HR+ HER2-ve Breast Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "HR Positive HER2 Negative Breast Cancer Pipeline Insight" report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative Breast Cancer pipeline landscape. It covers the HR+ HER2-ve Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the HR+ HER2-ve 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 HR+ HER2-ve Breast Cancer Pipeline Report

* In February 2025:- Merck Sharp & Dohme LLC:- The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus 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 HR+ HER2-ve Breast Cancer pipeline report depicts a robust space with 50+ active players working to develop 53+ pipeline therapies for HR+ HER2-ve Breast Cancer treatment.
* The leading HR+ HER2-ve Breast Cancer Companies such as Regor Therapeutics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche and others.
* Promising HR+ HER2-ve Breast Cancer Therapies such as TQB3616 capsule, NTQ1062 with Fulvestrant, Pembrolizumab, Sacituzumab Govitecan, Dapagliflozin 10Mg Tab, SM-88, VS-6766, Abemaciclib , and others.

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HR+ HER2-ve Breast Cancer Emerging Drugs Profile

* Camizestrant: AstraZeneca

Camizestrant is a potent, next-generation oral SERD and pure ER antagonist, that has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. The asset has been shown to promising anti-tumour profile when administered alone or in combination with palbociclib and thus, the company is running a Phase III trial for the same.

* Dato-DXd: Daiichi Sankyo, Inc.

Datopotamab deruxtecan (Dato-DXd) is an investigational currently in Phase III for HR-positive, HER2- negative breast cancer. It is a TROP2 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo's proprietary DXd ADC technology, datopotamab deruxtecan is one of the three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca's ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers.

* CX-2009: CytomX Therapeutics

CX-2009 is a Probody drug conjugate that consists of a humanized anti-CD166 monoclonal antibody conjugated to DM4, a potent microtubule inhibitor known to be active against multiple cancer types. It is currently being tested in Phase II trial in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination with Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer.

* RGT-419B: Regor Therapeutics

RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. The clinical development program of RGT-419B is designed to address the unmet medical needs of patients who are refractory or have relapsed after previous treatment, providing new opportunities to improve survival and quality of life for patients with advanced/metastatic breast cancer. It is currently being tested in Phase I trial in in subjects with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer.

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HR+ HER2-ve Breast Cancer Companies

Regor Therapeutics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche and others.

HR Positive/ HER2 Negative 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

* Intra-articular
* Intraocular
* Intrathecal
* Intravenous
* Ophthalmic
* Oral
* Parenteral
* Subcutaneous
* Topical
* Transdermal

HR+ HER2-ve Breast Cancer Products have been categorized under various Molecule types such as

* Oligonucleotide
* Peptide
* Small molecule

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Scope of the HR+ HER2-ve Breast Cancer Pipeline Report

* Coverage- Global
* HR+ HER2-ve Breast Cancer Companies- Regor Therapeutics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche and others.
* HR+ HER2-ve Breast Cancer Therapies- TQB3616 capsule, NTQ1062 with Fulvestrant, Pembrolizumab, Sacituzumab Govitecan, Dapagliflozin 10Mg Tab, SM-88, VS-6766, Abemaciclib , and others.
* HR+ HER2-ve Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* HR+ HER2-ve 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 HR+ HER2-ve Breast Cancer Pipeline on our website @ HR+ HER2-ve Breast Cancer Emerging Drugs and Companies [https://www.delveinsight.com/sample-request/hr-positive-her2-negative-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Content

* Introduction
* Executive Summary
* HR Positive/ HER2 Negative Breast Cancer: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* HR Positive/ HER2 Negative Breast Cancer- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Dato-DXd: Daiichi Sankyo, Inc.
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* CX-2009: CytomX Therapeutics
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* RGT-419B: Regor Therapeutics
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Inactive Products
* HR Positive/ HER2 Negative Breast Cancer- Unmet Needs
* HR Positive/ HER2 Negative Breast Cancer- Market Drivers and Barriers
* 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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