Shocking Results Hidden Before Trial Approval: 93 Patients Given COVID-19 Drug Despite Hamster Deaths and Lung Enlargement

Even though animal testing resulted in the death of a hamster, vomiting blood, and severe pulmonary enlargement, it has been confirmed that a COVID-19 treatment—approved for clinical trials with data omitting these crucial facts—was actually administered to 93 real patients.

This treatment is the very drug developed by Genencell, which recently sparked suspicions of lobbying after it was revealed that Justice Minister nominee Kim Seung-won requested the Ministry of Food and Drug Safety to process the clinical trial approval promptly.

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

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

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

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

It was also reported that its efficacy as a treatment was not verified.

Yet, when Genencell submitted its report to the Ministry of Food and Drug Safety to apply for Phase 2 clinical trial approval, these details were deleted or omitted.

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

The court ruled that Professor Kang ordered the deletion of the information to secure approval, knowing full well that the fact of the hamster's death could negatively impact the clinical trial authorization.

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

Genencell initially sought to proceed directly to Phase 3 trials in South Korea based on Phase 2 trials previously conducted in India, but the ministry rejected this and demanded that they reapply starting from Phase 2, while additionally requesting animal testing data and other materials.

While approval was being withheld during this process, Professor Kang was investigated for asking lawmaker Kim Seung-won, who was a member of the National Assembly at the time, to expedite the approval through a broker surnamed Yang.

On October 12, 2021, nominee Kim contacted then-Ministry of Food and Drug Safety chief Kim Gang-lip, stating that Genencell had applied for a clinical trial for a COVID-19 treatment and asking him to "take good care of it."

Fourteen days later, on October 26, the clinical trial was approved.

It has now been revealed that the approved treatment was not just limited to recruiting clinical trial participants but was actually administered to 93 patients. However, the ministry stated that no serious and unexpected suspected adverse drug reactions were reported among 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.