HER2 Positive Breast Cancer- Pipeline Insight, 2025

This “HER2 Positive Breast Cancer- Pipeline Insight, 2025” report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in HER2 Positive Breast Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical 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.

HER2 Positive Breast Cancer: Understanding

HER2 Positive Breast Cancer: Overview

HER2-positive breast cancer is a subtype of breast cancer characterized by the overexpression or amplification of the HER2 (human epidermal growth factor receptor 2) gene. It accounts for approximately 15-20% of all breast cancer cases and tends to be more aggressive than HER2-negative forms. Advances in targeted therapies have significantly improved outcomes for patients with HER2-positive breast cancer, making it one of the most treatable subtypes when detected early.

HER2 is a transmembrane receptor tyrosine kinase involved in cell growth and differentiation. Under normal conditions, HER2 plays a role in regulating cell proliferation. In HER2-positive breast cancer, the overexpression of HER2 leads to constant activation of downstream signaling pathways, such as PI3K/AKT and MAPK, driving uncontrolled tumor cell growth and survival. This makes HER2 a key target for therapy, as inhibiting its function can significantly impede cancer progression.

The symptoms of HER2-positive breast cancer are similar to other breast cancer types, including the presence of a lump in the breast, changes in breast shape or size, nipple discharge, and skin dimpling or redness. Risk factors include genetic predisposition, family history of breast cancer, hormonal factors, and certain lifestyle choices. HER2 positivity itself is not inherited but arises from somatic mutations within breast tissue.

Resistance to HER2-targeted therapies, such as trastuzumab (Herceptin), can develop over time. Mechanisms include mutations in the HER2 receptor preventing drug binding, activation of alternative signaling pathways (e.g., MET, IGF-1R), or loss of dependence on HER2 signaling. Tumor heterogeneity and immune evasion also contribute to resistance, posing challenges to long-term treatment efficacy.

HER2-positive breast cancer is diagnosed through immunohistochemistry (IHC) to measure HER2 protein levels or fluorescence in situ hybridization (FISH) to detect HER2 gene amplification. Treatment typically involves a combination of HER2-targeted therapies (e.g., trastuzumab, pertuzumab, or T-DXd), chemotherapy, and sometimes hormonal therapy, depending on hormone receptor status. In early-stage cases, neoadjuvant therapy is used to shrink tumors before surgery, while advanced cases are managed with systemic therapies to prolong survival. Emerging approaches, such as antibody-drug conjugates and HER2-targeted vaccines, are expanding the arsenal against this aggressive subtype.

'HER2 Positive Breast Cancer- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the HER2 Positive Breast Cancer pipeline landscape is provided which includes the disease overview and HER2 Positive Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth HER2 Positive Breast Cancer commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, HER2 Positive Breast Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence HER2 Positive Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve HER2 Positive Breast Cancer.

HER2 Positive Breast Cancer Emerging Drugs Chapters

This segment of the HER2 Positive Breast Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

HER2 Positive Breast Cancer Emerging Drugs

HD201: Prestige BioPharma

Prestige Biopharma’s HD201 is a biosimilar to Roche’s Herceptin (trastuzumab) to be prescribed for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer. Trastuzumab targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells. Currently the drug is in Preregistration stage for its development in HER2 Positive Breast Cancer.

SHR-A1811: Jiangsu HengRui Medicine Co., Ltd.

SHR-A1811 is an innovative HER2-targeted antibody-drug conjugate with a topoisomerase I payload conjugated to an anti-HER-2 mAb by a cleavable linker. Once bound to HER2 expressing tumor cells, the ADC is internalized and the linker releases the toxin, leading to tumor cell death. It can bind to the cell membrane surface of HER2 expressing cells, and then enter the cells to reach the lysosome to release small Molecular toxins eventually induce tumor cell apoptosis, combining the high targeting of antibodies and the powerful killing power of cytotoxic drugs on target cells.

Preclinical research results show that SHR-A1811 has good anti-tumor activity, safety, tolerability and pharmacokinetic characteristics, or can further improve drug resistance, enhance efficacy, meet clinical needs, and provide more cancer patients multiple choice. Currently, the drug is in the Phase III stage of its development for the treatment of HER2 Positive Breast Cancer.

Zanidatamab: Zymeworks Inc.

Zanidatamab is a bispecific antibody, based on Zymeworks' Azymetric™ platform that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase I, Phase II and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2.

Zymeworks has entered into separate agreements with each of BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz), granting each of BeiGene and Jazz with exclusive rights to develop and commercialize zanidatamab throughout various counties around world. Currently the drug is in Phase II stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.

CCT303-406: Shanghai EXUMA Biotechnology

CCT303-406 is EXUMA Biotech's tumor microenvironment restricted (TMR) autologous CAR-T product candidates targeting HER2, which is currently in the Phase I clinical trial in patients with metastatic HER2+ solid tumors. HER2 overexpression is a hallmark of several tumors, including those originating from breast, stomach, bladder, and colon. A significant proportion of patients relapse or become unresponsive to antibody-based products targeting HER2 in early lines of treatment, yet still retain overexpression of HER2. CCT303-406 may be a promising option for this patient population providing T cell-mediated antitumor activity via targeting of HER2. Differentiating itself from other HER2 CAR-T therapies, CCT303-406 incorporates EXUMA's TMR safety technology, which helps restrict CAR-T activity to the tumor microenvironment potentially reducing the risk of on-target, off-tumor cytotoxicity. Currently the drug is in Phase I/II stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.

HER2 Positive Breast Cancer: Therapeutic Assessment

This segment of the report provides insights about the different HER2 Positive Breast Cancer drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in HER2 Positive Breast Cancer

There are approx. 50+ key companies which are developing the therapies for HER2 Positive Breast Cancer. The companies which have their HER2 Positive Breast Cancer drug candidates in the most advanced stage, i.e. Preregistration include, Prestige BioPharma.

Phases

The report covers around 55+ products under different phases of clinical development like

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

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

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

HER2 Positive Breast Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses HER2 Positive Breast Cancer therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging HER2 Positive Breast Cancer drugs.

HER2 Positive Breast Cancer Report Insights

• HER2 Positive Breast Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

HER2 Positive Breast Cancer Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing HER2 Positive Breast Cancer drugs?
• How many HER2 Positive Breast Cancer drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of HER2 Positive Breast Cancer?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HER2 Positive Breast Cancer therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for HER2 Positive Breast Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Prestige BioPharma
• Jiangsu HengRui Medicine Co., Ltd.

Zymeworks Inc.

Shanghai EXUMA Biotechnology

• ORIC Pharmaceuticals
• Formosa Pharmaceuticals
• EirGenix
• ExpreS2ion Biotechnologies
• Theratechnologies
• Byondis
• Tanvex Biopharma
• Roche
• Alphamab
• Biocad
• Shanghai Henlius Biotech
• Novartis Pharmaceuticals
• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Zydus Cadila

Key Products

• HD201
• SHR-A1811
• Zanidatamab
• CCT303-406
• ORIC-114
• TSY-0110
• EG-13074
• ES2B C001
• TH-1902
• SYD-985
• TX-05
• Inavolisib
• Anbenitamab
• BCD-178
• HLX11
• Alpelisib
• FS-1502
• Pertuzumab biosimilar

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