[Alpha Biz= Kim Jisun] Seoul, South Korea – August 25, 2025 – Nature Cell Co., Ltd. announced that it will initiate an administrative lawsuit against the Ministry of Food and Drug Safety (MFDS) following the agency’s rejection of marketing authorization for JointStem, an investigational stem cell therapy for degenerative osteoarthritis developed by its affiliate, Alteogen Bio (Albio).



On August 6, MFDS issued a formal notice denying the product’s approval under the Advanced Biopharmaceuticals Act. Nature Cell argues that despite meeting statistical significance in its Phase 3 clinical trial—after increasing the trial size more than tenfold in accordance with MFDS requirements—the agency introduced what the company claims is an “arbitrary standard” of clinical significance to justify rejection.



According to Nature Cell, the Phase 3 trial expanded from 24 patients to 260 patients at the MFDS’s request to secure sufficient reliability. The company maintains that under international standards, the proper assessment is based on whether the response rate—patients who report improvement after receiving JointStem compared to a control—shows statistical significance. By contrast, MFDS applied its own criteria, requiring additional proof of “clinical meaningfulness” that goes beyond statistical outcomes.



Nature Cell emphasized that this approach deviates from global regulatory practice, noting that JointStem has already been recognized by the U.S. Food and Drug Administration (FDA) with designations including:



Regenerative Medicine Advanced Therapy (RMAT)

Breakthrough Therapy (BT)

Expanded Access Program (EAP)



These designations were granted based on evidence showing sustained therapeutic effect for up to three years.



A Nature Cell spokesperson stated, “We have complied with all requirements and demonstrated statistically significant results. The MFDS decision not only undermines international standards but also delays access to an innovative treatment for millions of patients suffering from osteoarthritis.”



The lawsuit seeks to overturn MFDS’s rejection and to secure marketing approval for JointStem in Korea.

 

 

 

 

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