China's innovative drugs spring is here

Written in front:

Remember the "7.

Since then, the State Council issued the "Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices", which proposes to encourage clinical value-oriented drug innovation, optimize the review and approval procedures for innovative drugs, and accelerate the review of innovative drugs that are urgently needed in the clinic

Policy boost, the era of innovative drugs is coming

In June 2021, the CDE released the 2020 Drug Evaluation Report, which showed that the Center for Drug Evaluation accepted 1,008 new drug clinical trial applications and 54 new drug marketing applications throughout the year, an increase of 49.

In fact, according to Dingxiangyuan Insight database statistics, the number of new drugs approved for NDA has increased significantly in the five years from 2016 to 2020, especially after the policy encouragement in 2015, the number of new drugs approved has soared, reaching a peak in 2018, with 72 approved drugs New medicine

Note: Count the number of new drugs approved for the first time in the dimensions of [ingredients-dosage forms-enterprises]

New drugs include first-in-class drugs and improved new drugs, the same below

At the same time, the research and development of domestically produced Class 1 innovative drugs is also accelerating

From 2016 to 2020, with the improvement of pharmaceutical policies, the speed of new drug review and approval has accelerated.

From two to six months, clinical acceleration has stimulated new drug declaration fever

As we all know, the research and development of new drugs is time-consuming, labor-intensive and costly

In the past two years, the State Drug Administration has successively issued relevant guidelines for clinical trials, proposing adaptive seamless design, master plan design, real-world research, etc.

In terms of the number of projects, the number of new drug clinical applications from 2016 to 2020 has increased year by year, reaching 521 projects in 2020.

New tumor drugs account for more than half, and new targets are emerging in endlessly

From 2016 to March 2021, the indications for clinical trials of innovative drugs are widely distributed

As innovative drug companies increase R&D investment, the layout of clinical pipelines has become more and more abundant, and some new targets have emerged, mainly in the field of anti-tumor

Concluding remarks

Challenges and opportunities for China's innovative drug research coexist.