"Clinical Trial Process Took Even Longer"

Kim Seungwon, nominee for Minister of Justice, denied the so-called "new drug clinical trial lobbying allegations" on September 5, stating that "the facts and the responsibility have been distorted."


On the same day, Kim's confirmation preparation team released a statement stating, "After reviewing materials indicating therapeutic effects up to phase 2 of overseas clinical trials, we merely relayed a civil complaint to the Commissioner of the Ministry of Food and Drug Safety (MFDS) to prevent undue delays in the clinical trial procedure of a domestically developed treatment."


They further emphasized, "We were not aware that Mr. Kang, the CEO of Genencell, omitted or manipulated some of the animal experiment data, and there is no evidence confirming any involvement."


Kim Seungwon, a member of the Democratic Party nominated as Minister of Justice, is attending the Legislation and Judiciary Committee’s Bill Review Subcommittee 1 held at the National Assembly on the 31st of last month. Photo by Kim Hyunmin

Kim Seungwon, a member of the Democratic Party nominated as Minister of Justice, is attending the Legislation and Judiciary Committee’s Bill Review Subcommittee 1 held at the National Assembly on the 31st of last month. Photo by Kim Hyunmin

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Kim's team also stated that it is not true that the Genencell review by the MFDS was conducted unusually quickly. Previously, Han Jia, a member of the People Power Party, claimed that approval of Genencell's clinical trial plan was completed more than twice as fast as for other COVID-19 treatments.


The confirmation preparation team explained, "According to official MFDS records, the total review period for Genencell was 11 days," adding, "This was not faster than the average for new compound clinical trials; in fact, it took longer."


At the time, under the 'GO·Fast Program' operated by the MFDS for COVID-19 treatment and vaccine development, the targeted review period for new compound clinical trials was within 15 days, and Genencell was also subject to this program.



In October 2021, Kim was found to have asked then-Commissioner Kim Ganglip of the MFDS, at the request of an old acquaintance, Yang, to give special attention to Genencell's clinical trial application. Two weeks later, the MFDS approved Genencell's clinical trial. Afterward, it was revealed that Genencell received clinical approval based on falsified reports, including the omission of adverse effects of the new drug. This development led to controversy over whether Kim was involved in improper lobbying.


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