Breast Cancer Clinical Pipeline | 100+ Companies, Including Adicet Therapeutics, Infinity Pharmaceuticals, Genentech, and AstraZeneca Driving the Next Breakthroughs

The Breast Cancer Market is Rapidly Advancing with Breakthrough Research and Innovative Treatments, Transforming Patient Care!

DelveInsight's 'Breast Cancer Pipeline Insight 2024' report provides comprehensive global coverage of pipeline Breast Cancer therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Breast Cancer pipeline domain.

For Breast Cancer emerging drugs, the Breast Cancer pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Breast Cancer Pipeline Report
• DelveInsight's Breast Cancer Pipeline analysis depicts a robust space with 100+ active players working to develop 120+ pipeline drugs for Breast Cancer treatment.
• The leading Breast Cancer companies include Merck Sharp & Dohme LLC, Oncorena AB, Hoffmann-La Roche, Huabo Biopharm Co., Ltd., Adicet Therapeutics, Infinity Pharmaceuticals, Inc., Apollomics Inc., ModeX Therapeutics, Genentech, AstraZeneca, Allogene Therapeutics, Merck & Co., Inc., X4 Pharmaceuticals, Argos Therapeutics, Pfizer, Eisai Inc., Bristol-Myers Squibb, AVEO Pharmaceuticals, Inc., Mabwell (Shanghai) Bioscience Co., Ltd., Beijing Scitech-Mq Pharmaceuticals Limited, Qilu Pharmaceutical Co., Ltd., Jiangsu Hansoh Pharmaceutical Co., Ltd., and others are evaluating their lead assets to improve the Breast Cancer treatment landscape.
• Key Breast Cancer pipeline therapies in various stages of development include Enobosarm, Amcenestrant (SAR439859), Giredestrant (RG6171, GDC-9545), Camizestrant (AZD9833), LY3484356/Imlunestrant, Lerociclib, TRODELVY (sacituzumab govitecan), Capivasertib, Lasofoxifene, SFX-01, SM-88, Inavolisib, SYD985 (trastuzumab duocarmazine), ARX788, Zanidatamab, IBRANCE, and others.
• In February 2025, the FDA granted Lumitron Technologies, Inc. "Breakthrough Device" designation for its HyperVIEWTM X-Ray system, which uses the K-Edge subtraction technique to enable contrast-enhanced imaging for breast cancer diagnosis. This technology utilizes Lumitron's proprietary distributed charge laser-Compton technology, offering 100 times higher resolution and significantly safer imaging compared to standard X-rays.
• In February 2025, the FDA approved a label expansion for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to help determine if patients with hormone receptor-positive, HER2-ultralow metastatic breast cancer are suitable candidates for fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu).
• In January 2025, the FDA approved AstraZeneca's Datroway (datopotamab deruxtecan or Dato-DXd) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer who have previously received endocrine therapy and chemotherapy.
• In Dec 2024, ScreenPoint Medical showcased new FDA clearance for advanced capabilities of its leading Breast AI, Transpara, at the 110th Annual Radiological Society of North America (RSNA) meeting (December 1-4, 2024, South Hall #5316). Transpara, the most clinically validated Breast AI on the market, assists radiologists in detecting cancers earlier and reducing recall rates.
• In October 2024, the FDA approved inavolisib (Itovebi), in combination with palbociclib and fulvestrant, for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.
• In October 2024, Roche announced FDA approval of its drug inavolisib, under the brand name Itovebi, for treating breast cancer. Inavolisib targets the PI3K pathway, which plays a critical role in cancer cell growth, offering new hope for patients with PIK3CA-mutated breast cancer that has become resistant to other treatments.
• In October 2024, Foundation Medicine received FDA approval for its FoundationOne Liquid CDx to serve as a companion diagnostic for the cancer therapy ITOVEBI (inavolisib), which was developed by Roche, Foundation's parent company.
• In October 2024, Novartis announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorization for KISQALI (ribociclib) as an adjuvant treatment for adults with early breast cancer (HR+/HER2-), who are at high risk of disease recurrence, including patients with node-negative disease.

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Breast Cancer Overview
Breast cancer is the most commonly diagnosed cancer in women, accounting for over 10% of new cancer cases annually and being the second leading cause of cancer-related deaths among women worldwide. The breast consists of milk-producing glands supported by ligaments and fat tissue, with lobules responsible for milk production in response to hormonal stimulation. Breast cancer typically develops silently due to DNA damage and genetic mutations, which can be influenced by estrogen exposure or inherited mutations such as BRCA1 and BRCA2. A family history of ovarian or breast cancer increases the risk of developing the disease. In healthy individuals, the immune system eliminates abnormal cells, but in breast cancer patients, this mechanism fails, allowing tumor growth and spread.

Diagnosis requires a triple assessment involving clinical evaluation, imaging, and tissue biopsy. Mammography is the primary diagnostic tool, detecting cancer through calcifications or dense lumps, but its sensitivity is lower in younger women, making ultrasonography a useful alternative. Magnetic resonance imaging (MRI) is particularly effective in identifying multifocal or bilateral malignancies, assessing treatment response, and guiding surgical planning. Tissue biopsy, obtained through fine-needle aspiration, core biopsy, or surgical excision, confirms the diagnosis. Early detection through routine screening improves survival rates, while late-stage disease often leads to distant metastasis and poor prognosis. Treatment focuses on reducing local recurrence and metastatic spread, with surgery and radiotherapy providing local control, and systemic therapies-such as hormone therapy, chemotherapy, and targeted therapy-used to manage the disease or as palliative care in advanced cases.

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Breast Cancer Treatment Analysis: Drug Profile
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 that 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 with 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 the 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 tumor 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.

Key Breast Cancer Therapies and Companies
• Enobosarm: Veru
• Amcenestrant (SAR439859): Sanofi
• Giredestrant (RG6171, GDC-9545): Roche
• Camizestrant (AZD9833): AstraZeneca
• LY3484356/Imlunestrant: Eli Lilly
• Lerociclib: EQRx
• TRODELVY (sacituzumab govitecan): Gilead
• Capivasertib: AstraZeneca
• Lasofoxifene: Sermonix Pharmaceuticals
• SFX-01: Evgen Pharma
• SM-88: Tyme
• Inavolisib: Roche/ Genentech
• Datopotamab deruxtecan (Dato-DXd): AstraZeneca and Daiichi Sankyo
• SYD985 (trastuzumab duocarmazine): Byondis
• Giredestrant: Roche
• ARX788: Ambrx
• Zanidatamab: Zymeworks/Jazz Pharmaceuticals
• IBRANCE (palbociclib): Pfizer

Learn more about the novel and emerging Breast Cancer pipeline therapies @ https://www.delveinsight.com/report-store/breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Breast Cancer Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical.

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

Scope of the Breast Cancer Pipeline Report
• Coverage: Global
• Key Breast Cancer Companies: Merck Sharp & Dohme LLC, Oncorena AB, Hoffmann-La Roche, Huabo Biopharm Co., Ltd., Adicet Therapeutics, Infinity Pharmaceuticals, Inc., Apollomics Inc., ModeX Therapeutics, Genentech, AstraZeneca, Allogene Therapeutics, Merck & Co., Inc., X4 Pharmaceuticals, Argos Therapeutics, Pfizer, Eisai Inc., Bristol-Myers Squibb, AVEO Pharmaceuticals, Inc., Mabwell (Shanghai) Bioscience Co., Ltd., Beijing Scitech-Mq Pharmaceuticals Limited, Qilu Pharmaceutical Co., Ltd., Jiangsu Hansoh Pharmaceutical Co., Ltd., and others.
• Key Breast Cancer Pipeline Therapies: Enobosarm, Amcenestrant (SAR439859), Giredestrant (RG6171, GDC-9545), Camizestrant (AZD9833), LY3484356/Imlunestrant, Lerociclib, TRODELVY (sacituzumab govitecan), Capivasertib, Lasofoxifene, SFX-01, SM-88, Inavolisib, SYD985 (trastuzumab duocarmazine), ARX788, Zanidatamab, IBRANCE, and others.

Dive deep into rich insights for drugs used for Breast Cancer treatment; visit @ https://www.delveinsight.com/report-store/breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Breast Cancer Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Breast Cancer Pipeline Therapeutics
6. Breast Cancer Pipeline: Late-Stage Products (Phase III)
7. Breast Cancer Pipeline: Late-Stage Products (Phase III)
8. Breast Cancer Pipeline: Mid-Stage Products (Phase II)
9. Breast Cancer Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

This release was published on openPR.