Kim Seung-won, the nominee for Minister of Justice, is under investigation for allegedly soliciting approval for a COVID-19 treatment from the pharmaceutical company Genensel. It has also come to light that he inquired about a treatment from Bukwang Pharmaceutical.
According to documents released by Kim Tae-kyu of the People Power Party on September 10, Kim Seung-won, while serving as a member of the National Assembly, requested information from the Korea Food and Drug Administration (KFDA) on June 7, 2021, regarding the conditional approval process for Bukwang Pharmaceutical's 'Levovir,' which was being developed as a COVID-19 treatment.
Originally developed as an antiviral drug for hepatitis B, Bukwang's Levovir received approval for Phase 2 clinical trials amid the COVID-19 pandemic. However, the company ultimately abandoned the development in September of the same year after failing to demonstrate sufficient therapeutic efficacy during the trials. Kim Seung-won made his inquiry while Bukwang was actively pursuing the treatment's development.
Kim Seung-won continued to request information related to pharmaceuticals. Two months later, on August 17, 2021, he again contacted the KFDA for detailed information on the approval status, usage, and application methods of COVID-19 antibody treatments that were in use by the government at the time.
Notably, an examination of the 35 requests made by Kim Seung-won to the KFDA from 2020 to this year revealed that inquiries related to pharmaceuticals were concentrated in 2021. Outside of that year, his major requests primarily concerned issues unrelated to drug approvals, such as health and safety enforcement statistics and operational status of government vehicles.
In October of the same year, Kim Seung-won contacted then-KFDA Commissioner Kim Kang-rip at the request of broker Yang Mo, asking for expedited processing of Genensel's clinical trial approval for its COVID-19 treatment.
Genensel submitted its application for Phase 2/3 trials on September 23, and Kim Seung-won reached out on October 12, during the KFDA's request for additional information. Following his contact, the KFDA quickly moved forward with the review process, instructing relevant officials to report on the progress. Genensel received final approval on October 26. The former commissioner reportedly stated during a prosecution investigation that it was unusual for a member of the National Assembly to specifically mention a particular company.
There are differing interpretations regarding the approval timeline for Genensel. According to the KFDA's official standards (excluding the time for the company to provide additional information), the processing time was 11 days, which is similar to the overall average of 10.8 days at that time. However, when including the entire calendar days from submission to approval, Genensel's process took 33 days, significantly shorter than the average of 60 days.
Kim Tae-kyu, who raised the allegations, stated, "If Kim Seung-won contacted the KFDA commissioner while the review was ongoing and approval followed shortly after, it raises suspicions. The bigger issue is that his interest was not limited to Genensel; he must clarify the background of his requests for approval processes and statuses of other COVID-19 treatments under his office's name."
However, Kim Seung-won's team has previously issued a rebuttal regarding the allegations of favoritism toward Genensel.
The personnel preparation team stated in a press release on September 5, "After reviewing data indicating therapeutic efficacy from overseas Phase 2 clinical trials, we simply conveyed a complaint to the KFDA commissioner to ensure that the clinical trial procedures for domestic treatments were not unjustly delayed. We were unaware that the Genensel representative had omitted or manipulated some animal test data, and there is no evidence that we were involved in that."
Regarding the unusually rapid approval speed for the clinical trial plan, they added, "When considering only the actual data review period, it was not faster than average; in fact, it took longer."
* This article has been translated by AI.
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