Breast Cancer- Pipeline Insight, 2025

DelveInsight's, "Breast Cancer- Pipeline Insight, 2025" report provides comprehensive insights about 250+ companies and 300+ pipeline drugs in Breast Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Breast Cancer: Understanding

Breast Cancer: Overview

Breast cancer is a malignant tumor that originates in the cells of the breast, most commonly in the ducts (ductal carcinoma) or lobules (lobular carcinoma). It is one of the most prevalent cancers among women worldwide, although it can also occur in men. Risk factors include age, family history, genetic mutations such as BRCA1 and BRCA2, hormonal factors, obesity, and lifestyle choices. Breast cancer can range from localized, slow-growing tumors to aggressive types that metastasize to other parts of the body.

Early-stage breast cancer may be asymptomatic, which is why routine screening is vital. When symptoms do appear, they can include a lump in the breast or underarm, changes in breast shape or size, nipple discharge (often bloody), skin dimpling, redness or scaling of the breast skin or nipple, and persistent breast pain. Not all lumps are cancerous, but any new or unusual changes should prompt medical evaluation. Breast cancer develops when normal breast epithelial cells undergo genetic mutations that disrupt normal cell cycle control, leading to uncontrolled proliferation. These mutations may be inherited (as in BRCA mutations) or acquired due to environmental and hormonal factors. Over time, cancer cells may invade surrounding tissue, enter the bloodstream or lymphatic system, and spread (metastasize) to distant organs such as the bones, liver, lungs, or brain. Breast cancers are classified by hormone receptor status (ER/PR), HER2/neu overexpression, and other molecular markers, which guide prognosis and treatment.

Diagnosis typically begins with imaging, such as mammography, ultrasound, or MRI, followed by a biopsy to confirm malignancy and determine subtype. Immunohistochemistry helps assess hormone receptor and HER2 status. Advanced imaging such as CT or PET scans may be used to evaluate metastatic spread. Staging is done using the TNM (Tumor, Node, Metastasis) system, which informs treatment decisions and prognosis. Treatment is multidisciplinary and tailored to the cancer's type, stage, and molecular characteristics. Options include surgery (lumpectomy or mastectomy), radiation therapy, chemotherapy, hormonal therapy (e.g., tamoxifen, aromatase inhibitors), targeted therapy (e.g., trastuzumab for HER2+ cases), PARP inhibitors for BRCA-mutated cancers, and emerging immunotherapies. Early-stage cancers may be cured with surgery and adjuvant therapies, while advanced cases often require systemic treatment to manage disease progression and symptoms.

"Breast Cancer- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Breast Cancer pipeline landscape is provided which includes the disease overview and Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth Breast Cancer commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Breast Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve Breast Cancer.

Breast Cancer Emerging Drugs Chapters

This segment of the Breast Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Breast Cancer Emerging Drugs

• Vepdegestrant (ARV-471): Pfizer/ Arvinas

Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy 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 granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy. Currently the drug is in Preregistration stage of development for the treatment of ER+/HER2- Metastatic Breast Cancer, ER+/HER2- Early Breast Cancer.

• Utidelone: Biostar Pharma, Inc.

Utidelone (UTD1), developed by Biostar Pharma, is a genetically engineered epothilone analog and next-generation microtubule inhibitor that received approval in China in March 2021 for metastatic breast cancer. Unlike taxanes, it binds a different site on microtubules, enabling it to overcome taxane resistance, demonstrate strong antitumor activity, and maintain low hematologic toxicity-showing both progression-free survival (PFS) and overall survival (OS) benefits in heavily pretreated patients when combined with capecitabine. Ongoing global trials include expanding indications such as neoadjuvant breast cancer, brain metastases, and even oral formulations to enhance convenience and broaden therapeutic impact. Currently the drug is in Phase III stage of development for the treatment of advanced breast cancer, Breast cancer neoadjuvant and breast cancer brain metastasis.

• ARX788: Ambrx, Inc.

ARX788, an anti-HER2 ADC currently being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumor clinical trials. ARX788 is a homogeneous and highly stable ADC, which targets the HER2 receptor and contains two AS269 cytotoxic payloads site-specifically conjugated to a trastuzumab-based antibody. ARX788 was designed to maximize potential anti-tumor activity by optimizing the number and position of the payloads and the chemical bonds that conjugate the payloads to the antibody. AS269, proprietary payload, is a tubulin inhibitor specifically designed to form a highly stable covalent bond with our SAAs and kill tumor cells only upon entry into the cell when aided by the conjugated targeting antibody, thereby limiting off-target effects on healthy tissue. Currently, the drug is in the Phase II/III stage of its development for the treatment of Triple Negative Breast Cancer.

• TSL-1502: Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

TSL-1502 is a pro-drug and its metabolite TSL-1502M has higher localized concentration at cancer sites with more potency, thus, our preclinical studies demonstrated that TSL-1502's anticancer activity is superior to competitor(s) while having a much wider therapeutic window. TSL-1502 is a small molecule drug, ready for clinical investigation (INDs) under both Chinese FDA (cFDA) and US FDA regulations. A phase II clinical trial will be managed and conducted in the USA. TSL-1502 is positioned to have strong PCT patent protections. Patents cover chemical structure, chiral auxiliary structures, crystal form, synthesize methods, and all potential indications. Currently the drug is in Phase II stage of its development for the treatment of HER2-negative Locally Advanced or Metastatic Breast Cancer Patients With Germline BRCA Mutations.

• PF-07104091: Pfizer

PF-07104091, also known as tegtociclib, is a first-in-class, orally administered, selective CDK2 inhibitor being developed for the treatment of various advanced solid tumors, with a particular focus on hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer that has progressed after prior CDK4/6 inhibitor therapy. By selectively inhibiting CDK2, PF-07104091 aims to induce cell cycle arrest through reduced phosphorylation of retinoblastoma protein (Rb) and other downstream targets, offering a novel approach to overcoming resistance to existing CDK4/6 inhibitors. Early-phase clinical trials have demonstrated that PF-07104091 is generally well tolerated and shows preliminary antitumor activity in heavily pretreated patients, with ongoing studies evaluating its use both as monotherapy and in combination with other agents such as fulvestrant and palbociclib. Currently, the drug is in the Phase II stage of its development for the treatment of Breast Cancer.

• XL092: Edgewood Oncology Inc.

XL092 is a third-generation oral tyrosine kinase inhibitor that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis and resistance to multiple therapies, including immune checkpoint inhibitors. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including genitourinary, colorectal and head and neck cancers. The drug is currently being evaluated under Phase I/II stage of development for the treatment of patients suffering from breast cancer.

Breast Cancer: Therapeutic Assessment

This segment of the report provides insights about the different Breast Cancer drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Breast Cancer

There are approx. 250+ key companies which are developing the therapies for Breast Cancer. The companies which have their Breast Cancer drug candidates in the most advanced stage, i.e. Preregistration include, Pfizer/ Arvinas

• Phases

DelveInsight's report covers around 300+ products under different phases of clinical development like

• 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
• Route of Administration

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

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Breast Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Breast Cancer therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Breast Cancer drugs.

Breast Cancer Report Insights

• Breast Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Breast Cancer Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Breast Cancer drugs?
• How many Breast Cancer drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Breast Cancer?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Breast Cancer therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Breast Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• 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
• Exelixis
• Beijing Wehand-Bio Pharmaceutical
• VM Oncology
• Hinova pharmaceuticals
• OS Therapies
• Syntab therapeutics

Key Products

• TX05
• A166
• HLX11
• SYD-985
• SYHX2011
• Vepdegestrant (ARV-471)
• Zanidatamab + chemo
• Utidelone
• TQB2102
• D-0502
• CBP-1008
• B013+Nab-Paclitaxel
• ARX788
• YL202
• TSL-1502
• CVL237
• Belzutifan (MK-6482) + fulvestrant
• AZD9574
• Puxitatug samrotecan
• Zumsemetinib
• Zongertinib
• XS-02
• Avutometinib + abemaciclib + fulvestrant
• Vosilasarm (EP0062)
• VB15010
• TYK-00540
• TransCon IL-2 B/Y
• TQB3912
• ES2B C001
• XMT-2056
• XL309
• XKDCT293
• XB010
• WH002
• VMD-928
• HP518
• OSTtADC
• ISEr Y9