Global Technology Report

The HER2-Positive 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.

“HER2-Positive Breast Cancer Pipeline Insight, 2023“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the HER2-Positive Breast Cancer Market.

Some of the key takeaways from the HER2-Positive Breast Cancer Pipeline Report:

• Companies across the globe are diligently working toward developing novel HER2-Positive Breast Cancer treatment therapies with a considerable amount of success over the years. 
• HER2-Positive Breast Cancer companies working in the treatment market are AdaptVac, Voronoi, Dizal Pharmaceuticals, Alteogen, Inc, Precirix, BioInvent International, Miracogen Inc., Alphamab BioPharmaceuticals, CSPC ZhongQi Pharmaceutical Technology, Jiangsu HengRui Medicine Co., Ltd, Shanghai Henlius Biotech, Ambrx, Genentech, Innate Pharma, EirGenix, GeneQuantum Healthcare Co., Ltd., and others, are developing therapies for the HER2-Positive Breast Cancer treatment 

• Emerging HER2-Positive Breast Cancer therapies in the different phases of clinical trials are- ES2B C001, VRN 10, DZD1516, ALT-P7, CAM-H2, BI-1607+ trastuzumab, MRG002 Shanghai, KN-026 Jiangsu, DP 303c, SHR-A1811, HLX11, ARX 788, Inavolisib, Monalizumab, Pertuzumab, GQ1001, and others are expected to have a significant impact on the HER2-Positive Breast Cancer market in the coming years. 
• In September 2022, Celltrion has entered into a collaboration to co-develop Abpro’s cancer molecule ABP-102, with a deal potentially valued at $1.75 billion. Abpro, located in Massachusetts, is working on ABP-102 as an antibody targeting T-cell activity in HER2-positive breast cancer patients. Celltrion will assume full responsibility for developing and marketing the pre-clinical molecule. Upon approval of ABP-102, Abpro stands to receive up to $1.75 billion in sales and $10 million in milestone payments.
• In September 2022, Artiva Biotherapeutics, Inc. declared that the U.S. Food and Drug Administration (FDA) has approved the company’s investigational new drug (IND) application for AB-201. AB-201 represents the initial systemically administered CAR-NK cell therapy designed to target prevalent HER2-positive cancer types, such as breast and gastric carcinomas.
• In August 2022, ALX Oncology Holdings Inc. and Quantum Leap Healthcare Collaborative™ have announced the selection of ALX Oncology’s advanced CD47 blocker, evorpacept, for inclusion in a new investigational treatment phase within the I-SPY-P1 TRIAL. This phase 1 (open-label), multi-center study arm, sponsored by Quantum Leap, aims to assess evorpacept in combination with ENHERTU® (fam-trastuzumab deruxtecan-nxki), an antibody-drug conjugate targeting HER2, for patients with unresectable or metastatic HER2-positive and HER2-low breast cancer, focusing on evaluating safety, tolerability, and efficacy of this drug combination.
• In August 2022, The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) has extended the conditional marketing authorization for fam-trastuzumab deruxtecan-nxki (Enhertu) for use as a single agent in adult patients across Great Britain. This includes individuals diagnosed with HER2-positive unresectable or metastatic breast cancer who have undergone one or more prior HER2-based treatments.
• In July 2022, Byondis B.V. revealed that the U.S. Food & Drug Administration (FDA) has approved the company’s submission of a Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985). This application targets patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC). The company has been assigned a Prescription Drug User Fee Act (PDUFA) action date scheduled for May 12, 2023.
• In July 2022, Jiangsu HengRui Medicine Co., Ltd. has commenced a Phase III, multicenter, randomized, open-label, parallel-controlled study titled ‘SHR-A1811 Versus Pyrotinib in Combination With Capecitabine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane’.
• In June 2022, The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advised the approval of fam-trastuzumab deruxtecan-nxki (Enhertu) as a standalone treatment for individuals diagnosed with metastatic HER2-positive breast cancer, having previously undergone at least one anti–HER2-based treatment.
• In February 2022, Alphamab Oncology reported the publication of data in Clinical Cancer Research regarding a phase I clinical trial on their proprietary HER2 bispecific antibody, KN026, designed for treating HER2-positive metastatic breast cancer. Titled ‘First-in-human HER2-targeted Bispecific Antibody KN026 for the Treatment of Patients with HER2-positive Metastatic Breast Cancer,’ this updated information from the China Phase I clinical study indicated that KN026 was well-tolerated, displayed promising early-stage tumor response, and exhibited potential effectiveness among patients with HER2-positive metastatic breast cancer (MBC) who had previously received at least one anti-HER2 therapy.

HER2-Positive Breast Cancer Overview

HER2-positive Breast cancer is the most common cancer in women worldwide and the second most common cancer worldwide. One in five breast cancers had HER2-positive status. Compared to other types of breast cancer, HER2-positive breast cancers are more aggressive.

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Emerging HER2-Positive Breast Cancer Drugs Under Different Phases of Clinical Development Include:

• ES2B C001: AdaptVac
• VRN 10: Voronoi
• DZD1516: Dizal Pharmaceuticals
• ALT-P7: Alteogen, Inc
• CAM-H2: Precirix
• BI-1607+ trastuzumab: BioInvent International
• MRG002 Shanghai: Miracogen Inc.
• KN-026 Jiangsu: Alphamab BioPharmaceuticals
• DP 303c: CSPC ZhongQi Pharmaceutical Technology
• SHR-A1811: Jiangsu HengRui Medicine Co., Ltd
• HLX11: Shanghai Henlius Biotech
• ARX 788: Ambrx
• Inavolisib: Genentech
• Monalizumab: Innate Pharma
• Pertuzumab: EirGenix
• GQ1001: GeneQuantum Healthcare Co., Ltd.

HER2-Positive Breast Cancer Route of Administration

HER2-Positive 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical

HER2-Positive Breast Cancer Molecule Type

HER2-Positive Breast Cancer Products have been categorized under various Molecule types, such as

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

HER2-Positive Breast Cancer Pipeline Therapeutics Assessment

• HER2-Positive Breast Cancer Assessment by Product Type
• HER2-Positive Breast Cancer By Stage and Product Type
• HER2-Positive Breast Cancer Assessment by Route of Administration
• HER2-Positive Breast Cancer By Stage and Route of Administration
• HER2-Positive Breast Cancer Assessment by Molecule Type
• HER2-Positive Breast Cancer by Stage and Molecule Type

DelveInsight’s HER2-Positive Breast Cancer Report covers around 65+ 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 HER2-Positive Breast Cancer product details are provided in the report. Download the HER2-Positive Breast Cancer pipeline report to learn more about the emerging HER2-Positive Breast Cancer therapies

Some of the key companies in the HER2-Positive Breast Cancer Therapeutics Market include:

Key companies developing therapies for HER2-Positive Breast Cancer are – Roche Pharma AG, Dizal Pharmaceuticals, Greenwich LifeSciences, Ambrx, Alteogen, Suzhou Zanrong Pharma Limited, AstraZeneca, Shanghai Henlius Biotech, GeneQuantum Healthcare (Suzhou) Co., Ltd., Klus Pharma Inc.,Shanghai Miracogen Inc., Carisma Therapeutics Inc, Triumvira Immunologics, Inc., Precirix, Seagen Inc., CSPC ZhongQi Pharmaceutical Technology Co., Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Zymeworks Inc., Pieris Pharmaceuticals, Inc., Orum Therapeutics, RemeGen Co., Ltd., and others.

HER2-Positive Breast Cancer Pipeline Analysis:

The HER2-Positive Breast Cancer pipeline report provides insights into 

• The report provides detailed insights about companies that are developing therapies for the treatment of HER2-Positive 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 HER2-Positive Breast Cancer Treatment.
• HER2-Positive Breast Cancer key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• HER2-Positive 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 HER2-Positive 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 HER2-Positive Breast Cancer drugs and therapies

HER2-Positive Breast Cancer Pipeline Market Drivers

• Increase in prevalence of Breast Cancer and its recurrence, robust Pipeline, higher Indulgence of Immunotherapy are some of the important factors that are fueling the HER2-Positive Breast Cancer Market.

HER2-Positive Breast Cancer Pipeline Market Barriers

• However, side effects associated with the treatment, high cost of the treatment and other factors are creating obstacles in the HER2-Positive Breast Cancer Market growth.

Scope of HER2-Positive Breast Cancer Pipeline Drug Insight    

• Coverage: Global
• Key HER2-Positive Breast Cancer Companies: AdaptVac, Voronoi, Dizal Pharmaceuticals, Alteogen, Inc, Precirix, BioInvent International, Miracogen Inc., Alphamab BioPharmaceuticals, CSPC ZhongQi Pharmaceutical Technology, Jiangsu HengRui Medicine Co., Ltd, Shanghai Henlius Biotech, Ambrx, Genentech, Innate Pharma, EirGenix, GeneQuantum Healthcare Co., Ltd., and others
• Key HER2-Positive Breast Cancer Therapies: ES2B C001, VRN 10, DZD1516, ALT-P7, CAM-H2, BI-1607+ trastuzumab, MRG002 Shanghai, KN-026 Jiangsu, DP 303c, SHR-A1811, HLX11, ARX 788, Inavolisib, Monalizumab, Pertuzumab, GQ1001, and others
• HER2-Positive Breast Cancer Therapeutic Assessment: HER2-Positive Breast Cancer current marketed and HER2-Positive Breast Cancer emerging therapies
• HER2-Positive Breast Cancer Market Dynamics: HER2-Positive Breast Cancer market drivers and HER2-Positive Breast Cancer market barriers 

Request for Sample PDF Report for HER2-Positive Breast Cancer Pipeline Assessment and clinical trials

Table of Contents

1. HER2-Positive Breast Cancer Report Introduction

2. HER2-Positive Breast Cancer Executive Summary

3. HER2-Positive Breast Cancer Overview

4. HER2-Positive Breast Cancer- Analytical Perspective In-depth Commercial Assessment

5. HER2-Positive Breast Cancer Pipeline Therapeutics

6. HER2-Positive Breast Cancer Late Stage Products (Phase II/III)

7. HER2-Positive Breast Cancer Mid Stage Products (Phase II)

8. HER2-Positive Breast Cancer Early Stage Products (Phase I)

9. HER2-Positive Breast Cancer Preclinical Stage Products

10. HER2-Positive Breast Cancer Therapeutics Assessment

11. HER2-Positive Breast Cancer Inactive Products

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

13. HER2-Positive Breast Cancer Key Companies

14. HER2-Positive Breast Cancer Key Products

15. HER2-Positive Breast Cancer Unmet Needs

16 . HER2-Positive Breast Cancer Market Drivers and Barriers

17. HER2-Positive Breast Cancer Future Perspectives and Conclusion

18. HER2-Positive 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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