This pharmaceutical company has a new drug approved for listing! Medication for rare diseases in children

Although the scale of the children's drug market has reached 100 billion yuan, domestic children's drugs have not been able to meet the actual clinical needs
of children in terms of variety, dosage form and standards.

In recent years, the issue of children's medication has attracted much attention, as the relevant departments continue to release a series of favorable policies to support children's drug research and development, at present, in the context of the continuous efforts of some pharmaceutical companies and the improvement of drug review and approval efficiency, domestic children's drug research and development is constantly ushering in good news
.

Recently, the State Food and Drug Administration issued an announcement to approve the registration and listing of chlorobachan tablets independently developed by Yichang Renfu Pharmaceutical, and simultaneously issued the registration number of chlorbachan's APIs
.

This is another batch of heavy products
approved by Renfu Pharmaceutical Group after it was approved as a new drug of Chinese medicine class 1 on September 15, Guangqian Herb Total Flavonoids Capsules.

Data show that clobachan tablets are rare disease drugs in children and are suitable for the combination treatment
of seizures in patients with Lennox-Gastaut syndrome (LGS) aged 2 years and older.

It is understood that the chlorbachan that has been marketed abroad is effective for children with rare epilepsy, but it belongs to the second class of psychologically controlled drugs in China and has not been approved for marketing
.

However, in June this year, in order to further improve the drug supply guarantee policy and meet the urgent needs of specific groups of people, the National Health Commission and the State Food and Drug Administration jointly issued the "Interim Import Work Plan for Chlorbachan", which accelerated the listing process
of Chlorbachan in China.

At present, in addition to the chlorobazan tablets, in fact, Yichang Renfu Pharmaceutical submitted a clinical application for chlorobachan oral suspension in May as a generic type 3, and has also been included in the list of priority review varieties on the grounds of "new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children, and other priority review and approval conditions stipulated by the State Food and Drug Administration", and was accepted
by CDE on August 16.

The industry expects that if it can be successfully approved for listing, it will further meet the drug needs
of children with epilepsy in China.

According to incomplete statistics, since the beginning of this year, more than 10 varieties related to children's drugs have been included in the priority review list
by CDE.

In addition to Yichang Renfu Medicine's Yelo Bazhan, Yuanda Pharmaceutical's carglutamic acid tablets have also recently been included in the priority review
.

This variety is proposed by CDE for priority review on the grounds of "new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children", and is intended for: 1) hyperammonia caused by N-acetylglutamate synthetase (NAGS) deficiency; 2) hyperammonia caused by isovaleric acidemia; 3) hyperammonia caused by methylmalonic acidemia; 4) Hyperammonia caused by propionic acidemia
.

In August, the acetaminophen suppositories of Zhejiang Er Infant Pharmaceutical Co.
, Ltd.
were included in the priority review on the grounds that new varieties, dosage forms and specifications
of children's drugs that meet the physiological characteristics of children were included.

The drug is an antipyretic analgesic developed by Er Bao Company, which is indicated for fever caused by the common cold or influenza in children, and is also used to relieve mild to moderate pain such as headache, joint pain, migraine, toothache, muscle pain, and neuralgia
.

Judging from the reasons for the approval of these varieties entering the "green channel", in addition to some drugs included in the breakthrough treatment drug program and the shortage of drugs urgently needed in the clinic, the new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children are mainly based
.

But in general, whether it is a new drug or a shortage of drugs urgently needed in the clinic, under the influence of the favorable policies to accelerate the approval review and listing progress, it is bringing more hope to children's drug patients, and also boosting the confidence and enthusiasm
of children's drug research and development enterprises.

It is understood that in recent years, Jianmin Group, Jichuan Pharmaceutical, Hengrui Pharmaceutical, Yiling Pharmaceutical and other pharmaceutical companies have aimed at the research and development and production of children's drugs, and a number of new Biotechs such as Tianjing Biological, Weisheng Pharmaceutical, Baitai Biologics, and Beimei Pharmaceutical have also laid out children's drug tracks in cooperation and other ways
.

The industry expects that in the future, under the joint efforts of favorable policies and pharmaceutical companies, the entire children's drug market may usher in a big outbreak
.

Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
to any person.