Bispecific Antibodies Competitive Landscape & Pipeline 2025: Emerging Therapies, Leading Companies, and Future Outlook

DelveInsight's "Bispecific antibody Competitive landscape, 2025," report provides comprehensive insights about 180+ companies and 250+ drugs in the Bispecific antibody Competitive landscape. It covers the Bispecific Antibodies therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive bispecific antibody pipeline products.

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Key Takeaways from the Bispecific Antibodies Competitive Landscape Report

* On 21 August 2025, BioNTech SE announced a a Phase II, multisite, open-label, single arm study with two parts in participants with advanced/metastatic NSCLC which progressed after a first-line chemoimmunotherapy. Part 1 is safety run-in with BNT327 (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants to be treated in Part 1A and 1B sequentially. Part 2 is a dose expansion at the deemed safe dose of BNT327 plus docetaxel.
* On 21 August 2025, Regeneron Pharmaceuticals announced a study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin's lymphoma (NHL).
* DelveInsight's Bispecific Antibodies competitive landscape report depicts a robust space with 180+ active players working to develop 250+ pipeline therapies for Bispecific Antibodies treatment.
* The leading Bispecific Antibodies Companies such as Janssen, Amgen, Akeso, Zymeworks, Roche, IGM Biosciences, MacroGenics, Provention Bio, Jiangsu Alphamab Biopharmaceuticals, Sichuan Baili Pharmaceutical, Regeneron Pharmaceuticals, Boehringer Ingelheim and others.
* Promising Bispecific Antibodies Pipeline Therapies such as Elranatamab, Mosunetuzumab, Glofitamab, Obinutuzumab, AK112, MCLA-158, AZD2936, AK104, Zanidatamab, Docetaxel, Tislelizumab and others.

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Bispecific Antibody Marketed Therapies Company

* Janssen

Janssen is creating a future where disease is a thing of the past. Janssen is the Pharmaceutical company of Johnson & Johnson, working 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 focuses on areas of medicine where they can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

* 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 Registered 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 Registered ) 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.

* Amgen

Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen is 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 has 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.

* Blinatumomab

Blinatumomab (AMG 103) is a bispecific T cell engager (BiTE Registered ) 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 lymphomas and leukemias. 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 Antibody Pipeline Therapies Company and Product Profiles

* 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.

* 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.

* 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.

* 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 EGFR times EGFR homodimers, the formation of EGFR times HER3 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.

* 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 Registered (Sintilimab Injection), BYVASDA Registered (Bevacizumab Injection), and Pemazyre Registered (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.

* 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 SIRP/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.

* 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.

* 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 Non-Hodgkin Lymphoma 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).

* 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.

* MGD024

MGD024 is an investigational, next-generation, bispecific CD123 times CD3 DART Registered 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.

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Bispecific antibody Analytical Perspective by DelveInsight

In-depth Commercial Assessment: Bispecific antibody 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 antibody Competitive Landscape

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

Bispecific antibody Report Assessment

* Company Analysis
* Bispecific Antibodies Therapeutic Assessment
* Bispecific Antibodies Pipeline Assessment
* Inactive drugs assessment
* Bispecific Antibodies Unmet Needs

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Scope of the Bispecific Antibodies Pipeline Report

* Coverage- Global
* Bispecific Antibodies Companies- Janssen, Amgen, Akeso, Zymeworks, Roche, IGM Biosciences, MacroGenics, Provention Bio, Jiangsu Alphamab Biopharmaceuticals, Sichuan Baili Pharmaceutical, Regeneron Pharmaceuticals, Boehringer Ingelheim and others.
* Bispecific Antibodies Pipeline Therapies- Elranatamab, Mosunetuzumab, Glofitamab, Obinutuzumab, AK112, MCLA-158, AZD2936, AK104, Zanidatamab, Docetaxel, Tislelizumab and others.
* Bispecific Antibodies Marketed Therapies and Pipeline Therapies
* Bispecific Antibodies Preclinical and Discovery Stage Products, Unmet Needs

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Table of Contents

* Introduction
* Executive Summary
* Bispecific antibodies: Overview
* Bispecific antibodies -Analytical Perspective: In-depth Commercial Assessment
* Competitive Landscape
* Therapeutic Assessment
* Bispecific antibodies: Company and Product Profiles (Marketed Therapies)
* Johnson & Johnson Innovative Medicine
* Amivantamab
* Bispecific antibodies: Company and Product Profiles (Pipeline Therapies)
* Late Stage Products (Phase III)
* AstraZeneca
* Gefurulimab
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* IGM Biosciences
* Imvotamab
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* MacroGenics
* MGD024
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Company Name
* Product Name
* Drug profiles in the detailed report.....
* Inactive Products
* Bispecific antibodies- Unmet needs
* Bispecific antibodies - Market drivers and barriers
* Appendix

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