Domestically-made "Class 1/2" innovative drugs that entered the NDA for the first time in 2021

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"
.
For the Chinese people, especially the patients, there are more choices, which are good.
Needless to say; for the national review department, the NDA workload is naturally increased; for some companies, the final answer sheet has finally been handed in, waiting for the official Conclusion and formal test of the market
.

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.
CDE official website data

2.
NMPA official website data

3.
Disclosure of information on the official websites of major pharmaceutical companies