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There are a large number of children in China, accounting for about 18% of the population.
These groups have a very urgent need for drugs.
At present, the size of China's children's drug market accounts for about 5% of the entire pharmaceutical industry.
It can be seen that the children's drug market is far from saturated.
There is still a lot of room to be tapped
.
At present, the current situation of children's drug use in China is manifested in the lack of suitable clinical dosage forms, off-label use, empirical use, and slow research and development of new and special drugs
.
According to data from the State Food and Drug Administration, as of June 2020, there were more than 3,000 registration numbers for pediatric medicines, and there were only more than 60 types of medicines for children, accounting for about 1.
7% of the entire variety of pharmaceutical preparations
.
There are only more than 10 companies specializing in the production of children's medicines, and only about 30 companies have children's medicine production departments
.
In order to solve these problems, relevant departments attach great importance to the issue of children's medicines, and have successively formulated a number of documents to encourage the development and production of children's medicines, and to guarantee and regulate children's medicines
.
In recent years, the speed of pediatric drug review has been significantly accelerated.
As of December 2021, CDE has released a total of 149 varieties of priority review for pediatric drugs, involving a total of 91 varieties
.
Among them, in 2021, 13 children's medicines will be approved through the priority review and approval process, and 4 varieties will be listed in the three batches of encouraged R&D lists issued by the National Health Commission
.
There has also been a marked increase in the number of drug approvals for children
.
On December 31, 2021, the State Food and Drug Administration approved the launch of pediatric calcium carbonate D3 granules, bringing good news to pediatric patients
.
According to statistics, as of January 24, 2022, the State Food and Drug Administration has approved a total of 651 special medicines for children (calculated by "generic name of medicine + dosage form"), of which only medicines for children approved in 2021 or more children's applications There are 30 kinds of medicines in the medicine, and the indications cover common respiratory diseases such as influenza, rhinitis, expectoration, as well as infantile spasms, hyperammonemia, primary tyrosinemia, infantile hemangioma, Gaucher disease, etc.
Rare diseases in children
.
Encouraged and supported by favorable policies, companies in the children's drug market have gradually increased their efforts, and their R&D investment has increased significantly
.
For example, the research and development expenses of Poinsettia in the first three quarters of 2021 were 99.
66 million yuan, a year-on-year increase of 50.
2%; the research and development expenses of Sunflower Pharmaceuticals in the first nine months of 2021 also increased by over 40% year-on-year
.
However, the industry also pointed out that, on the whole, the model of "focusing on sales and ignoring R&D" is still relatively common among pharmaceutical companies.
It is necessary to strengthen R&D innovation and find more effective marketing methods in order to occupy a good track
.
Since the research and development of new drugs often takes a long cycle of more than ten years, not to mention the special challenges of children's drug research and development, in this context, authorized introduction has become a way to quickly solve the status quo
.
For example, in November 2021, Sunflower Pharmaceutical announced a strategic cooperation with Dr.
Reddy Laboratories Co.
, Ltd.
of India.
Sunflower Pharmaceutical will introduce the latter for the treatment of infantile spasms and two rare diseases in children for the treatment of Wilson's disease in children.
medicines and joint promotion
.
In fact, whether it is independent new drug research and development or authorized introduction, it is good for the majority of children.
With the launch of more new drugs and good drugs, the situation of children without drugs will be improved, and children will be able to use them in time.
on medicine
.
In order to solve the problem of expensive treatment of children's medicines, especially children's rare disease medicines, relevant departments such as the National Medical Insurance Administration are also constantly trying to find ways
.
For example, in the medical insurance negotiation in 2021, 700,000 injections of Nosinagen Sodium Injection will be reduced to about 30,000 yuan
.
With the advancement of medical insurance negotiations and the normalization of centralized procurement, we also expect that more children's medicines will be included in the list in the future, bringing good news to related children
.
These groups have a very urgent need for drugs.
At present, the size of China's children's drug market accounts for about 5% of the entire pharmaceutical industry.
It can be seen that the children's drug market is far from saturated.
There is still a lot of room to be tapped
.
At present, the current situation of children's drug use in China is manifested in the lack of suitable clinical dosage forms, off-label use, empirical use, and slow research and development of new and special drugs
.
According to data from the State Food and Drug Administration, as of June 2020, there were more than 3,000 registration numbers for pediatric medicines, and there were only more than 60 types of medicines for children, accounting for about 1.
7% of the entire variety of pharmaceutical preparations
.
There are only more than 10 companies specializing in the production of children's medicines, and only about 30 companies have children's medicine production departments
.
In order to solve these problems, relevant departments attach great importance to the issue of children's medicines, and have successively formulated a number of documents to encourage the development and production of children's medicines, and to guarantee and regulate children's medicines
.
In recent years, the speed of pediatric drug review has been significantly accelerated.
As of December 2021, CDE has released a total of 149 varieties of priority review for pediatric drugs, involving a total of 91 varieties
.
Among them, in 2021, 13 children's medicines will be approved through the priority review and approval process, and 4 varieties will be listed in the three batches of encouraged R&D lists issued by the National Health Commission
.
There has also been a marked increase in the number of drug approvals for children
.
On December 31, 2021, the State Food and Drug Administration approved the launch of pediatric calcium carbonate D3 granules, bringing good news to pediatric patients
.
According to statistics, as of January 24, 2022, the State Food and Drug Administration has approved a total of 651 special medicines for children (calculated by "generic name of medicine + dosage form"), of which only medicines for children approved in 2021 or more children's applications There are 30 kinds of medicines in the medicine, and the indications cover common respiratory diseases such as influenza, rhinitis, expectoration, as well as infantile spasms, hyperammonemia, primary tyrosinemia, infantile hemangioma, Gaucher disease, etc.
Rare diseases in children
.
Encouraged and supported by favorable policies, companies in the children's drug market have gradually increased their efforts, and their R&D investment has increased significantly
.
For example, the research and development expenses of Poinsettia in the first three quarters of 2021 were 99.
66 million yuan, a year-on-year increase of 50.
2%; the research and development expenses of Sunflower Pharmaceuticals in the first nine months of 2021 also increased by over 40% year-on-year
.
However, the industry also pointed out that, on the whole, the model of "focusing on sales and ignoring R&D" is still relatively common among pharmaceutical companies.
It is necessary to strengthen R&D innovation and find more effective marketing methods in order to occupy a good track
.
Since the research and development of new drugs often takes a long cycle of more than ten years, not to mention the special challenges of children's drug research and development, in this context, authorized introduction has become a way to quickly solve the status quo
.
For example, in November 2021, Sunflower Pharmaceutical announced a strategic cooperation with Dr.
Reddy Laboratories Co.
, Ltd.
of India.
Sunflower Pharmaceutical will introduce the latter for the treatment of infantile spasms and two rare diseases in children for the treatment of Wilson's disease in children.
medicines and joint promotion
.
In fact, whether it is independent new drug research and development or authorized introduction, it is good for the majority of children.
With the launch of more new drugs and good drugs, the situation of children without drugs will be improved, and children will be able to use them in time.
on medicine
.
In order to solve the problem of expensive treatment of children's medicines, especially children's rare disease medicines, relevant departments such as the National Medical Insurance Administration are also constantly trying to find ways
.
For example, in the medical insurance negotiation in 2021, 700,000 injections of Nosinagen Sodium Injection will be reduced to about 30,000 yuan
.
With the advancement of medical insurance negotiations and the normalization of centralized procurement, we also expect that more children's medicines will be included in the list in the future, bringing good news to related children
.
