New Therapeutics Options in HER2-Positive Breast Cancer Pipeline as 60+ Key Companies are Working on Drug Profiles | DelveInsight

The prevalence of HER2-Positive Breast Cancer has been rising since the past few years, which prompts the growing demand for the treatment options. The market is driven by the increasing prevalence of breast cancer and its recurrence. The Companies developing the potential therapies in the last stage of development include Genentech, Ambrx ,Innate Pharma and several others.


New York, USA, Oct. 12, 2022 (GLOBE NEWSWIRE) -- New Therapeutics Options in HER2-Positive Breast Cancer Pipeline as 60+ Key Companies are Working on Drug Profiles | DelveInsight

The prevalence of HER2-Positive Breast Cancer has been rising since the past few years, which prompts the growing demand for the treatment options. The market is driven by the increasing prevalence of breast cancer and its recurrence. The Companies developing the potential therapies in the last stage of development include Genentech, Ambrx ,Innate Pharma and several others.

DelveInsight’s 'HER2-Positive Breast Cancer Pipeline Insight 2022' report provides comprehensive global coverage of available, marketed, and pipeline HER2-positive breast cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the HER2-positive breast cancer pipeline domain.

Key Takeaways from the HER2-Positive Breast Cancer Pipeline Report

  • DelveInsight’s HER2-positive breast cancer pipeline report depicts a robust space with 60+ active players working to develop 65+ pipeline therapies for HER2-positive breast cancer treatment. 
  • Key HER2-positive breast cancer companies such as Ambrx, Alteogen, Suzhou Zanrong Pharma Limited, AstraZeneca, Shanghai Henlius Biotech, GeneQuantum Healthcare (Suzhou) Co., Ltd., Klus Pharma Inc., Carisma Therapeutics Inc, Triumvira Immunologics, Inc., Precirix, Seagen Inc., CSPC ZhongQi Pharmaceutical Technology Co., Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Shanghai Miracogen Inc., Roche Pharma AG, Dizal Pharmaceuticals, Greenwich LifeSciences, Zymeworks Inc., Pieris Pharmaceuticals, Inc., Orum Therapeutics, RemeGen Co., Ltd., Mersana Therapeutics, Sichuan Baili Pharmaceutical Co., Ltd., Tianjin Hemay Biotech, Precirix, Zymeworks Inc., Menarini Group, Cadila Healthcare Limited, Merus N.V., Genentech, Shanghai PerHum Therapeutics Co., Ltd., ALX Oncology, Zymeworks Inc., Daiichi Sankyo, Byondis, Alphamab Oncology, Artiva Biotherapeutics, Celltrion, Levena Biopharma, and others are evaluating a new drug for HER2-positive breast cancer to improve the treatment landscape.
  • Promising HER2-positive breast cancer pipeline therapies in various stages of development include ALT P7, ARX 788, Inavolisib, ZN-A-1041, Monalizumab, HLX11, GQ1001, A166, CT-0508, SHR-A1811, TAC01-HER2, CAM-H2, ladiratuzumab vedotin, DP303c, KN026, MRG002, Monalizumab, PTC-Pz,  DZD1516, ZW25, PRS-343, ORM-5029, RC48-ADC, XMT-2056,  BL-M07D1, Hemay 022, CAM-H2, Zanidatamab,  MEN1611, ZRC-3277,  MCLA-128, Ipatasertib,  CCT303 406, Evorpacept, SYD985, AB-201, ABP-102, and others.
  • In September 2022, Celltrion agreed to jointly develop Abpro’s cancer molecule ABP-102 in a deal that could be worth as much as $1.75 billion.Massachusetts-based Abpro is developing ABP-102 as an antibody aimed at T-cell activity for patients with HER2-positive breast cancer. Celltrion will take over complete control, development, and marketing of the pre-clinical molecule. If ABP-102 is approved, Abpro will receive as much as $1.75 billion in sales and $10 million in milestone payments.
  • In September 2022, Artiva Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) had cleared the company’s investigational new drug (IND) application for AB-201.AB-201 is the first systemically administered CAR-NK cell therapy candidate targeting the most prevalent HER2-positive cancer indications, including breast and gastric carcinomas.
  • In August 2022, ALX Oncology Holdings Inc. and Quantum Leap Healthcare Collaborative™ (“Quantum Leap”) announced that ALX Oncology’s next generation CD47 blocker, evorpacept, has been selected for a new investigational treatment arm in the I-SPY-P1 TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer. Sponsored by Quantum Leap, this Phase 1 (open-label), multi-center study arm will investigate evorpacept in combination with ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody-drug conjugate (“ADC”), to determine the safety, tolerability and efficacy of this drug combination.
  • In August 2022, the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) extended the conditional marketing authorization of fam-trastuzumab deruxtecan-nxki (Enhertu) for single-agent use in adult patients in Great Britain who have HER2-positive unresectable or metastatic breast cancer and have received 1 or more prior HER2-based regimens.
  • In July 2022, Byondis B.V., announced that the U.S. Food & Drug Administration (FDA) accepted the company’s submission of a Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC). The company has been given a Prescription Drug User Fee Act (PDUFA) action date of May 12, 2023.
  • In June 2022, The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of fam-trastuzumab deruxtecan-nxki (Enhertu) monotherapy for patients with metastatic HER2-positive breast cancer who have received at least 1 prior anti–HER2-based regimen.
  • In February 2022, Alphamab Oncology announced Clinical Cancer Research, published the data from a phase I clinical study of the company's proprietary HER2 bispecific antibody KN026 for the treatment of HER2-positive metastatic breast cancer (“First-in-human HER2-targeted Bispecific Antibody KN026 for the Treatment of Patients with HER2-positive Metastatic Breast Cancer.The updated data of this China Phase I clinical study from this publication demonstrated that KN026 was well tolerated, showed encouraging preliminary antitumor activity and achieved promising efficacy in patients with HER2-positive metastatic breast cancer (MBC) who had progressed on at least 1 prior line of anti-HER2 therapies.
  • In November 2021, Zymeworks Inc. announced the publication of an abstract highlighting new clinical data for zanidatamab, a HER2-targeted bispecific antibody. Zanidatamab in combination with chemotherapy, was well tolerated, with encouraging and durable antitumor activity in heavily pretreated patients with HER2-positive breast cancer.

Request a sample and discover the recent advances in HER2-positive breast cancer treatment drugs @HER2-Positive Breast Cancer Pipeline Report

The HER2-positive breast cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage HER2-positive breast cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the HER2-positive breast cancer clinical trial landscape.

HER2-Positive Breast Cancer Overview

HER2-positive breast cancer occurs when breast cancer cells express the HER2 protein receptor (human epidermal growth factor receptor 2). Normally, this protein aids in growth, division, and repair. However, when something goes wrong in the gene that controls the HER2 protein, the body produces an excess of these receptors. This causes uncontrollable growth and division of breast cells. While HER2-positive breast cancer is more aggressive than other types of breast cancer, some treatments can help. The most common symptom of breast cancer is a lump in the breast that feels different from the surrounding area.

Other HER2-positive breast cancer symptoms include breast swelling, shape change, skin irritation or dimpling, pain in the breast or nipple, redness or thickness of the nipple or breast skin, and nipple discharge.


Find out more about HER2-positive breast cancer treatment drugs @Drugs for HER2-Positive Breast Cancer Treatment

A snapshot of the HER2-Positive Breast Cancer Pipeline Drugs mentioned in the report:

DrugsCompanyPhase MoARoA
ARX 788AmbrxPhase II/IIITubulin inhibitorsIntravenous
InavolisibGenentechPhase II/III1 Phosphatidylinositol 3 kinase inhibitorsOral
MonalizumabInnate PharmaPhase IIAntibody-dependent cell cytotoxicity; NK cell lectin-like receptor subfamily C antagonistsNA
ALT P7AlteogenPhase IApoptosis stimulants; Mitosis inhibitors; Tubulin inhibitors; Tubulin polymerization inhibitorsIntravenous
PertuzumabEirGenixPhase IAntibody-dependent cell cytotoxicity; Dimerisation inhibitorsIntravenous
GQ1001GeneQuantum Healthcare (Suzhou) Co., Ltd.Phase IApoptosis stimulants; Mitosis inhibitors; Tubulin inhibitors; Tubulin polymerization inhibitorsIntravenous

Learn more about the emerging new drug for HER2-positive breast cancer @HER2-Positive Breast Cancer Clinical Trials

HER2-Positive Breast Cancer Therapeutics Assessment

The HER2-positive breast cancer pipeline report proffers an integral view of the HER2-positive breast cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.

Scope of the HER2-Positive Breast Cancer Pipeline Report 

  • Coverage: Global 
  • Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
  • Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
  • Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal
  • Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule
  • Therapeutics Assessment By Mechanism of Action: Apoptosis stimulants, Mitosis inhibitors, Tubulin inhibitors, Tubulin polymerization inhibitors, 1 Phosphatidylinositol 3 kinase inhibitors, Antibody-dependent cell cytotoxicity, NK cell lectin-like receptor subfamily C antagonists, Dimerisation inhibitors.
  • Key HER2-Positive Breast Cancer Companies: Ambrx, Alteogen, Suzhou Zanrong Pharma Limited, AstraZeneca, Shanghai Henlius Biotech, GeneQuantum Healthcare (Suzhou) Co., Ltd., Klus Pharma Inc., Carisma Therapeutics Inc, Triumvira Immunologics, Inc., Precirix, Seagen Inc., CSPC ZhongQi Pharmaceutical Technology Co., Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Shanghai Miracogen Inc., Roche Pharma AG, Dizal Pharmaceuticals, Greenwich LifeSciences, Zymeworks Inc., Pieris Pharmaceuticals, Inc., Orum Therapeutics, RemeGen Co., Ltd., Mersana Therapeutics, Sichuan Baili Pharmaceutical Co., Ltd., Tianjin Hemay Biotech, Precirix, Zymeworks Inc., Menarini Group, Cadila Healthcare Limited, Merus N.V., Genentech, Shanghai PerHum Therapeutics Co., Ltd., ALX Oncology, Zymeworks Inc., Daiichi Sankyo, Byondis, Alphamab Oncology,  Artiva Biotherapeutics, Celltrion, Levena Biopharma, and others.
  • Key HER2-Positive Breast Cancer Pipeline Therapies: ALT P7, ARX 788, Inavolisib, ZN-A-1041, Monalizumab, HLX11, GQ1001, A166, CT-0508, SHR-A1811, TAC01-HER2, CAM-H2, ladiratuzumab vedotin, DP303c, KN026, MRG002,Monalizumab,PTC-Pz,  DZD1516, ZW25,PRS-343, ORM-5029,RC48-ADC, XMT-2056,  BL-M07D1, Hemay 022, CAM-H2, Zanidatamab,  MEN1611, ZRC-3277,  MCLA-128, Ipatasertib,  CCT303 406, Evorpacept, SYD985, AB-201, ABP-102, and others.

Dive deep into rich insights for new drugs for HER2-positive breast cancer treatment, visit @Chemotherapy Drugs for HER2-Positive Breast Cancer Treatment

Table of Contents

1.HER2-Positive Breast Cancer Pipeline Report Introduction
2.HER2-Positive Breast Cancer Pipeline Report Executive Summary
3.HER2-Positive Breast Cancer Pipeline: Overview
4.Analytical Perspective In-depth Commercial Assessment
5.HER2-Positive Breast Cancer Clinical Trial Therapeutics
6.HER2-Positive Breast Cancer Pipeline: Late Stage Products (Pre-registration)
7.HER2-Positive Breast Cancer Pipeline: Late Stage Products (Phase III)
8.HER2-Positive Breast Cancer Pipeline: Mid Stage Products (Phase II/III)
8.1ARX 788: Ambrx
9.HER2-Positive Breast Cancer Pipeline: Mid Stage Products (Phase II)
10.HER2-Positive Breast Cancer Pipeline: Early Stage Products (Phase I)
10.1.Pertuzumab: EirGenix
11.HER2-Positive Breast Cancer Pipeline Therapeutics Assessment
12.Inactive Products in the HER2-Positive Breast Cancer Pipeline
13.Company-University Collaborations (Licensing/Partnering) Analysis
14.Key Companies
15.Key Products in the HER2-Positive Breast Cancer Pipeline
16.Unmet Needs
17.Market Drivers and Barriers
18.Future Perspectives and Conclusion
19.Analyst Views
20.Appendix

For further information on the HER2-positive breast cancer pipeline therapeutics, reach out @Best Treatment for HER2-Positive Breast Cancer 

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