CDE priority review analysis in the first three quarters of 2021

The priority review and approval of drug marketing authorization is a rapid drug market channel established by the state to encourage research and creation of new drugs, solve urgent clinical shortages of drugs, and respond to emergencies
.

In July 2020, the new version of "Administrative Measures for Drug Registration" was formally implemented, and standardized arrangements were made for priority review and approval; in addition, "Breakthrough Therapeutic Drug Review Work Procedures (Trial)" and "Drug Conditional Approval Marketing Application Review and Approval Work Procedures" (Trial)" "Drug Marketing Authorization Priority Review and Approval Work Procedures (Trial)" and other guidance documents were announced, and the priority review and approval of drug marketing authorization has entered a new era

According to regulations, when applying for drug marketing authorization, drugs with obvious clinical value can apply for priority review and approval procedures
.

It can be divided into the following 6 situations

1) Shortage medicines urgently needed clinically, innovative medicines and improved new medicines for the prevention and treatment of major infectious diseases and rare diseases
.

2) New varieties, dosage forms and specifications of children's medicines that meet the physiological characteristics of children
.

3) Vaccines and innovative vaccines urgently needed for disease prevention and control;

4) Drugs included in the breakthrough therapeutic drug program;

5) Drugs that meet the conditions of approval;

6) The State Drug Administration stipulates other priority review and approval situations
.

Since 2021, China's pharmaceutical product innovation has continued to heat up
.

As of October 20, 2021, the number of drugs included in the priority review and approval procedures for drug marketing authorization reached 83 (according to the acceptance number), including 52 products (calculated by the generic name of the drug), involving 41 companies

High originality of medicine

High originality of medicine

Among the 52 products, 49 new drug applications were listed, accounting for 94%
.

This is in line with the original intention of prioritizing review and approval to encourage the development of innovative drugs

In addition, drugs are mostly "life-saving drugs" that are urgently needed in clinical practice
.

According to the reasons for the inclusion of drugs, 29 drugs were included on the grounds of "medicine eligible for conditional approval" and "included in the breakthrough treatment drug program"

Children's medication is focused on

Children's medication is focused on

Among the 52 drugs, 9 drugs were included because of "new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children"
.

For example, vigabatrin powder developed by Dr.

In order to solve the plight of children's drug use of "taking medicine by breaking, and dosage by guessing", the Food and Drug Administration has opened a green channel for review and approval, which has accelerated the launch of children's drugs
.

In addition, from 2016 to 2019, the State Food and Drug Administration has successively released three batches of lists of children's drugs to encourage research and development

Table: Addition of medication information for children in the instructions

The research and development of children's medicine is about to reach a new peak
.

According to data released by the State Food and Drug Administration, in 2020, a total of 26 special medicines for children and increased use of medicines for children were approved, a year-on-year increase of 36.

Anti-tumor drugs "get together"

Anti-tumor drugs "get together"

Anti-tumor drugs accounted for nearly 70%
.
Among the 52 drugs, there are 35 drugs related to tumor treatment, accounting for 68%
.
Focus on the clinically urgently needed treatment areas such as lung cancer, liver cancer, breast cancer and leukemia
.
For example, belintolumab for injection developed by BeiGene is used for the treatment of B-cell acute lymphoblastic leukemia, and trametinib tablets developed by Beijing Novartis is used for the treatment of non-small cell lung cancer.
Olapali tablets developed by Likang are used in the treatment of prostate cancer
.

In addition, drugs for the treatment of autoimmune diseases and drugs for rare diseases have also become a hot spot for enterprise development
.
For example, upatinib sustained-release tablets developed by AbbVie are used for adolescent patients with moderate to severe atopic dermatitis, Apster tablets developed by Amgen Biologics are used for the treatment of psoriasis, and developed by Xinji Medicine.
Rotexcept for injection is used for the treatment of patients with β-thalassemia, and moglizumab injection developed by Kylin Concord is used for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS)
.

Balanced competition between imports and domestic production

Balanced competition between imports and domestic production

Imported medicines still occupy a quantitative advantage
.
Among the 52 medicines, 32 are imported medicines and 20 are domestic medicines.
Imported medicines still have a certain advantage in terms of quantity
.
With the continuous strengthening of research and development of domestically-made innovative medicines, the number of domestically-made new medicines is rising, and it will be in a pattern of equal competition with imported medicines
.

Among the imported drug development companies, there are many pharmaceutical giants such as AstraZeneca, Novartis, Bayer and Sanofi.
At the same time, local companies such as Cinda Bio, Shanghai Jiyu Pharmaceutical, and Dalian Wanchun Bulin are also active.
Enterprise cooperation, the introduction of global product pipeline
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Among the local drug development companies, a number of innovative companies such as Betta Pharmaceuticals, Jiangsu Hausen Pharmaceuticals, Jiangsu Hengrui Pharmaceuticals, Rongchang Biologicals, and Fuhong Henlius are active
.

Concluding remarks

Concluding remarks

In recent years, China's drug marketing authorization priority review and approval system has been continuously optimized and improved, and more and more blockbuster innovative products have accelerated the listing process through this "green channel"
.
This "green channel" is clinically value-oriented, and clinically urgently needed drugs such as new anti-tumor drugs, children's drugs, rare disease drugs, and epidemic prevention and control vaccines have become priority review and approval objects
.
This "green channel" is open and inclusive, not only benefiting local innovative drugs, but also the speed of international innovative products entering China at an accelerating rate
.
This "green channel" is cutting-edge and forward-looking, and the inclusion of products represents the current technological frontier of medicine and the focus and direction of future industrial development
.

Attachment: In the first three quarters of 2021, it will be included in the list of priority review and approval for drug marketing authorization