Approved by MFDS, Rejected by MOHW: Questions Rise Over Contradictory Official Decisions

[Anchor]

Genencell, the company that obtained clinical trial approval from the Ministry of Food and Drug Safety (MFDS) after filing petitions through then-candidate Kim Seung-won, applied for government-backed funding worth 32 billion won across five separate occasions. Although Genencell ultimately failed to secure the funds, reasons obtained by SBS show that the Ministry of Health and Welfare (MOHW) judged there was insufficient evidence of efficacy. This has sparked growing questions over how the MFDS approval was granted in the first place.

Reporter Son Hyeong-an has the details.

[Reporter]

Kang Se-chan, the founder of COVID-19 therapeutic developer Genencell, applied five times starting from December 6, 2021, for a government grant program operated by the Ministry of Health and Welfare that supported clinical trial costs for COVID-19 treatment developers.

This followed a request made through businessman Yang to then-Justice Minister nominee Kim Seung-won for a "fast-track process" regarding the MFDS clinical trial plan approval for the new drug, which was granted by the MFDS on October 26 of the same year—41 days prior.

The total amount of funding requested across the five applications reached 32 billion won.

This is the MOHW New Drug Development Project Group's statement of reasons for rejecting Genencell's application for clinical trial subsidies, obtained by SBS.

The first application was rejected on the grounds that "the rationale for the mechanism of action and non-clinical efficacy was insufficient." From the second application through the fifth application in September 2022, funding was repeatedly denied for reasons such as "weak evidence of efficacy in animal tests" and "no significant non-clinical efficacy data."

The MOHW's conclusion that Genencell's COVID-19 treatment had a "low likelihood of development" starkly contrasts with the decision made by the MFDS to approve the clinical trial plan.

Prosecutors concluded that Kang's funding applications were based on false reports and indicted him for attempted fraud in 2024. However, Kang told SBS in an interview:

[Kang Se-chan / Founder of Genencell: Is everyone who fails to win a state project because their data is lacking considered a fraudster? If so, wouldn't all professors in our country be fraudsters?]

However, the court of first instance found him guilty, stating that it was an attempted crime where he tried to obtain government funds using a "research and development plan that contained false information and omitted side effects," though the attempt ended in failure.

[Han Ji-ah / People Power Party Representative: The Ministry of Health and Welfare must provide a clear explanation as to why the MFDS reached a different conclusion on matters that the MOHW judged to lack therapeutic efficacy.]

Suspicion is mounting over what grounds the MFDS used to grant approval, given the starkly different assessment by the MOHW.

(Photo: Yonhap News)
(Video reporting: Kim Yong-woo, Seol Chi-hwan | Video editing: Seunghee | Design: Im Chan-hyuk | Data provided by the office of People Power Party Representative Han Ji-ah)
※ Please note: This article was translated by AI and may contain errors.