Breast Cancer- Pipeline Insight, 2025

DelveInsight’s, “Breast Cancer- Pipeline Insight, 2025” report provides comprehensive insights about 120+ companies and 130+ 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 the most common cancer diagnosed in women, accounting for more than 1 in 10 new cancer diagnoses each year. It is the second most common cause of death from cancer among women in the world. Anatomically, the breast has milk-producing glands in front of the chest wall. They lie on the pectoralis major muscle, and there are ligaments support the breast and attach it to the chest wall. Fifteen to 20 lobes circularly arranged to form the breast. The fat that covers the lobes determines the breast size and shape. Each lobe is formed by lobules containing the glands responsible for milk production in response to hormone stimulation. Breast cancer always evolves silently. Breast cancer develops due to DNA damage and genetic mutations that can be influenced by exposure to estrogen. Sometimes there will be an inheritance of DNA defects or pro-cancerous genes like BRCA1 and BRCA2. Thus the family history of ovarian or breast cancer increases the risk for breast cancer development. In a normal individual, the immune system attacks cells with abnormal DNA or abnormal growth. This fails in those with breast cancer disease leading to tumor growth and spread.

Evaluation of Patients with breast cancer needs a triple assessment using clinical evaluation, imaging, and tissue biopsy. Mammography is the most commonly used modality for the diagnosis of breast cancer. Most of the asymptomatic cases are diagnosed during screening mammography. Breast cancer always presents as calcifications, dense lump, with or without architecture distortion. However, mammography is not sensitive in young women for whom breast ultrasonography can be used. Ultrasonography is useful in assessing the consistency and size of breast lumps. It has a great role in guided needle biopsy. Magnetic resonance imaging has good sensitivity for describing abnormalities in soft tissues, including the breast. It is indicated if there are occult lesions, or suspicion of multifocal or bilateral malignancy, especially ILC, and in the assessment of response to neoadjuvant chemotherapy, or when planning for breast conservation surgery and screening in the high-risk patient. Tissue biopsy is an important step in the evaluation of a breast cancer patient. There are different ways to take a tissue specimen, and these include fine-needle aspiration cytology, core biopsy (Trucut), and incisional or excisional biopsy.

Most of the patients discover their disease during their routine screening. Others may present with an accidentally discovered breast lump, change of breast shape or size, or nipple discharge. However, mastalgia is not uncommon. Physical examination, imaging, especially mammography, and tissue biopsy must be done to diagnose breast cancer. The survival rate improves with early diagnosis. The tumor tends to spread lymphatically and hematologically, leading to distant metastasis and poor prognosis.

The 2 basic principles of treatment are to reduce the chance of local recurrence and the risk of metastatic spread. Surgery with or without radiotherapy achieves local control of cancer. When there is a risk for metastatic relapse, systemic therapy is indicated in the form of hormonal therapy, chemotherapy, targeted therapy, or any combination of these. In locally advanced disease, systemic therapy is used as a palliative therapy with a small or no role for surgery.

""Breast cancer Disease- 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 Disease pipeline landscape is provided which includes the disease overview and Breast cancer Disease treatment guidelines. The assessment part of the report embraces, in depth Breast cancer Disease 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 Disease 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 II, 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

• 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 Breast Cancer.

• HLX11: Shanghai Henlius Biotech

HLX11 is a pertuzumab biosimilar developed by Henlius independently in line with relevant regulations and guidelines on biosimilars in China and the European Union (EU), which can be potentially used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2-positive early breast cancer and in combination with trastuzumab and docetaxel in patients with HER2-positive metastatic or unresectable locally recurrent breast cancer patients. HLX11 can specifically bind with the subdomain II of HER2 extracellular domain and inhibit the heterodimerisation of HER2 and other HER family receptors, i.e., EGFR, HER3, and HER4. This will inhibit signal transduction of relevant pathways and lead to the stop of growth and apoptosis of tumour cells. In the meantime, HLX11 can also enhance the tumour-killing activity of immune cells via antibody-dependent cell cytotoxicity. Currently, the drug is in the Phase III stage of its development for the treatment of HER2 positive Breast Cancer.

• Praluzatamab ravtansine: CytomX Therapeutics

Praluzatamab ravtansine (CX-2009) is a conditionally activated Probody drug conjugate (PDC) comprising an anti-CD166 mAb conjugated to DM4, with a protease-cleavable linker and a peptide mask that limits target engagement in normal tissue and circulation. The tumor microenvironment is enriched for proteases capable of cleaving the linker, thereby releasing the mask, allowing for localized binding of CX-2009 to CD166. Currently, the drug is in the Phase II stage of its development for the treatment of Breast Cancer.

• MCLA-128: Merus N.V.

MCLA-128 is an antibody-dependent cell-mediated cytotoxicity (ADCC) -enhanced Biclonics® that utilizes Merus Dock & Block® mechanism and inhibits the neuregulin/HER3 tumor-signaling pathway in solid tumors. MCLA-128 is believed to target the HER3 signaling pathway and to overcome the resistance of tumor cells to HER2-targeted therapies using two mechanisms: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor. The therapeutic candidate is a full-length IgG bi-specific antibody that acts by targeting HER2 and HER3. It is an antibody-dependent cellular cytotoxicity (ADCC)-enhanced Biclonic, which is developed based on Biclonics ENGAGE platform. Currently the drug is in the Phase II stage of clinical trial evaluation for the treatment of Breast Cancer.

• DX126 262: Hangzhou DAC Biotech

DX-126262 is under development for the treatment of HER2-positive or HER2-mutated unresectable locally advanced or metastatic non-squamous NSCLC, Breast Cancer, breast cancer. The drug candidate is an antibody drug conjugate comprising recombinant humanized anti-Her2 monoclonal antibody conjugated to Tub-114. It is formulated as lyophilized powder and administered via intravenous route of administration. Currently the drug is in Phase I stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.

Further product details are provided in the report……..

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. 120+ 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. phase III include, Jiangsu HengRui Medicine Co., Ltd.
• Phases

DelveInsight’s report covers around 130+ 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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

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

• Byondis
• Tanvex Biopharma
• Prestige BioPharma
• EirGenix
• AMbrx
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Roche
• Jiangsu Alphamab Oncology Co., Ltd.
• Jiangsu HengRui Medicine Co., Ltd.
• RemeGen
• Shanghai Henlius Biotech
• Merus N.V.
• Hangzhou DAC Biotech
• Lepu Biopharma
• Zymeworks
• Klus Pharma Inc.
• Bolt Biotherapeutics
• GeneQuantum Healthcare
• ALX Oncology
• Precirix
• BriaCell Therapeutics Corporation
• Bliss Biopharmaceutical
• BioInvent International
• Incyte Corporation
• Triumvira Immunologics, Inc.
• Horizon Therapeutics

Key Products

• SYD-985
• TX-05
• HD201
• EG-12014
• ARX788
• DP303c
• Inavolisib
• KN026
• SHR-A1811
• RC48-ADC
• HLX11
• MCLA-128
• DX126 262
• MRG002
• Zanidatamab
• A166
• BDC 1001
• GQ1001
• ALX-148
• CAM-H2
• SV-BR-1-GM
• BB-1701
• BI-1607
• Ruxolitinib
• TAC01-HER2
• Interferon-gamma

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