Wang Yaping, former FDA reviewer, commented on PD-1 going overseas

We work together and look forward to the day when our development and innovation know no borders and become a global innovative drug company
.

On February 10, 2022, the FDA convened a meeting of the Oncology Drugs Advisory Committee (ODAC) regarding the marketing applications of Innovent and Eli Lilly's PD-1 monoclonal antibody Sindile
.

Different from other ODAC conferences, this conference is of milestone significance for China's new drug research and development companies that are committed to going overseas, and has attracted much attention from the industry

As a statistical reviewer of the former FDA/OCE, the author analyzes the incident here, hoping to make a modest contribution to the overseas journey!

Let's trace it back to the source, I am afraid that the initial cause of the incident was that Richard Pazdur, director of the FDA/OCE, made some statements in some unofficial public occasions that sounded encouraging to Chinese innovative drugs
.

For example, at the 2019 AACR meeting, when asked about his views on the entry of Chinese PD-1 products into the United States, he said, "could potentially be a great thing for everyone because we haven't seen the major western pharmaceutical companies moving on price" and so on
.

Perhaps partly inspired by this information, Cinda made its first contact with the FDA at the end of April 2020, and submitted a BLA application in March 2021.
In many exchanges with the FDA, it seems that nothing is too big Then, in the second half of 2021, the situation took a turn for the worse, and the FDA seriously questioned the Pivotal Study (ORIENT-11) submitted by Cinda, and stated that if the company continues to review the company, it needs to go to the ODAC meeting
.

In fact, before the ODAC meeting was held, some people, like the author, had already felt the same trend
.

For example, Richard Pazdur personally wrote an article "The Wild West of Checkpoint Inhibitor Development" in "New England" on December 15, 2021, attacking the current chaos of PD-1/PD-L1 development
.

On January 28, 2022, Regeneron and Sanofi withdrew their PD-1 product applications for cervical cancer indications
.

If we look further forward, an ODAC meeting on June 25, 2021 once rejected the listing application of Incyte PD-1 product by 13:4
.

These information all point to the tightening of FDA/OCE approval of products like PD-1/PD-L1
.

These information all point to the tightening of FDA/OCE approval of products like PD-1/PD-L1
.

We can see this tightening trend, which was mainly manifested in the strict requirements for the application of domestic companies in the United States
.

At this time, Cinda and Eli Lilly joined the competition with data from a single-ethnic country like China

Until February 8, 2022, Richard Pazdur publicly stated "I have a right to change my mind" when asked about his previous views on the entry of Chinese PD-1 products into the United States
.

Based on this clear statement, there is basically no suspense about the outcome of this ODAC meeting

Regarding the causes of the above incidents, the author expresses some personal views
.

The FDA has long been concerned about the level of involution in PD-1 product development
.

The FDA has long been concerned about the level of involution in PD-1 product development
.

As early as 2018, the author felt the FDA's concern about the repeated development of PD-1 products on many occasions: any regulatory agency will eventually correct based on macro-control for excessive development
.

Therefore, we can see that in 2021, many PD-1 products will receive more stringent supervision than ever in terms of launching or expanding their indications.
This is not only for Chinese companies, so it is believed that the FDA has backtracked, even to Chinese companies.
It is very inappropriate to say that there is a prejudice to suppress
.

I am very sorry to hear Richard Pazdur publicly stated "I have a right to change my mind" on Chinese PD-1 products
.

It makes people feel that he has a feeling of being pushed into the corner by the voice of doubt and fighting back

Richard Pazdur publicly stated "I have a right to change my mind" on Chinese PD-1 products

Judging from the author's years of experience working with Richard Pazdur, as the head of the most important department of the FDA, he has strong professionalism, high vision, and forward-looking policy formulation, and he does not have any prejudice against Chinese companies.

.

He is also very happy to see the growth of Chinese companies over the years, and is looking forward to the development of real innovative drugs by Chinese innovative drug companies in the future

Many articles and reviews have fully analyzed the content and results of ODAC, and the author will not repeat the details, but only express some personal views on the main points
.

First of all, the FDA stated on the first page of its opening remarks that "FDA DOSE NOT consider cost or drug pricing in regulatory decision making"
.

This is actually the main advantage emphasized by China's PD-1 products.

This is actually the main advantage emphasized by China's PD-1 products.

However, judging from my experience and many cases of OCE's old Stat over the years, these should not be fatal in isolation.
How to improve these flaws is limited by the space involved in professional issues.
Can be discussed and analyzed separately
.

We can also see the overall affirmation of ODAC experts on the efficacy and safety of the product
.
Panel member Jorge Nieva also said "They failed to show a proper process, not that they failed scientifically.
"

So, where is the key question? As FDA stated in ODAC "landscape changed", "not unmet medical need", especially this "me-tooooo"
.

The matter is over, the impact will be far-reaching
.
Failure is not terrible, every fall will accumulate valuable experience for our future sailing voyages
.

The author has always been confused, why do we accept this ODAC conference? According to the theory, the sponsor has the right to withdraw the application and refuse to participate in the ODAC meeting, because in most cases the failure of the ODAC is worse than the withdrawal of the application
.

If it is a mistake in the situation analysis and the ODAC success rate is judged too high before the meeting, then we need to make more efforts in the maturity and perfection of the strategic analysis
.

If the previous strategy predicted that ODAC would fail, and still choose ODAC, there may be business logic that the author cannot understand
.

Through this ODAC meeting, we can also see the comprehensiveness of FDA's interpretation of various guiding principles and the depth of scientific understanding, which puts forward higher requirements for the quality of our future clinical research and development
.

Our innovative drug companies realize that it will be difficult to go overseas with "me-tooooo" products in the 1.
0 era alone
.
It can be expected that new or relatively new products in the future will have a greater success rate in going overseas
.

It will be difficult for "me-tooooo" products to go overseas
.
It can be expected that new or relatively new products in the future will have a greater success rate in going overseas
.

We work together and look forward to the day when our development and innovation know no borders and become a global innovative drug company
.