Sina Pharmaceutical's annual inventory of domestically-made "Class 1/2" innovative drugs that entered the NDA for the first time in 2021

In recent years, under the country's policy of vigorously promoting mass entrepreneurship and innovation, domestic new drug research and development has ushered in unprecedented development
.

Class 1 new drugs entering the NDA stage for the first time in 2021

Through data retrieval, as of the deadline for publication, a total of 16 chemical category 1 species have entered the NDA stage for the first time in 2021 and received acceptance
.

The indications of related varieties are mainly tumors, accounting for 50%.
Specifically, there are two varieties of Jiangsu Hengrui SHR6390 (CDK4/6-breast cancer) and SHR3680 (AR-prostate cancer), Betta Pharmaceuticals Befortinib Sulfonate (EGFR-T790M-Non-Small Cell Lung Cancer), Shanghai Beierda's Rezetinib Mesylate (EGFR-T790M-Non-Small Cell Lung Cancer), Limpris from Shanghai Yingli Pharmaceutical Tablets (PI3Kδ-Lymphoma), Carboxyamine Triazole (Non-Small Cell Lung Cancer) of Guangdong Yinzhu Pharmaceutical Technology, Yiluoke (ALK/ROS1-Non-Small Cell Lung Cancer) of Qilu Pharmaceutical, ASK120067 of Jiangsu Osaikang Pharmaceutical Tablets (EGFR-T790M-Non-Small Cell Lung Cancer); and it is not difficult to see from the above that the EGFR-T790M mutation, the third-generation drug of EGFR, has 3 varieties to enter the NDA, and combined with the current market and the use of osimertinib as For the representative third-generation drug varieties, the market will undoubtedly enter a white-hot state
.

Other NDA stage varieties also involve gastrointestinal tract, diabetes, immunity, hepatitis, anemia, etc.
See the table below for details
.

Table 1.
1 Class 1 new drugs entering the NDA stage for the first time in 2021

Class 2 new drugs entering the NDA stage for the first time in 2021

Since the implementation of the latest version of chemical drug registration classification, industry attention for Class 2 improved new drugs has risen sharply
.

According to the classification, Class 2 new drugs can be further divided into 2.
1, 2.
2, 2.
3, 2.
4.
The requirements are as follows.
In recent years, the registration and application of Class 2 new drugs have mainly concentrated on the 2.
2 and 2.
4 varieties, and the 2.
1 is currently The least category of the 2 categories of registration declaration
.

Table 2.
1 Classification, description and included circumstances of new registration of chemical drugs

By querying the category 2 new drugs that entered the NDA stage in 2021, and further eliminating non-first-entry products, a total of 17 products entered the NDA status of the category 2 new drugs for the first time to obtain CDE undertaking, see Table 2.
2 for details
.

Further research on the variety found that the main characteristics are as follows:

The follow-up declaration of new indications after domestically produced Class 1 new drugs are on the market, namely Class 2.
4;

The traditional two-category declaration direction, the new formulation of the marketed drug, namely the 2.
2 category
.

For domestically produced Class 1 new drugs, continuing to apply for Class 2 NDA declarations is the current routine operation method for domestically-made innovative drugs; such as Liaoning Haisco Pharmaceutical's cyclopofol injection, Jiangsu Hausen Pharmaceutical's Ametylate mesylate Nepal sheet, En Sha erlotinib hydrochloride Phar capsules, mesylate volts US Shanghai pharmaceutical Allist imatinib sheet or the like
.

For the 2.
2 category of innovative preparations, in accordance with the current review requirements, it is necessary to have obvious clinical advantages, which to a certain extent reflects the optimization and improvement effects of pharmaceutics on drugs, and reflects an enterprise’s ability to innovate preparation technology, such as Livzon Pharmaceutical’s triptorelin acetate injectable microspheres, given dexmedetomidine hydrochloride nasal spray Shanghai Henry medicine, biotechnology medicine source edaravone sublingual tablets and the like
.

Table 2.
2 Class 2 new drugs entering the NDA stage for the first time in 2021

The characteristics of NDA varieties and their reference significance

For the category 1 innovative drugs that entered the NDA stage for the first time in 2021, the varieties mainly have the following characteristics:

Most of them are still me-too type, and the innovation is not significant, but the development speed has reached a high level;

The field of indications is mainly tumor, and the further distinction is mainly non-small cell lung cancer.
Rare tumors need to be explored urgently;

There are more and more companies developing NDA varieties, the barriers of proceduralization are being broken, and the essence of innovation is more difficult to obtain
.

As for the two improved new drugs that entered the NDA stage for the first time in 2021, the varieties mainly have the following characteristics:

The traditional 2.
2/2.
4 development model is the mainstay, and it has not yet received amazing improvements;

The innovation ability of domestic preparation technology needs to be strengthened urgently;

Some Class 1 new drugs are essentially Class 2.
1 improvements, but due to various reasons, companies will not take the initiative to "dimension reduction" and so on
.

In summary, the first domestic NDA application for Class 1 new drugs + Class 2 improvements in 2021 has clearly formed a "growth rate and number"
.

In the future, with the fierce competition in the industry, the transformation of domestic me-too to FIC will surely bring about continuous improvement of pharmaceutical innovation capabilities, and at the same time, it will inevitably meet more unmet clinical needs

refer to:

1.