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There are reports that the US FDA has approved Livmarli (maralixibat) to be marketed for the treatment of cholestatic pruritus in children with Alagille syndrome (ALGS) over 1 year old
.
Public information shows that Alagille syndrome is a rare genetic disease.
The patient's bile ducts are congenital dysplasia, which causes bile to accumulate in the liver and prevents the liver from working properly
.
Severe itching is the main feature of the disease and is more common in patients around 3 years old
.
It is worth mentioning that a press release pointed out that Livmarli is the first FDA-approved therapy for the treatment of this rare liver disease
.
It is reported that it is an oral selective apical sodium-dependent bile acid transporter (ASBT) inhibitor that can excrete more bile acids in the feces, prevent excessive bile acid accumulation, and control extremes related to cholestatic liver disease Itching
.
It has been granted breakthrough therapy designation by the FDA
.
In fact, the lack of medication for children has always been a worldwide problem
.
However, in recent years, as the drug administration departments around the world have successively formulated relevant measures to promote the research and development and supervision of children's drugs, more and more new breakthroughs like Livmarli are emerging in this field
.
In China, in fact, the children's drug market in our country has long suffered from the problems of fewer special varieties, fewer suitable dosage forms, and fewer manufacturers in the past
.
However, as the issue of children’s medication has become a livelihood issue that the country attaches great importance to, in order to increase the enthusiasm of manufacturers for research and development, in recent years, the National Food and Drug Administration, the National Health Commission, and the Medical Insurance Bureau have successively introduced a series of policies and measures to encourage Development, production and sales of children's drugs
.
Among them, on the research and development side, the Drug Administration Law clearly encourages the development and innovation of children's drugs, and supports the development of new varieties, dosage forms and specifications for children that meet the physiological characteristics of children
.
At the same time, a number of drug research and development guidelines were issued to further standardize and guide the pharmacy, clinical and other related work involved in children's drug research and development
.
On the review side, many policies include children's medications in the priority review and approval, and a certain data protection period is granted to children's special drugs.
In addition, in the adjustment of the essential medicines list and the 2021 version of the medical insurance catalog, the priority of children's medications is also included in the adjustment.
Range
.
At present, with the encouragement and support of a series of favorable policies, the research and development, review and approval of children's medicines have shown a significant growth momentum
.
According to data from the National Food and Drug Administration, more than 10 children's drugs have been approved for marketing since 2021
.
In addition, there are currently more than 40 new pediatric drugs in China at the stage of clinical approval and above
.
The industry expects that with the inclination of policies, the children's drug market will further expand.
In 2021, China's children's drug market may exceed 200 billion yuan.
At the same time, attracted by the market, the number of pharmaceutical companies entering the market may further increase
.
In this context, the research and development results of pharmaceutical companies will continue to appear, and more and more children's drug products will emerge on the market, which will be great news for domestic children's patients
.
But it should be noted that, in the long run, this also means that a battle in the children's drug market is coming!
.
Public information shows that Alagille syndrome is a rare genetic disease.
The patient's bile ducts are congenital dysplasia, which causes bile to accumulate in the liver and prevents the liver from working properly
.
Severe itching is the main feature of the disease and is more common in patients around 3 years old
.
It is worth mentioning that a press release pointed out that Livmarli is the first FDA-approved therapy for the treatment of this rare liver disease
.
It is reported that it is an oral selective apical sodium-dependent bile acid transporter (ASBT) inhibitor that can excrete more bile acids in the feces, prevent excessive bile acid accumulation, and control extremes related to cholestatic liver disease Itching
.
It has been granted breakthrough therapy designation by the FDA
.
In fact, the lack of medication for children has always been a worldwide problem
.
However, in recent years, as the drug administration departments around the world have successively formulated relevant measures to promote the research and development and supervision of children's drugs, more and more new breakthroughs like Livmarli are emerging in this field
.
In China, in fact, the children's drug market in our country has long suffered from the problems of fewer special varieties, fewer suitable dosage forms, and fewer manufacturers in the past
.
However, as the issue of children’s medication has become a livelihood issue that the country attaches great importance to, in order to increase the enthusiasm of manufacturers for research and development, in recent years, the National Food and Drug Administration, the National Health Commission, and the Medical Insurance Bureau have successively introduced a series of policies and measures to encourage Development, production and sales of children's drugs
.
Among them, on the research and development side, the Drug Administration Law clearly encourages the development and innovation of children's drugs, and supports the development of new varieties, dosage forms and specifications for children that meet the physiological characteristics of children
.
At the same time, a number of drug research and development guidelines were issued to further standardize and guide the pharmacy, clinical and other related work involved in children's drug research and development
.
On the review side, many policies include children's medications in the priority review and approval, and a certain data protection period is granted to children's special drugs.
In addition, in the adjustment of the essential medicines list and the 2021 version of the medical insurance catalog, the priority of children's medications is also included in the adjustment.
Range
.
At present, with the encouragement and support of a series of favorable policies, the research and development, review and approval of children's medicines have shown a significant growth momentum
.
According to data from the National Food and Drug Administration, more than 10 children's drugs have been approved for marketing since 2021
.
In addition, there are currently more than 40 new pediatric drugs in China at the stage of clinical approval and above
.
The industry expects that with the inclination of policies, the children's drug market will further expand.
In 2021, China's children's drug market may exceed 200 billion yuan.
At the same time, attracted by the market, the number of pharmaceutical companies entering the market may further increase
.
In this context, the research and development results of pharmaceutical companies will continue to appear, and more and more children's drug products will emerge on the market, which will be great news for domestic children's patients
.
But it should be noted that, in the long run, this also means that a battle in the children's drug market is coming!
