Metastatic Breast Cancer Pipeline Assessment: FDA, EMA, and PMDA Approvals, Emerging Drugs, Clinical Trials, Therapeutic Analysis, and Growth Prospects | RemeGen, SynCore Biotech, Allarity Therapeutic

The Metastatic Breast Cancer Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

“Metastatic Breast Cancer Pipeline Insight, 2024“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Metastatic Breast Cancer Market.

Some of the key takeaways from the Metastatic Breast Cancer Pipeline Report:

• Companies across the globe are diligently working toward developing novel Metastatic Breast Cancer treatment therapies with a considerable amount of success over the years. 
• Metastatic Breast Cancer companies working in the treatment market are RemeGen, SynCore Biotechnology, Byondis B.V., Sichuan Baili Pharmaceutical, Allarity Therapeutics, Jiangsu Hansoh Pharmaceutical, Kind Pharmaceuticals LLC, Shanghai Miracogen, Dantari, Inc., Phoenix Molecular Designs, Daiichi Sankyo, Rhizen Pharmaceuticals SA, Olema Oncology, Immutep S.A.S, Jiangsu HengRui Medicine, Genor Biopharma, and others, are developing therapies for the Metastatic Breast Cancer treatment 

• Emerging Metastatic Breast Cancer therapies in the different phases of clinical trials are- Disitamab Vedotin, EndoTAG®-1 (SB05), trastuzumab duocarmazine, GNC 035, Stenoparib (2X-121), HS-10342, AND019, MRG002, DAN-222, PMD-026, Patritumab Deruxtecan, Tenalisib, OP-1250, Eftilagimod alpha, SHR-A1811, GB491+ Fulvestrant, and others are expected to have a significant impact on the Metastatic Breast Cancer market in the coming years.   
• In October 2023, The first patient was administered medication in a Phase II clinical trial by Carrick Therapeutics, which involves the combination of samuraciclib (CT7001) and Menarini Group’s elacestrant. This trial targets individuals with CDK4/6i resistant HR+/HER2- metastatic breast cancer. Samuraciclib, an oral inhibitor of CDK7 and the first of its kind, is being paired with elacestrant, an oral selective estrogen receptor degrader (SERD).
• On May 04, 2022, Rhizen Pharmaceuticals AG revealed positive interim findings from an ongoing Phase 2 trial assessing Tenalisib in individuals with locally advanced or metastatic breast cancer during the ESMO Breast Cancer Meeting in Berlin, Germany from May 3-5, 2022. The data showcased that Tenalisib demonstrated favorable tolerability and promising initial effectiveness when used as a standalone treatment in both primary and secondary resistant metastatic breast cancer (mBC). These encouraging results provide substantial support for the continued advancement of Tenalisib as a prospective treatment option for patients diagnosed with HR+ and HER2- MBC.
• In April 2022, Alphamab Oncology made an announcement regarding the presentation of data from the phase II clinical trial featuring the chemo-free treatment regimen involving KN026 alongside KN046 (KN026-203) at the AACR Annual Meeting 2022 (AACR 2022) via an E-poster. Up until August 10, 2021, a total of 24 patients diagnosed with HER2-positive solid tumors other than breast or gastric cancer, who had previously received at least one line of systemic therapy, were enrolled. Among these patients, 20 were eligible for overall response assessment. The results indicated an overall response rate (ORR) of 55.0%, a disease control rate (DCR) of 85.0%, and a 6-month progression-free survival (PFS) rate of 84.1%. Furthermore, among the 11 colorectal cancer (CRC) patients evaluated, the ORR stood at 45.5%, while the DCR was notably higher at 90.9%.
• In April 2022, Quantum Leap Healthcare Collaborative™ (Quantum Leap) and Ambrx Biopharma Inc. disclosed their decision to include Ambrx’s antibody-drug conjugate (ADC) ARX788 as a fresh investigational treatment arm in the I-SPY 2.2 TRIAL intended for managing HER2-positive breast cancer in the neoadjuvant setting. Spearheaded by Quantum Leap, the I-SPY 2.2 TRIAL extends the objectives of the I-SPY 2 TRIAL by customizing treatments for individual patients to enhance clinical outcomes.
• In March 2022, The Georgetown University researchers that submitted the poster abstract, “SM-88, D/L-alpha-metyrosine, is a novel anti-cancer agent in estrogen receptor-positive breast cancer,” have made it available, according to TYME Technologies, Inc. The abstract was given at the 2022 Annual Meeting of the American Association for Cancer Research (AACR) in New Orleans, Louisiana.  The Phase II OASIS trial, which is being conducted by Georgetown University (NCT04720664) at several MedStar Health hospitals, is for patients with metastatic hormone receptor-positive, human epidermal growth factor receptor 2 negative (“HR+/HER2-“) breast cancer who have previously received a CDK4/6 inhibitor regimen. TYME Technologies, Inc. announced in September 2021 that the first patient had been dosed in this trial. Georgetown’s academic clinical partner is MedStar Health.
• In February 2022, In their Phase 1b monotherapy clinical trial, Phoenix Molecular Designs (PhoenixMD) has stated that patient recruitment and PMD-026 dosing are now complete. PhoenixMD has made significant progress toward moving PMD-026 into Phase 2 combo trials for triple-negative breast cancer (TNBC) and hormone-positive breast cancer with the successful completion of patient enrollment in this Phase 1/1b trial. 

Metastatic Breast Cancer Overview

Metastatic breast cancer, also known as stage IV breast cancer, is a form of breast cancer that has spread beyond the breast and nearby lymph nodes to other parts of the body. In metastatic breast cancer, cancer cells break away from the primary tumor in the breast and travel through the bloodstream or lymphatic system to form new tumors (metastases) in distant organs such as the bones, lungs, liver, or brain.

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Emerging Metastatic Breast Cancer Drugs Under Different Phases of Clinical Development Include:

• Disitamab Vedotin: RemeGen
• EndoTAG®-1 (SB05): SynCore Biotechnology
• trastuzumab duocarmazine: Byondis B.V.
• GNC 035: Sichuan Baili Pharmaceutical Co., Ltd
• Stenoparib (2X-121): Allarity Therapeutics
• HS-10342: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• AND019: Kind Pharmaceuticals LLC
• MRG002: Shanghai Miracogen Inc
• DAN-222: Dantari, Inc.
• PMD-026: Phoenix Molecular Designs
• Patritumab Deruxtecan: Daiichi Sankyo Co., Ltd.
• Tenalisib: Rhizen Pharmaceuticals SA
• OP-1250: Olema Oncology
• Eftilagimod alpha: Immutep S.A.S
• SHR-A1811: Jiangsu HengRui Medicine Co., Ltd.
• GB491+ Fulvestrant : Genor Biopharma Co., Ltd

Metastatic Breast Cancer Route of Administration

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 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 

Metastatic Breast Cancer Pipeline Therapeutics Assessment

• Metastatic Breast Cancer Assessment by Product Type
• Metastatic Breast Cancer By Stage and Product Type
• Metastatic Breast Cancer Assessment by Route of Administration
• Metastatic Breast Cancer By Stage and Route of Administration
• Metastatic Breast Cancer Assessment by Molecule Type
• Metastatic Breast Cancer by Stage and Molecule Type

DelveInsight’s Metastatic Breast Cancer Report covers around 100+ products under different phases of clinical development like

• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Metastatic Breast Cancer product details are provided in the report. Download the Metastatic Breast Cancer pipeline report to learn more about the emerging Metastatic Breast Cancer therapies

Some of the key companies in the Metastatic Breast Cancer Therapeutics Market include:

Key companies developing therapies for Metastatic Breast Cancer are – 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, 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, and others.

Metastatic Breast Cancer Pipeline Analysis:

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 key 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.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Metastatic Breast Cancer drugs and therapies

Metastatic Breast Cancer Pipeline Market Drivers

• Increasing prevalence of breast cancer, launch of several diagnostic and screening programs are some of the important factors that are fueling the Metastatic Breast Cancer Market.

Metastatic Breast Cancer Pipeline Market Barriers

• However, high cost associated with the treatment, several side effects associated with the use of breast cancer therapeutics and other factors are creating obstacles in the Metastatic Breast Cancer Market growth.

Scope of Metastatic Breast Cancer Pipeline Drug Insight    

• Coverage: Global
• Key Metastatic Breast Cancer Companies: RemeGen, SynCore Biotechnology, Byondis B.V., Sichuan Baili Pharmaceutical, Allarity Therapeutics, Jiangsu Hansoh Pharmaceutical, Kind Pharmaceuticals LLC, Shanghai Miracogen, Dantari, Inc., Phoenix Molecular Designs, Daiichi Sankyo, Rhizen Pharmaceuticals SA, Olema Oncology, Immutep S.A.S, Jiangsu HengRui Medicine, Genor Biopharma, and others
• Key Metastatic Breast Cancer Therapies: Disitamab Vedotin, EndoTAG®-1 (SB05), trastuzumab duocarmazine, GNC 035, Stenoparib (2X-121), HS-10342, AND019, MRG002, DAN-222, PMD-026, Patritumab Deruxtecan, Tenalisib, OP-1250, Eftilagimod alpha, SHR-A1811, GB491+ Fulvestrant, and others
• Metastatic Breast Cancer Therapeutic Assessment: Metastatic Breast Cancer current marketed and Metastatic Breast Cancer emerging therapies
• Metastatic Breast Cancer Market Dynamics: Metastatic Breast Cancer market drivers and Metastatic Breast Cancer market barriers 

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Table of Contents

1. Metastatic Breast Cancer Report Introduction

2. Metastatic Breast Cancer Executive Summary

3. Metastatic Breast Cancer Overview

4. Metastatic Breast Cancer- Analytical Perspective In-depth Commercial Assessment

5. Metastatic Breast Cancer Pipeline Therapeutics

6. Metastatic Breast Cancer Late Stage Products (Phase II/III)

7. Metastatic Breast Cancer Mid Stage Products (Phase II)

8. Metastatic Breast Cancer Early Stage Products (Phase I)

9. Metastatic Breast Cancer Preclinical Stage Products

10. Metastatic Breast Cancer Therapeutics Assessment

11. Metastatic Breast Cancer Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Metastatic Breast Cancer Key Companies

14. Metastatic Breast Cancer Key Products

15. Metastatic Breast Cancer Unmet Needs

16 . Metastatic Breast Cancer Market Drivers and Barriers

17. Metastatic Breast Cancer Future Perspectives and Conclusion

18. Metastatic Breast Cancer Analyst Views

19. Appendix

20. About DelveInsight

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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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