Press release
Breast Cancer Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
Discover the latest drugs and treatment options in the Breast Cancer Pipeline. Dive into DelveInsight's comprehensive report today! @ Breast Cancer Pipeline Outlook [https://www.delveinsight.com/sample-request/breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Key Takeaways from the Breast Cancer Pipeline Report
* In March 2025, Merck Sharp & Dohme LLC announced a study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.
* DelveInsight's Breast Cancer pipeline report depicts a robust space with 100+ Breast Cancer companies working to develop 120+ pipeline therapies for Breast Cancer treatment.
* The leading Breast Cancer Companies such as Byondis, Tanvex Biopharma, Prestige BioPharma, EirGenix, AMbrx, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Roche, Jiangsu Alphamab Oncology Co., Ltd., Jiangsu HengRui Medicine Co., Ltd., RemeGen, Shanghai Henlius Biotech, Merus N.V., Hangzhou DAC Biotech, Lepu Biopharma, Zymeworks, Klus Pharma Inc., Bolt Biotherapeutics, GeneQuantum Healthcare, ALX Oncology, Precirix, BriaCell Therapeutics Corporation, Bliss Biopharmaceutical, BioInvent International, Incyte Corporation, Triumvira Immunologics, Inc., Horizon Therapeutics , and others.
* Promising Breast Cancer Pipeline Therapies such as Oraxol, ARV-471, Ribociclib, E7389, Trastuzumab, GM-CSF, GM-CSF, Trastuzumab, Paclitaxel, Gemcitabine/Carboplatin, Iniparib , and others.
Stay ahead with the most recent pipeline outlook for Breast Cancer. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Breast Cancer Treatment [https://www.delveinsight.com/sample-request/breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Breast Cancer Emerging Drugs Profile
* SHR-A1811: Jiangsu HengRui Medicine Co., Ltd.
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 Breast Cancer.
* HLX11: Shanghai Henlius Biotech
HLX11 is a pertuzumab biosimilar developed by Henlius independently in line with relevant regulations and guidelines on biosimilars in China and the European Union (EU), which can be potentially used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2-positive early breast cancer and in combination with trastuzumab and docetaxel in patients with HER2-positive metastatic or unresectable locally recurrent breast cancer patients. HLX11 can specifically bind with the subdomain II of HER2 extracellular domain and inhibit the heterodimerisation of HER2 and other HER family receptors, i.e., EGFR, HER3, and HER4. This will inhibit signal transduction of relevant pathways and lead to the stop of growth and apoptosis of tumour cells. In the meantime, HLX11 can also enhance the tumour-killing activity of immune cells via antibody-dependent cell cytotoxicity. Currently, the drug is in the Phase III stage of its development for the treatment of HER2 positive Breast Cancer.
* Praluzatamab ravtansine: CytomX Therapeutics
Praluzatamab ravtansine (CX-2009) is a conditionally activated Probody drug conjugate (PDC) comprising an anti-CD166 mAb conjugated to DM4, with a protease-cleavable linker and a peptide mask that limits target engagement in normal tissue and circulation. The tumor microenvironment is enriched for proteases capable of cleaving the linker, thereby releasing the mask, allowing for localized binding of CX-2009 to CD166. Currently, the drug is in the Phase II stage of its development for the treatment of Breast Cancer.
* MCLA-128: Merus N.V.
MCLA-128 is an antibody-dependent cell-mediated cytotoxicity (ADCC) -enhanced Biclonics Registered that utilizes Merus Dock & Block Registered mechanism and inhibits the neuregulin/HER3 tumor-signaling pathway in solid tumors. MCLA-128 is believed to target the HER3 signaling pathway and to overcome the resistance of tumor cells to HER2-targeted therapies using two mechanisms: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor. The therapeutic candidate is a full-length IgG bi-specific antibody that acts by targeting HER2 and HER3. It is an antibody-dependent cellular cytotoxicity (ADCC)-enhanced Biclonic, which is developed based on Biclonics ENGAGE platform. Currently the drug is in the Phase II stage of clinical trial evaluation for the treatment of Breast Cancer.
* DX126 262: Hangzhou DAC Biotech
DX-126262 is under development for the treatment of HER2-positive or HER2-mutated unresectable locally advanced or metastatic non-squamous NSCLC, Breast Cancer, breast cancer. The drug candidate is an antibody drug conjugate comprising recombinant humanized anti-Her2 monoclonal antibody conjugated to Tub-114. It is formulated as lyophilized powder and administered via intravenous route of administration. Currently the drug is in Phase I stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.
Explore groundbreaking therapies and clinical trials in the Breast Cancer Pipeline. Access DelveInsight's detailed report now! @ New Breast Cancer Drugs [https://www.delveinsight.com/sample-request/breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Breast Cancer Companies
Byondis, Tanvex Biopharma, Prestige BioPharma, EirGenix, AMbrx, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Roche, Jiangsu Alphamab Oncology Co., Ltd., Jiangsu HengRui Medicine Co., Ltd., RemeGen, Shanghai Henlius Biotech, Merus N.V., Hangzhou DAC Biotech, Lepu Biopharma, Zymeworks, Klus Pharma Inc., Bolt Biotherapeutics, GeneQuantum Healthcare, ALX Oncology, Precirix, BriaCell Therapeutics Corporation, Bliss Biopharmaceutical, BioInvent International, Incyte Corporation, Triumvira Immunologics, Inc., Horizon Therapeutics, and others
Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration
* Oral
* Intravenous
* Subcutaneous
* Parenteral
* Topical
Breast Cancer Products have been categorized under various Molecule types such as
* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy
Unveil the future of Breast Cancer Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Breast Cancer Market Drivers and Barriers [https://www.delveinsight.com/sample-request/breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Scope of the Breast Cancer Pipeline Report
* Coverage- Global
* Breast Cancer Companies- Byondis, Tanvex Biopharma, Prestige BioPharma, EirGenix, AMbrx, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Roche, Jiangsu Alphamab Oncology Co., Ltd., Jiangsu HengRui Medicine Co., Ltd., RemeGen, Shanghai Henlius Biotech, Merus N.V., Hangzhou DAC Biotech, Lepu Biopharma, Zymeworks, Klus Pharma Inc., Bolt Biotherapeutics, GeneQuantum Healthcare, ALX Oncology, Precirix, BriaCell Therapeutics Corporation, Bliss Biopharmaceutical, BioInvent International, Incyte Corporation, Triumvira Immunologics, Inc., Horizon Therapeutics , and others.
* Breast Cancer Pipeline Therapies- Oraxol, ARV-471, Ribociclib, E7389, Trastuzumab, GM-CSF, GM-CSF, Trastuzumab, Paclitaxel, Gemcitabine/Carboplatin, Iniparib , and others.
* Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Get the latest on Breast Cancer Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Breast Cancer Companies, Key Products and Unmet Needs [https://www.delveinsight.com/sample-request/breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Table of Content
* Introduction
* Breast Cancer Executive Summary
* Breast Cancer: Overview
* Breast Cancer Pipeline Therapeutics
* Breast Cancer Therapeutic Assessment
* Breast Cancer- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* SHR-A1811: Jiangsu HengRui Medicine Co., Ltd.
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* MCLA-128: Merus N.V.
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* DX126 262: Hangzhou DAC Biotech
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* ES2B C001: ExpreS2ion Biotechnologies
* Drug profiles in the detailed report.....
* Inactive Products
* Breast Cancer Companies
* Breast Cancer Products
* Breast Cancer Unmet Needs
* Breast Cancer Market Drivers and Barriers
* Breast Cancer Future Perspectives and Conclusion
* Breast Cancer Analyst Views
* Breast Cancer Companies
* Appendix
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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Contact Person: Yash Bhardwaj
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