumatic bleeding due to FⅧ deficiency
.
The most common bleeding sites include joints, muscles, and soft tissues.
Severe intracranial bleeding can be life-threatening
.
It is gratifying that through effective preventive treatment, it has become a reality for children with hemophilia to live like normal children
.
At present, the treatment of hemophilia is still based on preventive treatment and on-demand treatment
.
Preventive treatment is through regular injection of coagulation factors for replacement therapy, so that the coagulation factors in the plasma can be maintained at a certain level for a long time, which can effectively reduce the bleeding rate and disability rate
.
The preventive treatment of blood diseases includes primary prevention, secondary prevention and tertiary prevention
.
A large number of clinical trials have confirmed that the effect of primary prevention is very good, and it can avoid important organ bleeding, joint bleeding and teratogenicity.
It has been widely adopted at home and abroad
.
For children with hemophilia, long-term standardized preventive treatment can achieve the goal of zero bleeding, let the children return to normal life, and improve the quality of life
.
FⅧ currently used for replacement therapy mainly includes plasma-derived FⅧ and recombinant FⅧ
.
The half-life of these drugs is relatively short.
In acute bleeding or other preventive treatments, frequent intravenous injections are required, causing pain and inconvenience to patients, and may face the risk of viral infection and inhibitor production in clinical applications
.
Effectiveness and safety are both important, and the prophylactic treatment of imicelizumab makes "zero bleeding" possible.
For patients with hemophilia, choosing drugs with good efficacy and safety can better control bleeding and reduce life-threatening Of adverse health events occurred
.
The non-coagulation factor drug iimerizumab is the most interesting new drug for hemophilia in recent years.
It can be injected subcutaneously.
It has the advantages of convenient administration, long half-life, easy storage, and few adverse reactions.
It is suitable for patients with or without prevention and treatment of hemophilia a patients with inhibitors
.
Immexizumab can not only avoid the production of inhibitors, but also solve the problem of frequent injections and high costs of similar drugs
.
Eimexizumab is a drug with an innovative mechanism of action, leading the prevention and treatment of childhood hemophilia into the era of zero-treatment bleeding
.
Eimexizumab is a humanized bispecific monoclonal antibody with a half-life of 4-5 weeks.
By simulating the cofactor function of FⅧ and bridging FⅨa and FⅩ at the same time, FⅨa activates FⅩ without FⅧ , To restore the natural coagulation pathway and reduce the number of bleeding in patients with hemophilia
.
In addition, because Immexizumab has no FⅧ similar structure, it will not produce anti-FⅧ antibodies, which reduces side effects and improves the safety of preventive treatment
.
The results of the HAVEN3 and HAVEN4 studies showed that for patients with hemophilia with or without FⅧ inhibitors, compared with patients who did not receive preventive treatment, patients who received eimerizumab prophylaxis reduced bleeding events by 96%-97% , 56.
1% had no bleeding events, and 90.
2% had bleeding events ≤3 times
.
Both studies have demonstrated the better efficacy and safety of imitizumab
.
The HAVEN5 study also explored the efficacy and safety of iimerizumab in hemophilia patients with or without FⅧ inhibitors
.
Compared with patients with hemophilia who did not receive preventive treatment, the annualized bleeding rate of patients receiving imitolizumab preventive treatment was reduced by 96%, and the annualized bleeding rate of patients with different dosage regimens was 1.
0, and the zero bleeding rate reached 55.
6%
.
On May 7, 2021, Iimerizumab was formally approved by the National Medical Products Administration (NMPA) of China for use in patients with severe hemophilia A without FⅧ inhibitors (congenital FⅧ deficiency, FⅧ<1 %) Routine preventive treatment for adults and children to prevent bleeding or reduce the frequency of bleeding episodes
.
The approval of the new indications provides a safe, effective and convenient option for the prevention and treatment of blood disease patients, which has far-reaching significance
.
As an innovative drug for routine preventive treatment that can be used for both adult and pediatric patients, Eimexizumab greatly simplifies the treatment process while significantly reducing the risk of bleeding
.
The administration method of subcutaneous injection once a week solves the problem of intravenous accessibility and compliance of hemophilia patients, especially children, and provides more flexible and effective treatment options for children with hemophilia, so that more patients Children can return to school and grow up healthily
.
Professor Yang Renchi said that both hemophiliac doctors and patients expect that Immexizumab can enter the medical insurance as soon as possible, reduce the disease burden of patients, and allow more hemophilia patients to benefit from it
.
Summary The current diagnosis and treatment of hemophilia is still facing certain difficulties.
However, non-coagulation factor drugs represented by iimerizumab can improve the treatment route and injection frequency, in terms of the time and cost of treatment, the convenience of treatment, and the ease of treatment.
Sexuality greatly reduces the impact of hemophilia on patients’ work, study, and life, improves the efficacy of hemophilia prevention and treatment, and at the same time brings better quality of life to patients, and the approval of new indications is more hemophilia The treatment of the disease brought another breakthrough
.
I look forward to further improving the standardized diagnosis and treatment of hemophilia in the future, bringing clinical benefits to more hemophilia patients, getting rid of the heavy burden of treatment, improving the quality of life, and living a normal life
.
The little research that everyone is doing, come and move your little finger! ↓↓↓Poke "Read the original", we will make progress together
