DelveInsight’s “HER2-Negative Breast Cancer Pipeline Insight 2026” report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in HER2-Negative Breast Cancer pipeline landscape. It covers the HER2-Negative Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the HER2-Negative Breast Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the HER2-Negative Breast Cancer Pipeline Report

• On April 13, 2026- Merck Sharp & Dohme LLC initiated a phase 3 study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.
• On April 08, 2026- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. conducted a phase II study is a multicenter, open-label, multi-cohort phase II clinical trials to evaluate the efficacy and safety of TQB3616 capsules combined with Fulvestrant injection in subjects with HR-positive and HER2-negative advanced and/or metastatic breast cancer, including Cohort 1 and Cohort 2. Each cohort will enroll 30-60 cases.
• On April 08, 2026- Daiichi Sankyo announced a study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor [HR]-negative and HR-positive) unresectable and/or metastatic breast cancer.
• On April 06, 2026- Beijing Biotech conducted a phase 1/2 study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer. After a tumor antigen assessment (HER2/ERBB2, MUC1, ROR1,TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.
• On April 03, 2026- The Methodist Hospital Research Institute initiated a phase II study to test the safety and effectiveness of using the drug alpelisib together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2 negative metastatic or locally advanced metaplastic breast cancer, who have not responded to previous treatments.
• On April 02, 2026- Novartis Pharmaceuticals initiated a Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study.
• DelveInsight’s HER2-Negative Breast Cancer pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for HER2-Negative Breast Cancer treatment.
• The leading HER2-Negative Breast Cancer Companies such as Genentech, CytomX Therapeutics, H3 Biomedicine, Regor Therapeutics, Immutep Limited, Merck & Co, Klus Pharma, Olema Pharmaceuticals, BeiGene, AstraZeneca, Janssen/Merck/GSK, Ono Pharmaceutical, Laekna Therapeutics, NanoMab, InSilico Medicine, TYK Medicine, Shanghai Pharmaceutical Group, Verastem Oncology, Allarity Therapeutics, Shenzhen Yangli Pharmaceutical Technology, Phoenix Molecular Designs, and others.
• Promising HER2-Negative Breast Cancer Therapies such as Doxorubicin, Cyclophosphamide, Utidelone Combined with Bevacizumab, Capecitabine, Carboplatin, Cisplatin, and others.

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The HER2-Negative Breast Cancer Pipeline Report provides a disease overview, pipeline scenario, and therapeutic assessment of the key pipeline therapies in this domain. The HER2-Negative Breast Cancer Pipeline Report also highlights the unmet needs with respect to the HER2-Negative Breast Cancer.

HER2-Negative Breast Cancer Overview

Breast Cancer is the world’s most common disease in women, and is also a major factor that leads to death. It is reported that 5% of patients with breast cancer have distant metastasis at a diagnosis, and 30% of patients with early cancer subsequently experience the distant metastasis. Metastatic breast cancer cannot be completely cured; however, significant improvement in the survival period was observed consistent with the emergence of novel therapy. The purpose of the treatment for metastatic breast cancer is to prolong the survival period and improve the cancer patients’ quality of life (QOL) by managing cancer-related symptoms. To that end, not the same strategy for all patients but individual approach for each patient should be used. When a breast cancer is HER2-negative, it means that the cancerous cells do not contain high levels of the protein HER2.

HER2-Negative Breast Cancer Emerging Drugs Profile

• Giredestrant : Genentech

Giredestrant is a novel investigative small molecule that works as selective estrogen receptor degrader (SERD) by targeting the estrogen receptor (ER). The drug candidate is a new molecular entity (NME) which is administered through oral route. Preclinical studies suggest that Giredestrant is orally bioavailable and competitively inhibits the binding of estrogen to the ER. In preclinical models, Giredestrant has been shown to restrain the normally dynamic behavior of both wild-type and mutant ER, immobilizing the ER and attenuating the expression of its target genes. Currently, the drug is in Phase III stage of its development for the treatment of HER2 negative breast cancer.

• Inavolisib : Genentech

Inavolisib is an investigational small molecule designed to selectively inhibit mutant PI3Kα. In preclinical models, the molecule showed potent selective inhibition of PI3Kα and has increased potency to mutant PI3K cells over wild type. It is less sensitive for the other three PI3K isoforms. Inavolisib binds to the ATP-binding site of PI3Kα, thereby blocking phosphorylation of PIP2 to PIP3 and preventing downstream signaling as shown in preclinical models. Moreover, inavolisib specifically degrades the mutant form of PI3Kα, resulting in reduction of pathway activity. Currently the drug is in Phase III stage of its development for the treatment of HER2 negative breast cancer.

• CX-2009 : CytomX Therapeutics

CX-2009 (Praluzatamab ravtansine) is a conditionally activated antibody-drug conjugate (ADC) comprised of a CD166-directed humanized monoclonal antibody conjugated to the maytansinoid DM4, a tubulin inhibitor. Praluzatamab ravtansine utilizes CytomX Probody® platform technology, which incorporates a masking peptide to cover and block the cellular binding region of the antibody. Tethered to the antibody via a protease-cleavable linker, currently, the drug is in Phase II stage of its development for the treatment of HER2 negative breast cancer.

• H3B 6545 : H3 Biomedicine

H3B-6545 is an oral, selective estrogen receptor covalent antagonist (SERCA) for the research of metastatic ER-positive, HER2-negative breast cancer. H3B- 6545, a first-in-class small molecule selective estrogen receptor covalent antagonist (SERCA) demonstrates activity in tumor models that harbor wild-type or mutant ERα.4 H3B-6545 activity against ERα mutants resistant to standard therapy provides an opportunity to target a currently unmet medical need both as a single agent and in combination with other breast cancer therapies. Currently, the drug is in Phase II stage of its development for the treatment of HER2 negative breast cancer.

• RGT-419B : Regor Therapeutics

RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. Results from non-clinical studies showed that RGT-419B demonstrated full suppression of ER+ breast cancer cell proliferation with acquired resistance to CDK4/6 inhibitors. Additionally, RGT-419B’s tumor cell suppression was further augmented when combined with a selective estrogen receptor down-regulator or a PI3K signaling pathway inhibitor. Currently, the drug is in Phase I stage of its development for the treatment of HER2 negative breast cancer.

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The HER2-Negative Breast Cancer pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of HER2-Negative 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-Negative Breast Cancer Treatment.
• HER2-Negative Breast Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• HER2-Negative 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-Negative Breast Cancer market.

HER2-Negative Breast Cancer Companies

Genentech, CytomX Therapeutics, H3 Biomedicine, Regor Therapeutics, Immutep Limited, Merck & Co, Klus Pharma, Olema Pharmaceuticals, BeiGene, AstraZeneca, Janssen/Merck/GSK, Ono Pharmaceutical, Laekna Therapeutics, NanoMab, InSilico Medicine, TYK Medicine, Shanghai Pharmaceutical Group, Verastem Oncology, Allarity Therapeutics, Shenzhen Yangli Pharmaceutical Technology, Phoenix Molecular Designs, and others.

HER2-Negative 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
• Parenteral
• Intravitreal
• Subretinal
• Topical

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

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

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Scope of the HER2-Negative Breast Cancer Pipeline Report

• Coverage- Global
• HER2-Negative Breast Cancer Companies- Genentech, CytomX Therapeutics, H3 Biomedicine, Regor Therapeutics, Immutep Limited, Merck & Co, Klus Pharma, Olema Pharmaceuticals, BeiGene, AstraZeneca, Janssen/Merck/GSK, Ono Pharmaceutical, Laekna Therapeutics, NanoMab, InSilico Medicine, TYK Medicine, Shanghai Pharmaceutical Group, Verastem Oncology, Allarity Therapeutics, Shenzhen Yangli Pharmaceutical Technology, Phoenix Molecular Designs, and others.
• HER2 Negative Breast Cancer Therapies- Doxorubicin, Cyclophosphamide, Utidelone Combined with Bevacizumab, Capecitabine, Carboplatin, Cisplatin, and others.-
• HER2-Negative Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• HER2-Negative Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Find out in DelveInsight’s exclusive HER2-Negative Breast Cancer Pipeline Report—access it now! @ HER2-Negative Breast Cancer Emerging Drugs and Major Companies

Table of Content

1. Introduction
2. Executive Summary
3. HER2 Negative Breast Cancer: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. HER2 Negative Breast Cancer– DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. Giredestrant : Genentech
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. CX-2009 : CytomX Therapeutics
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. RGT-419B : Regor Therapeutics
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 Negative Breast Cancer Key Companies
21. HER2 Negative Breast Cancer Key Products
22. HER2 Negative Breast Cancer- Unmet Needs
23. HER2 Negative Breast Cancer- Market Drivers and Barriers
24. HER2 Negative Breast Cancer- Future Perspectives and Conclusion
25. HER2 Negative Breast Cancer Analyst Views
26. HER2 Negative Breast Cancer Key Companies
27. Appendix

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