Kim Seung-won’s drug approval inquiry reached working-level officials, fueling lobbying allegations

The allegations surrounding Justice Minister nominee Kim Seung-won’s request for approval of a new-drug clinical trial have moved beyond a ministerial office and into the working ranks of South Korea’s Food and Drug Safety Ministry. A recording and text messages have prompted claims that the request amounted to successful lobbying, while separate allegations tie the approval to a stock transaction.

Independent lawmaker Han Dong-hoon released a recording on the 6th of a phone call between Kim and businessman Yang, who reportedly acted as a broker for Kang, the largest shareholder of Genencell. Genencell had applied for approval of a clinical trial for a COVID-19 treatment. In the recording, Kim says he had spoken to the head of the Food and Drug Safety Ministry and was waiting for a report. When Yang says the request was not getting past the department-chief level, Kim responds, “It’s blocked at the department-chief level? I understand.”

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It’s blocked at the department-chief level? I understand.

Han also released a text message sent by an aide to then-minister Kim Gang-lip to the ministry’s clinical-policy department chief. The message says, “Chief, lawmaker Kim Seung-won sent a separate text. The minister said he would look into it, but asked that they make sure this kind of issue does not come up from that side again.” Han argues that the recording and message show a successful lobbying effort.

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Buy up that one, Sejong Medical. It’ll rise soon.

The dispute is linked to a deal being discussed by Kang and Sejong Medical. Genencell applied for clinical-trial approval on September 23, 2021, but the ministry requested supplements on 14 points. On October 8, Kang told Yang that approval around October 20 would accompany a 5.7 billion won sale of existing shares and a 5 billion won new-share investment with a call option. On October 19, Sejong Medical bought 6.29 billion won worth of Kang’s shares and invested 5 billion won in Genencell through convertible bonds. The next day, Kang texted Yang, “Buy up that one, Sejong Medical. It’ll rise soon,” and sent him 100 million won to purchase its shares.

The ministry approved Genencell’s trial plan on October 26. Sejong Medical’s stock rose as much as 15% the next day before falling to the daily limit down. The article says the circumstances raised suspicion that existing investors had sold shares to retail investors drawn in by favorable news. Genencell later was found to have falsified the clinical trial, and its drug development failed. Kang was convicted in December 2024 of using undisclosed material information and obstructing official duties, receiving a three-year prison sentence suspended for five years.

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We merely relayed a civil complaint to the head of the Food and Drug Safety Ministry to prevent a loss of national wealth, and we did not know that the clinical trial had been falsified.

The central questions are whether Kim’s request constituted improper solicitation and whether he knew about the alleged trial falsification or use of undisclosed information. Prosecutors under the Yoon Suk Yeol administration previously concluded that lawmakers’ civil complaints fell under an exception to the anti-graft law, making charges difficult. Kim’s camp says he only relayed a grievance to the ministry chief to prevent a loss of national wealth and did not know the trial was false. It says claims of successful lobbying require proof that review standards changed or special treatment occurred, and calls the accusations a political attack that distorts a public-interest complaint by removing its broader context.

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To call it successful lobbying, they must first prove that the review standards changed or that preferential treatment occurred.