Approval of innovative drugs continues to accelerate, with more than 25 domestically-made new drugs on the market

On October 19, Microchip Biopharmaceuticals issued an announcement stating that the company’s wholly-owned subsidiary Chengdu Microchip Pharmaceutical Co.
, Ltd.
declared that the class 1 innovative drug sitaglipta sodium tablets was approved for listing by the State Food and Drug Administration.
Exercise to improve blood sugar control in adults with type 2 diabetes
.
Siglipta sodium tablets is a new generation of insulin sensitizer molecular entity independently designed, synthesized, screened and developed by Chipset Biosciences.
It is a peroxisome proliferator activated receptor full agonist, which can improve insulin resistance.
, Dyslipidemia and reduce the risk of coronary artery disease, reduce fatty liver and lower triglycerides, improve energy metabolism
.
It is understood that in recent years, as the pace of approval has accelerated, the speed at which innovative drugs are approved for marketing has also increased day by day
.
According to data, as of October 20, there were more than 25 new drugs on the market this year, including 22 new drugs in category 1 (excluding vaccines and new indications), 21 new domestic drugs and 2 proprietary Chinese medicines
.
In addition, data shows that from 2018 to 2020, there were 32 new category 1 drugs (excluding imported drugs, new indications, and vaccines) approved for marketing in China for the first time.
In the first half of this year alone, there were 15 category 1 new drugs.
Approved for listing
.
Analysts pointed out that with the centralized procurement of generic drugs and the inclusion of innovative drugs in the new medical insurance, the Chinese pharmaceutical market is transforming into an innovation-driven market
.
At the same time, with the support of a series of policies such as speeding up drug approval, patent protection, and tax reduction, the development of innovative drugs is continuously heating up and promoting the growth of the innovative drug market in the future
.
For example, among the drugs approved this year, there is no shortage of cyclopofol injection, enovervirin tablets, hytrapopag ethanolamine tablets, Haibo Mibu tablets, syvotinib tablets, and levornidazole disodium phosphate for injection.
Waiting for blockbuster drugs
.
For clinically urgently needed therapeutic drugs involving tumors, vaccines, rare diseases and other fields, many pharmaceutical companies such as Hengrui, Baiji, and Hausen are actively deploying them
.
Driven by favorable national policies, China’s innovative drug R&D growth has been gratifying in recent years.
Data shows that the number of innovative drug IND contracts increased from 522 to 1182 from 2018 to 2020.

.
In January-July 2021, the number of IND acceptances of innovative drugs (including innovative chemical drugs, innovative biological drugs, and innovative traditional Chinese medicines) was 1,154, a significant increase of 100% year-on-year
.
From the perspective of enterprises, domestic innovative drug companies are also increasing their R&D investment
.
According to relevant data, the R&D investment of large-scale enterprises has increased by about 8% annually.
In 2020, the R&D expenses of listed companies will account for more than 6% of sales revenue
.
For example, Hengrui Pharmaceutical's R&D expenses in the third quarter of this year reached 1.
561 billion yuan, an increase of 5.
4% year-on-year and an increase of 23.
5% month-on-month; the R&D expense ratio was as high as 22.
63%
.
Another example is Huahai Pharmaceutical's research and development investment accounted for more than 10% of revenue in recent years.
Research and development expenses in the first half of this year were 359 million yuan, a year-on-year increase of more than 50%
.
BeiGene's R&D expenses in 2020 totaled 1.
29 billion U.
S.
dollars (equivalent to approximately 8.
3 billion yuan), an increase of 39.
11% year-on-year, accounting for approximately 412.
73% of revenue
.
Innovative drugs have the characteristics of high investment, long cycle and high risk.
In the past, Chinese pharmaceutical companies mainly produced generic drugs, and their R&D awareness and innovation capabilities were both weak
.
However, in recent years, as relevant departments have introduced supporting policies to strengthen clinical trial data verification and speed up the review and approval of innovative drugs, China's innovative drug industry has gradually developed
.
Data show that from 2016 to 2019, the market size of China's innovative drug industry increased from US$113.
7 billion to US$132.
5 billion, with a compound annual growth rate of 17.
9%
.
The China Business Industry Research Institute predicts that the market size of innovative drugs will reach US$146.
7 billion in 2021
.