이중 특이성 항체 : 경쟁 구도(2026년)

DelveInsight's, "Bispecific antibodies - Competitive landscape, 2026," report provides comprehensive insights about 180+ companies and 250+ drugs in Bispecific antibodies Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Bispecific antibodies: Understanding

Bispecific antibodies: Overview

Immunoglobulins (antibodies [Abs]) are major protein components of the adaptive immune system, directed against foreign compounds and infectious agents. The IgG molecule consists of two light and two heavy chains connected by disulfide bonds; IgG is a monomer with a molecular weight of 146-160 kDa. Antigen-binding centers of Abs are formed by hypervariable regions of heavy and light chains. In the classical point of view, the Ab molecule contains two identical antigen-binding sites (two HL fragments) and is monospecific and bivalent. Immunoglobulins are expressed as receptors of the cell membrane of B lymphocytes, as well as in the form of soluble molecules secreted by plasma cells. Soluble Abs can bind virtually any natural and artificial molecules (antigens) with high affinity and specificity. The ability of Abs to recognize and bind a broad spectrum of antigens is ensured by their extraordinary diversity, reaching 108-1010 different variants of antigen-binding centers. Bispecific immunoglobulins contain two different antigen-binding sites.

Bispecific antibodies have been developed in which one antigen-binding site is directed against the CD3 receptor (activates cytotoxic T lymphocytes) and the other against specific antigens of tumor cells (CD19, CD20, CD33, CD123, HER2, epithelial cell adhesion molecule [EpCAM], BCMA, CEA, and others). The convergence of cytotoxic T lymphocytes and tumor cells due to Bispecific antibody binding activates cytotoxic T cells and promotes the destruction of tumor cells. In addition to a wide range Bispecific antibodies directed against tumors, several bispecific molecules for the treatment of other diseases have been developed. The Bispecific antibody for the treatment of osteoporosis blocks the factors of Wnt signal-transduction pathway (sclerostin and Dkk1); it enhances the formation of osteoblasts and growth of bone tissue. ACE910 binds blood-coagulation factors IX and X and is designed to reduce bleeding rate in hemophilia A. The convergence of coagulation factors enhances the coagulation cascade. A Bispecific antibody against the transferrin receptor (provides passage through the blood-brain barrier) and protease BACE1 (accumulates amyloid peptides) is a candidate for an anti-Alzheimer's disease drug. Bispecific antibodies that are focused on autoimmune diseases usually bind cytokines: TNF, IL1, IL4, IL14, IL17, IL23, and others. It has been shown that simultaneous use of two mAbs against cytokines in autoimmune diseases has severe side effects without superior efficiency. In this regard, Bispecific antibodies against autoimmune diseases usually combine two anticytokine antigen-binding sites and provide higher therapeutic potential than a mixture of two mAbs. In particular, the most therapeutically important cytokines in psoriasis are IL17, IL23, IL6, and TNF. ABT122 against TNFa and IL17A has clinical effects in rheumatoid arthritis and psoriatic arthritis. In contrast, Phase I/II clinical trials of COVA322 (same specificity as ABT122) in psoriasis were preliminary terminated, due to safety concerns. Antigen-binding sites of ABT981 are directed against IL1a and IL1B, inflammatory cytokines found in the cartilage and synovial fluid of patients with osteoarthritis.

Bispecific antibodies have several significant advantages over monospecific Abs. Bispecific antibodies direct specific effectors of the immune system to target tumor cells, enhancing their cytotoxicity. Bispecific antibodies can provide higher binding specificity, since in contrast to monospecific Abs, they interact with two different surface antigens. The use of Bispecific antibodies compared to combination therapy with two monospecific drugs makes it possible to optimize expenses by reducing the cost of development and clinical trials. Since one disease modulator may play an essential role in several independent pathways and coexpression of different receptors has been found in many tumors, targeting of two different growth-promoting receptors on a single tumor cell may increase the antiproliferative effect and help to avoid the development of resistance.

Report Highlights:

• In January 2024, LAVA Therapeutics N.V. announced that it had entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Rahway, NJ, US to evaluate its anti-PD-1 therapy KEYTRUDA(R) (pembrolizumab) in combination with LAVA-1207, a Gammabody(R) designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells, in patients with therapy refractory metastatic castration-resistant prostate cancer (mCRPC).
• In January 2024, Biocytogen Pharmaceuticals (Beijing) Co., Ltd. announced that it had entered into an Exclusive Option and License Agreement with Radiance Biopharma Inc., a biotechnology company specializing in developing next generation Antibody Drug Conjugates. The agreement grants Radiance an option to license from Biocytogen a first-in-class fully human anti-HER2/TROP2 bispecific antibody-drug conjugate (BsADC) for therapeutic product development, manufacturing and commercialization for all human indications worldwide.
• In January 2024, Debiopharm entered an exclusive licensing deal with SunRock Biopharma to produce an enhanced HER3-EGFR bispecific antibody-drug conjugate (ADC). This option agreement prolongs the existing partnership that was initiated in September of this year allowing Debiopharm to further develop HER2/HER3 targeting antibodies.
• In December 2023, Pfizer Inc. announced the successful completion of its acquisition of Seagen, a global biotechnology company that discovers, develops and commercializes transformative cancer medicines. Pfizer completed its acquisition of all outstanding common stock of Seagen for USD 229 in cash per share, for a total enterprise value of approximately USD 43 billion. With the addition of Seagen, Pfizer's Oncology pipeline has doubled in size with 60 programs spanning multiple modalities, including ADCs, small molecules, bispecifics and other immunotherapies.
• In December 2023, NAYA Biosciences Inc. and ONK announced that they had entered into a research partnership to evaluate combination therapy consisting of NAYA's FLEX-NK(TM) bispecific antibodies and ONK's optimally engineered natural killer (NK) cells.
• In November 2023, I-Mab, a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics, announced that two poster presentations featuring preclinical data on Givastomig (also known as TJ-CD4B/ABL111) and TJ-L14B/ABL503, the Company's 4-1BB-targeting bispecific antibody assets, will be reported at the 38th Society for Immunotherapy of Cancer's (SITC) Annual Meeting, taking place November 1-5, 2023, in San Diego, California.
• In November 2023, Cantai Therapeutics announced its formation and the completion of a seed financing co-led by Agent Capital and 82VS (the affiliated venture studio of Alloy Therapeutics) with additional participation from Tellus BioVentures. The proceeds will be used to develop drug candidates to treat autoimmune and inflammatory disorders by developing cytokine-targeting bispecific antibodies that meaningfully improve the status quo for the millions of patients suffering from immune-mediated and autoimmune diseases.
• In April 2023, Lonza signed an agreement with ABL Bio focusing on bispecific antibodies for immuno-oncology and neurodegenerative diseases. The collaboration is intended to help in the development and manufacturing of ABL Bio's new bispecific antibody product.

Bispecific antibodies: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Johnson & Johnson Innovative Medicine

Johnson & Johnson Innovative Medicine (formerly k/a Janssen) is creating a future where disease is a thing of the past. Janssen is the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. The company focus on areas of medicine where they can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

Product Description: Amivantamab

Amivantamab is a fully human bispecific antibody that targets EGFR and Met, two validated cancer targets. In July 2012, Genmab entered into a collaboration with Janssen Biotech, Inc. to create and develop bispecific antibodies using Genmab's DuoBody(R) technology platform. The two antibody libraries used to produce amivantamab were both generated by Genmab. The antibody pair used to create Amivantamab was selected in collaboration between Genmab and Janssen. Subsequent development work was carried out by Janssen. In 2021, Janssen received approval from the U.S. FDA for amivantamab-vmjw (RYBREVANT(R)) for the treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. This is the first regulatory approval for a therapy that was created using Genmab's proprietary DuoBody bispecific technology platform.

2. Company Overview: Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines.

Product Description: Blinatumomab

Blinatumomab (AMG 103) is a bispecific T cell engager (BiTE(R)) antibody designed to direct the body's cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells to cancer cells. Blinatumomab is the first of the BiTE antibodies and Amgen has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of ALL, chronic lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia and indolent B cell lymphoma and from the European Medicines Agency for the treatment of indolent B cell lymphoma, ALL, CLL and mantle cell leukemia (MCL). The drug is approved for the treatment of Precursor B-cell lymphoblastic leukaemia-lymphoma. The drug is currently being evaluated for the treatment of Non-Hodgkin's lymphoma, diffuse large B cell lymphoma, and others.

Bispecific antibodies: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of diseases in these therapy areas - Oncology, Cardiovascular, Renal & Metabolism, Respiratory & Immunology, Vaccines & Immune Therapies, and Rare Diseases.

Product Description: Gefurulimab

Gefurulimab is an investigational, humanized bispecific VHH antibody directed against terminal complement protein C5 and albumin, with potential anti-inflammatory and immunomodulatory activities. Upon administration, gefurulimab, with its anti-C5 antibody moiety, targets and binds to terminal complement protein C5, thereby blocking the terminal complement pathway of complement activation. This inhibits complement-mediated inflammation and cell lysis. Excessive complement activation plays a key role in various inflammatory and autoimmune diseases and leads to tissue destruction. The binding of gefurulimab to albumin, with its albumin binding domain, increases its half-life.

2. Company Overview: Sichuan Baili Pharmaceutical

Sichuan Baili is a biopharmaceutical company focusing on the research and development, manufacturing, and commercialization of medicines for cancer and other diseases. With strong R&D teams in both China and US, it has developed fully integrated proprietary platforms in bispecific, multi-specific antibodies and antibody-drug conjugates. Its highly differentiated platforms have generated a pipeline of six clinical stage anti-cancer drug candidates. The Company also has state-of-the-art manufacturing capability designed and built to meet cGMP standards. It is a buyer of pharmaceutical products and has business partners. The company has not made any global approval of a PD-L1/4-1BB bispecific antibody for patients with pancreatic cancer. Sichuan Baili Tianheng Pharmaceutical, a subsidiary of Sichuan Baili Pharmaceutical, develops and manufactures small molecules as well as immunologicals. The products are of various therapeutic categories including anti-inflammatory, antiphlogistics, urology, gynecology, obstetrics, immunological preparations, and others. The primary business model of Sichuan Baili Tianheng Pharmaceutical is healthcare funding and investors.

Product Description: SI-B001

SI-B001 is a bispecific antibody designed with the proprietary platform technology developed by Baili and SystImmune. It can bind to EGFR and HER3, and simultaneously inhibits the ligand induced EGFRXEGFR homodimers, the formation of EGFRXHER3 heterodimers and the activation of its downstream signal pathway. SI-B001 can also induce endocytosis of EGFR and HER3, and down-regulate the levels of EGFR and HER3 tumor cells. In preclinical studies, SI-B001 has demonstrated superior tumor killing activities. SI-B001 Phase I trials have shown good safety and preliminary efficacy. The drug is in phase III stage of its clinical trial.

3. Company Overview: Innovent Biologics

Innovent Biologics is a global biopharmaceutical company established in 2011, focusing on the development, manufacturing, and commercialization of innovative medicines, particularly in the areas of cancer, autoimmune, cardiovascular, and metabolic diseases. The company is headquartered in Suzhou, Jiangsu, China, and has a presence in the United States, with a lab located in Rockville, Maryland. Innovent has 10 products in the market, including TYVYT(R) (Sintilimab Injection), BYVASDA(R) (Bevacizumab Injection), and Pemazyre(R) (Pemigatinib Oral Inhibitor). The company's pipeline consists of 36 high-quality assets, with 2 under NMPA NDA review, 5 in Phase III or pivotal clinical trials, and 19 more in early clinical stages. Innovent has entered into more than 30 strategic collaborations with international partners, including Eli Lilly, Roche, Sanofi, Adimab, Incyte, and MD Anderson Cancer Center. The company's mission is to discover and develop high-quality biopharmaceutical products that are affordable and accessible to ordinary people.

Product Description: IBI322

IBI322 is a recombinant anti-human CD47/PD-L1 bispecific antibody developed by Innovent Biologics. As a bispecific antibody, IBI322 targets CD47 on the surface of tumor cells, blocks SIRPa/CD47 pathway and activates macrophages to attack the tumor cells. Furthermore, IBI322 target PD-L1 on the surface of tumor cells, blocks the PD-1/PD-L1 pathway, which counteracts the inhibition of T cells and activates the T cells to attack the tumor cells. By inhibiting two different targets, IBI322 can not only activate both innate immune pathway and adaptive immune pathway, which provides synergistic effect, but also reduce the red blood cell destruction. IBI322 is currently being evaluated in Phase II for the treatment of Hematological malignancies and Solid tumors.

4. Company Overview: IGM Biosciences

IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases and autoimmune and inflammatory diseases. The Company's pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets.

Product Description: Imvotamab

Imvotamab is a novel IgM-based CD20 x CD3 bispecific antibody T cell engager (TCE) with the therapeutic potential to be a backbone treatment in hematology. Preclinical research demonstrates that imvotamab may have advantages over IgG bispecific antibodies including greater binding power to CD20 expressing cancer cells especially when CD20 expression has been reduced due to prior treatment with anti-CD20 antibodies. It has also been shown to have good target cell killing efficacy combined with a lower cytokine release profile associated with the T cell directed cellular cytotoxicity (TDCC) mechanism. Data generated from Phase 1 clinical trials provide evidence that imvotamab exhibits a favorable safety and tolerability profile with promising activity in refractory or relapsed NHL patients. Imvotamab is currently being studied in two Phase II trials to assess the safety and efficacy of two doses 100 mg and 300 mg, in patients with diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL).

5. Company Overview: MacroGenics

MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies.

Product Description: MGD024

MGD024 is an investigational, next-generation, bispecific CD123 X CD3 DART(R) molecule that engages CD3 on immune effector cells to kill CD123-expressing cancer cells in certain hematological malignancies, including acute myeloid leukemia (AML). MGD024 was designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing through a longer half-life. In December 2021, the company presented preclinical MGD024 data at the American Society of Hematology (ASH) Annual Meeting that showed the potential for anti-tumor activity from the combination of MGD024 with standard of care agents used to treat AML. MacroGenics initiated a Phase I study of MG024 in patients with hematologic malignancies in 2022. In October 2022, MacroGenics announced that it had entered into an exclusive option and collaboration agreement with Gilead to develop MGD024 and two additional bispecific research programs. MacroGenics is responsible for the ongoing Phase I study for MGD024 during which Gilead may elect to exercise its option to license the program at predefined decision points.

Bispecific antibodies Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Bispecific antibodies Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Bispecific antibodies Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Bispecific antibodies Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Bispecific antibodies drugs?
• How many Bispecific antibodies drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Bispecific antibodies?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Bispecific antibody therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Bispecific antibody and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• Janssen
• Amgen
• Akeso
• Zymeworks
• Roche
• IGM Biosciences
• MacroGenics
• Provention Bio
• Jiangsu Alphamab Biopharmaceuticals
• Sichuan Baili Pharmaceutical
• Regeneron Pharmaceuticals
• Boehringer Ingelheim

Key Products

• Amivantamab
• Blinatumomab
• Ivonescimab
• Zanidatamab
• Glofitamab
• Imvotamab
• MGD024
• PRV 3279
• KN-046
• SI-B001
• REGN-5458
• BI-905711

Table of Contents

Introduction

Executive Summary

Bispecific antibodies: Overview

• Introduction
• Formats
• Mechanism of Action
• Strategies to improve Bi-specific antibody production and quality
• Half-life extension strategies

Bispecific antibodies -Analytical Perspective: In-depth Commercial Assessment

• Bispecific antibodies Collaboration Analysis by Companies

Competitive Landscape

• Comparative Assessment of Companies (by therapy, development stage, and technology)

Therapeutic Assessment

• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type

Bispecific antibodies: Company and Product Profiles (Marketed Therapies)

Johnson & Johnson Innovative Medicine

• Company Overview

Amivantamab

• Product Description
• Research and Development Activities
• Product Developmental Activities

Bispecific antibodies: Company and Product Profiles (Pipeline Therapies)

Late Stage Products (Phase III)

• Comparative Analysis

AstraZeneca

• Company Overview

Gefurulimab

• Product Description
• Research and Development Activities
• Product Developmental Activities

Mid Stage Products (Phase II)

• Comparative Analysis

IGM Biosciences

• Company Overview

Imvotamab

• Product Description
• Research and Development Activities
• Product Developmental Activities

Early Stage Products (Phase I)

• Comparative Analysis

MacroGenics

• Company Overview

MGD024

• Product Description
• Research and Development Activities
• Product Developmental Activities

Preclinical and Discovery Stage Products

• Comparative Analysis

Company Name

• Company Overview

Product Name

• Product Description
• Research and Development Activities
• Product Developmental Activities

Inactive Products

• Comparative Analysis

Bispecific antibodies- Unmet needs

Bispecific antibodies - Market drivers and barriers