my country's new medicine research and development reached a record high, and how the innovative results have been achieved?

"The 2021 review passed the 47 innovative drugs, and hit a record high." The State Drug Administration recently released the "2021 Drug Review Report". This report on the registration of my country's drug registration concludes that my country's "innovation capabilities and high -quality development of the pharmaceutical industry and high -quality development" in China has been further enhanced. "

Coincidentally. Another report recently released by the Pharmaceutical Review Center of the State Drug Administration- "Annual Report of the Progress of the Progress of the Progress of the New Pharmaceutical Registration of China (2021)" shows that the number of new drugs in my country in 2021 has increased significantly. The number of tests is continuously increased, and the number of applications for the listing of new drugs in China will increase, and the process will be accelerated to meet the needs of new drugs for Chinese patients. "

What is the progress of China's new medicine research and development? You can get a glimpse of these two reports.

The number of new drug registration applications and clinical trials increase rapidly

As a technical review agency for pharmaceutical registration and listing, the Drug Review Center of the State Drug Administration summarizes the progress of the approval and clinical trials of the drug review and clinical trials of my country every year, and forms a report.

The "2021 Drug Review Report" shows that in 2021, the Drug Review Center of the State Drug Administration accepted 11,658 drug registration applications, of which 1,886 were applied for innovative drugs, an increase of 76.1%over the previous year. If the time cycle is stretched, the 2017 innovative drug registration application is 506, less than one third in 2021. The enthusiasm of new drugs is evident.

From the perspective of clinical trials, new drugs are full of energy.

"Annual Report on the Progress of China's New Pharmaceutical Registration Clinical Test (2021)" shows that in 2021, 3,358 clinical trials registered for clinical trial registration and information publicity platform in my country, an increase of 29.1%over 2020. Among them, the new drug clinical trials were registered with 2033 items, accounting for 60.5%.

Compared with data in the past three years, it can be found that the proportion of clinical trials of new drugs has increased year by year. In 2020 and 2019, the proportion of new drug clinical trials was 56.6%and 52.7%, respectively. Under the premise of maintaining rapid growth in clinical trials, it can also increase the proportion, which means that the number of clinical trials of new drugs has continued to increase.

The number of innovative drugs has reached a record high

From the rapidly growing new drug registration application, we saw the enthusiasm of innovation in the medical industry. But how the effectiveness of innovation depends on the results of the review and approval.

The "2021 Annual Drug Review Report" shows that in 2021, the National Drug Administration's Pharmaceutical Review Center approved or proposed to approve the application for innovative drug registration for 1,628 pieces, an increase of 67.32%year -on -year. Among them, most of the clinical trial applications for innovative drugs. The approved innovative drug listing permit is 69, an increase of 130%year -on -year, involving 47 varieties. 69 and 47, seemingly not much, but extremely difficult, all have a record high.

According to reporters, the 47 innovative drugs approved by the 2021 review involved many fields such as new coronary virus, tumor, immune system, blood system, endocrine system, and many of them have independently developed and have independent intellectual property rights in my country.

For example, a sulfonic acid vitinib nigibinic tablets suitable for patients with advanced or metastatic non -small cellular cancer, which are suitable for recurrence or metastatic breast cancer patients, are independently developed and owned by my country 1 type of innovative drugs for independent intellectual property rights. It is suitable for patients with lupus erythematosus. Their approved listing provides patients with new treatment options.

In addition, Chinese medicine innovation is also worthy of attention. Many Chinese medicine innovative drugs that meet the advantages and characteristics of the clinical treatment of traditional Chinese medicine are approved for listing. For example, it is used to treat seasonal allergic rhinitis TCM syndrome differentiation.

Pharmaceutical research and development innovation and homogenization issues must be vigilant

The enthusiasm of drug research and development and innovation is high, but there is no shortage of concerns.

The "2021 Drug Review Report" shows that in 2021, the review conclusion is 542 applications that are not approved or proposed not approved, of which 183 registration applications are mainly applied for the safety, effectiveness, or effectiveness or effectiveness or effectiveness of the application for registration drugs. Successive problems such as quality controllability. Moreover, the number of registration applications that have not been approved due to the rationality of drug development questions increased significantly.

According to the analysis of the Drug Review Center of the State Drug Administration, in terms of R & D issues, the clinical positioning of some drugs is unclear, and the selection of indications is unreasonable; Obviously, the target and mechanism of action are not clear, and the risk of patent medicine is high; the combination of medication violates the principles of clinical diagnosis and medication, or lacks effective and safety research data support.

The selection of indications and target targets determines the direction of drug development and innovation. But what worrying about drug reviewers is that there is a blind phenomenon of drug research and development innovation. The drug targets and indications are highly concentrated and the homogeneity is serious. In addition to the "tie" of drug targets, it is obviously not enough to pay attention to the elderly, children and rare diseases.

It is understood that in 2022, the State Drug Administration will continue to deepen the reform of the drug review and approval system, support and encourage enterprises to innovate in modern pharmaceutical technology, new targets, and new mechanisms, adhere to encouragement of clinical value -oriented new drugs and good medicines. As well as rare medical medication, children's medication, major infectious diseases, and public health urgently needed drug research and development innovation.

(Reporter Chen Haibo)

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