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HER2-Negative Breast Cancer Pipeline, Clinical Trial Analysis and NDA Approvals | 85+ Companies and 85+ Drugs

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HER2-Negative Breast Cancer Pipeline, Clinical Trial Analysis and NDA Approvals | 85+ Companies and 85+ Drugs

January 19
21:02 2023
HER2-Negative Breast Cancer Pipeline, Clinical Trial Analysis and NDA Approvals | 85+ Companies and 85+ Drugs

DelveInsight’s, “HER2-Negative Breast Cancer Pipeline Insight, 2023,” report provides comprehensive insights about 85+ companies and 85+ pipeline drugs in HER2-Negative Breast Cancer pipeline landscape. It covers the HER2-Negative Breast Cancer pipeline drug profiles, including HER2-Negative Breast Cancer clinical trial 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.

 

In the HER2-Negative Breast Cancer Pipeline Report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, HER2-Negative Breast Cancer NDA approvals (if any), and product development activities comprising the technology, HER2-Negative Breast Cancer collaborations, licensing, mergers and acquisition, funding, designations, and other product related details. 

 

Key takeaways from the HER2 Negative Breast Cancer Pipeline Insight Report

  • DelveInsight’s HER2 negative Breast Cancer Pipeline analysis depicts a robust space with 85+ active players working to develop 85+ pipeline treatment therapies.
  • Some of the key pharmaceutical companies working to develop potential drug candidates to improve the HER2 negative Breast Cancer treatment scenario include BeiGene, Olema Pharmaceuticals, AstraZeneca, Radius Health, Adagene Inc, H3 Biomedicine Inc., Daiichi Sankyo, Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., OncoSec Medical Incorporated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Pfizer, InventisBio Co., Ltd, Hoffmann-La Roche, Angiochem, Bristol-Myers Squibb, Eisai Co., Ltd., Context Therapeutics, Boehringer Ingelheim, CytomX Therapeutics, Beta Pharma (Suzhou) Co., Ltd., Eli Lilly and Company, Laekna Limited, Sermonix Pharmaceuticals Inc., Modra Pharmaceuticals, MedImmune LLC, QED Therapeutics, Inc., Tyme, Inc., PIQUR Therapeutics, Pfizer, Merus N.V., Seagen, Relay Therapeutics, Inc., Blueprint Medicines Corporation, TransThera Sciences (Nanjing), Inc., HUTCHMED, VelosBio Inc., Dantari, Inc., GlaxoSmithKline, G1 Therapeutics, Inc., Spectrum Pharmaceuticals, Inc, Taizhou EOC Pharma Co., Ltd., Xuanzhu Biopharmaceutical Co., Ltd., Regor Pharmaceuticals Inc, Astex Pharmaceuticals, Inc., Kind Pharmaceuticals LLC, Genor Biopharma Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Ltd., Nerviano Medical Sciences, Tolmar Inc., Zeno Alpha Inc., Accutar Biotechnology Inc, Jiangsu Hansoh Pharmaceutical Co., Ltd., Zenith Epigenetics, Cantargia, BioLite, Inc., PharmAbcine, Ayala Pharmaceuticals, Inc., ERYtech Pharma, SynCore Biotechnology Co., Ltd., Phoenix Molecular Designs, Chipscreen Biosciences, Ltd., OncoTherapy Science, Inc., OncoPep, Inc., and many others.
  • Essential HER2 negative Breast Cancer pipeline therapies such as BGB-290, OP-1250, AZD9833, Elacestrant, ADG106, H3B-6545, Dato-DXd, HRS8807, TAVO, Mitoxantrone Hydrochloride, Gedatolisib, D-0502, Ipatasertib, ANG1005, Nivolumab, Ipilimumab, Lenvatinib, Onapristone, Xentuzumab, CX-2009, BPI-1178, LY3484356, Afuresertib, Lasofoxifene, ModraDoc006/r, MEDI4736, Infigratinib, SM-88, PQR309, PF-07248144, MCLA-128, SGN-CD228A, RLY-2608, BLU-222, TT-00420, HMPL-013, Zilovertamab vedotin, DAN-222, Niraparib, G1T38, Poziotinib Hydrochloride, EOC202, XZP-3287, RGT-419B, ASTX727, AND019, Lerociclib, SGN-STNV, SCR-6852, NMS-03305293, TOL2506, ZN-c5, AC682, HS-10342, ZEN003694, Nadunolimab, BLEX 404, Olinvacimab, AL101, eryaspase, EndoTAG-1, PMD-026, Chiauranib, OTS167PO, PVX-410, and others are under development in different phases of clinical trials.
  • The HER2-Negative Breast Cancer Companies and academics are working to assess challenges and seek opportunities that could influence HER2-Negative Breast Cancer R&D. The HER2-Negative Breast Cancer pipeline therapies under development are focused on novel approaches to treat/improve HER2-Negative Breast Cancer.

 

To explore more information on the latest breakthroughs in the HER2-Negative Breast Cancer Pipeline treatment landscape of the report, click here @ HER2-Negative Breast Cancer Pipeline Outlook

 

Recent Developmental Activities of the HER2 negative Breast Cancer Treatment Landscape

  • In January 2022, Celcuity announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation to the Company’s lead drug candidate, gedatolisib, for the treatment of patients with HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy.
  • In December 2021, H3 Biomedicine Inc. (H3), announced the presentation of two posters at the 2021 San Antonio Breast Cancer Symposium (SABCS) being held in a hybrid format on December 7- 10, 2021. The presentations include interim investigational data from H3’s ongoing clinical development program, H3B-6545, a potential first-in-class, orally available Selective ERα Covalent Antagonist (SERCA), in women with ER-positive, HER2-negative breast cancer.
  • The investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly decreased the risk of death or disease progression and increased progression-free survival compared with standard-of-care endocrine therapy for postmenopausal patients with estrogen receptor (ER)-positive/HER2-negative metastatic breast cancers that progressed on prior endocrine and targeted therapies, according to results from the phase III EMERALD trial, which were presented at the San Antonio Breast Cancer Symposium, held December 7-10, 2021.
  • In November 2021, Olema Pharmaceuticals, Inc. announced the first clinical data from the Phase 1 dose-escalation portion of the ongoing Phase 1/2 clinical trial of OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) in development for the treatment of metastatic breast cancer and other women’s cancers.

 

HER2 negative Breast Cancer Overview

HER2-Negative Breast Cancer is classified as HR-positive if its cells have receptors for the hormones estrogen and/or progesterone along with no expression of the human epidermal growth factor receptor 2 (HER2). Immunohistochemistry (IHC) test and/or Fluorescent in situ hybridization (FISH) is done to find out if cancer cells have estrogen and progesterone receptors. Common therapies for the treatment of HER2-Negative Breast Cancer include endocrine therapy (ET), ovarian suppression, aromatase inhibition, and/or CDK4/6 inhibitors.

Request a sample and discover the recent advances in HER2-Negative Breast Cancer Ongoing Clinical Trial Analysis and Medications, click here @ HER2-Negative Breast Cancer Treatment Landscape

 

HER2-Negative Breast Cancer Emerging Drugs

 

Capivasertib + Fulvestrant: AstraZeneca

Capivasertib (AZD5363) is a potent selective oral inhibitor of all three isoforms of the serine/threonine kinase AKT. Capivasertib in combination with fulvestrant is currently in phase III clinical studies for the treatment of patients with locally advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following recurrence or progression on or after aromatase inhibitor (AI) therapy.

 

Dalpiciclib: Jiangsu HengRui Medicine

Dalpiciclib (formerly SHR 6390) is an orally administered small molecule and selective cyclin-dependent kinase (CDK)-4/6 inhibitor. Dalpiciclib in Combination with Letrozole or Anastrozole or Fulvestrant is in Phase III clinical evaluation in patients with HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer.

 

HER2-Negative Breast Cancer Pipeline Therapeutics Assessment

There are approx. 85+ key companies which are developing the therapies for HER2-Negative Breast Cancer. The companies which have their HER2-Negative Breast Cancer drug candidates in the most advanced stage, i.e. Phase III include, Jiangsu HengRui Medicine.

 

For further information, refer to the detailed HER2-Negative Breast Cancer Unmet Needs, HER2-Negative Breast Cancer Market Drivers, and HER2-Negative Breast Cancer Market Barriers, click here for HER2-Negative Breast Cancer Ongoing Clinical Trial Analysis

 

HER2-Negative Breast Cancer Phases

  • Late stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I) along with the details of
  • HER2-Negative Breast Cancer Pre-clinical and Discovery stage candidates
  • HER2-Negative Breast Cancer Discontinued & Inactive candidates

 

Scope of the HER2 negative Breast Cancer Pipeline Report

  • Coverage: Global
  • Key HER2 negative Breast Cancer Companies: BeiGene, Olema Pharmaceuticals, AstraZeneca, Radius Health, Adagene Inc, H3 Biomedicine Inc., Daiichi Sankyo, Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., OncoSec Medical Incorporated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Pfizer, InventisBio Co., Ltd, Hoffmann-La Roche, Angiochem, Bristol-Myers Squibb, Eisai Co., Ltd., Context Therapeutics, Boehringer Ingelheim, CytomX Therapeutics, Beta Pharma (Suzhou) Co., Ltd., Eli Lilly and Company, Laekna Limited, Sermonix Pharmaceuticals Inc., Modra Pharmaceuticals, MedImmune LLC, QED Therapeutics, Inc., Tyme, Inc., PIQUR Therapeutics, Pfizer, Merus N.V., Seagen, Relay Therapeutics, Inc., Blueprint Medicines Corporation, TransThera Sciences (Nanjing), Inc., HUTCHMED, VelosBio Inc., Dantari, Inc., GlaxoSmithKline, G1 Therapeutics, Inc., Spectrum Pharmaceuticals, Inc, Taizhou EOC Pharma Co., Ltd., Xuanzhu Biopharmaceutical Co., Ltd., Regor Pharmaceuticals Inc, Astex Pharmaceuticals, Inc., Kind Pharmaceuticals LLC, Genor Biopharma Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Ltd., Nerviano Medical Sciences, Tolmar Inc., Zeno Alpha Inc., Accutar Biotechnology Inc, Jiangsu Hansoh Pharmaceutical Co., Ltd., Zenith Epigenetics, Cantargia, BioLite, Inc., PharmAbcine, Ayala Pharmaceuticals, Inc., ERYtech Pharma, SynCore Biotechnology Co., Ltd., Phoenix Molecular Designs, Chipscreen Biosciences, Ltd., OncoTherapy Science, Inc., OncoPep, Inc., and many others.
  • Key HER2 negative Breast Cancer Pipeline Therapies:  BGB-290, OP-1250, AZD9833, Elacestrant, ADG106, H3B-6545, Dato-DXd, HRS8807, TAVO, Mitoxantrone Hydrochloride, Gedatolisib, D-0502, Ipatasertib, ANG1005, Nivolumab, Ipilimumab, Lenvatinib, Onapristone, Xentuzumab, CX-2009, BPI-1178, LY3484356, Afuresertib, Lasofoxifene, ModraDoc006/r, MEDI4736, Infigratinib, SM-88, PQR309, PF-07248144, MCLA-128, SGN-CD228A, RLY-2608, BLU-222, TT-00420, HMPL-013, Zilovertamab vedotin, DAN-222, Niraparib, G1T38, Poziotinib Hydrochloride, EOC202, XZP-3287, RGT-419B, ASTX727, AND019, Lerociclib, SGN-STNV, SCR-6852, NMS-03305293, TOL2506, ZN-c5, AC682, HS-10342, ZEN003694, Nadunolimab, BLEX 404, Olinvacimab, AL101, eryaspase, EndoTAG-1, PMD-026, Chiauranib, OTS167PO, PVX-410, and others.
  • HER2 negative Breast Cancer Segmentation: Phases, Product Type, Molecule Type, Route of administration, Mechanism of action

 

Dive deep into rich insights for drugs for HER2 negative Breast Cancer Market Drivers and HER2 negative Breast Cancer Market Barriers, click here @ HER2 negative Breast Cancer Unmet Needs and Analyst Views

 

Table of content

  1. Introduction
  2. Executive Summary
  3. HER2-Negative Breast Cancer: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. HER2-Negative Breast Cancer – DelveInsight’s Analytical Perspective
  7. In-depth Commercial Assessment
  8. HER2-Negative Breast Cancer Collaboration Deals
  9. Late Stage Products (Phase III)
  10. Capivasertib + Fulvestrant: AstraZeneca
  11. Mid Stage Products (Phase II/III)
  12. Inavolisib: Roche
  13. Early Stage Products (Phase I)
  14. Afuresertib + Fulvestrant: Laekna
  15. Preclinical and Discovery Stage Products
  16. Inactive Products
  17. HER2-Negative Breast Cancer Key Companies
  18. HER2-Negative Breast Cancer Key Products
  19. HER2-Negative Breast Cancer- Unmet Needs
  20. HER2-Negative Breast Cancer- Market Drivers and Barriers
  21. HER2-Negative Breast Cancer- Future Perspectives and Conclusion
  22. HER2-Negative Breast Cancer Analyst Views
  23. HER2-Negative Breast Cancer Key Companies
  24. Appendix

 

Got Queries? Find out the related information on HER2-Negative Breast Cancer Mergers and acquisitions, HER2-Negative Breast Cancer licensing activities @ HER2-Negative Breast Cancer Emerging Drugs and Recent Trends

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