January 2026: A Deep Dive into Last Year‘s Novel Antibody Drugs

In 2025, 21 novel monoclonal antibody (mAb) drugs were approved for the first time worldwide. These approvals represent an expansion of both antibody modality and therapeutic focus, with developments in bispecifics, ADCs, long-acting formulations, and first-in-class mechanisms. The approvals span a diverse range of indications from oncology to rare diseases, and reflect increasing global participation in antibody drug development, particularly from China.

Summary of 2025 First-Time mAb Approvals

Data from Biointron Industry Reports

Target Selection: Focus on Inflammatory and Immune Dysregulation Pathways

A major shift in the 2025 approval landscape is the dominance of targets involved in immune regulation, rather than tumor-associated antigens. Notably, over a third of the newly approved antibodies act on soluble immune mediators, including interleukins, complement factors, and antibody receptors. Key examples:

• Cytokines: Depemokimab targets IL-5 for type 2 inflammation in asthma. Firsekibart inhibits IL-1β in gout. Picankibart and Ebdarokimab block IL-23p19 and IL-12/23, respectively, in psoriasis. Sibeprenlimab targets APRIL to reduce IgA nephropathy-related proteinuria.

• Complement and coagulation regulators: Narsoplimab (MASP-2) for transplant-associated TMA. Vilobelimab (C5a) for COVID-19-induced ARDS.Garadacimab (FXIIa) for hereditary angioedema.

• Immunoglobulin regulation: Nipocalimab blocks FcRn to reduce pathogenic IgG recycling in myasthenia gravis.

While these targets are often soluble, they do not inherently require non-standard antibody formats. Most are IgG1 or IgG4 subclasses, with Fc function retained or modified based on the mechanism of action. For example, Nipocalimab and Garadacimab incorporate Fc engineering to alter FcRn or complement activity. Others, like Depemokimab and Firsekibart, function via standard IgG formats optimized for pharmacokinetics and neutralization.

Therapeutic Area Distribution: Oncology No Longer Dominates

2025 marks a notable reduction in oncology’s dominance in the new approvals for mAbs. Only 7 of the 21 approvals were for cancer therapy, while the majority were for autoimmune, inflammatory, or infectious diseases.  Oncology Approvals:

• Suvemcitug (VEGF) for ovarian/peritoneal cancer

• Finotonlimab (PD-1) for head and neck SCC

• Linvoseltamab (CD3 x BCMA bispecific) for multiple myeloma

• Telisotuzumab Vedotin (c-Met ADC) for NSCLC

• Becotatug Vedotin (EGFR ADC) for nasopharyngeal carcinoma

• Trastuzumab Botidotin (HER2 ADC) for breast cancer

• Trastuzumab Rezetecan (HER2 ADC) was approved for autoimmune IL-17–related diseases, not cancer

By contrast, 8 approvals addressed autoimmune or inflammatory diseases, and 3 were indicated for infectious disease prophylaxis. This reflects mAbs’ growing success in modulating chronic immune activity with high precision and durability.

Geographic Distribution of First Approvals

More than half of novel mAb approvals (11 of 21) were first granted by China’s NMPA. The United States had 5, Europe (EU/UK) had 4, and Australia had 1. The diversity of modalities approved in China is notable:

• ADCs: Trastuzumab Botidotin, Becotatug Vedotin, Trastuzumab Rezetecan

• Cytokine blockers: Firsekibart, Ebdarokimab, Picankibart

• Checkpoint inhibitors: Finotonlimab (PD-1)

This trend reflects both local innovation and increasingly efficient clinical and regulatory infrastructure. It also suggests that China may serve as a viable first-launch market for certain biologics, including complex formats.

Modality Trends: Long-Acting Formulations and Prophylactic Antibodies

Several 2025 approvals reflect the advancement of long-acting mAbs and their use in preventive medicine, particularly for viral infections and chronic inflammatory conditions.

Long-Acting or Prophylactic mAbs:

1. Depemokimab (IL-5 inhibitor) is formulated for ultra-long-acting administration.

2. Sipavibart and Clesrovimab were approved for COVID-19 and RSV prophylaxis, respectively, in vulnerable populations.

3. Siltartoxatug is used for emergency tetanus prophylaxis.

These agents rely on engineered Fc domains to extend half-life via enhanced FcRn binding or structural stabilization. The dosing intervals for some exceed six months. The antibody therapeutics approved in 2025 reflect a maturing field that is expanding in scope, geography, and scientific advancements.