21 July 2026

What Q2 2026 reveals about the direction of antibody therapeutics

From first-in-class approvals to billion-dollar deals, Q2 2026 signals a new era for antibody innovation


Jovena Sulistyo Marketing Manager, Biointron

Jovena Sulistyo
Marketing Manager, Biointron

The second quarter of 2026 involved six antibody drugs that received first approvals: four in China and two in the United States.

The modalities ranged from antibody-drug conjugates (ADCs), bispecific antibodies, monoclonal antibodies, infectious disease antibodies and rare disease programs:

Drug

Date

Region

Modality / target

Indication

Pivekimab sunirine-pvzy / Decnupaz

27 May

US

CD123-directed ADC

Blastic plasmacytoid dendritic cell neoplasm

Anbenitamab / 恩尼妥

29 May 

China

HER2 bispecific antibody

HER2-positive gastric / gastroesophageal junction cancer after trastuzumab-containing therapy

Gumokimab

11 June 

China

Anti-IL-17A monoclonal antibody

Moderate-to-severe plaque psoriasis

Silevimig

22 June 

China

Fully human bispecific antibody targeting rabies virus glycoprotein

Passive immunisation after rabies exposure

Iza-bren / izalontamab brengitecan

22 June

China

EGFR × HER3 bispecific ADC

Recurrent or metastatic nasopharyngeal carcinoma after platinum chemotherapy and PD-1/PD-L1 therapy

Veligrotug-vvze / Lumvoa

26 June

US

IGF-1R monoclonal antibody

Thyroid eye disease

The approvals show how far antibody formats have diversified. For example, silevimig is a fully human bispecific antibody approved in China for rabies post-exposure passive immunisation, highlighting bispecific development beyond oncology. Meanwhile, iza-bren is especially notable as the first bispecific ADC to receive regulatory approval globally, combining dual-target binding with targeted payload delivery to potentially improve tumor selectivity, internalisation and therapeutic potency compared with conventional single-target ADCs.

Deals: assets, platforms and infrastructure

Business development was also active this quarter, with the largest antibody-related transactions combining clinical assets, discovery platforms and research infrastructure.

Date

Companies

Potential value

Focus

12 May 

Bristol Myers Squibb / Hengrui Pharma

Up to $15.2 bilion

13 oncology, hematology and immunology programs

28 May 

Pfizer / Innovent Biologics

Up to $10.5 billion

12 early-stage oncology programs, including ADCs and multispecific antibodies

June 25

Merck KGaA / Bio-Techne

$11.3 billion enterprise value

Life science tools, analytical technologies, proteins, antibodies and workflow solutions

22 June 

AbbVie / Apogee Therapeutics

$10.9 billion

Zumilokibart, a half-life-extended anti-IL-13 antibody for atopic dermatitis

7 April

Gilead Sciences / Tubulis

Up to $5 billion

TUB-040, a NaPi2b-targeting ADC, and next-generation ADC platform capabilities

The BMS-Hengrui collaboration stands out for scale, covering 13 programs and up to about $15.2 billion in potential value. Pfizer’s Innovent agreement, worth up to $10.5 billion, also underlines continued interest in China-originated antibody innovation, particularly ADCs and multispecific formats.

Not every large deal was centred on a therapeutic asset, as Merck KGaA’s proposed $11.3 billion acquisition of Bio-Techne points to the importance of enabling technologies: reagents, proteins, antibodies, analytics and workflow tools that support discovery and development.

AI is changing the bottleneck

AI-enabled antibody discovery is also a central theme. Models can support sequence generation, de novo design, structure prediction, virtual screening, affinity optimisation and developability assessment.

But computational output is not the same as a drug candidate. Binding affinity, specificity, expression, stability, aggregation risk and developability still require wet-lab validation. As AI systems generate larger antibody panels, the pressure shifts toward high-throughput expression, rapid affinity testing and structured experimental datasets.

In practice, discovery is becoming more iterative: design, build, test, learn then repeat. The quality of experimental data may matter as much as the model used to generate candidates.

Conditional activation: aiming for therapeutic index

Conditionally activatable antibodies are another area to watch. These formats are designed to remain silent or attenuated in circulation, then activate preferentially in disease-associated microenvironments.

The rationale is that many targets are not fully disease-specific. They may be enriched in tumors or inflamed tissue but also present in healthy tissue. For ADCs, T cell engagers and immune-activating antibodies, this raises the risk of on-target, off-tumor toxicity.

Activation strategies can include protease-sensitive masking, pH-dependent binding, ATP-responsive designs or other disease-linked triggers. The broader question is no longer only whether an antibody binds, but where and under what biological conditions it binds.

What to watch next

Several regulatory decisions are expected soon:

Candidate

Company

Modality / target

Indication

Milestone

Apitegromab

Scholar Rock

Myostatin monoclonal antibody

Spinal muscular atrophy

FDA PDUFA expected late September 2026; EMA decision anticipated mid-2026

Garetosmab

Regeneron

Activin A monoclonal antibody

Fibrodysplasia ossificans progressiva

FDA target action date in August 2026

Ifinatamab deruxtecan

Daiichi Sankyo / Merck

B7-H3 ADC

Previously treated extensive-stage small cell lung cancer

FDA PDUFA date: 10 October 2026

For readers following antibody approvals, deal activity, AI-enabled discovery, emerging antibody formats and upcoming regulatory milestones, Biointron has released Antibody Industry Trends for Q2 2026, a report covering first approvals, major antibody drug deals, AI-driven discovery trends, conditionally activatable antibodies and antibody drugs to watch in the coming quarter.