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On July 12, the CDE official website showed that Sanofi's injection-use recombinant human coagulation factor VIII Fc-von Willebrand factor-XTEN fusion protein (efanesoctocog alfa, rFVIIIFc-VWF-XTEN, BIVV001) was approved by CDE as a breakthrough therapy.
suitable for adults and children with type a hemophilia
.
Image source: CDE official website Hemophilia is a rare bleeding disorder.
Due to the lack or insufficiency of a certain coagulation factor in the body, the coagulation time is prolonged and the patient has the symptoms of easy bleeding
.
Hemophilia A is a genetic disease in which FVIII is missing due to mutations in the gene encoding FVIII
.
At present, the common treatment for hemophilia A is regular infusion of FVIII.
However, patients usually need to receive FVIII infusions 3-4 times a week, which brings great inconvenience to their lives
.
Sanofi BIVV001 is a new type of coagulation factor VIII replacement therapy under development.
It consists of a recombinant FVIII Fc fusion protein molecule coupled to a specific region of VWF (FVIII binds to the D'D3 domain) and two XTEN unstructured peptides.
After allowing hemophilia A patients to receive an injection, they can obtain nearly normal FVIII factor activity levels for most of the week
.
According to currently released clinical trial data, the fusion protein BIVV001 can extend the half-life of factor VIII by three to four times.
On day 7, the patient’s factor VIII activity is still at a high level sufficient to prevent bleeding episodes
.
At the same time, BIVV001 showed good tolerance, and no FVIII inhibitor was detected within 28 days after administration
.
Currently, there are approximately 136,000 patients in China
.
If the patient bleeds repeatedly and is not treated in time, it will cause joint deformities and even disability, and severe bleeding symptoms may even be life-threatening
.
A new study released by researchers at McMaster University shows that more than 1.
125 million men worldwide suffer from hemophilia, and 418,000 of them suffer from severe hemophilia
.
BIVV001 has now entered a phase III clinical trial, aiming to evaluate the efficacy and safety of BIVV001 in previously treated patients with severe type A blood (n=150)
.
End reference materials: [1] CDE official website [2] https://mp.
weixin.
qq.
com/s/h_Jl1RNvUOZxqZUTbtzMxQ selected in the past to watch the sun really prevent cancer? The 186-country data research has been released.
Insufficient UV exposure or potential causes of colorectal cancer.
Cell releases the global city microbiome map.
Your residence information may be hidden in the shoes.
"Pure drug targets", overcoming the notorious oncogene craze Oxford University: AstraZeneca + Pfizer, is there a "miraculous effect" in the mixed use of the new crown vaccine? Safety is still the most important issue.
The light of hope for cancer patients, and the release of universal targeted drugs can reduce the risk of disease progression and death by 78%! Medical immunotherapy| Biosimilars| Vaccines| Drug resistance| Drug targets| Healthy life| Pharmaceutical company news| Drug inventory| Pharmaceutical technology| Basic research on drug side effects/ Translational medicine leukemia| Lung cancer| Gastric cancer| Colorectal cancer| Liver cancer| Breast Cancer | Pancreatic Cancer | Cardiovascular Diseases | Neurodegenerative Diseases | Intestinal Microbial Medical Devices / Biotechnology In Vitro Diagnosis | Medical Devices | Bio-Nano | 3D Printing | Gene Testing | Single Cell Sequencing | Gene Editing | Assisted Reproduction | Artificial Intelligence | Precision medicine policy anti-cancer drugs | 4+7 volume procurement | Consumables | Filing system | Registrant system | Healthy China | New version of the basic drug catalog | AI medical devices | Telemedicine | Same stock market with different rights/capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Growth Enterprise Market | R & D Investment | Acquisitions | Market & Consumption
suitable for adults and children with type a hemophilia
.
Image source: CDE official website Hemophilia is a rare bleeding disorder.
Due to the lack or insufficiency of a certain coagulation factor in the body, the coagulation time is prolonged and the patient has the symptoms of easy bleeding
.
Hemophilia A is a genetic disease in which FVIII is missing due to mutations in the gene encoding FVIII
.
At present, the common treatment for hemophilia A is regular infusion of FVIII.
However, patients usually need to receive FVIII infusions 3-4 times a week, which brings great inconvenience to their lives
.
Sanofi BIVV001 is a new type of coagulation factor VIII replacement therapy under development.
It consists of a recombinant FVIII Fc fusion protein molecule coupled to a specific region of VWF (FVIII binds to the D'D3 domain) and two XTEN unstructured peptides.
After allowing hemophilia A patients to receive an injection, they can obtain nearly normal FVIII factor activity levels for most of the week
.
According to currently released clinical trial data, the fusion protein BIVV001 can extend the half-life of factor VIII by three to four times.
On day 7, the patient’s factor VIII activity is still at a high level sufficient to prevent bleeding episodes
.
At the same time, BIVV001 showed good tolerance, and no FVIII inhibitor was detected within 28 days after administration
.
Currently, there are approximately 136,000 patients in China
.
If the patient bleeds repeatedly and is not treated in time, it will cause joint deformities and even disability, and severe bleeding symptoms may even be life-threatening
.
A new study released by researchers at McMaster University shows that more than 1.
125 million men worldwide suffer from hemophilia, and 418,000 of them suffer from severe hemophilia
.
BIVV001 has now entered a phase III clinical trial, aiming to evaluate the efficacy and safety of BIVV001 in previously treated patients with severe type A blood (n=150)
.
End reference materials: [1] CDE official website [2] https://mp.
weixin.
qq.
com/s/h_Jl1RNvUOZxqZUTbtzMxQ selected in the past to watch the sun really prevent cancer? The 186-country data research has been released.
Insufficient UV exposure or potential causes of colorectal cancer.
Cell releases the global city microbiome map.
Your residence information may be hidden in the shoes.
"Pure drug targets", overcoming the notorious oncogene craze Oxford University: AstraZeneca + Pfizer, is there a "miraculous effect" in the mixed use of the new crown vaccine? Safety is still the most important issue.
The light of hope for cancer patients, and the release of universal targeted drugs can reduce the risk of disease progression and death by 78%! Medical immunotherapy| Biosimilars| Vaccines| Drug resistance| Drug targets| Healthy life| Pharmaceutical company news| Drug inventory| Pharmaceutical technology| Basic research on drug side effects/ Translational medicine leukemia| Lung cancer| Gastric cancer| Colorectal cancer| Liver cancer| Breast Cancer | Pancreatic Cancer | Cardiovascular Diseases | Neurodegenerative Diseases | Intestinal Microbial Medical Devices / Biotechnology In Vitro Diagnosis | Medical Devices | Bio-Nano | 3D Printing | Gene Testing | Single Cell Sequencing | Gene Editing | Assisted Reproduction | Artificial Intelligence | Precision medicine policy anti-cancer drugs | 4+7 volume procurement | Consumables | Filing system | Registrant system | Healthy China | New version of the basic drug catalog | AI medical devices | Telemedicine | Same stock market with different rights/capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Growth Enterprise Market | R & D Investment | Acquisitions | Market & Consumption
