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According to data, the approval of domestically-made innovative drugs for the market this year is showing a blowout trend
.
From January to September, 27 innovative drugs have been reviewed and approved, including cyclopofol injection, enovervirin tablets, hytropopag ethanolamine tablets, hyperimibe tablets, savotinib tablets, and levofol phosphate for injection.
Ornidazole disodium and other blockbuster drugs
.
On the whole, not only the number has far exceeded the number of innovative drug reviews passed in 2020
.
The types of products have also become very rich, involving many clinically urgently needed therapeutic drugs in the fields of tumors, vaccines, and rare diseases
.
In addition, it is worth noting that this year there have been new breakthroughs in the number of Class 1 new drugs in China
.
According to statistics, from 2018 to 2020, there were 32 types of new drugs (excluding imported drugs, new indications, and vaccines) approved for listing in China for the first time.
In the first half of this year alone, there were 15 types of type 1 drugs.
The new drug was approved for marketing
.
In addition, in terms of traditional Chinese medicine, the number of innovative Chinese medicines on the market this year has also exceeded the same period last year
.
It is understood that since the beginning of this year, 5 innovative Chinese medicines have been approved for marketing
.
In September, Yiling Pharmaceutical's Yishen Yangxin Anshen Tablets and Huakang Pharmaceutical's Yiqi Tongqiao Pills were successively approved for listing
.
In this regard, the industry believes that with the centralized procurement of generic drugs and the inclusion of innovative drugs in the new medical insurance, the Chinese pharmaceutical market is shifting to an innovation-driven market
.
At the same time, with the support of a series of policies that encourage research and development, the development of innovative drugs continues to rise, and is further promoting the growth of the innovative drug market
.
It just needs to be noted that although innovative drugs are showing a trend of vigorous development, the industry has also pointed out that there are still many difficulties and risks in the development of innovative drugs
.
Judging from the research and development results of pharmaceutical companies in recent years, failures in the research and development of new drugs are still very common
.
Earlier, AstraZeneca announced that its diabetes drug Farxiga failed to reach the focus in a phase III study and officially declared a failure
.
Biotech also issued an announcement stating that the development of HER2 ADC was terminated because the efficacy did not reach the expected superiority target.
.
In addition, the clustering of targets is also the main dilemma faced by many enterprises in innovation
.
Taking PD-1 as an example, statistics show that the domestic track is already very crowded.
Among the 154 PD-1 products under research in the world, 85 are developed or jointly developed by Chinese companies, accounting for 55%
.
According to the current trend, the industry believes that in the next 2-3 years, there will be more than 20 PD-1 products on the global market, while 15 PD-1 products on the domestic market will become increasingly fierce
.
In general, China's innovative drug development is in a golden age, and it is also an era of fierce competition
.
Therefore, in the future, only products with real clinical value can stand out and become blockbuster products
.
In order to truly improve the foundation of domestically-made innovative drug R&D and innovation capabilities, the industry believes that in addition to continuously increasing investment in pharmaceutical companies for innovative R&D, it is also necessary to vigorously cultivate pharmaceutical talents with original awareness and capabilities
.
Relevant companies need to continuously incorporate professional talents, optimize talent structure, improve talent training mechanisms, and formulate appropriate development strategies in order to build an independent and controllable drug innovation system and usher in more development opportunities
.