Everything regarding the conducted clinical trials must be fully exposed (Long post warning. A new figure appears)

Several stages are required for new drug approval.
1. Preclinical
Verification of safety and efficacy through experiments on cells or animals.
2. Clinical
Phase 1, 2, 3 (Phase 4 is conducted after the manufacturing and sale of the new drug is approved)
It seems Professor Kang [redacted] conducted something during the preclinical stage.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4000447
This seems to be the trace.
This has not been peer-reviewed, and there does not appear to be a formally published paper.
According to reports
The 'treatment effect data' Kim Seung-won saw... turned out not to be a formal paper. edailyTV This article was pre-released as premium content from Pharm Daily on September 10, 2026, at 06:00. [Reporter Kim Ji-wan, Edaily] Minister of Justice nominee Kim Seung-won's controversy over the request for expedited processing of Genencell's COVID-19 treatment 'ES16001' clinical trials...
This is likely what they are talking about.
There are many people listed as co-authors here, and they must be extremely anxious right now.
Fearing that they might also become subjects of investigation.
They might have been happy when they were getting paid to conduct experiments, thinking it was a windfall, but I wonder?
Looking at the title here,
It appears as if they did everything from the laboratory stage to cell research, animal preclinical studies, and clinical trials on human subjects.
The animal preclinical study was done using Syrian hamsters,
and the human clinical trial was reportedly a Phase 2 study involving 60 subjects. (Perhaps in India?)
This substance is a plant extract that Professor Kang has been using as research material for a long time.
It does grow in India as well.
But why a clinical trial in India?
The basis for this (Damnalsu extract) being used as a COVID treatment in the Indian private sector seems slim to begin with???
It is true that Professor Kang has consistently dealt with the efficacy of extracts against other viruses,
and when the COVID era arrived,
he might have thought, 'Oh, if we apply this to the coronavirus, could it work? If it becomes a real treatment, won't we make a fortune?'
I understand such imagination is possible,
but to put this into practice, there are many hurdles lying ahead....
The following are my speculations.
https://trialsearch.who.int/?TrialID=CTRI/2020/09/027775
The site above is the WHO record for the clinical trial mentioned in this study.
And this record was transferred from the Clinical Trials Registry - India (CTRI).
https://www.ctri.nic.in/Clinicaltrials/login.php?id=
Records exist here.
However,
The actual government-led site in India that manages clinical trials is the CDSCO below.
https://cdsco.gov.in/opencms/opencms/en/Home/
No matter how much I searched there, I could not find any trace of the clinical trial in question.
I found another document on the CDSCO site.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjM2Mg==
Looking at this, the situation makes some sense. During the COVID period, all sorts of clinical trials related to this were popping up like mushrooms in India, and they were essentially declaring, [Since it is the COVID era (we cannot control everything individually), please proceed with your research while protecting the rights of subjects (clinical trial participants) and complying with the rules. (But if problems arise, you are responsible).]
In other words, because regulations were loose in India during the COVID period, it was easy to set up a clinical trial scene.
So, they set up the scene here and used it as a stepping stone to enter clinical trials in Korea.
(You can't really boost stock prices just based on what was done in India...)
But when it actually comes to conducting clinical trials in India,
which clinical trial institution (= hospital) could they have broken into?
Among the co-authors, there appears to be someone who materializes Professor Kang's academic imagination by setting up the scene and making connections.
Out of the 18 authors, the last one is Kang Se-chan, and the 17th author right before him is
Dean Kwak.
The Korean name is Kwak Jang Yul.
https://trialsearch.who.int/?TrialID=CTRI/2020/09/027775
I am re-writing the site I introduced above.
Because the public & scientific contact email address for this study provided by this site is
deankwak@syncorp.in
World Health Functional Food & Ingredients Exhibition Hi Korea
hi-korea.net
Discover the A to Z of functional/natural ingredients, health functional foods, and additives at Hi (Health Ingredients) Korea, a global professional brand exhibition for the health functional food and ingredient industry!
His face appears on this page. (No comment on his appearance)
I cannot tell whether they claimed to have conducted clinical trials when they didn't,
whether they actually did them and the results were truly effective, or whether they manipulated them.
But if they went that far, it seems likely they did it.
Where did all that money come from?
This is a study that Genencell should have sponsored,
so I am curious where and how they received investment.
Anyway, although there are results claiming effectiveness,
since it was conducted with the sponsor's money,
I suspect it wouldn't be easy for the results to show no effectiveness.
It seems they should have stopped at the animal testing level.
Normally, one should submit preclinical data and receive approval step-by-step starting from Phase 1,
but for herbal or traditional medicines, Phase 1 can be skipped under certain conditions.
As supporting data to skip Phase 1,
they would have presented such evidence when applying for domestic clinical trials to the MFDS (Ministry of Food and Drug Safety),
and since the MFDS is an authority in its own right,
it would have been difficult for them to blindly trust preclinical or Indian clinical data,
so they likely requested supplements for re-examination or rejected the application, stating that the requirements for direct approval of Phase 2 and 3 were not met and that they must start from Phase 1.
It seems this collapsed with a single push from a member of the National Assembly.
Then, in which actual hospital or oriental medicine hospital was the clinical trial involving over 90 subjects conducted?
The process involves recruiting subjects after receiving MFDS approval,
and while each institution (hospital) conducts approval work through its own IRB,
it is safe to assume there is no case where an institutional IRB twists a clinical trial approved by the MFDS
to say, "You cannot do it at our hospital!"...
Still, I am curious about where it was done.
I am also worried about whether this investigation (= prosecution) is being conducted properly...
If these parts (1. Manipulation of preclinical or Indian clinical trials / 2. Errors in the domestic clinical trial approval process) are ultimately acknowledged,
separately from the victims of stock manipulation,
the clinical trial subjects can file separate civil lawsuits. They can even sue the MFDS.
I keep thinking that the investigative authorities might not have dug deep enough because they don't know part 2 well
(The Minister of Food and Drug Safety was found not guilty ㅠ... or they might have intentionally not dug deep enough)
If you look specifically into what they were told to supplement when the application was rejected, the answer will come quickly.
(For example, whether there were instructions like, "Since it is a herbal medicine, let's exempt them from the previous stages...")