DelveInsight’s “Breast Cancer Pipeline Insight 2025” report delivers extensive analysis on over 250 Breast Cancer companies and more than 300 pipeline drugs in the Breast Cancer treatment arena. It includes thorough profiles of Breast Cancer pipeline drugs, encompassing clinical and nonclinical development stages. Additionally, it evaluates Breast Cancer pipeline therapeutics by product category, development phase, administration method, and molecular structure. It also points out discontinued pipeline products in this domain.

Discover the newest medications and treatment avenues in the Breast Cancer Pipeline. Explore DelveInsight's detailed report now! @ Breast Cancer Pipeline Outlook

Key Takeaways from the Breast Cancer Pipeline Report

On October 24, 2025, Sonya Reid conducted a Phase II clinical trial to assess the effect of second-line chemotherapy (such as capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC). 

On October 20, 2025, Merck Sharp & Dohme LLC conducted a trial to compare sacituzumab tirumotecan as a standalone agent and combined with pembrolizumab against 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 illustrates a vibrant arena with over 250 Breast Cancer companies developing more than 300 pipeline therapies for Breast Cancer care. 

The prominent Breast Cancer Companies include Tanvex Biopharma, Sichuan Kelun-Biotech Biopharmaceutical, Shanghai Henlius Biotech, Byondis, CSPC Ouyi Pharmaceutical Co., Ltd., Pfizer, Jazz Pharmaceuticals, Biostar Pharma, Inc., Chia Tai Tianqing Pharmaceutical Group, InventisBio, Coherent Biopharma, Shanghai Jiaolian Drug Research and Development Co., Ltd., Ambrx, MediLink Therapeutics (Suzhou) Co., Ltd., Tasly Pharmaceutical Group, Convalife (Shanghai) Co., Ltd., Merck & Co., AstraZeneca, Aclaris Therapeutics, Boehringer Ingelheim, NovaOnco Therapeutics Co., Ltd., Verastem Oncology, Ellipses Pharma, Shenzhen Yangli Pharmaceutical Technology Co., Ltd., TYK Medicine, Ascendis Pharma, ExpreS2ion Biotechnologies, Mersana Therapeutics, Exelixis, Shenzhen Celconta Life Science, Beijing Wehand-Bio Pharmaceutical, VM Oncology, Hinova Pharmaceuticals, OS Therapies, and Syntab Therapeutics, and others. 

Promising Breast Cancer Pipeline Therapies include Oraxol, ARV-471, Ribociclib, E7389, Trastuzumab, GM-CSF, GM-CSF, Trastuzumab, Paclitaxel, Gemcitabine/Carboplatin, Iniparib, and others. Stay updated with the latest pipeline overview for Breast Cancer. 

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

Breast Cancer Overview

Breast cancer is a malignant growth starting in breast cells, often in the ducts (ductal carcinoma) or lobules (lobular carcinoma). It's among the most common cancers in women globally, though it can affect men too. Risk factors encompass age, family history, genetic alterations like BRCA1 and BRCA2, hormonal influences, obesity, and lifestyle habits. Breast cancer varies from localized, slow-progressing tumors to aggressive forms that spread to other body parts.

Breast Cancer Emerging Drugs Profile

Vepdegestrant (ARV-471): Pfizer/ Arvinas Vepdegestrant is an experimental, orally available PROteolysis TArgeting Chimera (PROTAC) protein degrader engineered to target and break down the estrogen receptor (ER) for treating patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential standalone treatment for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second-line-plus setting. The U.S. Food and Drug Administration (FDA) has awarded vepdegestrant Fast Track designation as monotherapy for adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine therapy. The drug is currently in Preregistration phase for ER+/HER2- Metastatic Breast Cancer, ER+/HER2- Early Breast Cancer.

Utidelone: Biostar Pharma, Inc. Utidelone (UTD1), created by Biostar Pharma, is a genetically modified epothilone analog and advanced microtubule inhibitor approved in China in March 2021 for metastatic breast cancer. Unlike taxanes, it attaches to a distinct microtubule site, allowing it to bypass taxane resistance, exhibit potent anti-tumor effects, and show reduced blood toxicity—providing benefits in progression-free survival (PFS) and overall survival (OS) in heavily treated patients when paired with capecitabine. Ongoing global trials are expanding uses to neoadjuvant breast cancer, brain metastases, and even oral versions for better convenience and wider impact. The drug is in Phase III development for advanced breast cancer, neoadjuvant breast cancer, and breast cancer brain metastasis.

ARX788: Ambrx, Inc. ARX788, an anti-HER2 ADC under broad investigation in breast cancer, gastric/GEJ cancer, and other solid tumor trials. ARX788 is a uniform and highly stable ADC targeting the HER2 receptor with two AS269 cytotoxic payloads precisely linked to a trastuzumab-based antibody. ARX788 was engineered to optimize anti-tumor potential by refining payload count, placement, and linking chemistry. AS269, a proprietary payload, is a tubulin inhibitor crafted to create a highly durable covalent bond with our SAAs and eliminate tumor cells only after antibody-guided cell entry, thus limiting damage to healthy tissue. The drug is in Phase II/III trials for Triple Negative Breast Cancer.

TSL-1502: Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. TSL-1502 is a pro-drug whose metabolite TSL-1502M achieves higher localized levels at cancer sites with greater potency, making our preclinical studies show TSL-1502’s anti-cancer activity superior to rivals with a much broader safety margin. TSL-1502 is a small molecule drug, prepared for clinical testing (INDs) under both Chinese FDA (cFDA) and US FDA guidelines. A Phase II clinical trial will be overseen and executed in the USA. TSL-1502 has robust patent protections via PCT. Patents include chemical structure, chiral auxiliary structures, crystal form, synthesis methods, and all possible indications. The drug is in Phase II development for HER2-negative Locally Advanced or Metastatic Breast Cancer Patients With Germline BRCA Mutations.

PF-07104091: Pfizer PF-07104091, also called tegtociclib, is a pioneering, orally delivered, selective CDK2 inhibitor in development for various advanced solid tumors, especially hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer that has advanced after prior CDK4/6 inhibitor therapy. By selectively blocking CDK2, PF-07104091 aims to halt cell division via decreased phosphorylation of retinoblastoma protein (Rb) and other downstream targets, presenting a fresh strategy to overcome resistance to current CDK4/6 inhibitors. Initial clinical trials indicate PF-07104091 is generally well-tolerated and shows early anti-tumor effects in heavily pre-treated patients, with ongoing studies testing it alone and with agents like fulvestrant and palbociclib. The drug is in Phase II trials for Breast Cancer.

XL092: Edgewood Oncology Inc. XL092 is a next-generation oral tyrosine kinase inhibitor that blocks receptor tyrosine kinases involved in cancer progression and metastasis, such as VEGF receptors, MET, AXL, and MER. These kinases contribute to normal cell processes and pathological events like tumor initiation, spread, blood vessel formation, and resistance to therapies, including immune checkpoint inhibitors. Zanzalintinib is being developed for advanced solid tumors, including genitourinary, colorectal, and head and neck cancers. The drug is in Phase I/II trials for breast cancer patients.

Explore innovative treatments and clinical trials in the Breast Cancer Pipeline. Obtain DelveInsight's detailed report today! @ New Breast Cancer Drugs

Breast Cancer Companies

Tanvex Biopharma, Sichuan Kelun-Biotech Biopharmaceutical, Shanghai Henlius Biotech, Byondis, CSPC Ouyi Pharmaceutical Co., Ltd., Pfizer, Jazz Pharmaceuticals, Biostar Pharma, Inc., Chia Tai Tianqing Pharmaceutical Group, InventisBio, Coherent Biopharma, Shanghai Jiaolian Drug Research and Development Co., Ltd., Ambrx, MediLink Therapeutics (Suzhou) Co., Ltd., Tasly Pharmaceutical Group, Convalife (Shanghai) Co., Ltd., Merck & Co., AstraZeneca, Aclaris Therapeutics, Boehringer Ingelheim, NovaOnco Therapeutics Co., Ltd., Verastem Oncology, Ellipses Pharma, Shenzhen Yangli Pharmaceutical Technology Co., Ltd., TYK Medicine, Ascendis Pharma, ExpreS2ion Biotechnologies, Mersana Therapeutics, Exelixis, Shenzhen Celconta Life Science, Beijing Wehand-Bio Pharmaceutical, VM Oncology, Hinova Pharmaceuticals, OS Therapies, and Syntab Therapeutics, and others.

Breast Cancer pipeline report assesses the therapeutic potential of pipeline drugs by Route of Administration

Intravenous Subcutaneous Oral Intramuscular Breast Cancer Products have been categorized under various molecular types such as

Monoclonal antibody Small molecule Peptide Reveal the future of Breast Cancer Treatment. Learn about emerging drugs, pipeline advancements, and key companies with DelveInsight's expert analysis @ Breast Cancer Market Drivers and Barriers

Scope of the Breast Cancer Pipeline Report

Coverage- Global 

Breast Cancer Companies- Tanvex Biopharma, Sichuan Kelun-Biotech Biopharmaceutical, Shanghai Henlius Biotech, Byondis, CSPC Ouyi Pharmaceutical Co., Ltd., Pfizer, Jazz Pharmaceuticals, Biostar Pharma, Inc., Chia Tai Tianqing Pharmaceutical Group, InventisBio, Coherent Biopharma, Shanghai Jiaolian Drug Research and Development Co., Ltd., Ambrx, MediLink Therapeutics (Suzhou) Co., Ltd., Tasly Pharmaceutical Group, Convalife (Shanghai) Co., Ltd., Merck & Co., AstraZeneca, Aclaris Therapeutics, Boehringer Ingelheim, NovaOnco Therapeutics Co., Ltd., Verastem Oncology, Ellipses Pharma, Shenzhen Yangli Pharmaceutical Technology Co., Ltd., TYK Medicine, Ascendis Pharma, ExpreS2ion Biotechnologies, Mersana Therapeutics, Exelixis, Shenzhen Celconta Life Science, Beijing Wehand-Bio Pharmaceutical, VM Oncology, Hinova Pharmaceuticals, OS Therapies, and Syntab 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 comprehensive pipeline report now! @ Breast Cancer Companies, Key Products and Unmet Needs

Table of Contents

Introduction

Executive Summary 

Breast Cancer: Overview 

Pipeline Therapeutics 

Therapeutic Assessment 

Breast Cancer– DelveInsight’s Analytical Perspective 

Late Stage Products (Registration) 

Vepdegestrant (ARV-471): Pfizer/ Arvinas 

Mid Stage Products (Phase II) PF-07104091: Pfizer 

Early Stage Products (Phase I/II) XL092: Edgewood Oncology Inc. 

Preclinical and Discovery Stage Products Drug Name: Company Name 

Inactive Products 

Breast Cancer Key Companies 

Breast Cancer Key Products 

Breast Cancer- Unmet Needs 

Breast Cancer- Market Drivers and Barriers 

Breast Cancer- Future Perspectives and Conclusion 

Breast Cancer Analyst Views Breast Cancer 

Key Companies 

Appendix 

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