HER2-Positive Breast Cancer Pipeline Insight 2025: 55+ Pipeline Drugs, Targeted Therapies, and Next-Generation Antibodies Redefine the Treatment Landscape | DelveInsight

DelveInsight's "HER2-Positive Breast Cancer - Pipeline Insight, 2025" highlights over 55+ therapies in development for HER2-positive breast cancer, one of the most aggressive breast cancer subtypes. While current standards such as trastuzumab, pertuzumab, and T-DXd (trastuzumab deruxtecan) have significantly improved survival, resistance and relapse remain major challenges, sustaining unmet needs in the HER2-positive breast cancer treatment market.

The pipeline is rapidly expanding with next-generation HER2-directed therapies, including novel antibody-drug conjugates (ADCs), bispecific antibodies, and tyrosine kinase inhibitors (TKIs) aimed at overcoming resistance. Immuno-oncology is also playing a growing role, with checkpoint inhibitors and CAR-T cell therapies being evaluated in combination with HER2-targeted drugs. In addition, precision medicine approaches integrating HER2-targeted therapy with genomic and biomarker-driven strategies are under active investigation, broadening the spectrum of personalized care.

With HER2-positive breast cancer clinical trials spanning innovative modalities from small molecules to engineered antibodies and cell therapies, the therapeutic focus is shifting toward durable disease control and improved long-term outcomes. As late-stage candidates progress toward approval, the HER2-positive breast cancer market is expected to evolve into a more targeted and multi-modality landscape, extending survival and quality of life for patients worldwide.

Interested in learning more about the current treatment landscape and the key drivers shaping the HER2-Positive Breast Cancer pipeline? Click here: https://www.delveinsight.com/report-store/her2-positive-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the HER2-Positive Breast Cancer Pipeline Report
• DelveInsight's HER2-Positive Breast Cancer pipeline analysis depicts a strong space with 50+ active players working to develop 55+ pipeline drugs for HER2-Positive Breast Cancer treatment.
• The leading HER2-Positive Breast Cancer companies include Prestige BioPharma, Jiangsu HengRui Medicine Co., Ltd., Zymeworks Inc., Shanghai EXUMA Biotechnology, ORIC Pharmaceuticals, Formosa Pharmaceuticals, EirGenix, ExpreS2ion Biotechnologies, Theratechnologies, Byondis, Tanvex Biopharma, Roche, Alphamab, Biocad, Shanghai Henlius Biotech, Novartis Pharmaceuticals, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., Zydus Cadila, and others are evaluating their lead assets to improve the HER2-Positive Breast Cancer treatment landscape.
• Key HER2-Positive Breast Cancer pipeline therapies in various stages of development include HD201, SHR-A1811, Zanidatamab, CCT303-406, ORIC-114, TSY-0110, EG-13074, ES2B C001, TH-1902, SYD-985, TX-05, Inavolisib, Anbenitamab, BCD-178, HLX11, Alpelisib, FS-1502, Pertuzumab biosimilar, and others.
• In September 2025, Greenwich LifeSciences (Nasdaq: GLSI) announced that the FDA has granted Fast Track designation to GLSI-100 for HLA-A*02+ patients with HER2-positive breast cancer following standard HER2-targeted therapy, aiming to improve invasive breast cancer-free survival.
• In July 2025, Imagion Biosystems (ASX: IBX) announced positive FDA feedback on its planned Phase 2 clinical trial for the MagSense® HER2 imaging agent, designed for early detection of HER2 breast cancer. The company will meet with the FDA soon before submitting its Investigational New Drug (IND) application.
• In March 2025, the FDA granted orphan drug designation to Nerlynx® (neratinib) for breast cancer patients with brain metastases. Neratinib is a tyrosine kinase inhibitor approved for extended adjuvant treatment of HER2-positive breast cancer after trastuzumab therapy.
• In February 2025, Shanghai Henlius Biotech announced that the U.S. FDA has accepted its biologics license application for HLX11, a biosimilar to Perjeta® (pertuzumab). This marks a significant step in expanding the company's U.S. presence in treating HER2-positive breast cancer, following successful Phase 3 trials and a global commercialization agreement with Organon.

Request a sample and discover the recent breakthroughs happening in the HER2-Positive Breast Cancer pipeline landscape at https://www.delveinsight.com/report-store/her2-positive-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

HER2-Positive Breast Cancer Overview
HER2-positive breast cancer is a subtype of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein, which promotes the growth of cancer cells. This subtype accounts for approximately 15-20% of all breast cancer cases and is known for its aggressive behavior and higher risk of recurrence compared to HER2-negative forms. HER2 status is determined through biopsy testing, and its identification is crucial for guiding treatment decisions.

Treatment for HER2-positive breast cancer typically includes targeted therapies that specifically inhibit the HER2 receptor, such as trastuzumab, pertuzumab, and newer agents like trastuzumab deruxtecan. These are often combined with chemotherapy, hormonal therapy (if hormone receptors are also present), and sometimes immunotherapy. The prognosis for HER2-positive breast cancer has significantly improved in recent years due to advances in targeted treatments, making it one of the more manageable aggressive subtypes when caught early and treated appropriately.

Find out more about HER2-Positive Breast Cancer medication at https://www.delveinsight.com/report-store/her2-positive-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

HER2-Positive Breast Cancer Treatment Analysis: Drug Profile
HD201 (Prestige BioPharma):
HD201 is a biosimilar to Roche's trastuzumab (Herceptin), developed for the treatment of HER2-positive breast and metastatic gastric cancers. Trastuzumab works by selectively binding to HER2 receptors on cancer cells, inhibiting their growth. HD201 aims to provide a cost-effective alternative with similar efficacy and safety. The drug is currently in the preregistration stage for HER2-positive breast cancer.

SHR-A1811 (Jiangsu HengRui Medicine Co., Ltd.):
SHR-A1811 is a HER2-targeted antibody-drug conjugate (ADC) that delivers a topoisomerase I inhibitor directly to HER2-expressing tumor cells. After binding, the ADC is internalized, and the cytotoxic payload is released within the cell, leading to apoptosis. Preclinical studies have shown strong anti-tumor activity and good safety profiles. SHR-A1811 is currently in Phase III clinical trials for HER2-positive breast cancer.

Zanidatamab (Zymeworks Inc.):
Zanidatamab is a bispecific antibody engineered using Zymeworks' AzymetricTM platform, designed to bind two distinct sites on the HER2 receptor simultaneously. This biparatopic binding enhances HER2 blockade, internalization, and immune-mediated cell killing. It has shown promising anti-tumor activity in various solid tumors. Zanidatamab is in Phase II clinical trials for HER2-positive breast cancer and is being developed through global partnerships with BeiGene and Jazz Pharmaceuticals.

Learn more about the novel and emerging HER2-Positive Breast Cancer pipeline therapies at https://www.delveinsight.com/report-store/her2-positive-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

HER2-Positive Breast Cancer Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the HER2-Positive Breast Cancer Pipeline Report
• Coverage: Global
• Key HER2-Positive Breast Cancer Companies: Prestige BioPharma, Jiangsu HengRui Medicine Co., Ltd., Zymeworks Inc., Shanghai EXUMA Biotechnology, ORIC Pharmaceuticals, Formosa Pharmaceuticals, EirGenix, ExpreS2ion Biotechnologies, Theratechnologies, Byondis, Tanvex Biopharma, Roche, Alphamab, Biocad, Shanghai Henlius Biotech, Novartis Pharmaceuticals, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., Zydus Cadila, and others.
• Key HER2-Positive Breast Cancer Pipeline Therapies: HD201, SHR-A1811, Zanidatamab, CCT303-406, ORIC-114, TSY-0110, EG-13074, ES2B C001, TH-1902, SYD-985, TX-05, Inavolisib, Anbenitamab, BCD-178, HLX11, Alpelisib, FS-1502, Pertuzumab biosimilar, and others.

To dive deep into rich insights for drugs used for HER2-Positive Breast Cancer treatment, visit: https://www.delveinsight.com/report-store/her2-positive-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. HER2-Positive Breast Cancer Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. HER2-Positive Breast Cancer Pipeline Therapeutics
6. HER2-Positive Breast Cancer Pipeline: Late-Stage Products (Phase III)
7. HER2-Positive Breast Cancer Pipeline: Mid-Stage Products (Phase II)
8. HER2-Positive Breast Cancer Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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This release was published on openPR.