EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC)- Pipeline Insight, 2025

This “EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC)- Pipeline Insight, 2025” report provides comprehensive insights about 25+ companies and 30+ pipeline drugs in EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) 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.

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC): Understanding

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC): Overview

EGFR-positive non-small cell lung cancer (EGFR+ NSCLC) is a subtype of lung cancer characterized by mutations in the epidermal growth factor receptor (EGFR) gene. This receptor plays a critical role in cell growth and division. Mutations in EGFR lead to uncontrolled cell proliferation, contributing to cancer development. EGFR mutations are present in approximately 10-15% of NSCLC cases in Western populations and around 30-50% in Asian populations. This subtype of lung cancer is most commonly found in non-smokers, women, and patients with adenocarcinoma, a form of NSCLC.

Signs and symptoms of EGFR+ NSCLC are often subtle in the early stages, making early detection challenging. Symptoms may include persistent cough, chest pain, shortness of breath, wheezing, and unexplained weight loss. Some patients may experience coughing up blood (hemoptysis) or recurrent lung infections. As the disease progresses, the cancer may spread (metastasize) to other organs, leading to bone pain, headaches, or neurological issues.

Causes and risk factors for EGFR+ NSCLC are not fully understood, but certain factors increase the likelihood of developing this condition. A significant risk factor is genetic predisposition, as EGFR mutations can occur sporadically or be inherited. Environmental factors, such as exposure to secondhand smoke, air pollution, and radon, may also contribute. However, many patients with EGFR mutations have little or no smoking history, suggesting non-tobacco-related pathways in cancer development.

Diagnosis of EGFR+ NSCLC involves imaging tests such as chest X-rays, CT scans, and PET scans to identify suspicious lung nodules. A biopsy of lung tissue is essential for confirming NSCLC and conducting molecular testing to detect EGFR mutations. Liquid biopsy, analyzing circulating tumor DNA (ctDNA) from blood samples, is also emerging as a non-invasive diagnostic method. Accurate identification of EGFR mutations is crucial for tailoring targeted therapies.

Treatment for EGFR+ NSCLC typically involves targeted therapies known as EGFR tyrosine kinase inhibitors (TKIs), which block the activity of the mutated receptor and inhibit cancer growth. First-generation TKIs like erlotinib and gefitinib, second-generation drugs like afatinib, and third-generation options such as osimertinib are commonly used. Osimertinib is often preferred due to its effectiveness against resistance mutations (T790M) and its ability to penetrate the central nervous system, addressing brain metastases. In cases where TKIs are no longer effective, chemotherapy, immunotherapy, or combination treatments may be considered. Ongoing research is exploring new therapies to improve outcomes for patients with EGFR+ NSCLC.

'EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC)- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) pipeline landscape is provided which includes the disease overview and EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) treatment guidelines. The assessment part of the report embraces, in depth EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) 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, EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) 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 EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) R&D. The therapies under development are focused on novel approaches to treat/improve EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC).

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Emerging Drugs Chapters

This segment of the EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) 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.

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Emerging Drugs

CLN-081: Cullinan Oncology

CLN-081 is a novel irreversible Epidermal Growth Factor Receptor (EFGR) inhibitor. It is administered through oral route, and is developed by Cullinan Oncology. The drug is being developed in association with Taiho Pharmaceuticals. The drug is currently being investigated in the Phase III stage of development for the treatment of EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC).

BPI-361175: Betta Pharmaceuticals

BPI-361175 is a novel, oral, highly potent and selective 4th generation EGFR inhibitor developed by Betta Pharmaceutical Co., Ltd. The new chemical entity targets EGFR C797S mutation and other EGFR related mutations that are resistant to 3rd generation EGFR TKI in non-small cell lung cancer (NSCLC) and other solid tumors. It shows excellent inhibitory effect and selectivity in vitro assay and exhibits significant anti-tumor activity in a variety of xenograft models harboring EGFR C797S or other related mutations. The IND application of BPI-361175 has been approved by NMPA. Currently, the drug is the Phase I/II stage of its development for the treatment of Non-small Cell Lung Cancer.

G1T38: G1 Therapeutics

G1T38 is an investigational, oral CDK4/6 inhibitor designed to be used along with other targeted therapies for various oncology indications. G1 Therapeutics has entered a clinical trial collaboration to assess its G1T38 in combination with AstraZeneca’s Tagrisso (osimertinib) in a Phase Ib/II clinical trial to treat patients suffering from EGFR mutation-positive non-small cell lung cancer (NSCLC). Currently, the drug is being evaluated in the Phase I/II stage in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer.

JANX008: Janux Therapeutics

JANX008, is a TRACTr that targets Epidermal Growth Factor Receptor (EGFR), and is being developed by Janux Therapeutics for the treatment of various solid tumors including non-small cell lung cancer. According to preclinical studies, JANX008 showed potent cleavage dependent anti-tumor activity, with limited toxicities in healthy tissues or CRS. JANX008, is currently being evaluated in phase I clinical trial for the treatment of various solid tumors.

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC): Therapeutic Assessment

This segment of the report provides insights about the different EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC)

There are approx. 25+ key companies which are developing the therapies for EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC). The companies which have their EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) drug candidates in the most advanced stage, i.e. Phase III include, Cullinan Oncology.

Phases

The report covers around 30+ 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

EGFR Non-Small Cell Lung Cancer (EGFR + 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

• 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.

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) 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 EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) drugs.

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Report Insights

• EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) 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 EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) drugs?
• How many EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) 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 EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Cullinan Oncology
• Betta Pharmaceuticals
• G1 Therapeutics
• Janux Therapeutics
• Daiichi Sankyo Company
• Suzhou Puhe Pharmaceutical Technology
• Genor Biopharma
• J Ints Bio
• Avistone Pharmaceuticals
• Mythic Therapeutics

Key Products

• CLN-081
• BPI-361175
• G1T38
• JANX008
• Patritumab Deruxtecan
• YK 209A
• GB 263 T
• JIN-A02
• PLB1004
• MYTX-011

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