antibody drug conjugates adcs in oncology competitive landscape

DelveInsight’s, “Antibody–drug Conjugates (ADCs) - Competitive landscape, 2025,” report provides comprehensive insights about 200+ companies and 220+ drugs in Antibody–drug Conjugates (ADCs)  Competitive landscape. It covers the therapeutics assessment by product type, stage, and route of administration. It further highlights the inactive pipeline products in this space.  

Geography Covered

• Global coverage

Antibody–drug Conjugates (ADCs): Understanding

Antibody–drug Conjugates (ADCs): Overview

Antibody Drug Conjugates (ADCs) are a class of biopharmaceutical drugs designed as targeted cancer therapies. They combine the specificity of monoclonal antibodies (mAbs) with the potent cytotoxic effects of chemotherapy drugs. The basic concept of ADCs is to deliver cytotoxic agents directly to cancer cells while minimizing exposure to normal, healthy tissues. This targeted approach aims to reduce side effects and improve the therapeutic index of cancer treatments.

ADC is composed of antibody, cytotoxic payload, and chemical linker. An ideal ADC drug remains stable in blood circulation, reaches the therapeutic target accurately, and eventually releases the cytotoxic payloads in the vicinity of the targets (e.g. cancer cells). Each element can affect the final efficacy and safety of ADC, and in general ADC development needs to take into account all these key components, including the selection of target antigen, antibody, cytotoxic payload, linker, as well as conjugation methods.

The mechanism of action of Antibody Drug Conjugates (ADCs) involves the targeted delivery of cytotoxic drugs to cancer cells through a series of well-coordinated steps. Initially, the monoclonal antibody (mAb) component of the ADC specifically binds to an antigen overexpressed on the cancer cell surface, ensuring minimal interaction with normal cells. This binding triggers receptor-mediated endocytosis, internalizing the ADC-antigen complex into the cancer cell as an endosome. Within the acidic environment of the endosome, the linker connecting the cytotoxic drug to the antibody is cleaved, releasing the drug into the cytoplasm or nucleus. The cytotoxic drug, depending on its nature, either disrupts the microtubule network (as with microtubule inhibitors like auristatins and maytansinoids) or causes DNA damage (as with DNA-damaging agents like calicheamicin and duocarmycin), leading to cell death through apoptosis or other forms of programmed cell death. This targeted approach allows for the selective destruction of cancer cells while sparing healthy tissue, thereby enhancing the therapeutic efficacy and reducing side effects.

The first antibody-drug conjugate (ADC) approved by the FDA was gemtuzumab ozogamicin (Mylotarg), which was approved in 2000 for the treatment of acute myeloid leukemia. However, it was later withdrawn from the market and then reintroduced in 2017 with new dosing recommendations.

Report Highlights

• In June 2024, Hudson Therapeutics announced that Shaperon, an innovative biopharmaceutical company specializing in immune therapeutics, had signed a Memorandum of Understanding (MOU) with Dong-A ST for the development of nanobody-based new drugs. Shaperon is also exploring nanobody-based protein therapeutics, such as antibody-drug conjugates (ADCs) and radiopharmaceutical therapies.
• In June 2024, the US FDA Placed Partial Clinical Hold on Phase I Trial of YL202. The hold on YL202 is due to potential risks at higher doses, with five grade 5 adverse effects reported.
• In October 2023, Daiichi Sankyo and Merck, entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd antibody-drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd). The companies will jointly develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.
• In May 2023, Bliss Biopharmaceutical announced a clinical trial collaboration agreement with option for strategic collaboration with Eisai Co., Ltd. (""Eisai""), for BB-1701, eribulin-payload based ADC directed against Human Epidermal Growth Factor Receptor 2 (HER2) for the treatment of cancers. This collaboration with Eisai is an important advancement in BlissBio's corporate development plan to further develop BB-1701 globally and help advance BB-1701 toward late stage of development. BB-1701 is currently in Phase I/II studies in the US and China with over one hundred patients dosed in various types of cancers.
• In April 2023, Byondis B.V., announced that Molecular Cancer Therapeutics (an American Association for Cancer Research journal) had published encouraging preclinical data on its investigational, next generation antibody-drug conjugate (ADC) BYON3521.
• In February 2023, Gilead Sciences, Inc. announced the US Food and Drug Administration (FDA) had approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. The approval is based on statistically significant and clinically meaningful progression-free survival and overall survival data from the Phase III TROPiCS-02 study. Trodelvy is now also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network (NCCN) as defined in the Clinical Practice Guidelines in Oncology (NCCN Guidelines).

Antibody–drug Conjugates (ADCs): Company and Product Profiles (Marketed Therapies)

1. Company Overview: Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. 

Product Description: TRODELVY

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment. Trodelvy is approved in more than 40 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved in the U.S. to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer and has an accelerated approval for treatment of certain patients with second-line metastatic urothelial cancer. 

2. Company Overview: Astellas Pharma

Astellas Pharma Inc. is a leading Japanese multinational pharmaceutical company formed in 2005 from the merger of Yamanouchi Pharmaceutical and Fujisawa Pharmaceutical. Headquartered in Tokyo, Astellas is dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. 

Product Description: PADCEV

PADCEV (enfortumab vedotin-ejfv) is an antibody-drug conjugate used to treat advanced bladder cancer and other urothelial cancers. It is approved in combination with pembrolizumab for the treatment of adult patients in combination with locally advanced or metastatic urothelial cancer. PADCEV works by delivering a cell-killing chemotherapy drug directly to cancer cells that express a protein called Nectin-4. The antibody part of PADCEV attaches to Nectin-4 on the cancer cell surface, allowing the chemotherapy payload to enter and destroy the cell.

Antibody–drug Conjugates (ADCs): Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Jiangsu HengRui Medicine Co., Ltd.

Jiangsu Hengrui Medicine Co Ltd (Jiangsu Hengrui) is a biopharmaceutical company that focuses on the research, development, manufacture, and distribution of novel pharmaceutical products. Its product portfolio includes anti-tumor drugs, surgical drugs, contrast agents, angiomyocardiac drugs, and antibiotics. The company is also developing pipeline products for the treatment of cancer, Crohn’s disease, anemia, diabetes, atopic dermatitis, chronic bone disease, blood pressure, and hypercholesterolemia. Jiangsu Hengrui has R&D facilities in China, the US, and Japan. The company offers products through its sales and distribution network in China, the US, Japan, Germany Switzerland, and Australia. Jiangsu Hengrui is headquartered in Lianyungang, Jiangsu Province, China.

Product Description: SHR-A1811

SHR-A1811 is an innovative HER2-targeted antibody-drug conjugate with a topoisomerase I payload conjugated to an anti-HER-2 mAb by a cleavable linker. Once bound to HER2 expressing tumor cells, the ADC is internalized and the linker releases the toxin, leading to tumor cell death.  It can bind to the cell membrane surface of HER2 expressing cells, and then enter the cells to reach the lysosome to release small Molecular toxins eventually induce tumor cell apoptosis, combining the high targeting of antibodies and the powerful killing power of cytotoxic drugs on target cells. 

Preclinical research results show that SHR-A1811 has good anti-tumor activity, safety, tolerability and pharmacokinetic characteristics, or can further improve drug resistance, enhance efficacy, meet clinical needs, and provide more cancer patients multiple choice. 

Currently, the drug is in the Phase III stage of its development for the treatment of HER2 positive breast cancer. The drug is also being evaluated for the treatment of gynaecological cancer, gastric cancer, non-small cell lung cancer, oesophageal cancer, and solid tumors.

2. Company Overview: AbbVie

AbbVie is a global biopharmaceutical company founded in 2013 as a spin-off from Abbott Laboratories. Headquartered in North Chicago, Illinois, AbbVie focuses on developing and delivering advanced therapies that address complex and serious diseases. The company's portfolio includes treatments for conditions such as immunological disorders, oncology, virology, and neurology. With a commitment to innovation and patient-centric care, AbbVie continues to invest in research and development to create new therapeutic solutions, aiming to improve health outcomes and quality of life for patients worldwide.

Product Description: ABBV-399

Telisotuzumab vedotin (Teliso-V), formerly called ABBV-399, is a first-in-class antibody–drug conjugate (ADC) composed of the anti–c-Met humanized monoclonal antibody ABT-700 coupled to the cytotoxic monomethyl auristatin E (MMAE) through a valine–citrulline linker (ABT-700–vcMMAE). Teliso-V uses the same linker–drug payload as that of the US Food and Drug Administration–approved brentuximab vedotin. Teliso-V targets c-Met–expressing tumor cells with specific and high-affinity binding, and it mediates the delivery of MMAE directly to tumor cells. Engagement of c-Met by Teliso-V results in the internalization of the ADC and intracellular release of MMAE after proteolysis of the linker. MMAE then binds to tubulin, thereby inhibiting mitosis and causing tumor cell death. The drug is currently in Phase III stage of development for the treatment of patients with Non-Small Cell Lung Cancer.

3. Company Overview: Bio-Thera Solutions 

Bio-Thera Solutions is a biotechnology company based in Guangzhou, China, dedicated to the development and commercialization of innovative therapies for cancer, autoimmune diseases, and other serious conditions. Established in 2003, the company focuses on creating high-quality biologics, including monoclonal antibodies and antibody-drug conjugates. Bio-Thera Solutions leverages advanced research and development capabilities to address unmet medical needs and improve patient outcomes.

Product Description: BAT8006

BAT8006, is an antibody drug conjugate (ADC) that targets folic acid receptor α (FRα). FRα is a folic acid-binding protein located on cell membranes that is overexpressed in a variety of solid tumors such as ovarian, lung, breast cancer, etc., but has a limited distribution and a lower level of expression in normal human tissues. Differences in expression levels make FRα an ideal target for ADC drug development.  BAT8006 was developed using Bio-Thera's anti-FRα antibody and Bio-Thera’s proprietary ADC linker-payload combination that includes a systemically stable and cleavable linker and a small molecule topoisomerase I inhibitor. The drug is currently in Phase II stage of development for the treatment of patients with Solid tumors.

4. Company Overview: MediLink Therapeutics

MediLink Therapeutics is a biotechnology company focused on developing innovative therapeutic solutions for various medical conditions. Leveraging cutting-edge technology and extensive research, the company aims to create effective and targeted treatments. MediLink Therapeutics is committed to advancing healthcare through scientific discovery and collaboration, working towards improving patient outcomes and addressing unmet medical needs. The company has established a proprietary Tumor Microenvironment Activable LINker-payload (TMALIN®) ADC technology platform with independent intellectual property rights, which aims to improve the therapeutic window of ADC drugs.

Product Description: YL202

It is an antibody-drug conjugate (ADC) composed of a monoclonal antibody directed against human epidermal growth factor receptor 3 (HER3; ErbB3) conjugated via a tumor microenvironment (TME) activable protease-cleavable linker to a cytotoxic DNA topoisomerase I inhibitor, with potential antineoplastic activity. Upon administration of anti-HER3 ADC YL202, the anti-HER3 antibody moiety targets and binds to HER3 expressed on tumor cells. Upon proteolytic cleavage in the TME and the release of the topoisomerase I inhibitor, the topoisomerase I inhibitor targets and binds to DNA topoisomerase I, thereby stabilizing the cleavable complex between topoisomerase I and DNA and resulting in DNA breaks, inhibition of DNA replication and apoptosis in HER3-expressing tumor cells. The drug is currently in Phase II stage of development for the treatment of patients with Solid tumors.

5. Company Overview: Byondis

Byondis is an independent, privately held, clinical stage biopharmaceutical research and development company based in Nijmegen, the Netherlands. Founded in 2012 as a subsidiary of Dutch generics pharmaceutical company Synthon, Byondis quickly built a promising pipeline of innovative research and development programs aimed at creating precision medicines targeting intractable cancers and autoimmune diseases. In 2019, Synthon Biopharmaceuticals separated from Synthon, resulting in the formation of Byondis as a new independent company, which was rebranded in 2020. 

Product Description: BYON 3521

BYON3521 is comprised of the humanized IgG1 c-MET-targeting monoclonal antibody, SYD2884, and a cleavable linker-drug called valine-citrulline-seco-DUocarmycin-hydroxyBenzamide-Azaindole (vc-seco-DUBA or SYD980). It employs site-specific conjugation to an engineered cysteine residue located on heavy chain position 41 of the antibody. The antibody part of BYON3521 binds to c-MET on the surface of the cancer cell and the ADC is internalized. After proteolytic cleavage of the linker in the lysosome, the inactivated cytotoxin is activated, binds to the DNA and DNA damage is induced, resulting in tumor cell death. Treatment with BYON3521 is considered a form of targeted therapy. The drug is currently in Phase I stage of development for the treatment of patients with Solid tumors.

6. Company Overview: Iksuda Therapeutics

Iksuda Therapeutics is a biotechnology company focused on the development of next-generation antibody-drug conjugates (ADCs) for the treatment of cancer. Leveraging their proprietary PermaLink® conjugation platform and the IksuDRIVE payload platform, Iksuda aims to enhance the efficacy and safety profile of ADCs. The company's innovative approach is designed to address the limitations of existing cancer therapies, providing new treatment options for patients with hard-to-treat cancers. With a commitment to advancing oncology therapeutics, Iksuda is at the forefront of biopharmaceutical innovation. 

Product Description: IKS03

IKS03 is a CD19-targeting ADC with a PBD dimer pro-drug payload that induces DNA crosslinking and blocks DNA replication ultimately leading to cell death. IKS03 is generated by site-specific bioconjugation yielding a homogeneous conjugate with a drug to antibody ratio of 2. Linker-payload design in IKS03 utilizes LCB’s proprietary glucuronide-trigger for payload release and activation. Following CD19 tumor selective binding and uptake, IKS03 requires intracellular lysosomal processing of beta-glucuronidase protecting groups to fully activate the payload which minimizes systemic release of the PBD dimer in human plasma. Prodrug design results in an increased therapeutic margin compared to traditional ADCs with DNA-crosslinking payloads, with increased efficacy and decreased toxicity. The drug is currently in Phase I stage of development for the treatment of patients with B-cell lymphomas.

 

Further product details are provided in the report……..

Antibody–drug Conjugates (ADCs) Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Antibody–drug Conjugates (ADCs) 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.

Antibody–drug Conjugates (ADCs) Competitive Landscape 

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

Antibody–drug Conjugates (ADCs) 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 Antibody–drug Conjugates (ADCs) drugs?
• How many Antibody–drug Conjugates (ADCs) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Antibody–drug Conjugates (ADCs)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Antibody–drug Conjugates (ADCs) 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 Antibody–drug Conjugates (ADCs) and their status?
• What are the key designations that have been granted to the emerging and approved drugs?