Highlights

Korean MFDS grants IND approval for RC220 Phase 1 trial.

Approval enables trial activation at four clinical sites in South Korea.

Regulatory framework aligns with international standards used by the FDA and EMA.

Race Oncology Limited (ASX:RAC) saw its shares rise 8.33% to AUD 3.35 on 24 September 2025, following confirmation that the Republic of Korea Ministry of Food and Drug Safety (MFDS) has granted Investigational New Drug (IND) approval for RC220. The approval clears the way for a Phase 1 clinical trial evaluating RC220 in combination with doxorubicin in patients with solid tumours.

Regulatory Clearance in Korea

The IND approval from the Korean MFDS followed a comprehensive review of RC220’s chemistry, manufacturing, and controls (CMC), nonclinical pharmacology and toxicology data, and the proposed clinical trial protocol. The dossier package also included detailed specifications for the active pharmaceutical ingredient (API) and drug product, ensuring compliance with international standards.

This clearance allows Race to activate clinical trial sites in South Korea, with three already approved by Institutional Review Boards (IRB): Samsung Medical Center, Asan Medical Center, and Ewha Woman’s University Medical Center. A fourth site, Severance Hospital, is expected to receive IRB approval within the next month.

Global Regulatory Comparisons

The MFDS approval process mirrors the rigorous standards set by global regulators such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). All three agencies adhere to the guidelines of the International Conference of Harmonisation (ICH).

While dossier structures may vary slightly, the scope and level of detail required are consistent across regulators. For instance, all require Good Laboratory Practice (GLP)-compliant nonclinical safety studies and Good Manufacturing Practice (GMP)-compliant CMC data. The Korean MFDS, however, mandates full validation of the CMC package even for early-phase trials, compared to more flexible requirements sometimes permitted by the FDA.

Implications for Future Approvals

Although Korean IND approval demonstrates that RC220 has met high regulatory standards, it does not guarantee automatic approval by the FDA or EMA. Each regulator may request minor dossier adjustments before clearance. Nonetheless, these adjustments are generally procedural and do not compromise the likelihood of ultimate approval.

The Korean clearance follows regulatory approvals already obtained in Australia (March 2025) and Hong Kong (September 2025), underlining the steady progress of RC220’s clinical development program across multiple jurisdictions.

Next Steps

With IND approval secured in Korea, Race Oncology is set to begin patient recruitment for the Phase 1 study once the final clinical site receives IRB clearance. The trial will assess the safety, tolerability, and pharmacokinetics of RC220 in combination with doxorubicin, with initial enrolments expected in the coming months.

This milestone marks another step in advancing RC220’s global development strategy, as the company prepares to generate early clinical data that will inform subsequent trial phases.