| Company Name | Component Name | Clinical Trial Title | Clinical Trial Phase | Development Region | Approval Date |
| BMS Korea Co., Ltd. | Arlocabtagene autoleucel | A Phase 3, Randomized, Open-Label, Multicenter Trial (QUINTESSENTIAL-2) Comparing the Efficacy and Safety of the GPRC5D-Targeted CAR-T Cell Therapy Arlocabtagene Autoleucel (BMS-986393) Versus Standard Therapy in Adult Patients with Relapsed or Refractory Multiple Myeloma Exposed to Lenalidomide | Phase 3 | Overseas | 2025-10-02 |
| Pfizer Korea Co., Ltd. | PF-06821497 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (MEVPRO-3) of Mevrometostat (PF-06821497) in Combination with Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer | Phase 3 | Overseas | 2025-10-02 |
| Genewon Science Co., Ltd. | GNS-24M24-1 | An Open-Label, Randomized, Two-Arm, Two-Period, Fasting, Single-Dose, Oral Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety of '24M24-T' Versus '24M24-R' in Healthy Adult Volunteers | Phase 1 | Domestic | 2025-10-02 |
| Fortrea Korea Co., Ltd. | Nabenibat | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (ALPHA-ORBIT) to Evaluate the Efficacy and Safety of Nabenibat in Subjects with Hereditary Angioedema | Phase 3 | Overseas | 2025-10-02 |
| Novo Nordisk Korea Co., Ltd. | Coramitug (NNC6019-0001) | CLEOPATTRA: A Clinical Trial to Evaluate the Impact of NNC6019-0001 Versus Placebo on Cardiovascular Outcomes in Subjects with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) | Phase 3 | Overseas | 2025-10-02 |
| PPD Development Pte Ltd | Mezagitamab | A Phase 3, Open-Label, Multicenter Extension Clinical Trial to Evaluate the Long-Term Safety and Efficacy of Subcutaneous Mezagitamab in Adults with Chronic Primary Immune Thrombocytopenia | Phase 3 | Overseas | 2025-10-02 |
| Novartis Korea Co., Ltd. | DZR123, Darolutamide, Abiraterone | TulmiSTAR-02: A Two-Part Phase 1 Dose-Escalation Clinical Trial of Tulimetostat (DZR123) in Combination with Darolutamide or Abiraterone in Patients with Metastatic Hormone-Sensitive Prostate Cancer, Followed by a Phase 2 Dose-Expansion, Open-Label, Randomized Clinical Trial Evaluating the Safety and Efficacy of Tulimetostat + Darolutamide Versus Darolutamide Monotherapy | Phase 1/2 | Overseas | 2025-10-01 |
| Parexel Korea Co., Ltd. | REGN5459 | Substudy 1 of the Dose-Escalation Clinical Trial Investigating Dual-Specific Antibody Therapy in Lupus Nephritis Subjects: Bitentamig | Phase 1 | Overseas | 2025-09-30 |
| Daewon Pharm Co., Ltd. | DW4421 | A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Interactions Between DW4421 and Three Types of NSAIDs in Healthy Adult Volunteers | Phase 1 | Domestic | 2025-09-29 |
| BMS Korea Co., Ltd. | BMS-986504 | A Randomized Phase 2/3 Clinical Trial Comparing BMS-986504 in Combination with Pembrolizumab and Chemotherapy Versus Placebo + Pembrolizumab and Chemotherapy in Subjects with Metastatic Non-Small Cell Lung Cancer with Homozygous MTAP Deletion in the First-Line Setting | Phase 2/3 | Overseas | 2025-09-29 |
| PPD Development Pte Ltd | Inavolisib (GDC-0077, RO7113755) | A Phase 2, Randomized, Multicenter, Open-Label Clinical Trial to Evaluate the Efficacy and Safety of Inavolisib + Enzalutamide Combination Therapy Versus Physician's Choice of ARPI or Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer | Phase 2 | Overseas | 2025-09-29 |
| Boehringer Ingelheim Korea Co., Ltd. | BI 1810631 | Beamion LUNG-3: A Randomized, Controlled, Multicenter Clinical Trial Comparing Zongertinib as Monotherapy Adjuvant Therapy Versus Standard of Care in Patients with Early-Stage, Resectable Non-Small Cell Lung Cancer (Stage II–IIIB) with HER2 Tyrosine Kinase Domain Activating Mutations | Phase 3 | Overseas | 2025-09-29 |
| Onconic Therapeutics Inc. | JPI-547 | An Open-Label, Dose-Exploration and Dose-Expansion Phase 1b/2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of JPI-547, a PARP/TNKS Dual Inhibitor, in Combination with mFOLFIRINOX or Gemcitabine-nab-Paclitaxel (GemAbraxane) in Patients with Locally Advanced or Metastatic Pancreatic Cancer | Phase 1/2 | Domestic | 2025-09-29 |
