[Anchor]

A significant factor in the approval of clinical trial plans for Genexine, a new drug development company linked to allegations of lobbying the Ministry of Food and Drug Safety involving former Justice Minister nominee Kim Seung-won, was its animal testing result report. However, after obtaining and analyzing the initial experimental report, we found that it was drastically reduced from 17 pages to 6 pages during the submission process to the ministry. It has been confirmed that core content that could negatively affect the approval was omitted.

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 that Kang Se-chan, the founder of COVID-19 treatment developer Genexine, commissioned from Jeonbuk National University and received in August 2021.

Comparing it with the draft obtained by SBS, details showing drug reflux and hematemesis observed in hamsters before autopsy, as well as the core evaluation conclusion that "serious symptoms unrelated to infection were observed," are missing.

Drug safety evaluations unfavorable to the approval of the clinical trial plan were deleted at the request of Genexine.

Based on this, the first and second instance courts handling Kang's case ruled that a false report had been written, finding Kang 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 Genexine'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 even more core content related to drug side effects had been deleted.

Four photos attached with the description "edema and hemorrhage observed in hamster lung tissue" were omitted when submitted to the Ministry of Food and Drug Safety, and the researchers' comprehensive opinions were also deleted, shrinking the 17-page report down to 6 pages before it was submitted to the ministry on September 23, 2021.

In response, Jeonbuk National University researchers stated to the National Assembly that they had found it unusual when Genexine asked for the experimental report in a Hangul word processor file format, and that they only learned about the deletion of major contents during the prosecution's investigation.

Having seen only the modified report edited by Genexine rather than the original experimental report, the Ministry of Food and Drug Safety failed to recognize the problems and approved the clinical trial plan in October 2021.

[Lee Man-hee / National Assembly Health and Welfare Committee Chairperson (People Power Party) : I think institutional mechanisms to guarantee the completeness of data are absolutely necessary, especially in situations of national disaster or high-risk clinical trials.]

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

(Video reporting: Shin Dong-hwan, Cho Chang-hyun | Video editing: Lee Seung-hee | Design: Seo Seung-hyun | Data provided by the office of Representative Lee Man-hee of the People Power Party)