Metastatic Breast Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Metastatic Breast Cancer Pipeline Insight" report provides comprehensive insights about 100+ companies and 100+ pipeline drugs in Metastatic Breast Cancer pipeline landscape. It covers the Metastatic Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Metastatic 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 Metastatic Breast Cancer Pipeline Report

* In March 2025, MacroGenics announced a study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy. A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.
* In March 2025, BriaCell Therapeutics Corporation conducted a study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.
* In March 2025, Phoenix Molecular Designs organized a study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer. This study will prospectively enroll RSK2+, HR+, and human epidermal growth factor receptor 2 negative (HER2-) patients to evaluate PMD-026 in combination with a standard dose and schedule of fulvestrant.
* In March 2025, Merck Sharp & Dohme LLC conducted a study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) unresectable metastatic breast cancer. There is no formal hypothesis testing in this study.
* DelveInsight's Metastatic Breast Cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for Metastatic Breast Cancer treatment.
* The leading Metastatic Breast Cancer Companies working in the market include Roche, RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, GlycoMimetics Incorporated, Rhizen Pharmaceuticals SA, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd., Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Jiangsu Hengrui Medicine Co., Tyme, Inc., Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., and Taizhou Hanzhong biomedical co. Ltd , and others.
* Promising Metastatic Breast Cancer therapies in the various stages of development include Tucatinib, Capecitabine, Trastuzumab, Palifosfamide, Bavituximab, NK105, Paclitaxel, Navelbine, Herceptin , and others

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Metastatic Breast Cancer Emerging Drugs Profile

* Giredestrant: Roche

Giredestrant is a next generation investigational Selective estrogen receptor degrader (SERD), designed to fully block ER signalling with robust receptor occupancy. Oestrogen encourages HR-positive breast cancer cells to grow by attaching to the ER. Giredestrant works by blocking this receptor to prevent the action of oestrogen, and in the process causes the receptor to be degraded. This investigational medicine has also shown efficacy regardless of ESR1 mutation status (mutations in the ESR1 gene are important mechanisms of resistance to hormone therapy).

* Disitamab Vedotin: RemeGen

Disitamab Vedotin (RC48) is a novel anti-HER2 antibody-drug conjugate (ADC) which is currently across various solid tumor types. It was the first domestically-developed ADC in China approved by the CDE for clinical development in China. ADCs are a therapeutic modality consisting of an antibody molecule linked to a highly cytotoxic agent, and is typically designed to specifically deliver chemotherapies to tumor cells.

* EndoTAG Registered -1 (SB05): SynCore Biotechnology

SB05 is an innovative composition of the established cytostatic drug paclitaxel combined with neutral and positive lipids. Due to the positively charged lipids, SB05 interacts with newly developing, negatively charged endothelial cells, which are especially required for the growth of tumor blood vessels. The SB05 paclitaxel component attacks the activated endothelial cells as they divide, thus targeting the blood supply to tumors without affecting the supply to not activated endothelial cells of healthy tissue. By doing this, SB05 is expected to prevent the formation of new tumor blood vessels and to inhibit tumor growth.

* Stenoparib (2X-121): Allarity Therapeutics

Stenoparib (2X-121) is a unique, small molecule dual targeted inhibitor of Poly ADP-Ribose Polymerases (PARP 1 and 2) and telomerase maintenance enzymes (Tankyrase 1 and 2). Allarity exclusively in-licensed it (globally) from Eisai. Given its novel mechanism of action and ability to cross the blood brain barrier (BBB), plus its associated DRP Registered , stenoparib is poised to yield improved efficacy, lower toxicity, and lower drug resistance compared the other late-stage or marketed PARP inhibitors.

The Metastatic Breast Cancer Pipeline Report Provides Insights into

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

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Metastatic Breast Cancer Companies

Roche, RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, GlycoMimetics Incorporated, Rhizen Pharmaceuticals SA, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd., Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Jiangsu Hengrui Medicine Co., Tyme, Inc., Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., and Taizhou Hanzhong biomedical co. Ltd, and others.

Metastatic 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
* Intravenous
* Subcutaneous
* Topical.
* Molecule Type

Metastatic Breast Cancer Products have been categorized under various Molecule types such as

* Monoclonal Antibody
* Peptides
* Polymer
* Small molecule
* Gene therapy
* Product Type

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Scope of the Metastatic Breast Cancer Pipeline Report

* Coverage- Global
* Metastatic Breast Cancer Companies- Roche, RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, GlycoMimetics Incorporated, Rhizen Pharmaceuticals SA, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd., Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Jiangsu Hengrui Medicine Co., Tyme, Inc., Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., and Taizhou Hanzhong biomedical co. Ltd , and others.
* Metastatic Breast Cancer Therapies- Tucatinib, Capecitabine, Trastuzumab, Palifosfamide, Bavituximab, NK105, Paclitaxel, Navelbine, Herceptin , and others.
* Metastatic Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Metastatic Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

For a detailed overview of our latest research findings and future plans, read the full details of Metastatic Breast Cancer Pipeline on our website @ Metastatic Breast Cancer Emerging Drugs and Companies [https://www.delveinsight.com/sample-request/metastatic-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Content

* Introduction
* Executive Summary
* Metastatic Breast Cancer: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Metastatic Breast Cancer - DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Giredestrant: Roche
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* Stenoparib - Allarity Therapeutics
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I/II)
* ARV-471: Arvinas
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Metastatic Breast Cancer Key Companies
* Metastatic Breast Cancer Key Products
* Metastatic Breast Cancer- Unmet Needs
* Metastatic Breast Cancer- Market Drivers and Barriers
* Metastatic Breast Cancer- Future Perspectives and Conclusion
* Metastatic Breast Cancer Analyst Views
* Metastatic Breast Cancer Key Companies
* Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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