The international clinical trial of innovative drugs is not only "Development" but also "Research"

TextHead Feixue

The OADC meeting in early February, the popularity has not diminished, and it is still the most discussed topic in the industry

Medical practice: a new topic for Chinese innovative drug companies

From the content of this meeting, I am more concerned that the FDA has mentioned the concept of "Medical Practice" in many places, which is actually a very important content that is often ignored in China

In the past, many domestic companies believed that the application of innovative drugs should be a test paper, and the standard test paper should have the same answer.

In fact, this ODAC meeting, the various feedbacks from the FDA and the logic behind it should not be unfamiliar or unexpected to the innovative drug team with a deep clinical background and years of international clinical experience in China and the United States

The research and development of innovative drugs, especially clinical trials, is not a black-and-white test paper that is simply compared and supervised

Involution-driven internationalization: past logic has failed

There are many domestic innovative drug targets and tracks, needless to say about the involution situation

Of course, drugs with the same target and the same mechanism cannot be developed.

If there is no confidence to crush competitors with the same target, of course, there is no chance, that is, the real need to find differentiated clinical needs positioning

Many friends worry about whether the FDA's standards for PD-1 will be reflected in other Chinese innovative drug varieties that are clinically and declared in the United States in the future

FIC international clinical: it is Development, but also Research

For the international development of innovative drugs, U.

If domestic innovative drugs really want to go international, the clinical research conducted by China and the United States must not be just a superficial gesture, and it cannot go to the United States to do clinical trials in order to tell stories to investors

We may need to have a deeper understanding of clinical research on innovative drugs

Now we should better understand that the clinical trial of innovative drugs is not only development, but also research.

Where is the next breakthrough

The next step for China's innovative drugs requires the Biotech team to have a deeper understanding of clinical research and medical practice in China and the United States, to understand where the clinical needs are, to understand which preclinical model validation is more clinically relevant, and to know what preclinical model data may be in Which indications have more opportunities, after obtaining the clinical data of First in human, you will know which experimental studies to explore in the laboratory, and how to further optimize the follow-up clinical program based on these results

In the past two years, many innovative technologies and innovative treatments for drug discovery have emerged, which is of course a good thing, but these new explorations still need to clarify the future clinical scenarios and whether the verification process is truly related to the clinical scenarios

In the past decade or so, there have been several landmark breakthroughs in the capabilities of domestic innovative drug companies

Ideally, this node should be that a certain Chinese innovative drug, for a certain or even a variety of indications with great influence, a large number of patients, limited treatment methods and poor results, will be simultaneously clinically launched in China and the United States.
, and succeeded
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As long as the key clinical data is recognized as a significant advantage, even if it has not yet been approved by the FDA, the upsurge in the industry will likely be revived
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The previous US approval of zanubrutinib is of course also an important sign, but the target population of approved indications is still relatively limited
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The real breakthrough mark of the future should appear in the Chinese innovative drugs currently being developed for solid tumors
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