The March 2025 MFDS IND approvals provide a valuable snapshot of investigational new drug activity in South Korea. A total of 47 IND approvals were issued during the month; 33 approvals (about 70 %) were for overseas‑sponsored projects and 14 were for studies led by domestic developers. The dominance of overseas sponsors reflects global pharmaceutical companies’ trust in Korea’s rapid review system and high research quality, while the increase in domestic participation marks a positive shift.
The MFDS introduced its five‑stage IND review system in 2002; reviews typically conclude within 30 business days, helping make Korea the fourth‑largest clinical‑trial destination and the seventh‑largest host for phase‑I multinational trials in 2023. In 2025 the authorities continued to attract global sponsors by shortening average review times and enhancing dedicated review teams.
Approval phases and therapeutic areas
Phase III approvals were the most common in March (14 approvals, 29.8 %), followed by phase I (12 approvals) and phase II (10). There were six phase I/II approvals, two phase II/III and one each in phase 2b and phase 1/2a. Oncology accounted for roughly half of the approvals, but immune‑inflammatory diseases and rare disorders also saw increasing activity. Examples include adagrasib (MRTX849) combination studies targeting KRAS G12C‑mutated solid tumors, remibrutinib for myasthenia gravis, the antibody–drug conjugate U3‑1402 for triple‑negative or hormone‑receptor–positive/HER2‑negative breast cancer, and a CDK2 inhibitor (BG‑68501/BGB‑43395) for advanced solid tumors.
A vaccine trial using an RSV ΔNS2/Δ1313/I1314L virus strain evaluates safety and immunogenicity in infants, and a gene‑therapy project using detalimogene voraplasmid (EG‑70) seeks to stimulate immune responses in BCG‑unresponsive non‑muscle‑invasive bladder cancer. These examples show the breadth of modalities—targeted therapies, vaccines, antibody–drug conjugates, cell and gene therapies—being pursued in Korea.
Major sponsors and domestic vs. overseas trends
MSD Korea submitted the largest number of approvals (six), followed by AstraZeneca Korea (four). Gilead Sciences Korea recorded three approvals and Novartis Korea two. Other approvals came from Pfizer, Roche, AbbVie and PPD Korea, underscoring Korea’s role as a global clinical‑trial hub. Domestic companies such as Dongkook Pharmaceutical, Vastera Therapeutics and Daewoong Pharmaceutical were active in early‑stage studies, and investigator‑initiated trials from Korean hospitals appeared in the list.
Overseas projects accounted for about 70 % of approvals because sponsors take advantage of MFDS’s rapid review system and high‑quality infrastructure for late‑stage research. However, domestic approvals increased compared with the previous month, including cell‑ and gene‑therapy projects, antibody treatments and studies that expand indications of existing drugs, indicating that Korean companies are moving beyond discovery into later development stages.
Changing regulatory environment and the 2025 overhaul
To address complaints about lengthy review times, the MFDS is implementing a comprehensive overhaul to reduce average drug approval times from 420 days to about 295 days. The new framework introduced in January 2025 assigns a dedicated review team to each application, increases the number of formal consultations from three to ten, mandates written records of all meetings and requires manufacturing‑site evaluations to be completed within 90 days. Programs such as GILJABI and GIFT provide tailored regulatory support to developers, while new legislation on regenerative medicine establishes a pathway for cell and gene therapies. Fee restructuring, tiered pricing for early‑stage sponsors and simplified GMP certification are also attracting domestic and foreign interest.
Global perspective and implications for Korean firms
Viewed globally, the March approvals underscore Korea’s status as a hub for multinational phase‑III studies across oncology, infectious diseases, rare disorders and immune‑mediated conditions. Sponsors choose Korea not only for its speed and quality but also for experienced physicians, rapid patient recruitment and competitive costs. For Korean pharmaceutical and biotech firms, this environment represents both opportunity and challenge. They must generate data that meet global standards and form partnerships to advance pipelines from early discovery into later stages.
Companies with next‑generation platforms—such as cell and gene therapies or mRNA vaccines—should leverage the new regenerative‑medicine law and tailored support programs to accelerate development. Collaborations with global partners can provide capital and know‑how, while investigator‑initiated trials at Korean hospitals can generate real‑world evidence.
Detailed analysis of notable approvals
Several March approvals point to upcoming therapeutic innovations. A study of adagrasib (MRTX849) combined with docetaxel for KRAS‑mutated non‑small‑cell lung cancer signals the formal launch of KRAS‑targeted research in Korea. The RSV ΔNS2/Δ1313/I1314L vaccine trial in infants may open the door to preventing respiratory syncytial virus. Remibrutinib’s clinical trial for myasthenia gravis offers a potential therapy for a rare autoimmune condition.
The antibody–drug conjugate U3‑1402 focuses on high‑risk early‑stage breast cancer, and the selective CDK2 inhibitor BG‑68501/BGB‑43395 explores CDK2 inhibition across solid tumors. The gene‑therapy project EG‑70 (detalimogene voraplasmid) aims to trigger immune responses in non‑muscle‑invasive bladder cancer that has failed BCG therapy. Together, these projects illustrate the diversity of modalities and the pursuit of innovation in the Korean clinical‑trial landscape.
March 2025 approvals show that Korea maintains its position as a global research hub with a balanced portfolio across therapeutic areas and clinical stages. The prominence of late‑stage studies, the expansion of early research by domestic firms and regulatory reforms that accelerate reviews offer important insights for pharmaceutical and biotech professionals planning trials in Korea. Our company provides tailored quotations for MFDS IND submission strategies and clinical‑trial design, and we share the latest regulatory updates and clinical opportunities through our newsletter. If you would like to discuss your research plans or request a quotation, please use the button below, and subscribe to our newsletter to stay informed.
