HER2-Positive Breast Cancer Pipeline 2025: Therapies Under Investigation, Clinical Trials Milestones, and FDA Approvals by DelveInsight | Roche Pharma AG, Dizal Pharma, Greenwich LifeSciences, Ambrx

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, HER2-Positive Breast Cancer pipeline constitutes 50+ key companies continuously working towards developing 55+ HER2-Positive Breast Cancer treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"HER2-Positive Breast Cancer Pipeline Insight, 2025 [https://www.delveinsight.com/sample-request/her2-positive-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the HER2-Positive Breast Cancer Market.

The HER2-Positive Breast Cancer Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the HER2-Positive Breast Cancer Pipeline Report:

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Companies across the globe are diligently working toward developing novel HER2-Positive Breast Cancer treatment therapies with a considerable amount of success over the years.

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HER2-Positive Breast Cancer companies working in the treatment market are AdaptVac, Voronoi, Dizal Pharmaceuticals, Alteogen, Inc, Precirix, BioInvent International, Miracogen Inc., Alphamab BioPharmaceuticals, CSPC ZhongQi Pharmaceutical Technology, Jiangsu HengRui Medicine Co., Ltd, Shanghai Henlius Biotech, Ambrx, Genentech, Innate Pharma, EirGenix, GeneQuantum Healthcare Co., Ltd., and others, are developing therapies for the HER2-Positive Breast Cancer treatment

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Emerging HER2-Positive Breast Cancer therapies in the different phases of clinical trials are- ES2B C001, VRN 10, DZD1516, ALT-P7, CAM-H2, BI-1607+ trastuzumab, MRG002 Shanghai, KN-026 Jiangsu, DP 303c, SHR-A1811, HLX11, ARX 788, Inavolisib, Monalizumab, Pertuzumab, GQ1001, and others are expected to have a significant impact on the HER2-Positive Breast Cancer market in the coming years.

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In September 2025, The U.S. FDA has accepted and granted Priority Review to Daiichi Sankyo (TSE: 4568) and AstraZeneca's (LSE/STO/Nasdaq: AZN) supplemental Biologics License Application (sBLA) for ENHERTU Registered (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab, intended as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.

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In March 2025, The FDA awarded orphan drug designation to Nerlynx Registered (neratinib) for treating breast cancer patients with brain metastases. Neratinib, a tyrosine kinase inhibitor, is already approved for extended adjuvant therapy in HER2-positive breast cancer following trastuzumab treatment.

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In February 2025, Shanghai Henlius Biotech announced that the U.S. FDA has accepted its Biologics License Application (BLA) for HLX11, a biosimilar of Perjeta Registered (pertuzumab). This milestone strengthens the company's expansion into the U.S. market for HER2-positive breast cancer treatment, following positive Phase 3 trial results and a global commercialization deal with Organon.

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In September 2024, A study presented at the ESMO Congress revealed that AstraZeneca and Daiichi Sankyo's Enhertu offers benefits to women with HER2-positive breast cancer, including those with brain metastases. Findings from the DESTINY-Breast12 trial showed that 61.6% of patients with brain metastases remained progression-free after one year, with a central nervous system progression-free survival rate of 58.9%, regardless of whether the metastases were stable or progressing. These results highlight Enhertu's potential in effectively treating HER2-positive breast cancer with brain involvement.

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In April 2024, The PHERGain clinical trial, led by MEDSIR-an organization focused on advancing independent oncology research globally-has been published in the esteemed journal The Lancet. The study's positive findings indicate that one-third of patients with localized HER2-positive breast cancer can achieve a cure without the need for chemotherapy, significantly minimizing side effects.

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In March 2024, Phesgo is a fixed-dose combination of Perjeta and Herceptin with hyaluronidase, used to treat HER2-positive breast cancer and HER2-positive colorectal cancer that has progressed after chemotherapy. It can be administered with chemotherapy as a neoadjuvant treatment for patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer as part of a comprehensive early breast cancer treatment regimen. Additionally, it is approved as an adjuvant treatment for patients with HER2-positive early breast cancer at high risk of recurrence.

HER2-Positive Breast Cancer Overview

HER2-positive breast cancer is a type of breast cancer that tests positive for human epidermal growth factor receptor 2 (HER2), a protein that promotes the growth of cancer cells. In about 20% of breast cancers, the cancer cells have a higher than normal level of HER2 due to a gene mutation, making the cancer more aggressive.

Get a Free Sample PDF Report to know more about HER2-Positive Breast Cancer Pipeline Therapeutic Assessment-

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Emerging HER2-Positive Breast Cancer Drugs Under Different Phases of Clinical Development Include:

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ES2B C001: AdaptVac

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VRN 10: Voronoi

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DZD1516: Dizal Pharmaceuticals

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ALT-P7: Alteogen, Inc

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CAM-H2: Precirix

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BI-1607+ trastuzumab: BioInvent International

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MRG002 Shanghai: Miracogen Inc.

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KN-026 Jiangsu: Alphamab BioPharmaceuticals

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DP 303c: CSPC ZhongQi Pharmaceutical Technology

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SHR-A1811: Jiangsu HengRui Medicine Co., Ltd

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HLX11: Shanghai Henlius Biotech

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ARX 788: Ambrx

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Inavolisib: Genentech

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Monalizumab: Innate Pharma

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Pertuzumab: EirGenix

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GQ1001: GeneQuantum Healthcare Co., Ltd.

HER2-Positive Breast Cancer Route of Administration

HER2-Positive Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

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Oral

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Intravenous

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Subcutaneous

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Parenteral

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Topical

HER2-Positive Breast Cancer Molecule Type

HER2-Positive Breast Cancer Products have been categorized under various Molecule types, such as

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Recombinant fusion proteins

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Small molecule

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Monoclonal antibody

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Peptide

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Polymer

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Gene therapy

HER2-Positive Breast Cancer Pipeline Therapeutics Assessment

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HER2-Positive Breast Cancer Assessment by Product Type

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HER2-Positive Breast Cancer By Stage and Product Type

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HER2-Positive Breast Cancer Assessment by Route of Administration

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HER2-Positive Breast Cancer By Stage and Route of Administration

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HER2-Positive Breast Cancer Assessment by Molecule Type

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HER2-Positive Breast Cancer by Stage and Molecule Type

DelveInsight's HER2-Positive Breast Cancer Report covers around 55+ products under different phases of clinical development like

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Late-stage products (Phase III)

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Mid-stage products (Phase II)

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Early-stage product (Phase I)

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Pre-clinical and Discovery stage candidates

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Discontinued & Inactive candidates

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Route of Administration

Further HER2-Positive Breast Cancer product details are provided in the report. Download the HER2-Positive Breast Cancer pipeline report to learn more about the emerging HER2-Positive Breast Cancer therapies [https://www.delveinsight.com/sample-request/her2-positive-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Some of the key companies in the HER2-Positive Breast Cancer Therapeutics Market include:

Key companies developing therapies for HER2-Positive Breast Cancer are - Roche Pharma AG, Dizal Pharmaceuticals, Greenwich LifeSciences, Ambrx, Alteogen, Suzhou Zanrong Pharma Limited, AstraZeneca, Shanghai Henlius Biotech, GeneQuantum Healthcare (Suzhou) Co., Ltd., Klus Pharma Inc.,Shanghai Miracogen Inc., Carisma Therapeutics Inc, Triumvira Immunologics, Inc., Precirix, Seagen Inc., CSPC ZhongQi Pharmaceutical Technology Co., Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Zymeworks Inc., Pieris Pharmaceuticals, Inc., Orum Therapeutics, RemeGen Co., Ltd., and others.

HER2-Positive Breast Cancer Pipeline Analysis:

The HER2-Positive Breast Cancer pipeline report provides insights into

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The report provides detailed insights about companies that are developing therapies for the treatment of HER2-Positive Breast Cancer with aggregate therapies developed by each company for the same.

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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for HER2-Positive Breast Cancer Treatment.

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HER2-Positive Breast Cancer key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

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HER2-Positive Breast Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the HER2-Positive Breast Cancer market.

The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about HER2-Positive Breast Cancer drugs and therapies [https://www.delveinsight.com/sample-request/her2-positive-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

HER2-Positive Breast Cancer Pipeline Market Drivers

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Increase in prevalence of Breast Cancer and its recurrence, robust Pipeline, higher Indulgence of Immunotherapy are some of the important factors that are fueling the HER2-Positive Breast Cancer Market.

HER2-Positive Breast Cancer Pipeline Market Barriers

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However, side effects associated with the treatment, high cost of the treatment and other factors are creating obstacles in the HER2-Positive Breast Cancer Market growth.

Scope of HER2-Positive Breast Cancer Pipeline Drug Insight

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Coverage: Global

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Key HER2-Positive Breast Cancer Companies: AdaptVac, Voronoi, Dizal Pharmaceuticals, Alteogen, Inc, Precirix, BioInvent International, Miracogen Inc., Alphamab BioPharmaceuticals, CSPC ZhongQi Pharmaceutical Technology, Jiangsu HengRui Medicine Co., Ltd, Shanghai Henlius Biotech, Ambrx, Genentech, Innate Pharma, EirGenix, GeneQuantum Healthcare Co., Ltd., and others

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Key HER2-Positive Breast Cancer Therapies: ES2B C001, VRN 10, DZD1516, ALT-P7, CAM-H2, BI-1607+ trastuzumab, MRG002 Shanghai, KN-026 Jiangsu, DP 303c, SHR-A1811, HLX11, ARX 788, Inavolisib, Monalizumab, Pertuzumab, GQ1001, and others

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HER2-Positive Breast Cancer Therapeutic Assessment: HER2-Positive Breast Cancer current marketed and HER2-Positive Breast Cancer emerging therapies

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HER2-Positive Breast Cancer Market Dynamics: HER2-Positive Breast Cancer market drivers and HER2-Positive Breast Cancer market barriers

Request for Sample PDF Report for HER2-Positive Breast Cancer Pipeline Assessment and clinical trials [https://www.delveinsight.com/sample-request/her2-positive-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Table of Contents

1. HER2-Positive Breast Cancer Report Introduction

2. HER2-Positive Breast Cancer Executive Summary

3. HER2-Positive Breast Cancer Overview

4. HER2-Positive Breast Cancer- Analytical Perspective In-depth Commercial Assessment

5. HER2-Positive Breast Cancer Pipeline Therapeutics

6. HER2-Positive Breast Cancer Late Stage Products (Phase II/III)

7. HER2-Positive Breast Cancer Mid Stage Products (Phase II)

8. HER2-Positive Breast Cancer Early Stage Products (Phase I)

9. HER2-Positive Breast Cancer Preclinical Stage Products

10. HER2-Positive Breast Cancer Therapeutics Assessment

11. HER2-Positive Breast Cancer Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. HER2-Positive Breast Cancer Key Companies

14. HER2-Positive Breast Cancer Key Products

15. HER2-Positive Breast Cancer Unmet Needs

16 . HER2-Positive Breast Cancer Market Drivers and Barriers

17. HER2-Positive Breast Cancer Future Perspectives and Conclusion

18. HER2-Positive Breast Cancer Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach

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