Kwangjang Wins First Trial in Lawsuit Over Cancellation of "JointStem" Product Rejection Order

Regulatory Predictability and Institutional Trust Expected

Kwangjang Law Firm announced on July 10 that it had secured a first-instance victory while representing RNL Bio Stem Cell Research Institute (formerly known as RNL BIO) in an administrative lawsuit against the Ministry of Food and Drug Safety (MFDS) regarding the cancellation of the rejection order for the stem cell therapy “JointStem.”

Kwangjang Law Firm

According to the legal community, the Seoul Administrative Court recently ruled in the first trial that the rejection of the product approval for JointStem was unlawful and should be revoked.

The case began when RNL Bio Stem Cell Research Institute, after 16 years of development since 2005, applied for product approval for “JointStem”—a stem cell therapy for degenerative knee osteoarthritis whose clinical efficacy had been objectively proven. Regulatory authorities rejected the application, applying unreasonable criteria, prompting RNL Bio Stem Cell Research Institute to file an administrative lawsuit to overturn the MFDS’s rejection order.

Kwangjang Law Firm incorporated advanced scientific and statistical issues—such as clinical trial design related to clinical statistics and biopharmaceutical approval criteria, statistical analysis plans (SAP), hypothesis testing for primary and secondary endpoints, interpretation of efficacy and safety indicators, and the concepts of statistical and clinical significance—within the legal argumentation concerning the unlawfulness of the rejection. The firm comprehensively analyzed the validity of the clinical trial design, the appropriateness of the patient group selection, the rationality of the statistical testing methods, and the interpretability of long-term follow-up data, all in relation to the MFDS’s concerns over clinical efficacy, and challenged whether the MFDS’s decision was reasonable based on the trial results and approval review standards.

This case is regarded as not just an ordinary administrative lawsuit over product approval rejection, but also as a precedent for evaluating the rationality, predictability, and international alignment of domestic approval review standards for stem cell therapies and advanced biopharmaceuticals. In fields like advanced biopharmaceuticals, where scientific and technological complexity is high, the expertise of regulatory authorities should be respected. However, such judgments must also be based on ▲ objective clinical data ▲ pre-established clinical trial designs and statistical analysis principles ▲ consistent approval review standards, among others. Therefore, this ruling is expected to provide significant implications for future regulatory and approval practices involving new drugs, cell therapies, and medicines in the field of regenerative medicine.

In particular, it is anticipated that this decision will enhance regulatory predictability and institutional trust for domestic pharmaceutical and biotech companies pursuing innovative therapies, thereby contributing to strengthening the global competitiveness of the K-bio industry.

This case was overseen by attorney Park Geumnang (31st Judicial Research and Training Institute), a pharmacist and co-leader of Kwangjang Law Firm’s Healthcare Group, who managed all legal issues related to biopharmaceutical approval and regulation. Attorney Kang Donghyuk (31st class), a former presiding judge at the Seoul Administrative Court, led the strategy by reconstructing challenging scientific and statistical issues to fit the legal framework for determining the unlawfulness of the decision. Attorney Hwang Seyeon (9th bar exam), also a pharmacist, and attorney Jeon Hyeongmi (10th bar exam), who majored in genetic engineering, contributed by analyzing clinical data and approval review standards based on their expertise in pharmacy, pharmaceuticals, biotechnology, clinical statistics, and intellectual property, and by structuring these points as arguments within the lawsuit.

This content was produced with the assistance of AI translation services.