80% of China's clinical data are not true is the "evidence" or "examination" of Innovent's rejection

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On the evening of February 10, the FDA convened the Oncology Drug Advisory Committee ODAC to discuss and vote on the review of the new drug marketing application (BLA) for sintilimab injection

Innovent’s sintilimab, as the “touchstone” of the single-country clinical data of a domestic innovative drug in the U.

Uncover "Black History"

Is it true that 80% of Chinese clinical data are untrue?

However, it is worth noting that when the review committee raised several controversial points about dilimumab, the FDA directly cited the report of the Chinese drug regulatory department, saying that 80% of Chinese clinical studies were fraudulent or substandard

It is not difficult for careful readers to find that the report data cited by the FDA is the 2016 report of the China Food and Drug Administration

Since then, China's new drug policy reform, chemical drug registration classification reform, BE filing system, recognition of foreign clinical trial data, and simultaneous development of international new drug clinical trials have been implemented.

After years of policy combination and top-level design, China's drug research and development environment has been traced back to its roots, and China's new drug research and development has basically achieved international standards

And the speed and data of China's drug research and development has been supported by many countries around the world

FDA cites "7.

The ODAC's review of sintilimab, citing the data from the "7.

The author believes that the FDA citing outdated data is actually unconvincing, or it is not a strong data supporting evidence that sintilimab is not approved by the FDA

Looking back on the research and development process of sintilimab, according to Yaozhi's global marketed drug screening system, Innovent Bio first applied for the clinical trial of sintilimab in January 2016, and was approved for the trial license in early September 2016

Data source: Yaozhi Data

In addition, at this review meeting, the FDA actually recognized the clinical research data of sintilimab

In fact, since the verification of clinical data on 7.

Epilogue

However, we should face up to history and take this as a lesson to learn

At the same time, I also hope that whether it is FDA, EMA or other national drug regulatory agencies, they will not turn out the "black history" every time they review the clinical data of Chinese drugs

Look at problems from a developmental perspective
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