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Report Overview
HER2-positive gastric cancer is a molecular subtype of gastric and gastroesophageal junction cancer characterized by overexpression or amplification of the HER2 (ERBB2) receptor, which drives tumor growth and progression. As reported by Shimozaki et al., 2024, recent clinical evidence indicates that roughly one-sixth of advanced gastric and gastroesophageal junction cancer cases show HER2 alterations. Current therapies include HER2-targeted monoclonal antibodies, antibody–drug conjugates, and combination regimens with chemotherapy and immunotherapy. According to the HER2-positive gastric cancer pipeline analysis by Expert Market Research, increasing biomarker testing, novel targeted agents, and rising global gastric cancer burden are expected to drive pipeline expansion and sustained growth in the coming years.
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Major companies involved in the HER2 positive gastric cancer pipeline analysis include JMT-Bio Inc., Enliven Therapeutics, and others.
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Leading drugs currently in the pipeline include KN026, JSKN003, ELVN-002 plus Trastuzumab, and others.
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The pipeline expansion is driven by next-generation HER2-targeted antibodies, antibody–drug conjugates, and combination regimens with immunotherapy, supported by biomarker stratification and rising clinical trial activity across advanced gastric cancer stages.
Report Coverage
The HER2 Positive Gastric Cancer Pipeline Analysis Report by Expert Market Research gives comprehensive insights into HER2 positive gastric cancer therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for HER2 positive gastric cancer. The HER2 positive gastric cancer report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The HER2 positive gastric cancer pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with HER2 positive gastric cancer treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to HER2 positive gastric cancer.
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HER2 Positive Gastric Cancer Pipeline Outlook
HER2-positive gastric cancer is a type of stomach or gastroesophageal junction adenocarcinoma characterized by overexpression of the human epidermal growth factor receptor 2 (HER2). This genetic alteration drives uncontrolled cell growth, tumor progression, and aggressive disease behavior, often resulting in poor prognosis.
Treatment options for HER2-positive gastric cancer include targeted therapy with trastuzumab, immune checkpoint inhibitors such as pembrolizumab, and combination chemotherapy with fluoropyrimidine- and platinum-based regimens to enhance survival outcomes. In March 2025, pembrolizumab (Keytruda), in combination with trastuzumab and fluoropyrimidine- and platinum-based chemotherapy, received FDA approval for first-line treatment of locally advanced, unresectable, or metastatic disease expressing PD-L1 (CPS ≥1), demonstrating significant improvements in overall survival and progression-free survival.
HER2 Positive Gastric Cancer Epidemiology
The pipeline is advancing with several targeted and immuno-oncology therapies under development. According to K. Shimozaki et al., 2024, around 15 to 20% of patients with advanced gastric and gastroesophageal junctional cancers exhibit overexpression or amplification of human epidermal growth factor receptor 2, a key biomarker driving tumor progression. According to Nuopei Ta et al., 2024, gastric cancer ranks fifth in global prevalence, with over 960,000 new cases and nearly 660,000 deaths annually. East Asia bears the highest burden, accounting for 53.8% of cases and 48.2% of deaths, with Mongolia, Japan, and the Republic of Korea reporting the highest incidence rates. Males are disproportionately affected, with male-to-female incidence ratios up to 2.38 in East Asia, and incidence increases sharply in individuals aged 50 years and older. These prevalence trends highlight the urgent need for effective HER2-targeted therapies and precision treatment strategies worldwide.
HER2 Positive Gastric Cancer – Pipeline Therapeutic Assessment
This section of the report covers the analysis of HER2 positive gastric cancer drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
By Drug Class
The HER2 positive gastric cancer pipeline analysis report covers 50+ drug analyses based on drug classes:
- Small Molecules
- Monoclonal Antibodies
- Gene Therapies
- Peptides
- Polymers
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration:
- Oral
- Parenteral
- Others
HER2 Positive Gastric Cancer Pipeline Assessment Segmentation, By Phases
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II, with 51%, covers a major share of the total HER2 positive gastric cancer clinical trials. It is followed by phase I at 29%, and other phases. This strong emphasis assets reflects robust clinical exploration, potentially accelerating new treatment options and enhancing competitive dynamics in the HER2 positive gastric cancer market.
HER2 Positive Gastric Cancer Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the HER2 positive gastric cancer pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and polymers. The HER2 positive gastric cancer report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for HER2 positive gastric cancer. Targeted therapies in the HER2-positive gastric cancer pipeline are rapidly evolving to improve patient outcomes. For instance, Henlius’ HLX22, a novel anti-HER2 monoclonal antibody, is under investigation in combination with trastuzumab and chemotherapy as a first-line treatment. HLX22 binds a unique HER2 epitope, enhancing receptor internalization and anti-tumor activity, with ongoing phase 2 and phase 3 studies demonstrating promising efficacy and manageable safety profiles.
HER2 Positive Gastric Cancer Clinical Trials – Key Players
The EMR report for the HER2 positive gastric cancer pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed HER2 positive gastric cancer therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in HER2 positive gastric cancer clinical trials:
- JMT-Bio Inc.
- Pieris Pharmaceuticals, Inc.
- Henlius Biotech
- Mersana Therapeutics
- AstraZeneca
- Jiangsu HengRui Medicine Co., Ltd.
- Carisma Therapeutics Inc.
- Convalife (Shanghai) Co., Ltd.
- Vironexis Biotherapeutics Inc.
- BioInvent International
- DualityBio Inc.
- Novartis Pharmaceuticals
HER2 Positive Gastric Cancer – Emerging Drugs Profile
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for HER2 positive gastric cancer. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of HER2 positive gastric cancer drug candidates.
Drug: KN026
KN026 is an innovative anti-HER2 bispecific antibody developed by Shanghai JMT-Bio Inc., utilizing Alphamab Oncology’s proprietary CRIB (Charge Repulsion Induced Bispecific) platform. Designed to simultaneously bind two non-overlapping HER2 epitopes, KN026 effectively blocks HER2 signaling, showing superior tumor inhibition compared with trastuzumab and pertuzumab. This Phase II/III study is examining KN026 combined with chemotherapy, with or without enlonstobart, versus trastuzumab-based chemotherapy, with or without pembrolizumab, as first-line treatment for HER2-positive unresectable locally advanced or metastatic gastric cancer. KN026 is administered intravenously and is demonstrating potential even in trastuzumab-resistant tumors.
Drug: JSKN003
JSKN003, developed by Shanghai JMT-Bio Inc., is an innovative bispecific antibody-drug conjugate (ADC) targeting HER2-positive gastric cancer. This Phase II study is designed to evaluate the safety and efficacy of JSKN003 combination therapy as a first-line treatment in unresectable locally advanced, metastatic, or resectable gastric cancer. JSKN003 binds two HER2 epitopes on tumor cells, delivering topoisomerase I inhibitors via endocytosis, resulting in potent anti-tumor effects with improved serum stability and reduced hematological toxicity. Administered intravenously, it is being studied alongside agents like trastuzumab, capecitabine, oxaliplatin, and pembrolizumab in a cohort of 153 patients, with outcomes examining tumor response, safety, and tolerability.
Drug: ELVN-002 + Trastuzumab
ELVN-002 + trastuzumab is an investigational combination therapy, sponsored by Enliven Therapeutics, Inc., being evaluated in a Phase I clinical study (NCT06328738) to assess safety, tolerability, pharmacokinetics, and recommended dose of ELVN-002 when administered with trastuzumab in patients with advanced HER2-positive solid tumors, including gastric cancer. ELVN-002 is an oral, irreversible HER2 tyrosine kinase inhibitor (TKI) designed to selectively inhibit HER2 signaling while minimizing EGFR-related toxicity. Trastuzumab is a HER2-targeted monoclonal antibody that binds the extracellular domain of HER2, blocking receptor activation and promoting immune-mediated tumor cell killing. The combination provides dual HER2 blockade, targeting both intracellular and extracellular HER2 signaling pathways to overcome resistance and enhance antitumor activity.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
Key Questions Answered in the HER2 Positive Gastric Cancer Pipeline Insight Report
- Which companies/institutions are leading the HER2 positive gastric cancer drug development?
- Which company is leading the HER2 positive gastric cancer pipeline development activities?
- What is the current HER2 positive gastric cancer commercial assessment?
- What are the opportunities and challenges present in the HER2 positive gastric cancer pipeline landscape?
- What is the efficacy and safety profile of HER2 positive gastric cancer pipeline drugs?
- Which company is conducting major trials for HER2 positive gastric cancer drugs?
- Which companies/institutions are involved in HER2 positive gastric cancer collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in HER2 positive gastric cancer?
Reasons To Buy This Report
The HER2 Positive Gastric Cancer Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for HER2 positive gastric cancer. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into HER2 positive gastric cancer collaborations, regulatory environments, and potential growth opportunities.
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Report Summary
Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.
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