"47 innovative drugs will be reviewed and approved in 2021, setting a new record high." The State Food and Drug Administration recently released the "2021 Drug Review Report".This report on the review of my country's drug registration puts forward the conclusion that my country's "pharmaceutical industry innovation capability and high-quality development are further enhanced".
Coincidentally.Another report recently released by the Drug Evaluation Center of the State Food and Drug Administration - "Annual Report on the Progress of New Drug Registration Clinical Trials in China (2021)" shows that the number of new drug clinical trials in my country will increase significantly in 2021. The number of trials continues to increase, and it is expected that the number of new drug marketing applications in China will increase and the process will accelerate to meet the new drug treatment needs of Chinese patients."
How is the progress of new drug research and development in China?Take a look at these two reports.
Rapid growth in the number of new drug registration applications and clinical trials
As a technical review agency for drug registration and marketing, the Drug Evaluation Center of the State Food and Drug Administration summarizes and summarizes the progress of drug review and approval and clinical trials in my country every year, and forms a report.
The "2021 Drug Evaluation Report" shows that in 2021, the Drug Evaluation Center of the State Food and Drug Administration will accept 11,658 drug registration applications, including 1,886 innovative drug registration applications, an increase of 76.1% over the previous year.If the time period is extended, the number of innovative drug registration applications in 2017 is 506, less than one-third of that in 2021.The enthusiasm for new drug research and development is evident.
From the perspective of clinical trials, the research and development of new drugs is full of stamina.
The "Annual Report on the Progress of Clinical Trials of New Drug Registration in China (2021)" shows that in 2021, there will be 3,358 clinical trials registered on my country's drug clinical trial registration and information publicity platform, an increase of 29.1% over 2020.Among them, 2033 new drug clinical trials were registered, accounting for 60.5%.
Comparing the data of the past three years, it can be found that the proportion of new drug clinical trials has increased year by year.In 2020 and 2019, the proportion of new drug clinical trials was 56.6% and 52.7%, respectively.On the premise that the total number of clinical trials maintains rapid growth, the proportion can still be increased, which means that the number of new drug clinical trials continues to increase.
The number of innovative drug approvals hits a record high
From the rapid growth of new drug registration applications, we see the enthusiasm for innovation in the pharmaceutical industry.However, the effectiveness of innovation depends on the results of review and approval.
The "2021 Drug Evaluation Report" shows that in 2021, the Drug Evaluation Center of the State Food and Drug Administration approved or recommended approval of 1,628 applications for registration of innovative drugs, a year-on-year increase of 67.32%.Among them, the vast majority are applications for clinical trials of innovative drugs.The number of approved applications for marketing authorization of innovative drugs was 69, a year-on-year increase of 130%, involving 47 varieties.69 and 47, which may seem small, are extremely difficult, and both are record highs.
According to the reporter’s review, the 47 innovative drugs reviewed and approved in 2021 involve the new coronavirus, tumor, immune system, blood system, endocrine system and many other fields, many of which are independently developed by my country and have independent intellectual property rights.
For example, fumetinib mesylate tablets suitable for patients with locally advanced or metastatic non-small cell lung cancer, and Euclidean injection suitable for patients with recurrent or metastatic breast cancer, etc., are independently developed and owned by my country. Class 1 innovative drugs with independent intellectual property rights.Taitacept for injection for patients with lupus erythematosus is also an innovative drug independently developed by my country.Their approval for marketing provides patients with new treatment options.
In addition, the innovation of traditional Chinese medicine is also worthy of attention.A number of innovative Chinese medicine drugs that meet the advantages and characteristics of clinical treatment of Chinese medicine have been approved for marketing, such as Yiqi Tongqiao Pills for the treatment of seasonal allergic rhinitis, which is a syndrome of spleen-lung qi deficiency.
The problem of homogenization of drug R&D innovation must be vigilant
The enthusiasm for drug R&D and innovation is high, but there are many hidden concerns.
The "2021 Drug Review Report" shows that in 2021, the review conclusion is that there are 542 registration applications that are not approved or recommended not to be approved, of which 183 registration applications are mainly because the application materials cannot prove the safety, efficacy or safety of the registered drugs. Defects such as quality controllability.Moreover, the number of registration applications that have not been approved due to the rationality of drug development issues has increased significantly.
The Center for Drug Evaluation of the State Food and Drug Administration pointed out that in terms of research and development, the clinical positioning of some drug research and development is unclear, and the selection of indications is unreasonable; the choice of dosage form or route of administration is unreasonable; existing research data suggest that the efficacy of drugs is not effective. Obviously, the target and mechanism of action are not clear, and the risk of druggability is high; the combination of drugs violates the principles of clinical diagnosis and treatment, or lacks efficacy and safety research data to support.
The choice of indications and targets determines the direction of drug development and innovation.But what worries drug reviewers is that there is a blind swarming phenomenon in current drug R&D innovation, with highly concentrated drug targets and indications, and serious homogeneity.In addition to the "clustering" of drug targets, the attention to groups such as the elderly, children and rare disease patients is obviously not enough.
It is understood that in 2022, the State Food and Drug Administration will continue to deepen the reform of the drug review and approval system, support and encourage enterprises to innovate in new technologies, new targets and new mechanisms of modern medicine, and insist on encouraging new and good drugs oriented by clinical value. As well as drug research and development innovations for rare diseases, children's drugs, major infectious diseases, and public health.
