Pharmaceutical 3rd Week Of Oct 2025

 Overview of Approvals (3rd Week of Oct 2025)

In the third week of October 2025, the Ministry of Food and Drug Safety (MFDS) approved 14 major clinical trial applications for new drug candidates in Korea. These MFDS IND approvals span a broad range of therapeutic areas – including oncology, immune-mediated diseases, and rare diseases – indicating robust R&D activity by both domestic and global pharmaceutical companies. The approved trials range from early-phase first-in-human studies of novel drug candidates to late-phase multinational trials led by global pharma, reflecting a well-balanced pipeline. This diverse portfolio underscores Korea’s strengthened status as a global clinical trial hub, where an efficient regulatory environment and advanced medical infrastructure accelerate drug development. Such trends provide valuable insights for shaping global clinical strategy and navigating the MFDS regulatory approval process for sponsors aiming to conduct trials in Korea.

Highlights of Key Approved Trials

1. Acceleration of Oncology Trials Globally

Oncology remains a focal point, with multiple cancer trials receiving approval, showcasing collaboration between global initiatives and local expertise.

• ST Cube – Initiated a Phase II trial evaluating the safety and efficacy of Nelmastobart in combination with docetaxel for patients with advanced or metastatic non-small cell lung cancer (NSCLC). This trial targets NSCLC patients who have shown resistance or intolerance to platinum-based chemotherapy and/or immunotherapy, aiming to validate an innovative therapeutic approach for treatment-refractory lung cancer.
• Parexel Korea – Revumenib (a menin inhibitor) entered a Phase III trial (REVEAL-ND NPM1) in patients with NPM1-mutated acute myeloid leukemia, in combination with intensive chemotherapy. Conducted by a global CRO, this randomized, double-blind study in Korea is part of a multinational effort to improve outcomes in genetically defined AML subgroups.
• ICON Clinical Research Korea – Launched a Phase III trial to evaluate the efficacy of a novel biologic (RO7790121) for Crohn’s disease. This study is assessing the induction and maintenance therapy effects of RO7790121 in patients with moderate-to-severe Crohn’s, representing a collaboration that brings cutting-edge global IBD research to Korean sites.
• Pharmaceutical Research Associates (PRA) Korea – Conducting a Phase II/III trial of XL092 (zanzalintinib) in patients with unresectable, locally advanced or metastatic neuroendocrine tumors. This trial compares the efficacy of the novel MET inhibitor zanzalintinib versus everolimus in previously treated NET patients, potentially offering a new targeted therapy option for this rare cancer type.

2. Expansion of Autoimmune & Dermatology Studies

Significant approvals were granted in the fields of immunology and dermatology, reflecting active development of therapies for autoimmune and skin diseases.

• Pfizer Korea – Received approval for two notable trials. First, a Phase 2b trial of Ritlecitinib (PF-06651600) in adults with chronic spontaneous urticaria uncontrolled by standard antihistamines is underway, aiming to evaluate this JAK inhibitor’s efficacy in refractory hives. Concurrently, Pfizer is running a Phase III trial of a PF-07248144 series compound (combined with fulvestrant) in patients with hormone receptor-positive, HER2-negative advanced breast cancer who progressed on CDK4/6 inhibitors. These parallel studies illustrate Pfizer’s broad commitment to developing innovative treatments in both immunology and oncology in the Korean market.
• Yuhan Corporation – Initiated a Phase II trial for its novel drug YH35324 (Lesigercept) in patients with chronic spontaneous urticaria not adequately controlled by H₁-antihistamines. As a leading domestic pharmaceutical company, Yuhan’s progress in this trial highlights the contribution of Korean pharma to addressing unmet needs in difficult-to-treat dermatological conditions.
• Janssen Korea – Expanded its portfolio with two key trials in immune-mediated conditions. The company is conducting a Phase III basket trial of Guselkumab (CNTO 1959) across multiple pediatric populations, including Crohn’s disease, ulcerative colitis, and juvenile psoriatic arthritis, to assess long-term safety in chronic inflammatory diseases. In parallel, Janssen initiated a Phase I trial of JNJ-95437446 in patients with advanced solid tumors (an immuno-oncology agent), demonstrating the company’s ongoing investment in early-phase oncology research in Korea.

3. More Early-Phase Trials by Domestic Pharma

There is a clear uptick in early-stage clinical trials sponsored by domestic Korean pharmaceutical companies, indicating their growing pipeline of innovative drug candidates.

• DongKook Pharmaceutical – Launched a Phase I trial comparing the pharmacokinetics of two formulations, DKF-460 and DKF-460R, in healthy volunteers. This open-label, randomized, crossover study will gather safety and PK data, providing critical insight into the optimized formulation for their new compound and marking DongKook’s entry into first-in-human testing for this candidate.
• Vastera Inc. – Received approval for a Phase I trial of its novel compound VTB-10. This randomized, double-blind, placebo-controlled single and multiple ascending dose study in healthy adults will evaluate the safety, tolerability, and pharmacokinetics of VTB-10. The initiation of this trial exemplifies a smaller Korean biotech moving its lead candidate into human testing, expanding the domestic early-phase landscape.
• Daewon Pharm – Initiated a Phase III trial for DW4421, an investigational treatment for erosive gastroesophageal reflux disease (GERD). This multicenter, double-blind, active-controlled study will assess the efficacy and safety of DW4421 in relieving GERD symptoms. As a locally developed therapy reaching late-stage trials, this underscores Daewon’s efforts to enhance competitiveness in the gastrointestinal therapeutics market.

4. Rise in Investigator-Initiated and Hospital-Based Trials

Korea’s major hospitals and academic medical centers continue to drive investigator-initiated trials (IITs) and clinical research, contributing to medical innovation and supporting the development of clinical evidence outside of industry-sponsored studies.

• Korea University Medical Center – Conducting a physician-led Phase II trial of Fruzaqla (HMPL-013) in patients with metastatic colorectal cancer who failed standard chemotherapy. This single-arm investigator-initiated study combines Fruquintinib with best supportive care to explore efficacy and safety in a heavily pretreated population, potentially guiding future use of this targeted therapy.
• Seoul National University Hospital – Running a prospective randomized controlled trial to evaluate the efficacy of ultrasound-guided oblique subcostal transverse abdominis plane (OSTAP) blocks in children undergoing laparoscopic gastrostomy. This hospital-driven research aims to improve perioperative pain management and outcomes in pediatric surgical patients, reflecting how academic centers are innovating in clinical practice through research.