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▎The editor of WuXi AppTec’s content team not long ago, Japan’s Kyowa Hakko Kirin Company issued a press release stating that China’s National Medical Products Administration (NMPA) has approved the company’s brozoyuumab injection (trade name).
: Linping®) marketing application for the treatment of X-linked hypophosphatemia (XLH) in adults and children 1 year and older.
According to the press release, China has no effective treatment drugs for X-linked hypophosphatemia for a long time.
In order to meet the urgent clinical treatment needs, brosoyuumab was included in the "second batch of clinically urgently needed overseas new drugs in 2019.
" List", its listing provides patients with new treatment options.
Screenshot source: NMPA official website about X-linked hypophosphatemia X-linked hypophosphatemia is a kind of hypophosphatemic rickets, and it is also a serious rare genetic disease with a prevalence of about 1 case/20,000; most of them are families Sexual cases; can cause abnormal bones, muscles, and joints in patients.
Although the disease is not life-threatening, its burden on patients is lifelong and gradual, and may reduce the quality of life of patients.
In addition, X-linked hypophosphatemia is still a genetic disease that will be passed on to the next generation.
It has been reported that a family of 6 people have the disease in clinical practice, which makes the family burden even heavier.
Patients with X-linked hypophosphatemia have genetic defects on the X chromosome, which can cause excessive loss of phosphate through the urine, poor intestinal absorption, and long-term low phosphate levels in the blood.
Phosphate is a key mineral needed to maintain human energy levels, muscle function, and the formation of healthy bones and teeth.
X-linked hypophosphatemia can affect children and adults.
Its signs and symptoms often begin in early childhood and can lead to lower limb deformities, developmental delays, short stature, and pain in children.
These will lead to walking and physical dysfunction in children, and affect the quality of life.
At the same time, the combination of skeletal deformities and unresolved hypophosphatemia means that the disease continues to develop in adults, leading to pain and stiffness, as well as an increased risk of musculoskeletal defects and fractures.
Although X-linked hypophosphatemia cannot be cured, treatments designed to help restore normal levels of phosphate in the patient's body may help improve the symptoms of the disease.
Image source: 123RF About Brozoyuumab Brozoyuumab is a recombinant fully human source that directly targets fibroblast growth factor 23 (FGF23), jointly developed by Japan Kyowa Fermented Kirin and Ultragenyx Pharmaceutical.
Monoclonal IgG1 antibody.
FGF23 is a hormone that can cause phosphate to be excreted in the urine and inhibit the production of active vitamin D by the kidneys.
Brozoyuumab can inhibit the activity of FGF23, thereby increasing and normalizing serum phosphorus levels, thereby improving bone mineralization, as well as rickets in children and fractures in adults.
In the United States, Brozoyuumab was granted breakthrough therapy designation and orphan drug designation by the Food and Drug Administration (FDA).
In April 2018, the FDA approved the marketing of brozoyuumab for the treatment of X-linked hypophosphatemia in children and adults 1 year and older.
Brozoyuumab is the first drug approved by the FDA to treat X-linked hypophosphatemia in children and adults 1 year and older.
According to the data published when brozoyuumab was approved in the United States, the drug has shown good safety and effectiveness in the treatment of X-linked hypophosphatemia.
In a placebo-controlled clinical trial, 94% of adults who received brozoyuumab once a month reached a normal phosphorus level, compared to only 8% of patients in the placebo group.
Among children, 94%-100% of patients receiving brozoyuumab every two weeks can reach normal phosphorus levels.
In addition, in children and adults, the X-ray (associated with XLH) results of patients receiving brozoyuumab therapy have improved.
Photo source: Professor Li Dingguo, chairman of 123RF Shanghai Rare Disease Prevention Foundation and vice chairman of China Rare Disease Alliance, said: "The low-phosphorus rickets specific drug Linping® was successfully approved in the country on the national clinically urgently needed overseas new drug list.
The listing has brought gospel and new hope to patients with rare diseases. "Recommended reading "Chronic disease" that has changed from no medicine to be preventable and controllable.
China's first NMOSD treatment drug approved for Gaucher disease patients! An enzyme replacement therapy approved in China for influenza treatment ushered in an innovative drug! The single-dose oral drug Mabaloxavir has been approved in China to cover platinum-sensitive and platinum-resistant recurrent ovarian cancer.
PARP inhibitors have been approved in China! Blockbuster! Once a week, a new diabetes treatment drug has been approved in China.
[1] Kyowa Kirin's breakthrough drug Linping was approved in China, opening a new era of targeted therapy for low-phosphorus rickets.
Retrieved May 11, 2021, from 2] Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita®(burosumab-twza) for the Treatment of Children and Adults with X--Linked Hypophosphatemia (XLH).
Retrieved May 11 ,2021,from media_center/news_releases/2018/e20180418_01.
html[3] Kyowa Kirin Receives Positive CHMP Opinion for the Expanded Use of CRYSVITA® (burosumab) to Include Older Adolescents and Adults for the Treatment of X-Linked Hypophosphataemia (XLH).
Retrieved May 11, 2021, from The State Food and Drug Administration has conditionally approved the marketing of brozoyuumab injection.
Retrieved May 11, 2021, from Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation. If you need guidance on treatment plans, please go to a regular hospital for treatment.
: Linping®) marketing application for the treatment of X-linked hypophosphatemia (XLH) in adults and children 1 year and older.
According to the press release, China has no effective treatment drugs for X-linked hypophosphatemia for a long time.
In order to meet the urgent clinical treatment needs, brosoyuumab was included in the "second batch of clinically urgently needed overseas new drugs in 2019.
" List", its listing provides patients with new treatment options.
Screenshot source: NMPA official website about X-linked hypophosphatemia X-linked hypophosphatemia is a kind of hypophosphatemic rickets, and it is also a serious rare genetic disease with a prevalence of about 1 case/20,000; most of them are families Sexual cases; can cause abnormal bones, muscles, and joints in patients.
Although the disease is not life-threatening, its burden on patients is lifelong and gradual, and may reduce the quality of life of patients.
In addition, X-linked hypophosphatemia is still a genetic disease that will be passed on to the next generation.
It has been reported that a family of 6 people have the disease in clinical practice, which makes the family burden even heavier.
Patients with X-linked hypophosphatemia have genetic defects on the X chromosome, which can cause excessive loss of phosphate through the urine, poor intestinal absorption, and long-term low phosphate levels in the blood.
Phosphate is a key mineral needed to maintain human energy levels, muscle function, and the formation of healthy bones and teeth.
X-linked hypophosphatemia can affect children and adults.
Its signs and symptoms often begin in early childhood and can lead to lower limb deformities, developmental delays, short stature, and pain in children.
These will lead to walking and physical dysfunction in children, and affect the quality of life.
At the same time, the combination of skeletal deformities and unresolved hypophosphatemia means that the disease continues to develop in adults, leading to pain and stiffness, as well as an increased risk of musculoskeletal defects and fractures.
Although X-linked hypophosphatemia cannot be cured, treatments designed to help restore normal levels of phosphate in the patient's body may help improve the symptoms of the disease.
Image source: 123RF About Brozoyuumab Brozoyuumab is a recombinant fully human source that directly targets fibroblast growth factor 23 (FGF23), jointly developed by Japan Kyowa Fermented Kirin and Ultragenyx Pharmaceutical.
Monoclonal IgG1 antibody.
FGF23 is a hormone that can cause phosphate to be excreted in the urine and inhibit the production of active vitamin D by the kidneys.
Brozoyuumab can inhibit the activity of FGF23, thereby increasing and normalizing serum phosphorus levels, thereby improving bone mineralization, as well as rickets in children and fractures in adults.
In the United States, Brozoyuumab was granted breakthrough therapy designation and orphan drug designation by the Food and Drug Administration (FDA).
In April 2018, the FDA approved the marketing of brozoyuumab for the treatment of X-linked hypophosphatemia in children and adults 1 year and older.
Brozoyuumab is the first drug approved by the FDA to treat X-linked hypophosphatemia in children and adults 1 year and older.
According to the data published when brozoyuumab was approved in the United States, the drug has shown good safety and effectiveness in the treatment of X-linked hypophosphatemia.
In a placebo-controlled clinical trial, 94% of adults who received brozoyuumab once a month reached a normal phosphorus level, compared to only 8% of patients in the placebo group.
Among children, 94%-100% of patients receiving brozoyuumab every two weeks can reach normal phosphorus levels.
In addition, in children and adults, the X-ray (associated with XLH) results of patients receiving brozoyuumab therapy have improved.
Photo source: Professor Li Dingguo, chairman of 123RF Shanghai Rare Disease Prevention Foundation and vice chairman of China Rare Disease Alliance, said: "The low-phosphorus rickets specific drug Linping® was successfully approved in the country on the national clinically urgently needed overseas new drug list.
The listing has brought gospel and new hope to patients with rare diseases. "Recommended reading "Chronic disease" that has changed from no medicine to be preventable and controllable.
China's first NMOSD treatment drug approved for Gaucher disease patients! An enzyme replacement therapy approved in China for influenza treatment ushered in an innovative drug! The single-dose oral drug Mabaloxavir has been approved in China to cover platinum-sensitive and platinum-resistant recurrent ovarian cancer.
PARP inhibitors have been approved in China! Blockbuster! Once a week, a new diabetes treatment drug has been approved in China.
[1] Kyowa Kirin's breakthrough drug Linping was approved in China, opening a new era of targeted therapy for low-phosphorus rickets.
Retrieved May 11, 2021, from 2] Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita®(burosumab-twza) for the Treatment of Children and Adults with X--Linked Hypophosphatemia (XLH).
Retrieved May 11 ,2021,from media_center/news_releases/2018/e20180418_01.
html[3] Kyowa Kirin Receives Positive CHMP Opinion for the Expanded Use of CRYSVITA® (burosumab) to Include Older Adolescents and Adults for the Treatment of X-Linked Hypophosphataemia (XLH).
Retrieved May 11, 2021, from The State Food and Drug Administration has conditionally approved the marketing of brozoyuumab injection.
Retrieved May 11, 2021, from Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation. If you need guidance on treatment plans, please go to a regular hospital for treatment.
