Zenas BioPharma

What Zenas BioPharma does

Zenas BioPharma is a clinical-stage biopharmaceutical company founded in 2020 and headquartered in Waltham, Massachusetts, focused on developing immune-based therapies for patients with autoimmune diseases. The company is publicly traded on NASDAQ under the ticker ZBIO and operates with a global team distributed across the United States, Europe, and Asia. Its therapeutic focus spans B-cell-mediated conditions, central nervous system autoimmunity, and broader autoimmune pathways, with lead indications including IgG4-Related Disease (IgG4-RD), multiple sclerosis, and systemic lupus erythematosus.

The company's pipeline is anchored by two late-stage franchises: obexelimab, a proprietary bifunctional monoclonal antibody designed to simultaneously engage CD19 and FcγRIIb to inhibit B-cell activity, and orelabrutinib, a CNS-penetrant, highly selective oral BTK inhibitor licensed from InnoCare Pharma. Obexelimab received Breakthrough Therapy and Fast Track Designations, met its Phase 3 INDIGO primary endpoint in IgG4-RD in January 2026, and had a BLA submitted to the FDA in May 2026. The pipeline is further broadened by ZB021 (oral IL-17AA/AF inhibitor in Phase 1), ZB022 (TYK2-JH2 inhibitor in IND-enabling studies), and ZB014 (half-life-extended anti-CD19 antibody in preclinical development).

Zenas BioPharma is pre-commercial and currently generates partnership-related revenue rather than product sales, with reported revenue of $10M in 2025 (up from $5M in 2024). The company funds operations through equity financings, a $250M Pharmakon term loan, and approximately $718M in cash and equivalents. The leadership team, including founder and CEO Lonnie Moulder (previously co-founder and CEO of TESARO through its GSK acquisition), is built from operators with prior late-stage development and commercial launch experience at companies including TESARO, Cubist, Deciphera, Seres Therapeutics, and Sanofi/Genzyme. Planned go-to-market upon approval relies on specialty pharmacy and specialty distributor channels.

Name

Zenas BioPharma

Legal name

Zenas BioPharma, Inc.

Website

https://zenasbio.com

Company type

Public

Founded year

2020

Operating status

Operating

Headcount range

101–250 employees

Short description

Zenas BioPharma is a clinical-stage biopharmaceutical company developing immunology-based therapies for autoimmune diseases, with lead candidates obexelimab (a CD19/FcγRIIb bifunctional antibody) and orelabrutinib (a CNS-penetrant BTK inhibitor) targeting IgG4-Related Disease, multiple sclerosis, and related conditions.

Ownership category

akta.pro rank

Product category

Autoimmune Disease Therapeutics

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro industry

PRIMARYHLAIACAB

Immunology & Autoimmune Specialty Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Specialty Pharmaceuticals

SECONDARYHLAIAAAD

Immunology & Inflammation Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Branded (Innovator) Pharmaceuticals

SECONDARYHLAIAIAE

Rare Immunology, Autoimmune & Autoinflammatory Therapies

Healthcare & Life Sciences/Pharmaceuticals/Orphan & Rare Disease Pharmaceuticals

SECONDARYHLAAAAAF

Bispecific & Multispecific Antibodies

Healthcare & Life Sciences/Biotechnology & Biologics/Therapeutic Biologics (mAbs, recombinant proteins, cytokines)

SECONDARYHLAAAIAB

Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering)

Healthcare & Life Sciences/Biotechnology & Biologics/Biologic Drug Discovery Platforms (screening, antibody engineering, synthetic biology)

Keywords

• Autoimmune disease therapies
• Monoclonal antibody drugs
• Clinical-stage biopharmaceuticals
• B cell inhibitors
• Immunology drug development

Headquarters

HQ city

Waltham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Distribution channels1 record

Marketing channels3 records

Core offering

Zenas BioPharma is a clinical-stage biopharmaceutical company developing immune-based therapies for patients with autoimmune diseases. Its lead asset, obexelimab, is a CD19 × FcγRIIb bifunctional monoclonal antibody designed to inhibit B cell activity, currently in late-stage development with a Biologics License Application submitted to the FDA in May 2026 for IgG4-Related Disease. Its second lead franchise, orelabrutinib, is a highly selective, CNS-penetrant oral BTK inhibitor licensed from InnoCare Pharma, in development for multiple sclerosis and systemic lupus erythematosus, supported by additional early-stage programs (ZB021, ZB022, ZB014).

Product overview

Zenas BioPharma is a clinical-stage biopharmaceutical company developing a portfolio of immunology-based therapies for autoimmune diseases. The company is advancing two lead product candidates: obexelimab, a bifunctional monoclonal antibody targeting CD19 and FcγRIIb for IgG4-Related Disease, relapsing multiple sclerosis, and systemic lupus erythematosus; and orelabrutinib, a CNS-penetrant BTK inhibitor for progressive multiple sclerosis. Additional pipeline programs include ZB021 (oral IL-17 inhibitor in Phase 1), ZB022 (TYK2 inhibitor in IND-enabling studies), and ZB014 (half-life extended anti-CD-19 antibody in pre-clinical development).

Differentiator

Problem solved

Functional benefit

Products and services

• Obexelimab A bifunctional monoclonal antibody engineered to bind both CD19 and FcγRIIb, designed to inhibit B cell activity for the treatment of autoimmune diseases including IgG4-Related Disease, relapsing multiple sclerosis, and systemic lupus erythematosus. Co-engagement of these targets suppresses antibody production, B cell proliferation, cytokine secretion, and antigen presentation to T cells. In Phase 3 development with a BLA submitted to the FDA.
• Orelabrutinib (ZB088) A potentially best-in-class, highly selective CNS-penetrant, oral small molecule Bruton's Tyrosine Kinase (BTK) inhibitor being developed for progressive forms of multiple sclerosis and other autoimmune diseases. Licensed from InnoCare Pharma for global (ex-China) development and commercialization.
• ZB021 A potentially best-in-class, novel oral IL-17AA/AF inhibitor designed to selectively block signal transduction pathways of both IL-17AA homodimer and IL-17AF heterodimer, inhibiting downstream pro-inflammatory cytokine and chemokine release for autoimmune and inflammatory diseases.
• ZB022 A potentially best-in-class, oral, brain-penetrant TYK2-JH2 inhibitor in IND-enabling studies with potential for treating neuroinflammatory and neurodegenerative diseases.
• ZB014 A half-life extended anti-CD-19 and FcγRIIb monoclonal antibody developed using half-life extension technology, with potential for once-monthly dosing schedule.

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• InnoCare PharmacoreOEM/ Whitelabel/ Licensing Partner · 6 September 2021Zenas BioPharma entered into a licensing agreement with InnoCare Pharma to acquire exclusive rights to develop and commercialize three autoimmune product candidates in all indications globally, excluding China. The licensed products include orelabrutinib (ZB088, a CNS-penetrant BTK inhibitor), ZB021 (IL-17AA/AF inhibitor), and one additional undisclosed candidate. Under the terms of the agreement, InnoCare granted Zenas exclusive rights in exchange for an upfront payment, development and commercial milestone payments, and tiered royalties on net sales.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Xencor: Xencor develops XmAb-engineered bispecific antibodies for autoimmune disease and oncology. Zenas's obexelimab shares the bispecific antibody engineering modality, and both companies target inflammatory/autoimmune indications with platform-derived candidates.
• Apogee Therapeutics: Apogee Therapeutics develops antibodies for inflammatory and immunologic diseases, including IL-13 and OX40L programs in atopic dermatitis and other autoimmune indications. Apogee is similarly positioned as a clinical-to-commercial-stage immunology company with biologics in autoimmune disease.
• Acelyrin: Acelyrin develops bispecific antibodies and biologics for immunology indications, including hidradenitis suppurativa and uveitis. The company shares Zenas's late-stage clinical positioning, biologic modality focus, and autoimmune disease strategy.
• Cabaletta Bio: Cabaletta Bio is a clinical-stage biotechnology company developing cell therapies for autoimmune diseases. Both Cabaletta and Zenas target B-cell-driven autoimmune pathology and are positioned at similar clinical stage with lead assets advancing toward registration.
• RemeGen: RemeGen is a China-based biopharmaceutical company developing bispecific antibodies and antibody-drug conjugates, including autoimmune disease candidates. RemeGen's bispecific antibody work in autoimmune disease is directly comparable to obexelimab's mechanism.

Broad incumbents

• Sanofi: Sanofi is a major immunology player with Dupixent (dupilumab) in multiple autoimmune indications and tolebrutinib in late-stage MS. Both companies target B-cell and BTK pathways in autoimmune disease, and Sanofi is a relevant incumbent competitor across Zenas's portfolio.
• Bristol Myers Squibb: BMS markets Zeposia (ozanimod) for MS and ulcerative colitis and has a broader autoimmune franchise. BMS represents established competition in MS and related autoimmune indications that Zenas's orelabrutinib and obexelimab programs would compete against.
• Amgen: Amgen operates a substantial autoimmune and inflammation franchise including biologics for inflammatory diseases. Amgen is a relevant incumbent in autoimmune disease therapeutics and is identified alongside Zenas as a major company in the IgG4-RD market analysis.
• Eli Lilly: Eli Lilly markets Taltz (ixekizumab) and other autoimmune biologics across rheumatology and dermatology indications. Lilly's immunology franchise represents established competition in autoimmune disease with IL-17 pathway overlap with Zenas's ZB021 program.
• Roche: Roche markets Ocrevus (ocrelizumab), a leading anti-CD20 B-cell therapy for MS, and has a broader autoimmune/neurology franchise. Ocrevus is the most directly comparable approved B-cell-targeting MS therapy to Zenas's obexelimab in relapsing MS.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/zenas-biopharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds7 records

Investors22 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Zenas BioPharma