"Shocking Results of Vomiting Blood and Enlarged Lungs Hidden": COVID-19 Treatment Approved, Administered to 93 Patients in "Human Experiment"

Even though animal testing showed hamsters dying, vomiting blood, and suffering from severe pulmonary hypertrophy, a COVID-19 treatment that received clinical trial approval using data omitting these details was confirmed to have been actually administered to 93 patients.

According to data obtained from the Ministry of Food and Drug Safety by the office of People Power Party lawmaker Yoon Sang-hyun, Genencell's COVID-19 treatment ES16001 was actually administered to 93 participants during the domestic Phase 2 clinical trials in 2022.

This treatment was originally developed as a candidate substance for a shingles treatment.

Genencell conducted preclinical tests in 2021 using COVID-19-infected hamsters to develop it as a COVID-19 treatment.

However, out of five hamsters in the high-dose administration group, one showed symptoms of drug regurgitation and vomiting blood before dying, and severe pulmonary hypertrophy was observed even in the surviving subjects.

It was also reported that the efficacy as a treatment was not confirmed.

However, in the report submitted by Genencell to the Ministry of Food and Drug Safety when applying for Phase 2 clinical trial approval, these details were deleted or omitted.

This was also confirmed in the first-instance sentencing of Professor Kang, the founder of Genencell, for violating the Pharmaceutical Affairs Act.

The court judged that Professor Kang ordered the deletion of the relevant information to secure approval, knowing that the fact of the hamsters' deaths could have an adverse effect on the clinical trial approval.

The problem is that the Ministry of Food and Drug Safety did not immediately approve Genencell's clinical trial application at the time either.

Genencell initially attempted to proceed directly to Phase 3 clinical trials in Korea based on Phase 2 trials conducted in India, but the Ministry of Food and Drug Safety did not accept this and demanded that they reapply starting from Phase 2, requesting additional animal testing data.

While approval was withheld in this process, investigations showed that Professor Kang asked then-lawmaker candidate Kim Seung-won for prompt approval through a broker named Yang.

Candidate Kim requested then-Minister of Food and Drug Safety Kim Gang-lip on October 12, 2021, stating that Genencell had applied for clinical trials for a COVID-19 treatment and asking him to "take good care of it."

And 14 days later, on October 26, the clinical trials were approved.

It has been revealed that the approved treatment did not merely stop at recruiting clinical trial participants but was actually administered to 93 patients. However, the Ministry of Food and Drug Safety stated that no serious and unexpected suspected adverse drug reactions were reported from them.

(Reported by Kim Minjeong | Video by Ahn Jun-hyeok | Graphics by Yook Do-hyun | Produced by SBS Digital News)
※ Please note: This article was translated by AI and may contain errors.