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 fever of drug research and development in the fields of infection, cardiovascular and cerebrovascular, digestion, endocrinology and metabolism is gradually cooling down

From the perspective of enterprises, the development of domestic innovative drugs is also showing a trend of concentrating on leading enterprises

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.

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

The above content comes from the "China New Drug Registration Review and Research Report (2021)"jointly written by the Medical Cube Global New Drug Database Team and the Basic Data Team

China New Drug Registration Review Research Report (2021)

IND drug analysis Clinical trends of innovative drug applications, composition of new drug projects under development, application of emerging therapies, target analysis of products under development in China, and pipeline analysis of 2021 new drug IND TOP20 companies

Clinical Trial Analysis Analysis of the registration of new drug clinical trials over the years, the distribution of registered indications in different clinical stages, the core clinical statistics of pharmaceutical companies in various countries in the past ten years, the analysis of the differences in the core clinical registration indications of Chinese and foreign companies, and the core clinical development strategies of China's top pharmaceutical companies

Analysis of NDA Drugs

Analysis of Listed Drugs Category Distribution of New Drugs Approved for the First Time in China, Analysis of Approval Duration of Listed Drugs in the Past Years, Statistics of the World's First Launched Innovative Drugs and First Launch Countries in the Past Years, Analysis of the Time Difference between the Domestic First Launch and Global First Launch of Different Drugs, Evaluation of Overseas New Drugs in Urgent Clinical Need, Recent Statistics of commercialized products of domestic pharmaceutical companies in ten years

Summary: Overview of New Drug R&D Trends in China