Dilemma and Breakthrough——Thinking about the failure of China's innovative drug research and development

In recent years, with the reform of drug review and approval policies and the assistance of the capital market, my country's pharmaceutical industry has developed vigorously and has entered a period of rapid development.

Number of first IND innovative drugs in China over the years

The development of innovative drugs is a long-term and high-risk work.

Successful projects often have similar paths.

1.

High incidence of cancer phase III clinical trial success rate (data source: NextPharma database of Medicine Rubik's Cube)

The recent news that Biotech’s HER2 ADC has been discontinued because its efficacy has not reached the expected superior efficacy target, and the news that Kanghong Pharmaceutical’s core product Conbercept’s global multi-center clinical practice has been blocked has attracted much attention, and the capital market has also reached 20%-40%.

Projects terminated/suspended due to efficacy issues

2.

When safety issues are discovered in clinical trials, even if improvements are made through adjustments to dosage or dosing schedules, it will have a greater impact on its efficacy and compliance, which may cause the failure of the project.

Projects terminated/suspended due to security issues

3.

For innovative drugs, with the reform of pharmaceutical policies and the smoothness of drug registration paths, domestic pharmaceutical companies need to directly face competition from multinational pharmaceutical companies.

Projects terminated/suspended due to market competition

Four, other

Drug development decision-making is a choice made by considering multiple factors.

At the same time, in recent years, the number of innovative drugs entering clinical trials has increased significantly, and CRO companies have ushered in huge development opportunities.

Other terminated/suspended projects

According to the statistics of Medical Rubik's Cube, there are 119 products in the pipeline of 821 oncology drugs under research in China that have innovative mechanisms and are in the world's leading R&D stage, accounting for 14.

Success will be late, but will not be absent

China's innovative drug development is in the best era, and it is also the most competitive era.

At the same time, decision-making in the drug development process is very important.
In the face of early clinical trials with poor results, how to evaluate and the conclusions drawn by subgroup analysis cannot ensure that the verification is correct in large-scale clinical trials.
Researchers and decision makers often need to The decision to go or no go is made with the support of sufficient data.

The development of innovative drugs requires great courage and long-term persistence.
For example, Roche's continuous exploration of TIGIT and Amgen's research on RANKL have been over ten years, from target discovery to mechanism verification to drug design and clinical research.
The iteration of the product resulted in a product with great value for disease treatment.
With the rapid development of China's pharmaceutical industry, everyone will view the failure of product development from a more rational perspective.
It is only a matter of time before blockbuster products with source innovation appear.