Published: August 2023
Bispecific antibodies have the capability to treat wide range of indications, owing to which, this therapeutic drug class has garnered significant attention from the drug developers. We analyzed over 155 drug developers that have the required capabilities to develop over 400 bispecific antibodies for the treatment of wide range of disorders. In this article, discover 5 leading bispecific antibody companies and their respective development pipeline.
In recent years, antibodies have become the predominant class of pharmacological therapeutics. In fact, antibodies are one of the best-selling drugs in the pharmaceutical market and upsurge in the demand for antibodies has resulted in the commercial success of these drugs over the past few years. Till 2023, over 160 therapeutic antibodies have been approved by various regulatory bodies for the treatment of several disease conditions, including oncological disorders, autoimmune disorders and inflammatory disorders. Despite the commercial success of monoclonal antibodies, monotherapies were not much effective in some cases of oncological disorders, particularly due to lesser involvement of T lymphocytes in the destruction of tumor. This inspired various innovators to improve the efficacy of these drug candidates, which led to the development of a new wave of antibodies, known as bispecific antibodies, having much higher effector functions and relatively higher clinical efficacy as compared to monoclonal antibodies. Bispecific antibodies consist of two binding sites, which are directed at two different antigens or two different epitopes on the same antigen. In recent years, a number of clinical trials have been registered to evaluate the efficacy of bispecific antibodies, and their potential in the treatment of a wide range of disorders. Owing to the higher efficacy of bispecific antibodies and rising demand for this therapeutic class, we anticipate the market of bispecific antibody therapeutics to witness healthy growth in the foreseen future. Roots Analysis has conducted an exhaustive study on Bispecific Antibodies Market featuring the current market landscape and future opportunity for the drug developers involved in the development of bispecific antibodies, over a span of 12 years.
The top five companies developing bispecific antibody are listed below (in alphabetical order):
Interested in exploring all 155+ Bispecific Antibody Companies and their Development Pipeline?
This article highlights the five leading bispecific antibody drug developers to watch out for in 2023. For shortlisting the companies from more than 155 players, we looked at their portfolio strength (number of drug candidates in clinical studies, indications and phase of development). For 5 leading companies, we have presented information on drug pipeline, recent developments and anticipated milestones in 2023. It is essential to note that the selection of top players can differ substantially according to the defined criteria(s).
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Akeso Bio is a China based, biopharmaceutical company, that is focused on discovering, developing, and commercializing immuno-oncology therapies. The company's research and development efforts are centered on the discovery and development of novel antibodies that are intended to treat oncological disorders. In June 2022, Akeso Bio achieved a milestone with the NMPA approval for the world’s first dual immune checkpoint inhibitor, Kaitanni (cadonilimab / AK104). The bispecific antibody received approval for the treatment of relapsed or metastatic cervical cancer patients who progressed on or after platinum-based chemotherapy and had achieved sales of more than USD 76 million in six months till 31 December 2022. The company claims to have a diverse pipeline of potential therapies at various stages of development, including clinical and preclinical stage candidates. It is worth mentioning that the company has established several partnerships with other pharmaceutical companies, in the past few years, to advance the development and commercialization of its drug candidates.
Bispecific Antibody Pipeline
Akeso Bio is currently involved in the development of two bispecific antibody drugs – AK104 (Cadonilimab) and AK112 (Ivonescimab) for multiple indications and in various stages of development. The list of bispecific antibodies drug candidates that are being developed by the firm, along with information on their respective phase of development and target indication is mentioned below:
| Drug Candidate | Phase of Development | Target Indication |
| AK104 | Approved | Relapsed or Metastatic Cervical Cancer |
| AK104 | Phase III | Gastric Cancer, Esophagogastric Junction (GEJ) adenocarcinoma, HCC Adjuvant Therapy |
| AK112 | Phase III | Non-small Cell Lung Cancer |
| AK104 | Phase I / II | Hepatocellular Carcinoma, Small Cell Lung Cancer, Non-small Cell Lung Cancer, Pancreatic Cancer |
| AK112 | Phase I / II | Ovarian Cancer, Advanced Solid Tumors, Head and neck squamous cell carcinomas, Colorectal cancer, Triple Negative Breast Cancer, Gastric Cancer, Esophagogastric Junction (GEJ) Adenocarcinoma |
| AK104 | Phase I | Esophageal Carcinoma, Advanced Solid Tumors |
| AK112 | Phase I | Advanced Solid Tumors |
Recent Developments and Future Outlook
In December 2022, the company entered into a product licensing agreement with Summit Therapeutics. Akeso Bio licensed out the development and commercialization rights of its proprietary bispecific antibody candidate, Ivonescimab (AK112) in the United States, Canada, Europe, and Japan to Summit Therapeutics in return of an upfront payment of USD 500 million and an additional USD 4.5 billion achievable in regulatory and commercial milestones.
Akeso Bio is looking forward to filing NDA to NMPA for Ivonescimab for treatment of EGFR-mutated NSCLC patients who have failed to EGFR-TKI treatment in 2023. Further information related to development pipeline, financial performance, regulatory approvals and recent developments is available in the full report.
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Alphamab Oncology is a biopharmaceutical company based in Suzhou, China. According to the company's website, it is focused on the discovery and development of innovative biologics for the treatment of oncological disorders. The company's pipeline includes a wide range of bispecific antibodies, recombinant proteins, and fusion proteins, which are designed to treat several types of oncological disorders, including lung cancer, gastric cancer, and esophageal cancer. Further, the company claims to be committed to develop safe, effective, and affordable therapies for patients across the globe. The company has also entered into several partnerships with leading companies in the biopharmaceutical industry in order to advance its research and development efforts.
Bispecific Antibody Pipeline
Alphamab Oncology is currently involved in the development of four bispecific antibodies, KN046, KN026, KN052 and JSKN003. The latest bispecific to enter clinical trial, JSKN003 is an anti-HER2 bispecific ADC. The list of bispecific antibodies drug candidates that are being developed by the firm, along with information on their respective phase of development and target indication is mentioned below:
| Drug Candidate | Phase of Development | Target Indication |
| KN046 | Phase II / III | Squamous Non-small Cell Lung Cancer, Thymic Carcinoma, Pancreatic Cancer |
| KN026 | Phase II / III | Gastric Cancer |
| KN046 | Phase II | Hepatocellular Carcinoma |
| KN026 | Phase II | Breast Cancer, Solid Tumors |
| KN046 | Phase I / II | Triple-negative Breast Cancer, Esophageal cancer |
| KN052 | Phase I | Solid Tumors |
| JSKN003 | Phase I | Solid Tumors |
Recent Developments and Future Outlook
In May 2023, the company announced that its IND application was approved in China for the pivotal trial of anti-HER2 bispecific antibody KN026 combined with Docetaxel for the treatment of HER2 positive recurrent metastatic breast cancer.
Alphamab Oncology expects to submit its first BLA application for KN046 in first line Squamous Non-small Cell Lung Cancer and first line pancreatic ductal adenocarcinoma in China. The company has already set up its manufacturing capabilities for manufacturing of KN046 and other bispecific antibodies. As claimed by the company, they have completed the process verification for KN046 manufacturing, with a single batch output of more than 37,000 vials (300mg/vial). Further information related to development pipeline, financial performance, regulatory approvals and recent developments is available in the full report.
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Regeneron is a leading biotechnology company headquartered in New York, US. According to the company's website, it is primarily focused on discovering and developing novel therapies for the treatment of eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, and infectious diseases. The firm claims that its proprietary bispecific antibody platform, VelociSuite, enables the rapid discovery and development of novel bispecific antibodies. Its peers including Amgen, Janssen and Roche already have approved bispecific antibodies. Regeneron has also developed a rich pipeline of bispecific antibody therapeutics. The company’s lead bispecific antibody Odronextamab, is competing in the CD20 T-cell engager market against Roche’s approved drug Lunsumio.
Bispecific Antibody Pipeline
Regeneron is currently involved in the clinical development of 10 bispecific antibody therapeutics in different stages of development and for various indications. The list of bispecific antibodies drug candidates that are being developed by the firm, along with information on their respective phase of development and target indication is mentioned below:
| Drug Candidate | Phase of Development | Target Indication | |
| Odronextamab | Phase II | B-cell non-Hodgkin lymphoma | |
| Linvoseltamab | Phase I / II | Multiple Myeloma, Chronic Kidney Disease | |
| Ubamatamab | Phase I / II | Recurrent Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Primary Peritoneal Cancer | |
| REGN4336 | Phase I / II | Prostate Cancer | |
| REGN5093 | Phase I / II | MET-Altered Advanced Non-small Cell Lung Cancer | |
| REGN5093-M114 | Phase I / II | Advanced Non-small Cell Lung Cancer | |
| REGN5459 | Phase I / II | Relapsed / Refractory Multiple Myeloma, Transplant Desensitization in Patients with Chronic Kidney Disease | |
| REGN5668 | Phase I / II | Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer | |
| REGN5678 |
|
Prostate Cancer | |
| REGN7075 |
|
Solid Tumors | |
| Ubamatamab | Phase I / II | Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer | |
| Odronextamab | Phase I | Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia | |
| REGN5837 | Phase I | B-cell non-Hodgkin lymphoma |
Recent Developments and Future Outlook
In November 2022, the company entered into a product development and commercialization agreement with CytomX Therapeutics in order to develop and commercialize bispecific antibodies combining CytomX's Probody therapeutic platform and Regeneron's Veloci-Bi.
At ASH 2022, held in December 2022, Regeneron presented promising results from a phase II clinical trial evaluating Odronextamab in patients with heavily pre-treated, relapsed/refractory (R/R) follicular lymphoma (FL) grades 1 to 3a. After having received Fast Track Designation for the drug for follicular lymphoma from FDA and Orphan Drug Designation from the EMA, the company plans to begin a phase III clinical trial (OLYMPIA) in 2023. Further information related to development pipeline, financial performance, regulatory approvals and recent developments is available in the full report.
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Roche is a multinational pharmaceutical company based in Basel, Switzerland. According to the company’s website, its portfolio includes treatment for breast cancer, lung cancer, leukemia, lymphoma, and other types of cancers. In addition to its oncology portfolio, Roche also has a strong presence in the field of neuroscience, ophthalmology, and rare diseases. The company's pipeline includes several promising candidates which are at various stages of development, including bispecific antibodies, gene therapies, and RNA-based therapeutics. The company is one of the players at the forefront of bispecific antibody research and development with four approvals under its belt. Columvi became the latest CD20 bispecific antibody to receive accelerated FDA approval in June 2023 for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). This came after the December 2022 approval of Lunsumio, another CD20 bispecific antibody, for R/R follicular lymphoma. With two CD20 approvals, the company is leading the race in the CD20 T-cell engager market.
Bispecific Antibody Pipeline
Roche has a number of active clinical trials currently being conducted to evaluate its bispecific antibodies for their clinical use for various oncological and non-oncological indications. The list of bispecific antibodies drug candidates that are being developed by the firm, along with information on their respective phase of development and target indication is mentioned below:
| Drug Candidate | Phase of Development | Target Indication |
| Vabysmo | Approved | Diabetic Macular Edema, Neovascular Age Related Macular Degeneration |
| Hemlibra | Approved | Hemophilia A |
| Lunsumio | Approved | Follicular Lymphoma |
| Columvi | Approved | Diffuse Large B-cell Lymphoma |
| Vabysmo | Phase III | Macular Edema Secondary To Branch Retinal Vein Occlusion, Macular Edema Secondary To Central Retinal Vein Occlusion |
| Lunsumio | Phase III | Follicular Lymphoma, Diffuse Large B-cell Lymphoma |
| RG7769 | Phase II | Esophageal Squamous Cell Carcinoma |
| RG7802 | Phase I | Solid Tumors |
| RG7827 | Phase I | Solid Tumors |
| RG7769 | Phase I | Metastatic Melanoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer |
| Glofitamab | Phase I | Non-Hodgkin’s Lymphoma, Hematological Tumors |
| Runimotamab | Phase I | HER2-positive Cancers |
| Lunsumio | Phase I | Chronic Lymphocytic Leukemia, Hemetological Tumors, Systemic Lupus Erythematosus |
| RG6007 | Phase I | Acute Myeloid Leukemia |
Recent Developments and Future Outlook
Roche received approval for its fourth bispecific antibody Columvi in June 2023 in the US and July 2023 in EU. This was post the approval of Lunsumio in December 2022. From the point of view of CD20 bispecific market, Roche has appeared a clear winner in 2023. Additionally, considering the overall bispecific antibody portfolio, the company recorded sales of USD 3.5 billion in first half of 2023, contributed by Vabysmo and Hemlibra.
The company’s bispecific antibody portfolio will be a major contributor to the company’s performance in 2023, as both Lunsumio and Columvi become available in the global markets. Further information related to development pipeline, financial performance, regulatory approvals and recent developments is available in the full report.
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Xencor is a biotechnology company based in California, US. The company is focused on developing innovative antibody and protein therapeutics in order to treat patients with cancer and autoimmune diseases. According to the company’s website, its platform technology, XmAb, uses an advanced protein engineering technology to create next-generation antibodies with enhanced therapeutic properties. The company’s pipeline includes several clinical-stage programs that target both hematologic malignancies and solid tumors. The company is not only limiting the potential of bispecific formats to treatment of cancer but has also moved one candidate in to phase I clinical trial for autoimmune diseases, specifically atopic dermatitis and psoriasis. Xencor is working on the development of new bispecific antibody formats as well as new targets for bispecific antibodies. It is worth mentioning that the company has signed several agreements with various pharmaceutical companies, in order to develop new therapies using its proprietary XmAb technology. Amongst these, Amgen and Astellas have a bispecific antibody each in phase I clinical trials and Janssen Biotech has a bispecific product in preclinical development.
Bispecific Antibody Pipeline
Xencor is currently involved in the development of 8 clinical-stage bispecific antibody products. The list of bispecific antibodies drug candidates that are being developed by the firm, along with information on their respective phase of development and target indication is mentioned below:
| Drug Candidate | Phase of Development | Target Indication |
| Vudalimab | Phase II | Metastatic Castration-Resistant Prostate Cancer, Advanced Gynecologic and Genitourinary Malignancies |
| Plamotamab | Phase I | B-cell Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia |
| XmAb104 | Phase I | Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma, Pancreatic Carcinoma, Breast Carcinoma (That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative),Hepatocellular Carcinoma, Urothelial Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Nasopharyngeal Carcinoma, Renal Cell Carcinoma, Colorectal Carcinoma, Endometrial Carcinoma, Non-small Cell Lung Carcinoma, Small Cell Lung Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma, Selected Advanced Solid Tumors |
| XmAb3061 | Phase I | Multiple Myeloma |
| XmAb5641 | Phase I | Atopic Dermatitis, Psoriasis |
| XmAb819 | Phase I | Renal Cell Carcinoma |
| XmAb968 | Phase I | Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, Acute Myelogenous Leukemia |
| XmAb808 | Phase I | Advanced Solid Tumors |
| XmAb6621 | Preclinical | Oncology (Unspecified) |
| XmAb541 | Preclinical | Ovarian Cancer |
1 These candidates are based on company’s XmAb technology; however, these are bispecific fusion protein
Recent Developments and Future Outlook
In February 2023, the firm signed a product development and commercialization agreement with Atreca in order to develop and commercialize bispecific antibody program combining Atreca and Xencor’s XmAb technology.
In 2022, the company initiated phase I clinical trials for XmAb819 and XmAb808, both based on Xencor’s latest 2+1 bispecific format. XmAb 808 is also their first CD28 targeted bispecific antibody to enter clinical trials. Xencor is an early entrant in the CD28 market, which is being evaluated as a new anti-cancer target. In the rest of 2023, Xencor is expected to file more IND applications, which will further expand its clinical pipeline of bispecific antibodies. Additionally, the pharmaceutical industry will be looking forward to the results from safety study of Xencor’s 2+1 bispecific format, which is designed to provide enhanced selectivity in targeting of tumor cells. Further information related to development pipeline, financial performance, regulatory approvals and recent developments is available in the full report.
The above presentation features five promising drug developers selected from a pool of over 150 bispecific antibody companies that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com
Ankita is an associate, working with Roots Analysis since 2019. She has a master’s degree in pharmacology from a renowned university. Her passion lies in life sciences, so post completing her degree, she embarked upon her career in pharmaceutical market research with us. She has worked on some of the trending sectors within the pharmaceutical industry including viral vectors, aseptic manufacturing, continuous manufacturing, bioprinting, ADC technology, membrane filtration, liquid biopsy and more. Till date, she has contributed to over 20 research reports.
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