DelveInsight’s, “HER2 Positive Breast Cancer Pipeline Insight, 2025” report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in HER2 Positive Breast Cancer pipeline landscape. It covers the HER2 Positive Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the HER2 Positive Breast Cancer pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Stay ahead with the latest insights! Download DelveInsight’s comprehensive HER2 Positive Breast Cancer Pipeline Report to explore emerging therapies, key players, and future treatment landscapes @ HER2 Positive Breast Cancer Pipeline Outlook Report

Key Takeaways from the HER2 Positive Breast Cancer Pipeline Report

• In June 2025, Sichuan Baili Pharmaceutical Co. Ltd announced a Phase Ill Clinical Study of BL-M07D1 for Injection Versus Trastuzumab Emtansine (T-DM1) in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy.
• In June 2025, Seagen conducted a study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.
• In June 2025, Alliance Foundation Trials LLC organized a study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
• DelveInsight’s HER2 Positive Breast Cancer Pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for HER2 Positive Breast Cancer treatment.
• The leading HER2 Positive Breast Cancer Companies such as 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.
• Promising HER2 Positive Breast Cancer Pipeline Therapies such as Trastuzumab, Paclitaxel, Zanidatamab, Letrozole, Tamoxifen, PTC+Pertuzumab, FEC-T+Pertuzumab, SHR-A1811, Pyrotinib and others.

Discover how the HER2 Positive Breast Cancer Treatment paradigm is evolving. Access DelveInsight’s in-depth HER2 Positive Breast Cancer Pipeline Analysis for a closer look at promising breakthroughs @ HER2 Positive Breast Cancer Clinical Trials and Studies

HER2 Positive Breast Cancer Emerging Drugs Profile

• HD201: Prestige BioPharma

Prestige Biopharma’s HD201 is a biosimilar to Roche’s Herceptin (trastuzumab) to be prescribed for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer. Trastuzumab targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells. Currently the drug is in Preregistration stage for its development in HER2 Positive Breast Cancer.

• 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 HER2 Positive Breast Cancer.

• Zanidatamab: Zymeworks Inc.

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric™ platform that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase I, Phase II and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. Zymeworks has entered into separate agreements with each of BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz), granting each of BeiGene and Jazz with exclusive rights to develop and commercialize zanidatamab throughout various counties around world. Currently the drug is in Phase II stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.

• CCT303-406: Shanghai EXUMA Biotechnology

CCT303-406 is EXUMA Biotech’s tumor microenvironment restricted (TMR) autologous CAR-T product candidates targeting HER2, which is currently in the Phase I clinical trial in patients with metastatic HER2+ solid tumors. HER2 overexpression is a hallmark of several tumors, including those originating from breast, stomach, bladder, and colon. A significant proportion of patients relapse or become unresponsive to antibody-based products targeting HER2 in early lines of treatment, yet still retain overexpression of HER2. CCT303-406 may be a promising option for this patient population providing T cell-mediated antitumor activity via targeting of HER2. Differentiating itself from other HER2 CAR-T Therapies, CCT303-406 incorporates EXUMA’s TMR safety technology, which helps restrict CAR-T activity to the tumor microenvironment potentially reducing the risk of on-target, off-tumor cytotoxicity. Currently the drug is in Phase I/II stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.

The HER2 Positive Breast Cancer Pipeline Report Provides Insights into

• 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.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for HER2 Positive Breast Cancer Treatment.
• HER2 Positive Breast Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• 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.
• 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

Explore groundbreaking therapies and clinical trials in the HER2 Positive Breast Cancer Pipeline. Access DelveInsight’s detailed report now! @ New HER2 Positive Breast Cancer Drugs

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.

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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

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

Download DelveInsight’s latest report to gain strategic insights into upcoming therapies and key developments @ HER2 Positive Breast Cancer Market Drivers and Barriers, and Future Perspectives

Scope of the HER2 Positive Breast Cancer Pipeline Report

• Coverage- Global
• 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.
• HER2 Positive Breast Cancer Pipeline Therapies- Trastuzumab, Paclitaxel, Zanidatamab, Letrozole, Tamoxifen, PTC+Pertuzumab, FEC-T+Pertuzumab, SHR-A1811, Pyrotinib and others.
• HER2 Positive Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• HER2 Positive Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Which companies are leading the race in HER2 Positive Breast Cancer drug development? Find out in DelveInsight’s exclusive HER2 Positive Breast Cancer Pipeline Report—access it now! @ HER2 Positive Breast Cancer Emerging Drugs and Major Companies

Table of Content

1. Introduction
2. Executive Summary
3. HER2 Positive Breast Cancer: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. HER2 Positive Breast Cancer– DelveInsight’s Analytical Perspective
7. Late Stage Products (Preregistration)
8. HD201: Prestige BioPharma
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. Zanidatamab: Zymeworks Inc.
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I/II)
14. CCT303-406: Shanghai EXUMA Biotechnology
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug Name: Company Name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. HER2 Positive Breast Cancer Key Companies
21. HER2 Positive Breast Cancer Key Products
22. HER2 Positive Breast Cancer- Unmet Needs
23. HER2 Positive Breast Cancer- Market Drivers and Barriers
24. HER2 Positive Breast Cancer- Future Perspectives and Conclusion
25. HER2 Positive Breast Cancer Analyst Views
26. HER2 Positive Breast Cancer Key Companies
27. Appendix

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