Introduction
The January 2025 MFDS IND approval status includes 31 investigational drugs authorized for clinical trials. This report targets domestic and international professionals in the pharmaceutical and biotechnology sectors, focusing on antibody‑drug conjugates (ADCs), cell therapies, autoimmune diseases and clinical trial trends. ADCs link a monoclonal antibody to a cytotoxic payload via a chemical linker, enabling precise delivery to tumor cells while minimizing off‑target toxicity, and their scope has expanded beyond oncology to autoimmune conditions.
Oncology: Targeted and Cellular Therapies
A majority of approvals were oncology‑focused. Novel ADCs such as BG‑C137 targeting FGFR2b and BGB‑58067 targeting PRMT5, a gene‑therapy vector RX001 for KRAS‑mutated lung cancer and the DLL3‑targeted bispecific T‑cell engager tarlatamab entered early‑phase trials. These ADCs exploit sophisticated linkers and payloads, enabling intracellular or bystander release of cytotoxic agents to selectively attack cancer cells.
Cell therapies also gained traction. Lifileucel (LN‑144), an autologous tumor‑infiltrating lymphocyte (TIL) therapy combined with pembrolizumab, entered a Phase 3 trial for unresectable or metastatic melanoma. The U.S. National Cancer Institute notes that lifileucel is the first TIL‑based treatment approved for a solid tumor; it uses a patient’s own T cells harvested from their tumor, expanded to billions of cells and reinfused, achieving responses in about one‑third of patients with some complete responses. Other cell‑therapy and antibody programs include AbbVie’s ABBV‑319 and Novartis’s VHB937.
Neurological and Rare Diseases
The list features several candidates for neurological and psychiatric conditions. Remternetug (LY3372993) and MK‑1167 are monoclonal antibodies targeting early Alzheimer’s disease, while KarXT aims to treat psychosis associated with Alzheimer’s with fewer adverse effects than conventional antipsychotics. VHB937 is being developed for amyotrophic lateral sclerosis (ALS). Rare diseases are represented by GC1134A for Fabry disease and Belumosudil (SAR445761) for chronic lung allograft dysfunction after bilateral lung transplant.
Autoimmune and Inflammatory Diseases
Immunomodulatory agents include SAR444656 for moderate‑to‑severe atopic dermatitis and hidradenitis suppurativa, Nipocalimab for Sjögren’s disease, and SAR441566 for Crohn’s disease. These drugs work by inhibiting inflammatory cytokine pathways or reducing recycling of autoantibodies. JW0108 + C2407 combination therapy for dyslipidemia and other metabolic disorders overlaps immunologic and metabolic pathways.
Cardiovascular, Metabolic and Renal Diseases
Baxdrostat combined with dapagliflozin aims to improve renal outcomes and reduce cardiovascular mortality in patients with chronic kidney disease and hypertension. Other novel agents target hyperlipidemia, aldosterone synthesis and vascular signaling. These trials reflect the growing need for therapies that manage comorbid metabolic and renal diseases.
Vaccines and Infectious Diseases
Sanofi’s 21‑valent pneumococcal conjugate vaccine (PCV21) moved into a Phase 3 study assessing immunogenicity and safety in infants. Antiviral therapy remains a priority: a Phase 3 trial evaluating Molnupiravir (MK‑4482) continues in non‑hospitalized adults at high risk of COVID‑19 progression. Such programs underscore preparedness for infectious threats.
Other Trends
Early pharmacokinetic and drug‑interaction studies, such as those involving Tecfidera with aspirin and SB17170 with midazolam, form the foundation for dosing strategies. Complex platform trials combine radiation and immunotherapy or integrate PD‑1 blockade with T‑cell engagers. Roughly half of approvals are early‑phase studies, reflecting expansion of the pipeline, and domestic institutions and biotech firms are active participants.
Conclusions and Outlook
The January 2025 MFDS IND approvals signal expansion of ADCs and cell therapies, innovative approaches for rare and neurological diseases and diversification of immunomodulators and metabolic agents. ADCs leverage targeted delivery and various release mechanisms to attack tumors while sparing healthy tissue. The NCI describes lifileucel as the first TIL therapy approved for a solid tumor, with significant tumor responses and durable disease control in melanoma patients, heralding broader applications of cellular therapies. Additional monoclonal antibodies, vaccines and antiviral agents broaden patient options and enhance public health preparedness. Growing participation of Korean institutions in multinational trials underscores the nation’s rising biomedical capabilities.
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