Under the adjustment of the medical insurance catalogue, these two major drug markets will usher in new development opportunities

【Pharmaceutical Network Market Analysis】Recently, the National Medical Insurance Administration issued the "Announcement on the Phased Results of Expert Review of Declared Drugs Adjusted by the National Medical Insurance Drug Catalogue in 2022 and Passed the Formal Review", announcing the results of the expert review of the adjustment of
the National Medical Insurance Catalogue in 2022.
According to preliminary statistics, 344 drugs passed the preliminary examination
this time.
Compared with previous rounds of directory adjustments, there are many new practices
in the adjustment of the national medical insurance catalogue this time.
For example, as many as 199 drugs that passed the preliminary examination this time
.
Compared with the number of new drugs adjusted in previous times, the number of new drugs added to the catalogue is expected to reach a new high
.
It is worth noting that a more distinct difference in this adjustment is that it has made an appropriate tilt
to special groups such as patients with rare diseases and children.
Among them, there is no time limit for "approval for marketing after January 1, 2017" for the declaration conditions for rare disease drugs, and drugs included in the national list of encouraged generic drugs and encouraged research and development to apply for children's drugs can be declared in this year's medical insurance catalogue
.
Among the drugs that passed the preliminary review this time, 19 rare disease drugs were encouraged (3 of which were also encouraged children's drugs/generic drugs), and 5 encouraged children's drugs/generic drugs
.
With the release of good news, the industry generally believes that the children's drug and rare disease drug market will usher in new development opportunities
.
Children's drugs Due to the difficulty of clinical research in children, in China, children's drugs have always existed in the "four less" situation
of few varieties, few dosage forms, few specifications, and few special drugs.
According to public data, as of May 2022, the number of approved products in China is about 18,400, of which about 930 are children's drugs, accounting for only 5%.

In order to vigorously develop children's drugs, in fact, before the adjustment of this medical insurance catalogue, the state has issued a series of favorable documents, such as the newly revised "Drug Administration Law" in 2019 to encourage the development and innovation of children's drugs, support the development of new varieties, dosage forms and specifications of children's drugs that meet children's physiological characteristics, and give priority to the review and approval
of children's drugs.
The newly revised Measures for the Administration of Drug Registration in 2020 will accelerate the establishment of priority review channels in the marketing registration process, and include children's drugs in the priority review and approval process
.
In June 2022, the State Food and Drug Administration said that it would give priority to the review and approval of children's drugs with clinical value and urgent needs of patients, and open a green channel for children's drugs.
.
.
A series of policy support will undoubtedly benefit the development of the children's pharmaceutical industry, and will also give major pharmaceutical companies a "shot in the arm" and continuously stimulate their enthusiasm
for research and development.
Therefore, the industry suggests that children's pharmaceutical companies
such as Jichuan Pharmaceutical, Changchun High-tech, Jianmin Group, Huatdyne, and Poinsettia can be focused on in the future.
Rare disease drugs Rare disease is a disease
with a very low prevalence and a small number of patients.
In China, there are about 1,400 rare diseases, corresponding to more than 20 million potential
patients.
Compared with the huge market, the majority of patients with rare diseases are still facing problems such as
"no drugs available" and "unable to use drugs".
In fact, in recent years, it can be clearly found that the state is also constantly introducing policies to encourage the research and development and production
of rare disease drugs.
For example, in 2022, CDE has successively issued the "Technical Guidelines for Clinical Research and Development of Rare Disease Drugs" and "Statistical Guidelines for Clinical Research of Rare Disease Drugs (Trial)", which provides new ideas for the formulation of clinical trial protocols for rare disease drugs and forms an important technical help
.
The industry believes that from the current concerns of the country and relevant departments for children and rare disease patients, the importance of the rare disease drug track will continue to increase
.
In the future, more and more rare disease drugs may enter the medical insurance catalogue to meet the treatment needs
of more patients.
In fact, from the list of drugs that have passed the preliminary formal review of the national medical insurance catalogue, it can be found that the included drug treatment areas have begun to become increasingly rich, and 19 rare disease drugs are Western medicines, including hereditary angioedema, spinal muscular atrophy, Gaucher disease, mucopolysaccharide accumulation disease, Pompe disease, etc
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.