[Edaily Reporter KIM SAE-MI ] Members of the People Power Party on the National Assembly’s Health and Welfare Committee visited the Ministry of Food and Drug Safety (MFDS) in Osong, North Chungcheong Province, at around 3:30 p.m. on the 21st to demand the submission of documents related to the approval process for Genencell’s Investigational New Drug (IND) application for its COVID-19 treatment. In particular, the lawmakers protested that approximately two weeks had passed since they requested the documents related to Genencell, yet they had not received a response from the MFDS.

The lawmakers who visited the Ministry of Food and Drug Safety that day included Health and Welfare Committee Chairman Lee Man-hee, People Power Party Secretary Baek Jong-heon, and members Kim Ki-woong, Lee Dal-hee, Lee So-hee, Jo Bae-sook, Choi Bo-yoon, and Han Ji-ah—a total of eight. This marks the first time since the Ministry’s establishment that members of the National Assembly have made a direct protest visit to the Ministry’s headquarters in Osong, North Chungcheong Province, regarding a specific issue.

On September 23, 2021, GenenCell filed an Investigational New Drug (IND) application for Phase 2/3 clinical trials of “ES16001,” a candidate COVID-19 treatment. On the 30th of that month, the MFDS requested supplementary information on 14 items, and GenenCell Co., Ltd. submitted the supplementary materials on October 18. Subsequently, without any further requests for additional information, the IND was approved on the 26th of the same month.

During this process, it came to light that Kim Seung-won, the former nominee for Minister of Justice, had submitted a petition to Kim Kang-rip, then Commissioner of the Ministry of Food and Drug Safety, on October 12—during the period when additional information was being requested—asking him to expedite the review of GenenCell’s application. This revelation sparked controversy over the appropriateness of the approval process.

In a public statement that day, Rep. Jo Bae-sook of the People Power Party said, “The Commissioner must be well aware of why we have come to this point,” adding, “Problems with the MFDS’s clinical approval of ENCell Co., Ltd. were revealed during the confirmation hearing for nominee Kim Seung-won.”

Rep. Cho specifically pointed out that the Ministry of Food and Drug Safety (MFDS) has been delaying the submission of documents. She remarked, “I have repeatedly requested documents from the MFDS and asked what the 14 items requiring supplementation are, but there has still been no response,” noting, “It’s already been about two weeks.” She continued, “I mentioned this at the last standing committee meeting as well; they said they would submit them then, but there has been no response. What is going on?”

He continued, “The reason we are here today is that the public is outraged over this matter, and we must get to the bottom of it,” and demanded, “Please respond in good faith to our requests for information and submit the necessary documents.”

Rep. Cho also took issue with the process by which former nominee Kim’s communication was relayed within the Ministry of Food and Drug Safety (MFDS). According to previously disclosed documents, former Commissioner Kim’s office—having received the communication from former nominee Kim—conveyed the relevant details to the section chief in charge, who then instructed an administrative officer to report on the progress of the GenenCell review.

Referring to the text message sent at the time, Rep. Cho asked, “What would the person in charge do upon receiving a text like this?” He pointed out, “This is not a matter where the MFDS can simply say, ‘We approved it through proper procedures.’”

Rep. Cho criticized the fact that GenenCell’s IND approval was subsequently used as a catalyst for stock price manipulation involving SEJONG MEDICAL Co.Ltd.,(258830). He stated, “Once clinical approval was granted, it became positive news for stock price manipulation, causing the stock price of SEJONG MEDICAL Co.Ltd., which had acquired GenenCell, to skyrocket, and speculators reaped enormous profits,” adding, “Subsequently, as the stock price fell, many victims emerged,” and emphasized the need for a thorough investigation into the IND approval process.

During the public hearing that day, the question of whether former nominee Kim’s communications were actually relayed to the IND reviewers also emerged as a key issue.

Choi Bo-yoon, a lawmaker from the People Power Party, pointed out, “We need to verify whether the content of the contact or request made by then-lawmaker Kim Seung-won was actually conveyed to the reviewer of the COVID-19 treatment.”

While it has been confirmed that former nominee Kim’s communication was relayed within the Ministry of Food and Drug Safety (MFDS) and that ENCell Co., Ltd.’s review status was reported, it remains unconfirmed whether the reviewer actually in charge of the IND review was aware of this communication.

The process by which GenenCell’s application was approved without requiring further revisions after the company submitted supplementary materials has also come under scrutiny. Rep. Choi stated, “We must clarify why the application was approved without any additional requests for revisions after the supplementary materials were submitted on October 18,” adding, “It must also be clarified whether the decision to approve the application was effectively finalized at the advisory meeting on October 22, and what additional reviews took place between then and the final approval on the 26th.”

ENCell Co., Ltd.’s IND review was finally approved on October 26, following the submission of supplementary materials on October 18 and an expert advisory meeting on October 22. However, it remains unclear what additional reviews and assessments took place during the four days between the advisory meeting and the final approval.

Rep. Choi argued that the Ministry of Food and Drug Safety (MFDS) must also disclose the specific duties of the employees under investigation in the Genencell case at the time, as well as the impact their appearances before investigative authorities had on the review of COVID-19 treatments. He emphasized, “It must be clarified whether the urgent review of COVID-19 treatments was disrupted due to these employees’ appearances before investigative authorities, and what administrative and national losses the MFDS has identified.”

MFDS Commissioner Oh Yu-kyung replied, “We tried to cooperate with the submission of materials as quickly as possible, but it ended up requiring the lawmakers to visit in person,” adding, “We will carefully consider the opinions the lawmakers share today and cooperate as faithfully as possible.”

After concluding their public remarks, lawmakers from the People Power Party are currently holding a closed-door meeting with MFDS Commissioner Oh Yu-kyung and others. They plan to subsequently visit the department responsible for GenenCell’s IND application to hear an explanation regarding the approval process at that time.