HER2-Mutant NSCLC Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, And Companies

DelveInsight's “HER2-mutant NSCLC Pipeline Insights 2025” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in the HER2-mutant NSCLC pipeline landscape. It covers the HER2-mutant NSCLC pipeline drug profiles, including clinical and nonclinical stage products. It also covers the HER2-mutant NSCLC therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Download DelveInsight's comprehensive HER2-mutant NSCLC Pipeline Report to explore emerging therapies, key Companies, and future treatment landscapes @ HER2-mutant NSCLC Pipeline Outlook Report

Key Takeaways from the HER2-mutant NSCLC Pipeline Report

• On 28 August 2025, AstraZeneca conducted a Phase 2 Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for Patients With HER2-mutant Metastatic NSCLC Who Have Disease Progression on or After at Least One-line of Treatment.
• DelveInsight's HER2-mutant NSCLC pipeline report depicts a robust space with 5+ active players working to develop 5+ pipeline therapies for HER2-mutant NSCLC treatment.
• The leading HER2-mutant NSCLC Companies such as Dizal Pharmaceuticals, Puma Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, Spectrum Pharmaceuticals Inc . and others.
• Promising HER2-mutant NSCLC Therapies such as Trastuzumab Deruxteca, Neratinib, Temsirolimus, Poziotinib, Rezatapopt, Pembrolizumab and others.

Access DelveInsight's in-depth HER2-mutant NSCLC Pipeline Analysis for a closer look at promising breakthroughs @ HER2-mutant NSCLC Clinical Trials and Studies

HER2-mutant NSCLC Emerging Drugs Profile

• DZD-9008: Dizal Pharmaceuticals

DZD9008 is a selective, irreversible EGFR inhibitor, which is currently being evaluated for the treatment of both EGFRexon20 insertion mutation-positive NSCLC and HER2-mutated NSCLC. In the open-label, multicenter phase I/II study (NCT03974022), 220 patients with EGFRexon20 insertion mutation-positive or HER2-positive NSCLC were treated with DZD9008 at doses of 50 mg to 400 mg once daily.

• Enhertu: AstraZeneca

Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca's ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker. Enhertu (5.4mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial. Enhertu (6.4mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastro esophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

• Pyrotinib: Jiangsu Hengrui Medicine

Pyrotinib is a novel irreversible and selective EGFR/HER2 tyrosine kinase inhibitor developed by Hengrui. In 2018, pyrotinib was approved in China in combination with capecitabine for the treatment of relapsed or metastatic HER2-positive breast cancer. Currently, two Phase III studies are ongoing to evaluate pyrotinib as 1st-line treatment (NCT03863223) and extended adjuvant treatment (NCT03980054), respectively in HER2-positive breast cancer patients. In addition to breast cancer, pyrotinib demonstrated superior clinical benefits in advanced non-small cell lung cancer (NSCLC) with HER2 exon 20 mutation in a Phase II study. A global Phase III study (NCT04447118) is ongoing to investigate pyrotinib in patients with advanced non-squamous NSCLC with HER2 exon 20 mutation who previously failed platinum-based chemotherapy.

The HER2-mutant NSCLC Pipeline report provides insights into

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

Get a detailed analysis of the latest innovations in the HER2-mutant NSCLC pipeline. Explore DelveInsight's expert-driven report today! @ HER2-mutant NSCLC Unmet Needs

HER2-mutant NSCLC Companies

Dizal Pharmaceuticals, Puma Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, Spectrum Pharmaceuticals Inc . and others.

HER2-mutant NSCLC pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

HER2-mutant NSCLC Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Download DelveInsight's latest report to gain strategic insights into upcoming HER2-mutant NSCLC Therapies and key Developments @ HER2-mutant NSCLC Market Drivers and Barriers, and Future Perspectives

Scope of the HER2-mutant NSCLC Pipeline Report

• Coverage- Global
• HER2-mutant NSCLC Companies- Dizal Pharmaceuticals, Puma Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, Spectrum Pharmaceuticals Inc . and others.
• HER2-mutant NSCLC Therapies- Trastuzumab Deruxteca, Neratinib, Temsirolimus, Poziotinib, Rezatapopt, Pembrolizumab, and others.
• HER2-mutant NSCLC Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• HER2-mutant NSCLC Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Find out in DelveInsight's exclusive HER2-mutant NSCLC Pipeline Report-access it now! @ HER2-mutant NSCLC Emerging Drugs and Major Companies

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