Genexel Report Cut from 17 to 6 Pages... Unfavorable Findings Omitted

[Anchor]

Genexel, a new drug development company embroiled in allegations that former Minister of Justice nominee Kim Seung-won lobbied the Ministry of Food and Drug Safety, heavily relied on an animal testing results report to secure approval for its clinical trial plan. However, an analysis of the original test report obtained exclusively by our network revealed that the document was drastically reduced from its initial 17 pages down to 6 pages during the submission process to the ministry. It has been found that core details that could have negatively impacted the approval were deleted.

This is an exclusive report by reporter Son Hyeong-an.

[Reporter]

This is the final version of a 17-page COVID-19 treatment evaluation report received in August 2021 by Gang Se-chan, the founder of COVID-19 treatment developer Genexel, after commissioning animal testing from Jeonbuk National University.

Comparing it with a draft obtained by SBS, details indicating that drug reflux and hematemesis were observed in hamsters before autopsy, as well as the core evaluative conclusion that "severe symptoms separate from the infection were observed," are missing.

The drug safety evaluations that were unfavorable to the approval of the clinical trial plan were removed at the request of Genexel.

Based on this, the first and second instance courts handling the case of Gang Se-chan ruled that a false report was produced and found Gang guilty of obstruction of official duties by fraudulent means.

However, when the office of National Assembly Health and Welfare Committee Chairperson Lee Man-hee reviewed Genexel's treatment evaluation report submitted to the Ministry of Food and Drug Safety and compared it with the Jeonbuk National University report, it was confirmed that additional core details related to drug side effects were removed.

Four attached photos together with the description "edema and hemorrhage observed in hamster lung tissue" were omitted upon submission to the Ministry of Food and Drug Safety, and the research team's comprehensive opinion was also deleted, heavily condensing the 17-page report into 6 pages before it was submitted to the ministry on September 23, 2021.

Regarding this, the research team at Jeonbuk National University stated to the National Assembly that they found it puzzling at the time when Genexel asked for the experimental report in an HWP (Hangul) file format, and that they only learned about the deletion of major contents during the prosecution's investigation.

Without recognizing the issues, the Ministry of Food and Drug Safety—having seen only the modified report edited by Genexel rather than the original experimental report—approved the clinical trial plan in October 2021.

[Lee Man-hee / Chairperson of the National Assembly Health and Welfare Committee (People Power Party): In cases of national disasters or high-risk clinical trials, I believe that institutional safeguards to guarantee the completeness of data are absolutely necessary.]

Criticism regarding the clinical trial plan approval process and demands for institutional improvement are expected to follow during the parliamentary audit of the Ministry of Food and Drug Safety by the National Assembly Health and Welfare Committee tomorrow.

(Video reporting: Shin Dong-hwan, Cho Chang-hyun | Video editing: Lee Seung-hee | Design: Seo Seung-hyun | Photo courtesy of: Office of Representative Lee Man-hee of the People Power Party)
※ Please note: This article was translated by AI and may contain errors.