Analysis of China's innovative drug IND trends

This round of drug policy reform, which started in 2015, has gradually improved the policy review and approval system, solved the problem of low regulatory efficiency before new drug research and development, and created a good policy environment; on the other hand, it has attracted a lot of capital.

After nearly five years of development, China's new drug innovation landscape has undergone tremendous changes

In terms of drug types, the development of innovative drugs in China is mainly based on small molecule drugs and antibodies, and the cumulative proportions of the first IND new drugs in the past 10 years are 55% and 22% respectively

The development of emerging therapies is in the ascendant in China, and the types of drug technologies submitted by IND are also more diversified

Although the data on the surface looks like a thriving scene, the hidden problem is equally prominent, that is, the homogeneity of new drugs under development is serious, and the targets are highly concentrated

Among the new drugs that will apply for IND for the first time in 2021, due to the explosion in the number of double antibodies, the popularity of PDL1, TGF-β, 4-1BB, CD47 and other target combinations has also increased rapidly, and the targets of small molecule drugs are concentrated in KRAS G12C, BTK, SHP2, TOP15 target related drugs totaled 155, accounting for 25%

In terms of indication selection, the focus of new drug development is more and more inclined to tumors, blood and immune-related diseases, while the heat of drug research and development in the fields of infection, cardiovascular and cerebrovascular, digestion, endocrinology and metabolism is gradually cooling down
.
Autoimmune diseases such as systemic lupus erythematosus (SLE) and atopic dermatitis have also been hotspots in drug development in the past two years
.

From the perspective of enterprises, the development of domestic innovative drugs is also showing a trend of concentrating on leading enterprises
.
In the past 10 years, the top 50 pharmaceutical companies (groups) in the number of INDs have declared a total of 1,160 new drugs, accounting for 47%
.
Among them, Hengrui Medicine declared 90 models, and the number is far ahead
.

Especially in 2021, Hengrui, Chia Tai Tianqing, Haosen, Junshi, Qilu and other leading companies will have an explosive growth in the number of new drug applications.
1 CD112R/TIGIT double antibody
.
At the same time, other traditional pharmaceutical companies have also accelerated the pace of transformation to innovation, and start-up pharmaceutical companies have also grown rapidly, submitting a large number of innovative drugs to IND and promoting them to clinical development in China
.

From the overall data, during the ten years from 2012 to 2021, a total of 689 Chinese companies have completed the clinical application of their first new drugs, entered the arena of innovative drug development, and participated in the enrichment of China's innovative drug ecosystem
.